Journal articles: 'Cambridge, Eng. Cambridge Research Hospital'

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Rifkin, Robert M., Faith E. Davies, Antonio Palumbo, et al. "Global, Prospective, Non-Interventional, Observational Study of Presentation, Treatment Patterns, and Outcomes in Multiple Myeloma Patients: The Insight-MM Study." Blood 128, no. 22 (2016): 5681. http://dx.doi.org/10.1182/blood.v128.22.5681.5681.

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Abstract Advances in novel agents and treatment combinations have improved prognosis and increased disease-free and overall survival for patients (pts) with multiple myeloma (MM). However, currently available data on disease presentation, treatment patterns, and outcomes for real-world MM pts at the global level are limited. This is due to several factors, including the overrepresentation of medically fit pts in clinical trials making generalization of outcomes challenging, the large number of treatment combinations, and varying global access/practice patterns. INSIGHT-MM (NCT02761187) is a global, prospective, non-interventional, observational study which aims to further understand disease and pt characteristics at presentation, treatment and clinical outcomes of real-world MM pts, as well as the association of treatment with tolerability, effectiveness, health-related quality of life (HRQoL), and healthcare resource utilization (HRU), on both a country-specific and global basis. As this is an observational study, no formal hypothesis will be tested. The INSIGHT-MM objectives are summarized in the Table. At least 5000 pts aged ≥18 yrs with newly diagnosed or relapsed/refractory MM will be enrolled over a 3-yr period and followed prospectively for ≥5 yrs, until death or end of study, whichever comes first. Pts not available for data collection for >9 mos will have follow-up for survival. No study drug or medications will be provided; no modification of standard of care pt management will be assigned per protocol. Choice of therapy for all pts will be decided by the treating healthcare provider independent of study participation. Baseline pt and MM-specific characteristics, diagnosis, comorbidities, and prior therapies will be recorded based on review of hospital/clinic records. MM management, disease status and safety data will be obtained as part of routine office visits and recorded quarterly by each site in electronic case report forms. Quarterly assessment of MM management will be done based on prior and current treatment and recorded reason for treatment changes. Effectiveness of therapy will be assessed based on response, progression status, time to next therapy, vital status, and date and cause of death. Treatment tolerability will be assessed based on serious and non-serious adverse events leading to treatment discontinuation or dose modification. Incidence of second primary malignancies will be recorded. HRQoL, a specific type of patient reported outcome (PRO), will be collected at study entry and at predefined intervals following initiation of therapy using a secure electronic data collection system. HRQoL will be collected using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the MM module (EORTC QLQ-MY20). To capture pt satisfaction with MM-directed therapy, including the dimension of convenience, the 9-item Treatment Satisfaction Questionnaire for Medication will be used. The 5-dimension, 5-level EuroQol (EQ-5D-5L) PRO instrument will capture self-reported preference-based measures of health status suitable for calculating quality-adjusted life year (QALY) data to inform health economic evaluations. Frailty will be assessed using the Charlson Comorbidity Index, the Katz Index of Independence in Activities of Daily Living, and the Lawton Instrumental Activities of Daily Living. HRU will be evaluated using inpatient and intensive care unit admissions, length of stay, outpatient clinic visits, and emergency room visits. Data for all participating pts will be extracted by healthcare professionals at the site level and entered into a central database; descriptive statistical analyses will be done to address the study objectives. Interim analyses are planned after 1000 and 5000 pts have been enrolled and a final analysis will be conducted within 1 year after the last pt entered has completed ≥5 yrs follow-up. Data will be analyzed biannually to address emerging clinical questions identified by investigators to increase understanding of real-world treatment patterns. INSIGHT-MM aims to promote better understanding of contemporary demographics, patterns of care, and outcomes for real-world MM pts to inform treatment practice, supportive care, and pt outcomes. The study is currently ongoing and recruiting pts; further details regarding study rationale and protocol will be provided. Table 1 Table 1. Disclosures Davies: Takeda: Consultancy, Honoraria; Celgene: Consultancy, Honoraria; Janssen: Consultancy, Honoraria. Palumbo:Janssen Cilag: Honoraria; Takeda: Employment, Honoraria. Zonder:Bristol Myers Squibb: Consultancy, Honoraria; Celgene: Consultancy, Honoraria, Research Funding; Takeda: Consultancy, Honoraria; Janssen: Consultancy, Honoraria; Prothena: Consultancy, Honoraria; Seattle Genetics: Consultancy, Honoraria; Pharmacyclics: Other: DSMC membership. Girnius:Takeda: Consultancy, Membership on an entity's Board of Directors or advisory committees; Celgene: Speakers Bureau. Costello:Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding. Usmani:Array: Research Funding; Celgene: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Amgen: Consultancy, Research Funding, Speakers Bureau; Takeda: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Sanofi: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Millenium: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Onyx: Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Janssen: Membership on an entity's Board of Directors or advisory committees, Research Funding; BioPharma: Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Pharmacyclics: Research Funding; Britsol-Myers Squibb: Consultancy, Research Funding; Skyline: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Novartis: Speakers Bureau. Berdeja:Abbvie, Acetylon, Amgen, Bluebird, BMS, Calithera, Celgene, Constellation, Curis, Epizyme, Janssen, Karyopharm, Kesios, Novartis, Onyx, Takeda, Tragara: Research Funding. Omel:Takeda: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Member of Takeda's "Patient Leadership Council". Token payment. Thompson:Celgene: Membership on an entity's Board of Directors or advisory committees, Other: MDS/AML Registry; Bristol-Myers Squibb: Membership on an entity's Board of Directors or advisory committees; AIM Specialty Health: Membership on an entity's Board of Directors or advisory committees; VIA Oncology: Membership on an entity's Board of Directors or advisory committees; Takeda: Membership on an entity's Board of Directors or advisory committees, Other: Multiple Myeloma International Registry; Doximity: Equity Ownership, Membership on an entity's Board of Directors or advisory committees. Shah:Array: Research Funding; Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Amgen: Honoraria, Research Funding; Bristol-Myers Squibb: Research Funding; Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding. Schwartz:Bayer: Consultancy; Blue Cross and Blue Shield Associations: Consultancy; Pfizer: Consultancy; Takeda: Consultancy. Hajek:Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees. Terpos:Amgen: Consultancy, Honoraria, Research Funding; Celgene: Honoraria; Bristol-Myers Squibb: Consultancy, Honoraria; Janssen: Consultancy, Honoraria, Research Funding; Takeda: Consultancy, Honoraria; Genesis: Consultancy, Honoraria, Research Funding; Novartis: Honoraria. Hungria:Takeda: Consultancy; Roche: Consultancy; International Myeloma Foundation Latin America: Membership on an entity's Board of Directors or advisory committees; Janssen: Consultancy, Speakers Bureau; Bristol: Consultancy; Amgen: Consultancy. Mateos:Takeda: Honoraria; Amgen: Honoraria; Janssen: Honoraria; Celgene: Honoraria. Cook:Bristol-Myers Squibb: Consultancy, Honoraria; Amgen: Consultancy, Honoraria, Research Funding, Speakers Bureau; Takeda: Consultancy, Honoraria, Research Funding, Speakers Bureau; Glycomimetics: Consultancy, Honoraria; Celgene: Consultancy, Honoraria, Research Funding, Speakers Bureau; Sanofi: Consultancy, Honoraria, Speakers Bureau; Janssen: Consultancy, Honoraria, Research Funding, Speakers Bureau. Leleu:Novartis: Honoraria; LeoPharma: Honoraria; Pierre Fabre: Honoraria; Amgen: Honoraria; Bristol-Myers Squibb: Honoraria; Takeda: Honoraria; Celgene: Honoraria; Janssen: Honoraria; TEVA: Membership on an entity's Board of Directors or advisory committees. Goldschmidt:Celgene: Membership on an entity's Board of Directors or advisory committees, Research Funding; Bristol-Myers Squibb: Membership on an entity's Board of Directors or advisory committees, Research Funding; Chugai: Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Janssen: Membership on an entity's Board of Directors or advisory committees, Research Funding; Novartis: Membership on an entity's Board of Directors or advisory committees, Research Funding; Millennium: Membership on an entity's Board of Directors or advisory committees, Research Funding; Onyx: Honoraria, Membership on an entity's Board of Directors or advisory committees; Takeda: Membership on an entity's Board of Directors or advisory committees; Amgen: Membership on an entity's Board of Directors or advisory committees. Seal:Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Employment, Equity Ownership. Pashos:Millennium Pharmaceuticals, Inc., Cambridge, MA, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Employment. Stull:Millennium Pharmaceuticals, Inc., Cambridge, MA, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Employment. Romanus:Millennium Pharmaceuticals, Inc., Cambridge, MA, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Employment. Cacioppo:Millennium Pharmaceuticals, Inc., Cambridge, MA, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Employment. Bell:Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Employment, Equity Ownership. Yu:Takeda Restricted Stock Unit (RSU), a publicly traded company: Equity Ownership; Takeda Development Center Americas, Inc., Deerfield, IL, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Employment. Luptakova:Takeda Oncology: Employment. Niculescu:Millennium Pharmaceuticals, Inc., Cambridge, MA, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Employment. Noga:Millennium Pharmaceuticals, Inc., Cambridge, MA, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Employment, Equity Ownership. Skacel:Millennium Pharmaceuticals, Inc., Cambridge, MA, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Employment. Chari:Array Biopharma: Consultancy, Research Funding; Amgen Inc.: Honoraria, Research Funding; Celgene: Consultancy, Research Funding; Takeda: Consultancy, Research Funding; Pharmacyclics: Research Funding; Novartis: Consultancy, Research Funding; Janssen: Consultancy, Research Funding.

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Pride, Natalie A., Belinda Barton, Paul Hutchins, et al. "Effects of methylphenidate on cognition and behaviour in children with neurofibromatosis type 1: a study protocol for a randomised placebo-controlled crossover trial." BMJ Open 8, no. 8 (2018): e021800. http://dx.doi.org/10.1136/bmjopen-2018-021800.

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IntroductionDopamine dysregulation has been identified as a key modulator of behavioural impairment in neurofibromatosis type 1 (NF1) and a potential therapeutic target. Preclinical research demonstrates reduced dopamine in the brains of genetically engineered NF1 mouse strains is associated with reduced spatial-learning and attentional dysfunction. Methylphenidate, a stimulant medication that increases dopaminergic and noradrenergic neurotransmission, rescued the behavioural and dopamine abnormalities. Although preliminary clinical trials have demonstrated that methylphenidate is effective in treating attention deficit hyperactivity disorder (ADHD) symptoms in children with NF1, its therapeutic effect on cognitive performance is unclear. The primary aim of this clinical trial is to assess the efficacy of methylphenidate for reducing attention deficits, spatial working memory impairments and ADHD symptoms in children with NF1.Methods and analysisA randomised, double-blind, placebo-controlled trial of methylphenidate with a two period crossover design. Thirty-six participants with NF1 aged 7–16 years will be randomised to one of two treatment sequences: 6 weeks of methylphenidate followed by 6 weeks of placebo or; 6 weeks of placebo followed by 6 weeks of methylphenidate. Neurocognitive and behavioural outcomes as well as neuroimaging measures will be completed at baseline and repeated at the end of each treatment condition (week 6, week 12). Primary outcome measures are omission errors on the Conners Continuous Performance Test-II (attention), between-search errors on the Spatial Working Memory task from the Cambridge Neuropsychological Test Automated Battery (spatial working memory) and the Inattentive and Hyperactivity/Impulsivity Symptom Scales on the Conners 3-Parent. Secondary outcomes will examine the effect of methylphenidate on executive functions, attention, visuospatial skills, behaviour, fine-motor skills, language, social skills and quality of life.Ethics and disseminationThis trial has hospital ethics approval and the results will be disseminated through peer-reviewed publications and international conferences.Trial registration numberACTRN12611000765921.

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Usmani, Saad Z., Vania T. M. Hungria, Xavier Leleu, et al. "Transplant Status Does Not Impact the Selection of Induction Regimens for Newly Diagnosed Multiple Myeloma (NDMM) Patients (Pts) in the Insight MM Prospective, Observational Study." Blood 132, Supplement 1 (2018): 3289. http://dx.doi.org/10.1182/blood-2018-99-112846.

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Abstract Background The introduction of multiple novel agents and regimens for NDMM and relapsed/refractory MM (RRMM) has improved outcomes while increasing the complexity of treatment selection and disease management. The real-world effectiveness of many novel-agent-based regimens remains to be elucidated. INSIGHT MM (NCT02761187) is the largest global, prospective, observational MM study to date. It aims to understand global NDMM/RRMM disease and pt characteristics, treatment patterns, and clinical outcomes, as well as regional variations. Here we report data for 1056 NDMM pts enrolled from July 1, 2016 to April 27, 2018. Methods INSIGHT MM is enrolling ~4200 adult pts with NDMM/RRMM (1-3 prior therapies) from 15 countries; 9 in Europe (EU), 3 in Latin America (LA), the United States (US), and 2 in Asia. Pts will be followed prospectively for ≥5 yrs. Data are collected from hospital/clinic records at baseline (MM-specific disease characteristics, prior therapies) and every 3 mos (disease management, effectiveness, safety). Results At data cut-off, 1056 NDMM pts had been enrolled from 14 countries, including 495 (47%) from EU, 361 (34%) from the US, 112 (11%) from LA, and 88 (8%) from Taiwan. Median age at enrollment was 64 (range 32-89) yrs and 139 (13%) pts were aged >75 yrs (14%/12%/11%/13% in EU/US/Taiwan/LA); 57% of pts were male (60%/58%/61%/39% in EU/US/Taiwan/LA); 72%, 13%, and 8% were White/Caucasian, Asian, and Black/African American, respectively. Overall, 62% of pts were treated at academic centers and 38% in community settings. Based on accrual at data cut-off, regional differences were observed, with more pts treated at academic centers in EU/Taiwan (88%/91%) vs the US/LA (30%/25%). 87% of pts were treated outside of clinical trials (88%/82%/95%/98% in EU/US/Taiwan/LA). Bone pain (32%, including 33%/28%/40%/37% in EU/US/Taiwan/LA), weakness/fatigue (anemia; 11%, including 12%/10%/6%/18% in EU/US/Taiwan/LA), and kidney problems (5%, including 3%/3%/17%/2% in EU/US/Taiwan/LA) were the most common reasons for pts seeking care; 32% (36%/32%/22%/24% in EU/US/Taiwan/LA) were asymptomatic at diagnosis. At diagnosis, 27%/26%/31% of pts had physician-reported ISS Stage I/II/III MM, and 88% had ECOG PS 0-1; 8% of pts had hypercalcemia, 34% creatinine clearance <60 ml/min, 56% anemia, and 30% >3 bone lesions. The most common reasons for initiating therapy were the presence of CRAB criteria, e.g. bone involvement (54%) and anemia (37%). At start of treatment, fixed-duration therapy, treat-to-best-response, and treat-to-progression approaches were planned for 38%, 29%, and 31% of pts, respectively. The most frequently administered regimens are shown in the Table; 20%/66% of pts received a doublet/triplet. V-based regimens were the most frequently used. Regional differences in regimen selection are emerging: among IMiDs, T is most commonly prescribed in EU, Taiwan, and LA; R is more common in the US. After a median follow-up of 9.3 mos, 72 (7%) pts had discontinued the study, most often due to death (57%), consent withdrawal (14%), or change of treatment provider (11%). At data cut-off, data for 236 (22%) pts who received 1st-line ASCT were available (median age 60 yrs; 12%/63%/25% of pts aged <50/50-65/>65 yrs). Of these, 64% received ASCT at academic centers; 42% of pts each in EU and the US received ASCT vs 11% in Taiwan and 4% in LA. The most frequently administered regimens in ASCT-eligible (n=429) vs ASCT-ineligible (n=571) pts were VC±d (21% vs 21%), VR±d (19% vs 17%) and VT±d (17% vs 10%). At data cut-off, 115 NDMM pts had progressed to 2nd-line therapy; 99 pts received a PI with 1st-line therapy, of whom 33 (33%) then received a PI-based regimen in 2nd line; 61 pts received an IMiD with 1st-line therapy, of whom 35 (57%) then received an IMiD-based regimen in 2nd line. Among 1st/2nd-line pts, 2%/12% received monoclonal antibody therapy. Conclusions PIs and IMiDs remain the global backbones of MM therapy, with V-based regimens most commonly used in NDMM pts, regardless of intended transplant status. These data from INSIGHT MM are beginning to elucidate regional differences in disease presentation and treatment selection, including higher numbers of pts receiving ASCT in the US/EU vs Taiwan/LA, which are likely reflective of differences in healthcare systems and access to MM treatments in the participating countries. Future studies will evaluate the impact of these regional variations on outcomes. Table. Table. Disclosures Usmani: Abbvie, Amgen, Celgene, Genmab, Merck, MundiPharma, Janssen, Seattle Genetics: Consultancy; Amgen, BMS, Celgene, Janssen, Merck, Pharmacyclics,Sanofi, Seattle Genetics, Takeda: Research Funding. Hungria:Celgene: Honoraria; Takeda: Honoraria; Janssen: Honoraria; Amgen: Honoraria. Leleu:Karyopharm: Honoraria; Incyte: Honoraria, Other: steering committee membership ; Celgene: Honoraria, Other: steering committee membership ; Janssen: Honoraria, Other; BMS: Honoraria, Other: steering committee membership ; Merk: Honoraria, Other: steering committee membership ; Takeda: Honoraria, Other: steering committee membership ; Amgen: Honoraria, Other: steering committee membership ; Sanofi: Honoraria, Other: steering committee membership steering committee membership ; Novartis: Honoraria, Other: steering committee membership ; Roche: Honoraria; Gilead: Honoraria. Lee:Celgene: Consultancy, Membership on an entity's Board of Directors or advisory committees; Adaptive Biotechnologies Corporation: Consultancy; Amgen: Consultancy, Membership on an entity's Board of Directors or advisory committees; Chugai Biopharmaceuticals: Consultancy; Takeda Oncology: Consultancy, Membership on an entity's Board of Directors or advisory committees; Kite Pharma: Consultancy, Membership on an entity's Board of Directors or advisory committees. Davies:Abbvie: Consultancy; Janssen: Consultancy, Honoraria; Takeda: Consultancy, Membership on an entity's Board of Directors or advisory committees; Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Amgen: Consultancy, Membership on an entity's Board of Directors or advisory committees; TRM Oncology: Honoraria; ASH: Honoraria; MMRF: Honoraria. Costello:Poseida Therapeutics, Inc.: Research Funding; Takeda: Consultancy; Celgene: Consultancy. Rifkin:Takeda: Consultancy; EMD Serono: Consultancy; McKesson: Equity Ownership; Celgene: Consultancy; Amgen: Consultancy; Sandoz: Consultancy; Boehringer Ingelheim: Consultancy. Weisel:Amgen, BMS, Celgene, Janssen, and Takeda: Honoraria; Amgen, BMS, Celgene, Janssen, Juno, Sanofi, and Takeda: Consultancy, Membership on an entity's Board of Directors or advisory committees; Amgen, Celgene, Janssen, and Sanofi: Research Funding. Chari:Adaptive Biotechnology: Membership on an entity's Board of Directors or advisory committees; Celgene: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Novartis: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Takeda: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; The Binding Site: Consultancy; Pharmacyclics: Research Funding; Seattle Genetics: Membership on an entity's Board of Directors or advisory committees; Array Biopharma: Research Funding; Amgen: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Bristol Myers Squibb: Consultancy; Janssen: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding. Puig:Janssen: Consultancy, Honoraria, Research Funding; Takeda: Consultancy, Honoraria; Celgene: Honoraria, Research Funding. Boccadoro:Amgen: Honoraria, Research Funding; Celgene: Honoraria, Research Funding; Janssen: Honoraria, Research Funding; Novartis: Honoraria, Research Funding; AbbVie: Honoraria; Mundipharma: Research Funding; Bristol-Myers Squibb: Honoraria, Research Funding; Sanofi: Honoraria, Research Funding. Cook:Bristol-Myers Squibb: Consultancy, Honoraria; Glycomimetics: Consultancy, Honoraria; Sanofi: Consultancy, Honoraria, Speakers Bureau; Janssen: Consultancy, Honoraria, Research Funding, Speakers Bureau; Celgene Corporation: Consultancy, Honoraria, Research Funding, Speakers Bureau; Janssen: Consultancy, Honoraria, Research Funding, Speakers Bureau; Takeda: Consultancy, Honoraria, Research Funding, Speakers Bureau; Seattle Genetics: Honoraria; Amgen: Consultancy, Honoraria, Research Funding, Speakers Bureau. Berdeja:Teva: Research Funding; Janssen: Research Funding; Takeda: Research Funding; Amgen: Research Funding; Poseida Therapeutics, Inc.: Research Funding; Bristol-Myers Squibb: Research Funding; Celgene: Research Funding; Bluebird: Research Funding; Genentech: Research Funding; Glenmark: Research Funding; Novartis: Research Funding; Sanofi: Research Funding. Zonder:Takeda: Honoraria; Coelum: Honoraria; BMS: Research Funding; Celgene: Consultancy, Honoraria; Alnylam: Honoraria; Janssen: Honoraria; Pharmacyclics: Other: DSMC. Abonour:Prothena: Research Funding; Takeda: Consultancy, Research Funding; Celgene: Consultancy, Research Funding. Hajek:Takeda: Consultancy, Honoraria, Research Funding; Bristol-Myers Squibb: Consultancy, Honoraria, Research Funding; Janssen: Consultancy, Honoraria, Research Funding; Amgen: Consultancy, Honoraria, Research Funding; Celgene: Consultancy, Honoraria, Research Funding. Spencer:Celgene: Honoraria, Research Funding, Speakers Bureau; Janssen-Cilag: Honoraria, Research Funding, Speakers Bureau; Amgen: Honoraria, Research Funding; BMS: Research Funding; Takeda: Honoraria, Research Funding, Speakers Bureau; STA: Honoraria. Omel:Takeda Oncology: Honoraria, Membership on an entity's Board of Directors or advisory committees; Celgene Corporation: Honoraria, Membership on an entity's Board of Directors or advisory committees. Demers:Millennium Pharmaceuticals, Inc., Cambridge, MA, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Employment. Romanus:Millennium Pharmaceuticals, Inc., Cambridge, MA, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Employment. Ren:Takeda Pharmaceuticals International Co.: Employment. Skacel:Department of Hematology, Charles University General Hospital, Prague, Czech Republic: Other: Affiliation; Millennium Pharmaceuticals, Inc., Cambridge, MA, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Employment. Stull:Millennium Pharmaceuticals, Inc., Cambridge, MA, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Employment. Terpos:Novartis: Honoraria; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees; Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel Grant, Patents & Royalties; Genesis: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel Grant, Research Funding; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel Grant, Patents & Royalties; Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel Grant, Research Funding.

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Burdukova, Yu A., and O. S. Alekseeva. "The Function of Planning in Children with a History of Neuro-Oncological Disease." Клиническая и специальная психология 5, no. 4 (2016): 50–60. http://dx.doi.org/10.17759/cpse.2016050404.

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The aim of the study was to estimate the influence of radio- and chemotherapy and tumor's localization on executive functions of the prefrontal cortex. Research involved 58 children with neuro-oncological disease in anamnesis (cerebellum localization and temporal – parietal lobes localization) treated in the Morozov Children's Clinical Hospital. Also research involved 120 typically developing children. Planning was assessed using the Cambridge planning test (Stockings of Cambridge) computer battery of neuropsychological tests CANTAB (Cambridge Neuropsychological Test Automated Battery). Additionally, it is revealed that there is an adverse effect of chemotherapy and radiotherapy on executive functions in tumor of the cerebellum. Funding This work was supported by grant RFBR № 15-06-08680. Acknowledgements The authors thank neuropsychologist E.Yu. Vlasova and neurologist E.V. Andreeva for help in gathering data.

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Gaine, Sean, Nicholas W. Morrell, Stuart Rich, and Norbert Voelkel. "Future Directions: An Expert Panel Explores the Challenge of Halting Progression and Reversing the Pathology of PAH." Advances in Pulmonary Hypertension 2, no. 4 (2003): 22–27. http://dx.doi.org/10.21693/1933-088x-2.4.22.

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This discussion was moderated by Sean Gaine, MD, Director, Pulmonary Hypertension Unit, Mater Misericordiae Hospital, University College, Dublin, Ireland. The physicians participating included Stuart Rich, MD, Professor of Medicine, and Director, Rush Heart Institute Center for Pulmonary Heart Disease, Rush Presbyterian-St. Luke's Medical Center, Chicago, Illinois, Norbert Voelkel, MD, The Hart Family Professor of Emphysema Research, University of Colorado Health Sciences Center, Denver, Colorado, and Nicholas W. Morrell, MD, Director, Pulmonary Vascular Diseases Unit, Papworth and Addenbrooke's Hospitals, University of Cambridge School of Clinical Medicine, Cambridge, UK.

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Jani, Chinmay, Arashdeep Rupal, Omar Al Omari, et al. "Prevalence of pathogenic mutations and variants of uncertain significance in patients undergoing hereditary cancer genetic testing in Cambridge, MA." Journal of Clinical Oncology 39, no. 15_suppl (2021): e22506-e22506. http://dx.doi.org/10.1200/jco.2021.39.15_suppl.e22506.

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e22506 Background: Genetic testing allows for enhanced prognostication and early intervention in patients with high risk of developing cancer. Genetic testing often reveals variants of uncertain significance (VUS), for which association with disease risk is unclear. The ambiguity of this finding creates a dilemma for patients and providers and has been associated with significant communication error and distress. In this retrospective observational study, we seek to characterize the indications, outcomes, and trends in patients undergoing genetic testing in a community hospital in Cambridge, MA. As our study spanned the beginning of the COVID-19 pandemic, we also assessed its impact on care accessibility. Methods: We included patients undergoing genetic testing at our hospital between December 2019 and October 2020 (n=371). Medical charts were abstracted to identify patient characteristics, family history, indication for genetic testing, genetic findings, and subsequent management. Results: Our population had a mean age of 48 years (SD=15), was predominantly female (88.1%), and had a high proportion of Ashkenazi Jewish descent (15.3%). The vast majority (351, 94.6%) had a family history of cancer, while 123 (33.2%) had a personal history of cancer, most commonly breast (n=89). The most common indications for genetic testing were Hereditary Breast and Ovarian Cancer (HBOC in 280, 75%), Lynch Syndrome (LS in 22, 5.9%), and Familial Adenomatous Polyposis (FAP in 7, 2%). Of patients who met HBOC, LS, or FAP criteria for genetic testing, pathogenic mutations were identified in 9.5% and VUS in 28.6%. Out of total 35 (9.4%) pathogenic mutations found in our entire study population, the most common were in BRCA (9, 25.7%), MUTYH (5, 14.2%), and Lynch genes (3, 8.6%). Out of 103 patients with VUS (27.8%), the most common sites were APC (14) and MSH3 (9). We found no significant trend in genetic counseling consultations over our 11 months study period despite the COVID-19 pandemic (R2 = 0.006). Conclusions: Among patients who met criteria for genetic cancer screening at a community hospital, 9.5% were found to have a pathogenic mutation while 28.6% were found to have VUS. These numbers are comparable to previously published estimates. Despite advances in our understanding of genetic colon and gynecological cancers, the majority of patients presenting for genetic cancer counseling continue to do so due to breast cancer concerns. Lastly, we noted high efficacy in our conversion of in-person genetics consultations to telemedicine during the COVID-19 pandemic, suggesting telemedicine is a robust format for genetic counselling. Mutations (N): BRCA1 (3), BRCA2 (6); MUTHY (5); MSH2 (2), MSH6 (1); ATM (2), and one each in PALB2, RAD50, RAD51C, RAD51D, Tp53, CDKN2A, APC, F2, SDHA, SDHB, VHL. FANCL, NTHL1.

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Logan, Lindsey M., Samuel K. Jensen, Noreen Singh, et al. "Proceedings from the 8th Annual University of Calgary Leaders in Medicine Research Symposium." Clinical and Investigative Medicine 41, no. 4 (2019): E165—E185. http://dx.doi.org/10.25011/cim.v41i4.32220.

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On November 14, 2016, the Leaders in Medicine (LIM) program at the Cumming School of Medicine, University of Calgary hosted its 8th Annual Research Symposium. Professor Stephen Sawcer, Professor of Neurological Genetics at the University of Cambridge and an Honorary Consultant Neurologist at Addenbrooke's Hospital, was the keynote speaker and presented a lecture entitled, “Multiple sclerosis genetics - prospects and pitfalls”. This was not only a cutting edge address on genetics but also a thoughtful overview on Dr. Sawcer’s career and career choices. We were extremely grateful for the opportunity to have Dr. Sawcer participate in our annual symposium.

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Eden, Allaina, Claire Purkiss, Gabriella Cork, et al. "In-patient physiotherapy for adults on veno-venous extracorporeal membrane oxygenation – United Kingdom ECMO Physiotherapy Network: A consensus agreement for best practice." Journal of the Intensive Care Society 18, no. 3 (2017): 212–20. http://dx.doi.org/10.1177/1751143717705801.

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Clinical specialist physiotherapists from the five severe respiratory failure centres in England where respiratory extracorporeal membrane oxygenation (ECMO) is practiced have established this consensus agreement for physiotherapy best practice. The severe respiratory failure centres are Wythenshawe Hospital, Manchester; Glenfield Hospital, Leicester; Papworth Hospital, Cambridge; Guy’s and St Thomas’ Hospital, London and The Royal Brompton Hospital, London. Although research into physiotherapy and ECMO is increasing, there is not a sufficient amount to write evidence-based guidelines; hence the development of a consensus document, using knowledge and experience of the specialist physiotherapists working with patients receiving ECMO. The document outlines safety aspects, practicalities and additional treatment considerations for physiotherapists conducting respiratory care and physical rehabilitation.

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Skinner, Guy CM, David P. Farrington, and Jonathan P. Shepherd. "Offender trajectories, health and hospital admissions: relationships and risk factors in the longitudinal Cambridge Study in Delinquent Development." Journal of the Royal Society of Medicine 113, no. 3 (2020): 110–18. http://dx.doi.org/10.1177/0141076820905319.

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Objectives Research suggests that antisocial lifestyles constitute significant health risks. However, there are marked individual differences in the stability of antisocial behaviour. These different offending pathways may bear differential risks for adult health. Design Injury and illness data were collected prospectively in the longitudinal Cambridge Study in Delinquent Development. Setting Working-class inner-city area of South London. Participants Participants included the 411 men from the Cambridge Study in Delinquent Development, with interview data collected at ages 18, 32 and 48 years for each individual. Main outcome measures Organic illness, hospitalisation and injuries. Results By age 48, adjusted odds ratios showed that the incidence of organic illness was higher among Life-Course-Persistent, Late-Onset offenders and offenders in general. Based on adjusted odds ratios at age 32, the incidence of hospitalisations was higher for Late-Onset offenders. Adjusted odds ratios at age 48 also showed that the incidence of hospitalisations was higher for all three offender types and offenders in general. Our results also provide evidence that offenders were more likely to suffer injuries than non-offenders. Conclusions The findings of this study imply that preventing individuals from offending is likely to have substantial benefits for health.

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Ferhanoglu, Burhan, Tae Min Kim, Gayane Tumyan, et al. "Interim Analysis Results from an International, Multi-Centre, Non-Interventional Retrospective Study to Describe Treatment Pathways, Outcomes, and Resource Use in Patients with Classical Hodgkin Lymphoma: B-CD30+ Hodgkin Lymphoma International Multi-Centre Retrospective Study of Treatment Practices and Outcomes (B-HOLISTIC)." Blood 132, Supplement 1 (2018): 2917. http://dx.doi.org/10.1182/blood-2018-99-111146.

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Abstract Background: The cure rate for advanced classical Hodgkin lymphoma (cHL) is approximately 70%, which is calculated based on data from clinical trials performed in North American and/or European countries (Canellos GP, et al. N Engl J Med. 1992;327:1478-84; Carde P, et al. J Clin Oncol. 2016;34:2028-36; Gordon LI, et al. J Clin Oncol. 2013;31:684-91). However, there are limited outcome data available in other countries, apart from some small hospital-based studies (Ramirez P, et al. Rev Bras Hematol E Hemoter. 2015;37:184-9; Law MF, et al. Arch Med Sci. 2014;10:498-504; Jaime-Pérez JC, et al. Oncologist. 2015;20:386-92; Omer Al-Sayes FM, Sawan A. J Taibah Univ Med Sci. 2006;1:48-56). The B-HOLISTIC retrospective chart review study seeks to address the paucity of data on cHL treatment patterns, clinical outcomes, and healthcare resource utilization in 13 countries across Latin America, Africa, Middle East, and the Asia-Pacific region. Methods: The study will collect data from approximately 2,600 patients aged ≥18 years and newly diagnosed with stage IIB-IV cHL or relapsed/refractory cHL (RRHL) between 01 January 2010 and 31 December 2013, and will follow them until death or chart review, whichever occurs first. The primary objective is to describe progression-free survival (PFS) in patients with RRHL. Secondary objectives include describing demographic and clinical characteristics, clinical outcomes (overall survival, best clinical response after completion of treatment, response duration), key adverse events associated with each line of therapy, and cHL-related healthcare resource use. Results: As of 14 May 2018, a total of 165 patients from 12 sites have been included in the interim analysis, predominantly from Turkey and South Korea. At this time, 150 patients had cHL and 24 patients had RRHL, including 9 patients who were enrolled in the cHL group and had a documented relapse/progression during the study period. Here, we report the results of the newly diagnosed cHL group; data from the RRHL group will be reported in subsequent publications. At diagnosis, 64.7% of the cHL group were male, with a median age of 36.5 years (range, 18-89 years); 22.7% had stage IV disease, 30% had extranodal disease, 59.3% had 'B' symptoms, and 34.9% had an International Prognostic Score (IPS) of ≥4. Patients were classified as 13.3% in stage I-IIA; 24% in stage IIB; 53.3% in stage IIIA-IVB; and 9.3% as unknown. Patients classified as stage I-IIA are a deviation from the clinical study protocol and will be removed from the final study analysis. The proportion of patients alive was 94%, with the cause of death reported as either HL-related (44.4%), due to an adverse event (11.1%), or other (44.4%). Positron emission tomography (PET) or PET-computed tomography (CT) imaging was performed in 58.5% of patients at baseline, 48% of patients at interim, and 36.6% at end-of-treatment; CT imaging was performed in 68.7% of patients at baseline, 83.6% of patients at interim, and 59.7% of patients at end-of-treatment. At frontline treatment, 95.3% of patients received chemotherapy (mostly doxorubicin, bleomycin, vinblastine, dacarbazine [ABVD], 92.3% [median number of cycles, 6; range, 2-8]), 22.7% of patients received radiotherapy, with 22% of patients receiving radiotherapy and chemotherapy (median total dose, 34.5 Gy; range, 24-45 Gy). The majority of patients received involved-field radiotherapy (53.1%), with other modalities including involved-node (21.9%), involved-site (18.8%), whole body (3.1%), or other (3.1%). The proportion of patients who achieved a complete or partial response to frontline treatment was 52.1% and 21.1%, respectively. The PFS for treatment in frontline cHL in the overall patient population at 48 months was 81% (95% CI, 73.1-86.7; Figure 1), with a median duration of follow-up of 58.9 months (range, 2.6-128.3 months). The PFS for treatment in frontline cHL excluding ineligible patients classified as stage I-IIA (13.3%) at 48 months was 78.9% (95% CI 69.7-85.6). Due to the retrospective nature of this study, adverse events were under-reported and will be presented once the data are mature. Conclusion: The B-HOLISTIC study is ongoing, with final patient enrolment anticipated in December 2018. These interim data provide real-world information on the incidence, treatment, and outcomes of cHL in countries where little is known about this patient population. Disclosures Ferhanoglu: Takeda: Membership on an entity's Board of Directors or advisory committees; Roche: Membership on an entity's Board of Directors or advisory committees; Janssen: Membership on an entity's Board of Directors or advisory committees. Yeh:GNT Biotech & Medicals Crop.: Research Funding. Brittain:Takeda: Membership on an entity's Board of Directors or advisory committees. Karduss:Novartis: Membership on an entity's Board of Directors or advisory committees; Janssen: Honoraria; Amgen: Honoraria; Takeda: Honoraria. Kwong:Bayer: Consultancy, Honoraria; Beigene: Consultancy, Honoraria; Bristol Myers Squibb: Consultancy, Honoraria; Celgene: Consultancy, Honoraria; Gilead: Consultancy, Honoraria; Janssen: Consultancy, Honoraria; Merck: Consultancy, Honoraria, Research Funding; Novartis: Consultancy, Honoraria, Research Funding; Roche: Consultancy, Honoraria; Astellas: Consultancy, Honoraria; Amgen: Consultancy, Honoraria; Takeda: Consultancy, Honoraria. Song:Peking University Cancer Hospital (Beijing Cancer Hospital): Employment. Zerga:Bristol Myers Squibb: Other: Conference fees; Roche: Other: Conference fees; Janssen: Other: Conference fees; Takeda: Other: Conference fees. Blair:Takeda Pharmaceuticals International Co.: Employment. Dalal:Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Ltd, Cambridge, MA, USA: Employment, Equity Ownership. Wan:Takeda Pharmaceuticals International Co.: Employment. Hertzberg:Amgen: Membership on an entity's Board of Directors or advisory committees; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees; Roche: Membership on an entity's Board of Directors or advisory committees; Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees; MSD: Membership on an entity's Board of Directors or advisory committees.

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Bogert, Ralph. "Haunted Serbia: Representations of History and War in the Literary Imagination. By David A. Norris. Cambridge, Eng.: Legenda, Modern Humanities Research Association; Abingdon, Oxon, Eng.: Routledge, 2016. ix, 190 pp. Notes. Bibliography, Index. $120.00, hard bound." Slavic Review 77, no. 2 (2018): 510–12. http://dx.doi.org/10.1017/slr.2018.156.

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Sadarangani, Manish. "Separating myths from reality for vaccines causing adverse events following immunization: an interview with Manish Sadarangani." Future Microbiology 14, no. 11 (2019): 925–26. http://dx.doi.org/10.2217/fmb-2019-0187.

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Dr Manish Sadarangani is Director of the Vaccine Evaluation Center at the BC Children's Hospital Research Institute and an Assistant Professor in the Division of Infectious Diseases, UBC Department of Pediatrics. He completed his undergraduate medical and pediatric training in Cambridge, Oxford and London in the UK. He then completed his DPhil with the Oxford Vaccine Group in the UK, developing novel vaccine candidates for protection against capsular group B meningococcal disease, and completed a fellowship in pediatric infectious diseases in Vancouver in 2013 before returning to Oxford to work as a pediatric infectious diseases physician. His research links clinical trials with basic microbiology, immunology and epidemiology to address clinically relevant problems related to immunization and vaccine-preventable diseases.

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Evens, Andrew M., Joseph M. Connors, Anas Younes, et al. "Older Patients (pts) with Previously Untreated Classical Hodgkin Lymphoma (cHL): A Detailed Analysis from the Phase 3 ECHELON-1 Study." Blood 132, Supplement 1 (2018): 1618. http://dx.doi.org/10.1182/blood-2018-99-112178.

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Abstract Background Survival rates for older pts with advanced HL (aged ≥60 yrs) were historically poor with doxorubicin, bleomycin, vinblastine and dacarbazine (ABVD). Reasons may include decreased tolerance of therapy, increased toxicity (particularly with bleomycin), comorbidities, and disease biology. The pivotal phase 3 ECHELON-1 study demonstrated superior 2-yr modified progression-free survival (mPFS) with frontline brentuximab vedotin + doxorubicin, vinblastine and dacarbazine (A+AVD) vs ABVD in pts with stage III/IV cHL (Connors JM et al, NEJM 2018). The study allowed entry of older pts, with no upper age limit. Alternative dosing schedules of the A+AVD regimen have been studied (e.g., sequential brentuximab vedotin before and after AVD; NCT01476410, Evens AM et al, J Clin Oncol 2018). We report efficacy and safety results from ECHELON-1 for older pts with cHL and compare these with those for pts aged <60 yrs. Methods mPFS per independent review facility (IRF) for pts ≥60 years was a prespecified subgroup analysis of ECHELON-1. Additional exploratory safety and efficacy analyses were also assessed and compared with younger pts (<60 yrs). The study was not powered for age-based subgroup analyses; p-values are descriptive without multiplicity adjustment. Results 14% (186/1334) of pts in the intent-to-treat (ITT) population were aged ≥60 yrs (A+AVD, n=84; ABVD, n=102) and included in the sub analyses. Median age (range) of older pts was: A+AVD, 68.0 yrs (60-82); ABVD, 66.0 yrs (60-83). Baseline pt and disease characteristics in older pts were similar in both arms. ECOG PS scores were 0 (36% vs 36%), 1 (52% vs 54%), and 2 (12% vs 10%) in A+AVD and ABVD arms, respectively. Pts received a median of 6 cycles with mean relative dose intensities for each drug (%) in older pts of: A+AVD, 92.3, 96.6, 93.3, and 97.9; ABVD, 97.3, 88.7, 93.3, and 95.9. With median follow-up of ~25 months, 2-yr mPFS per IRF was similar in both arms for older ITT pts (A+AVD 70.3% [95% CI: 58.4, 79.4] vs ABVD 71.4% [95% CI: 60.5, 79.8]; HR=1.00 [95% CI: 0.58, 1.72]; p=0.993). An exploratory analysis of standard PFS per investigator (INV) showed HR=0.85 ([95% CI: 0.49, 1.48]; p=0.576) (Table 1). For older pts with stage IV cHL (A+AVD n=51; ABVD n=67), there was an increase in 2-yr PFS per INV with A+AVD vs ABVD (74.0% [95% CI: 59.5, 84.0] vs 59.9% [95% CI: 45.6, 71.5]; HR, 0.66 [95% CI: 0.34, 1.26]; p=0.20); mPFS per IRF improvement with A+AVD in older stage IV pts was lower (HR=0.80; [95% CI: 0.42, 1.53]). In younger stage III/IV pts (<60 yrs) 2-yr mPFS per IRF and PFS per INV were also higher compared with older pts in both arms (Table 1). 66 of 83 older A+AVD pts required ≥1 dose modification of brentuximab vedotin, reasons were: dose reduction (n=27), dose held (n=4), dose delayed (n=51), brentuximab vedotin discontinued (n=17). In older pts, grade (G) 3/4 AEs occurred in 88% of A+AVD pts vs 80% ABVD pts; for younger pts, rates were 82% (A+AVD) vs 63% (ABVD) (Table 2). In older pts there were 3 (4%) on-study deaths in the A+AVD arm (1 each: hemophagocytosis, neutropenic sepsis, and myocardial infarction) and 5 (5%) with ABVD (all pulmonary-related). In pts <60 yrs, there were 6 on-study deaths (1%) with A+AVD vs 8 (1%) with ABVD. G3 neutropenia in older pts was (70%) A+AVD pts vs (59%) ABVD pts, and febrile neutropenia (FN) in 31 (37%) vs 17 (17%) pts. In older pts who had G-CSF primary prophylaxis (PP) neutropenia was seen in 4/10 (40%) A+AVD pts vs 1/9 (11%) ABVD pts (on-study FN in 3 [30%] vs 2 [22%] pts). In older pts, treatment-emergent peripheral neuropathy (PN) was reported in 54 (65%) of A+AVD pts vs 42 (43%) of ABVD pts (G≥3 in 15 [18%] vs 3 [3%] pts), respectively. In pts <60 yrs PN was reported in 388 (67%) A+AVD pts vs 244 (43%) ABVD pts (G≥3 in 55 [9%] vs 8 [1%] pts), respectively. In older pts at last follow-up, 65% (35/54) of A+AVD pts and 60% (25/42) of ABVD pts had complete resolution (A+AVD, 39%; ABVD, 38%) or improvement (A+AVD, 26%; ABVD, 21%) of PN events. 2% older A+AVD pts had pulmonary AEs (both G1/2 pulmonary infiltration) vs 13% older ABVD pts. Conclusions For older ECHELON-1 pts, mPFS and PFS were similar in both arms. In the larger subgroup of younger pts, mPFS and PFS were improved vs older pts. As expected, incidence of treatment-emergent AEs was higher in older pts, with regimen-specific AEs seen, including fatal pulmonary events in ABVD pts. The high incidence of FN in older A+AVD pts points to the need for G-CSF PP. Disclosures Evens: Acerta: Consultancy; Pharmacyclics International DMC: Membership on an entity's Board of Directors or advisory committees; Seattle Genetics, Inc.: Membership on an entity's Board of Directors or advisory committees, Research Funding; Affimed: Consultancy; Janssen: Consultancy; Abbvie: Consultancy; Novartis: Consultancy, Membership on an entity's Board of Directors or advisory committees; Bayer: Consultancy; Tesaro: Research Funding; Novartis: Consultancy. Connors:Merck: Research Funding; Amgen: Research Funding; Takeda: Research Funding; Roche Canada: Research Funding; NanoString Technologies: Patents & Royalties: Named Inventor on a patent licensed to NanoString Technologies, Research Funding; Seattle Genetics: Honoraria, Research Funding; Janssen: Research Funding; F Hoffmann-La Roche: Research Funding; Bayer Healthcare: Research Funding; Cephalon: Research Funding; Bristol Myers-Squibb: Research Funding; Lilly: Research Funding; Genentech: Research Funding. Younes:Sanofi: Honoraria; Merck: Honoraria; Astra Zeneca: Research Funding; Celgene: Honoraria; Incyte: Honoraria; Seattle Genetics: Honoraria; Bayer: Honoraria; Novartis: Research Funding; Curis: Research Funding; J&J: Research Funding; Genentech: Research Funding; Takeda: Honoraria; Roche: Honoraria, Research Funding; Abbvie: Honoraria; Janssen: Honoraria, Research Funding; Pharmacyclics: Research Funding; BMS: Honoraria, Research Funding. Ansell:Merck & Co: Research Funding; LAM Therapeutics: Research Funding; Trillium: Research Funding; Affimed: Research Funding; Seattle Genetics: Research Funding; Regeneron: Research Funding; Takeda: Research Funding; Pfizer: Research Funding; Celldex: Research Funding; Bristol-Myers Squibb: Research Funding. Radford:Takeda: Consultancy, Research Funding, Speakers Bureau; GlaxoSmithKline: Equity Ownership; AstraZeneca: Equity Ownership; Seattle Genetics: Consultancy, Speakers Bureau; ADC Therapeutics: Consultancy, Research Funding; Novartis: Consultancy, Speakers Bureau; Pfizer: Research Funding; Celgene: Research Funding; BMS: Consultancy, Speakers Bureau. Feldman:Seattle Genetics: Research Funding, Speakers Bureau; Janssen: Speakers Bureau; Pharmacyclics: Speakers Bureau; Johnson and Johnson: Speakers Bureau; Celgene: Speakers Bureau; Portola: Research Funding; KITE: Speakers Bureau. Tuscano:Takeda: Research Funding; Genentech: Consultancy, Research Funding; Amgen: Honoraria, Speakers Bureau; Seattle Genetics: Honoraria, Speakers Bureau; Celgene: Honoraria, Research Funding, Speakers Bureau; Pharmacyclics: Research Funding. Oki:Seattle Genetics: Research Funding; Takeda Millenium: Honoraria, Research Funding; Jazz Pharmaceuticals: Employment. Grigg:Roche: Membership on an entity's Board of Directors or advisory committees; Gilead: Membership on an entity's Board of Directors or advisory committees; BMS: Membership on an entity's Board of Directors or advisory committees; Takeda: Membership on an entity's Board of Directors or advisory committees. Pocock:Kent & Canterbury Hospital: Employment. Dlugosz-Danecka:Roche: Consultancy; Servier: Consultancy. Fenton:Seattle Genetics, Inc.: Employment, Equity Ownership. Engley:Seattle Genetics: Employment. Liu:Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Employment. Miao:Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Employment. Jolin:Takeda Pharmaceuticals International Co.: Employment. Gautam:Millennium Pharmaceuticals, Inc., Cambridge, MA, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Employment. Gallamini:Takeda: Consultancy, Speakers Bureau.

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Rood, Julian. "Vertical Transmission, June 2005." Microbiology Australia 26, no. 2 (2005): 50. http://dx.doi.org/10.1071/ma05050.

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Congratulations are in order. I am pleased to announce that Associate Professor Bill Rawlinson from the Department of Microbiology at the Prince of Wales Hospital in Sydney is the recipient of the 2004 Fenner Prize. A/Prof Rawlinson is a medical graduate who went on to obtain his PhD from the University of Cambridge in 1993. He then returned to Australia to take up his position at the Prince of Wales Hospital, where he is currently Senior Medical Virologist within South East Health Laboratories. His research has been very productive and has involved antiviral agents, cytomegalovirus and hepatitis C virus. Bill has been very active in ASM in the role of a Division 2 Chair on NSAC and as the guest editor of the March 2005 edition of Microbiology Australia. He will present his Fenner Lecture entitled ?Virus transmission from mother to baby ? infections, disease and emerging paradigms? at the Canberra meeting in September.

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Baraban, Elena V. "The Poetics of Early Russian Crime Fiction 1860–1917: Deciphering Stories of Detection. By Claire Whitehead. Cambridge, Eng.: Legenda, Modern Humanities Research Association, 2018. xii, 266 pp. Bibliography. Index. $99.00, hard bound." Slavic Review 78, no. 4 (2019): 1093–95. http://dx.doi.org/10.1017/slr.2019.298.

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Hartley, J. M., and E. M. Tansey. "White coats and no trousers: narrating the experiences of women technicians in medical laboratories, 1930–90." Notes and Records: the Royal Society Journal of the History of Science 69, no. 1 (2014): 25–36. http://dx.doi.org/10.1098/rsnr.2014.0058.

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Laboratory technicians are a vital part of any working lab. Not only is their knowledge and expertise important for the success of research, but they also often maintain the lab's intellectual and social life. Despite the importance of their work, they are rarely acknowledged in publications, and leave only a few traces within the historical record—the voices of women laboratory technicians are even harder to uncover. This paper attempts to correct this imbalance by presenting the narratives of women who worked as laboratory technicians at places such as the National Institute for Medical Research (NIMR), the Wellcome Research Laboratories, and established hospital and university labs in Cambridge, Oxford and London. The data were collected though narrative interviews. Specifically, the paper looks at the roles of these women within the lab, their experiences of the social and gender dynamics of the lab, and the development of expertise in regard to the work they carried out and the extent to which they received credit for their contributions to science.

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Andreev, Alexander Alekseevich, and Anton Petrovich Ostroushko. "William GARVEY - founder of modern physiology and embryology (to the 440th anniversary of his birth and 400th anniversary from the day of opening of the circulation)." Vestnik of Experimental and Clinical Surgery 11, no. 2 (2018): 152. http://dx.doi.org/10.18499/2070-478x-2018-11-2-152.

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William Harvey was born in 1578 in Folkestone. After graduating from private elementary school, William continued his education in the Royal school of Canterbury, Cambridge and Padua universities. In 1602 he received the degree of doctor of medicine, but in 1603, the second doctoral degree at Cambridge University and a license to practice a medical practice in England. In 1604 he was elected a candidate, and in 1607 – a member of the Royal College of physicians, later takes up the chair of anatomy and surgery, where she worked until death. In 1609 Harvey became the Junior, and later chief physician of the hospital of St. Bartholomew's in London. In 1618 William Harvey becoming court physician of James I, and in 1832 Charles I. In 1645 William was appointed Dean of Merton College (Oxford). In 1646 Garvey returned to London, where he devoted himself entirely to his studies. My thoughts about circulation he first gave the lecture, read them in London in 1618, and published in 1628. Research Garvey has revealed the importance of the pulmonary circulation and found that the heart is a muscular organ which provides the injection of blood into the circulatory system. In 1651 he published his second treatise "Studies on the origin of animals," which first formulated the theory of epigenesis. He stated and substantiated the idea that ontogeny recapitulates phylogeny. In 1654 Harvey was unanimously elected President of the London medical College, but for health reasons, refuses the position. Harvey died in 1657 and was buried in the town of Hempstead (Essex).

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Anne Stephenson, F. "Eric A. Barnard. 2 July 1927—23 May 2018." Biographical Memoirs of Fellows of the Royal Society 69 (September 9, 2020): 37–61. http://dx.doi.org/10.1098/rsbm.2020.0017.

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Eric Barnard was a protein biochemist who played a leading role in the delineation of the molecular components of neuromuscular transmission and the emergence of molecular neuroscience as a scientific discipline. He began his career at King's College London, moving to the State University of Buffalo, New York, in 1965 before returning to Imperial College, London, in 1975. In 1985 he became the Director of the Medical Research Council (MRC) Molecular Neurobiology Unit in Cambridge. Upon retirement from the MRC, he moved to the Royal Free Hospital in London where he continued as Director of Molecular Neurobiology, but in 1998 returned to the University of Cambridge (Department of Pharmacology) as Emeritus Professor. In 2014, at the age of 86, he finally retired from active research. Although Eric was elected FRS for his early pioneering work on the protein chemistry of enzymes and the nicotinic acetylcholine receptor, his seminal contribution, initiated during his time at Imperial, was the application of molecular biological methods to the study of many neurotransmitter receptors. With Ricardo Miledi FRS (and later David Brown FRS and colleagues), he developed the Xenopus oocyte system for the expression of receptors from total tissue mRNA. His was the first group to clone a neurotransmitter receptor subunit cDNA, the nicotinic acetylcholine receptor α subunit of Torpedo marmorata . This was followed by purification and subsequent cloning of inhibitory γ-aminobutyric acid (GABA) A receptor subunit cDNAs. This achievement, driven by Eric and aided by his collaborator Peter Seeburg, led to the discovery of the ligand-gated ion channel superfamily, the discovery of neurotransmitter receptor heterogeneity, and the development of concepts of receptor families and superfamilies. His pioneering work was pivotal for the foundation of modern central nervous system drug discovery.

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Maier, T., P. Peirce, L. Baird, SL Whitehouse, NKH Slater, and K. Beardsall. "O18 Therapeutic delivery during breastfeeding: a feasibility study." Archives of Disease in Childhood 104, no. 6 (2019): e8.2-e8. http://dx.doi.org/10.1136/archdischild-2019-esdppp.18.

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BackgroundAt an age when breastfeeding is the optimal nutritional support for infants, enteral drug delivery can be physically and emotionally challenging for parents. Delivery during breastfeeding could serve as an alternative to currently existing approaches. This study aimed to explore its feasibility and acceptability.MethodsVitamin B12 was administered as part of a single-centre feasibility study to breastfed infants at the University of Cambridge Addenbrooke´s Hospital NHS Trust. Hereby a solid formulation (tablet) was placed inside an ultra-thin silicone nipple shield, and worn by a mother during the feed. The study investigated i.) quantitative changes in B12 blood serum levels at baseline and 6–8 hours after the study feed, ii.) mothers’ expectations and experiences via a mixed method approach by a single investigator. Local ethics approval was obtained prior to any study procedures being undertaken (18/LO/0551).ResultsTwenty dyads completed the study protocol. In all cases, no residual tablet was left after the feed, and the tablet’s presence within the shield did not appear to impact feeding. A pharmacokinetic-dependent vitamin B12 increase to 1871 pg/mL (610–4981 pg/mL) from a baseline of 533 pg/mL (236–925 pg/mL) was observed. Mothers described the nipple shield´s surprising ease of use and comfort for delivery, not affecting normal breastfeeding behaviour/sensation, while decreasing infant/maternal distress compared to the use of an oral syringe. All mothers expressed their wish for this approach to become available to parents in the future. Reasoning included the desire (1) of parents to have choices in relation to their infants’ health, (2) to replace a medical intervention with one that was felt to be more ‘natural’.ConclusionsThis study showed that solid formulations can be used for therapeutic delivery whilst breastfeeding and is viewed by mothers as advantageous compared to currently available methods.Disclosure(s)FundingThe research was supported by a WD Armstrong PhD studentship for the Application of Engineering in Medicine, University of Cambridge, the German Academic Scholarship Foundation, and the Kurt Hahn Trust, University of Cambridge. Competing interests (applicable to all authors): None declared.

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Wilkes, Fiona A., Harith Akram, Jonathan A. Hyam, Neil D. Kitchen, Marwan I. Hariz, and Ludvic Zrinzo. "Publication productivity of neurosurgeons in Great Britain and Ireland." Journal of Neurosurgery 122, no. 4 (2015): 948–54. http://dx.doi.org/10.3171/2014.11.jns14856.

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OBJECT Bibliometrics are the methods used to quantitatively analyze scientific literature. In this study, bibliometrics were used to quantify the scientific output of neurosurgical departments throughout Great Britain and Ireland. METHODS A list of neurosurgical departments was obtained from the Society of British Neurological Surgeons website. Individual departments were contacted for an up-to-date list of consultant (attending) neurosurgeons practicing in these departments. Scopus was used to determine the h-index and m-quotient for each neurosurgeon. Indices were measured by surgeon and by departmental mean and total. Additional information was collected about the surgeon's sex, title, listed superspecialties, higher research degrees, and year of medical qualification. RESULTS Data were analyzed for 315 neurosurgeons (25 female). The median h-index and m-quotient were 6.00 and 0.41, respectively. These were significantly higher for professors (h-index 21.50; m-quotient 0.71) and for those with an additional MD or PhD (11.0; 0.57). There was no significant difference in h-index, m-quotient, or higher research degrees between the sexes. However, none of the 16 British neurosurgery professors were female. Neurosurgeons who specialized in functional/epilepsy surgery ranked highest in terms of publication productivity. The 5 top-scoring departments were those in Addenbrooke's Hospital, Cambridge; St. George's Hospital, London; Great Ormond Street Hospital, London; National Hospital for Neurology and Neurosurgery, Queen Square, London; and John Radcliffe Hospital, Oxford. CONCLUSIONS The h-index is a useful bibliometric marker, particularly when comparing between studies and individuals. The m-quotient reduces bias toward established researchers. British academic neurosurgeons face considerable challenges, and women remain underrepresented in both clinical and academic neurosurgery in Britain and Ireland.

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Gifford, David J. "Support perfusion for liver transplantation." Perfusion 6, no. 3 (1991): 203–8. http://dx.doi.org/10.1177/026765919100600309.

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Addenbrooke's Hospital, Cambridge, UK, has had an ongoing orthotopic liver transplant programme since 1968. Various support bypass techniques have been used intermittently since 1977. In 1990 bypass was needed for 38% of adult liver transplants, and bypass standby was provided for a further 25%. Adult liver recipients (high-risk) are selected for bypass in accordance with a number of surgical and anaesthetic criteria in order to maximize patient benefit and minimize risk. Before the start of the operation two cannulae (8 or 10 Fg) are placed into left and right internal jugular veins and/or the left brachial vein for rapid volume replacement. Femoral and portal vein cannulation (16 to 22 Fg) can quickly be achieved for splanchnic venous drainage to a heparin coated Biomedicus bypass system. This technique provides flows of 1.5 to 2.5 litres per minute with modest perfusion pressures (around 120mmHg) and provides adequate surgical venous decompression and circulatory support during the anhepatic phase.

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Murphy, Priscilla Eng Lian, Tanya Evans, Sergiy Klymchuk, Julia Novak, Jason Stephens, and Michael Thomas. "University STEM students' perceptions of creativity in non-routine problem-solving." ANZIAM Journal 61 (July 27, 2020): C152—C165. http://dx.doi.org/10.21914/anziamj.v61i0.15052.

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The primary purpose of this study is to investigate students' perceptions about the characteristics of creativity and engagement in solving non-routine problems. It involved 64 science, technology, engineering, and mathematics (STEM) university students, who participated in a two-year research project in New Zealand during which participants were given opportunities to utilise puzzle-based learning in their courses. Comparing open-ended responses of two surveys, this article focuses on student perceptions about attributes of creativity in non-routine problem-solving. These results have pedagogical implications for tertiary stem education. References A. J. Baroody and A. Dowker. The development of arithmetic concepts and skills: Constructive adaptive expertise. Routledge, 2013. URL https://www.routledge.com/The-Development-of-Arithmetic-Concepts-and-Skills-Constructive-Adaptive/Baroody-Dowker/p/book/9780805831566. S. A. Costa. Puzzle-based learning: An approach to creativity, design thinking and problem solving. implications for engineering education. Proceedings of the Canadian Engineering Education Association (CEEA), 2017. doi:10.24908/pceea.v0i0.7365. N. Falkner, R. Sooriamurthi, and Z. Michalewicz. Teaching puzzle-based learning: Development of transferable skills. Teach. Math. Comput. Sci., 10(2):245–268, 2012. doi:10.5485/TMCS.2012.0304. A. Fisher. Critical thinking: An introduction. Cambridge University Press, 2011. URL https://www.cambridge.org/us/education/subject/humanities/critical-thinking/critical-thinking-2nd-edition/critical-thinking-introduction-2nd-edition-paperback?isbn=9781107401983. E. C. Fortes and R. R. Andrade. Mathematical creativity in solving non-routine problems. The Normal Lights, 13(1), 2019. URL http://po.pnuresearchportal.org/ejournal/index.php/normallights/article/view/1237. P. Gnadig, G. Honyek, and K. F. Riley. 200 puzzling physics problems: With hints and solutions. Cambridge University Press, 2001. URL https://www.cambridge.org/us/academic/subjects/physics/general-and-classical-physics/200-puzzling-physics-problems-hints-and-solutions?format=AR&isbn=9780521774802. J. P. Guilford. Creativity: Yesterday, today and tomorrow. J. Creative Behav., 1(1):3–14, 1967. doi:10.1002/j.2162-6057.1967.tb00002.x. J. P. Guilford. Characteristics of Creativity. Illinois State Office of the Superintendent of Public Instruction, Springfield. Gifted Children Section, 1973. URL https://eric.ed.gov/?id=ED080171. G. Hatano and Y. Oura. Commentary: Reconceptualizing school learning using insight from expertise research. Ed. Res., 32(8):26–29, 2003. doi:10.3102/0013189X032008026. S. Klymchuk. Puzzle-based learning in engineering mathematics: Students\T1\textquoteright attitudes. Int. J.Math. Ed. Sci. Tech., 48(7): 1106–1119, 2017. doi:10.1080/0020739X.2017.1327088. B. Martz, J. Hughes, and F. Braun. Developing a creativity and problem solving course in support of the information systems curriculum. J. Learn. High. Ed., 12(1):27–36, 2016. URL https://files.eric.ed.gov/fulltext/EJ1139749.pdf. Z. Michalewicz, N. Falkner, and R. Sooriamurthi. Puzzle-based learning: An introduction to critical thinking and problem solving. Hybrid Publishers, 2011. B. Parhami. A puzzle-based seminar for computer engineering freshmen. Comp. Sci. Ed., 18(4):261–277, 2008. doi:10.1080/08993400802594089. URL http://www.informaworld.com/openurl?genre=article&id. G. Polya. How to solve it: A new aspect of mathematical method. Princeton University Press, 2004. URL https://press.princeton.edu/books/paperback/9780691164076/how-to-solve-it. M. A. Runco. Creativity: Theories and themes: Research, development, and practice. Elsevier, 2014. URL https://www.elsevier.com/books/creativity/runco/978-0-12-410512-6. A. H. Schoenfeld. Mathematical problem solving. Elsevier, 2014. URL https://www.elsevier.com/books/mathematical-problem-solving/schoenfeld/978-0-12-628870-4. C. Thomas, M. Badger, E. Ventura-Medina, and C. Sangwin. Puzzle-based learning of mathematics in engineering. Eng. Ed., 8(1):122–134, 2013. doi:10.11120/ened.2013.00005. M. O. J. Thomas. Developing versatility in mathematical thinking. Med. J. Res. Math. Ed., 7(2):67–87, 2008. A. Valentine, I. Belski, and M. Hamilton. Developing creativity and problem-solving skills of engineering students: A comparison of web and pen-and-paper-based approaches. Eur. J. Eng. Ed., 42(6):1309–1329, 2017. doi:10.1080/03043797.2017.1291584. G. Wallas. The art of thought. Solis Press, 1926.

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Kolchevska, Natasha. "Intellectual Life and Literature at Solovki 1923–1930: The Paris of the Northern Concentration Camps. By Andrea Gullotta. Cambridge, Eng.: Legenda: Modern Humanities Research Association, 2018. x, 359 pp. Appendixes. Bibliography. Index. Illustrations. Photographs. Tables. Maps. $99.00, hard bound." Slavic Review 78, no. 4 (2019): 1102–3. http://dx.doi.org/10.1017/slr.2019.304.

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Pastryk, Tetyana, Olena Kotys, Nataliia Dyachuk, and Volodymyr Milinchuk. "Conscious Control in Speech Pathology and Speech Rehabilitation Following Stroke." East European Journal of Psycholinguistics 6, no. 2 (2019): 89–97. http://dx.doi.org/10.29038/eejpl.2019.6.2.pas.

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The article presents results of the research conducted in speech rehabilitation period of patients after stroke. The study aims to identify conscious control in speech rehabilitation period of the patients who were diagnosed to have Broca’s aphasia. A sample of 22 patients with Broca’s aphasia, or efferent motor aphasia (Luria, 2004) in the left hemisphere, who stayed at the Volyn Regional Clinical Hospital (Lutsk, Ukraine) during rehabilitation period, was approached through purposeful sampling method for this research. The non-laboratory measure of speech assessment was administered along with demographic data. Results showed that conscious control that usually remains in this group of people plays a crucial role in psychological intervention. The article also discusses the main neuropsycholinguistic principles that help to utilize the potential of conscious control in the process of speech rehabilitation of the patients after stroke. References  Лурия А.Р. Лекции по общей психологии. СПб.: Питер, 2004. Мілінчук В. І., Засєкіна Л. В. Нейропсихолінгвістичний підхід до дослідження мовлення пацієнтів після інсульту // Актуальні проблеми практичної психології. Ч. І. 2010. С. 143-146. Мілінчук В. І. Вплив емоційних станів на мовленнєву діяльність пацієнтів після інсульту // Психологічні перспективи. Вип. 15. 2010. С. 207-218. Хомская Е. Д. Нейропсихология. СПб.: Питер, 2005. Шохор-Троцкая М. К. Речь и афазия. М.: Изд-во ЭКСМО-Пресс, 2001. Brown C., Hagoort P. (2003). The Neurocognition of Language. Oxford: Oxford University Press. Hauk, O, Johnsrude, I., & Pulvermüller, F. (2004). Somatotopic representation of action words in motor and premotor cortex. Neuron, 41, 301-307. Kohno, M. (2007). Two neural clocks: humans’ innate temporal systems for spoken language processing. In: J. Arabski, Ed. Challenging Tasks for Psycholinguistics in the New Century. (pp. 283-292). Katowice: University of Silesia. Marshall, J. (2000a). Speech and language problems following stroke In: R. Fawcus, Ed. Stroke Rehabilitation. (pp. 113-129). Oxford: Blackwell. Marshall J. (2000b). The treatment of speech and language disorders following stroke. In: R. Fawcus, Ed. Stroke Rehabilitation. (pp. 130-146). Oxford: Blackwell. Northoff, G. (2003). Philosophy of the Brain. Boston: Harvard University. Pulvermüller, F. (2002). The Neuroscience of Language. On Brain Circuits of Words and Serial Order. Cambridge: Cambridge University Press. Pulvermüller, F., Berthier, M. L. (2008). Aphasia therapy on a neuroscience basis. Aphasiology, 22(6), 563–599.  References (translated and transliterated)  Luria, R. (2004). Lektsii po Obschey Psikhologii [Lectures on General Psychology]. S.-Petersburg: Piter. Milinchuk, V., Zasiekina, L. (2010). Neuropsycholinhvistycgbyi pidhid do doslidzhennia movlennia patsientiv pislia insultu [Neuropsycholinguistic approach to the study of patients after stroke]. Aktualni Problemy Praktychnoi Psykholohii, 1, 143-146. Milinchuk, V. (2010). Vplyv emotsiinykh staniv na movlennevu diyalnist patsientiv pislia insultu. Psyholohichni Perspectyvy – Psychological Prospects, 15, 207-218. Khomskaya, Y. (2005). Neuropsihologiia [Neuropsychology]. S.-Petersburg: Piter. Shohor-Trotskaya, M. (2001). Rech I Afaziya [Speech and Aphasia]. Moscow: Eksmo-Press. Brown C., Hagoort P. (2003). The Neurocognition of Language. Oxford: Oxford University Press. Hauk, O, Johnsrude, I., & Pulvermüller, F. (2004). Somatotopic representation of action words in motor and premotor cortex. Neuron, 41, 301-307. Kohno, M. (2007). Two neural clocks: humans’ innate temporal systems for spoken language processing. In: J. Arabski, Ed. Challenging Tasks for Psycholinguistics in the New Century. (pp. 283-292). Katowice: University of Silesia. Marshall, J. (2000a). Speech and language problems following stroke In: R. Fawcus, Ed. Stroke Rehabilitation. (pp. 113-129). Oxford: Blackwell. Marshall J. (2000b). The treatment of speech and language disorders following stroke. In: R. Fawcus, Ed. Stroke Rehabilitation. (pp. 130-146). Oxford: Blackwell. Northoff, G. (2003). Philosophy of the Brain. Boston: Harvard University. Pulvermüller, F. (2002). The Neuroscience of Language. On Brain Circuits of Words and Serial Order. Cambridge: Cambridge University Press. Pulvermüller, F., Berthier, M. L. (2008). Aphasia therapy on a neuroscience basis. Aphasiology, 22(6), 563–599.

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Greenop, Kathryn R., Osvaldo P. Almeida, Graeme J. Hankey, Frank van Bockxmeer, and Nicola T. Lautenschlager. "Premorbid personality traits are associated with post-stroke behavioral and psychological symptoms: a three-month follow-up study in Perth, Western Australia." International Psychogeriatrics 21, no. 6 (2009): 1063–71. http://dx.doi.org/10.1017/s1041610209990457.

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ABSTRACTBackground: Previous research has found an association between post-stroke depressive symptoms and premorbid personality. This study sought to investigate further the relationship between premorbid personality and a number of common post-stroke behavioral and psychological symptoms in a three-month follow-up study.Methods: This prospective study was conducted between May 2003 and January 2005 in a Perth metropolitan teaching hospital. The pre-stroke personality of stroke survivors was assessed by interviewing a close family member (informant) within four weeks of the index stroke using the NEO Personality Inventory-Revised. Three months after the stroke, patients were followed up and assessed with the Cambridge Cognitive examination and Hospital Anxiety and Depression Scale, and their informants completed the Neuropsychiatric Inventory-carer distress version (NPI) and instrumental activities of daily living scale.Results: Depressive symptoms were the most commonly reported post-stroke symptom (45.1%). Spearman's correlations showed that high neuroticism was positively correlated with NPI total scores (ρ = 0.37, p = 0.007), NPI total distress scores (ρ = 0.47, p = 0.001), and specifically with agitation and irritability NPI composite scores. Agreeableness was inversely correlated with agitation (ρ = −0.40, p = 0.004) and irritability (ρ = −0.37, p = 0.007) composite scores.Conclusions: Premorbid personality traits of high neuroticism and low agreeableness are associated with the presence of post-stroke agitation, irritability, and carer distress. This knowledge may contribute to the development of strategies designed to identify patients and families who require more intense supervision and support during post-stroke rehabilitation.

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Kanter, Julie, Amber L. Allison, Caitlin Henry, et al. "The Cambridge Automated Neuropsychological Testing Automated Battery (CANTAB) Is Feasible and Valuable for the Evaluation of Neurocognitive Deficits in Pediatric Patients with Sickle Cell Disease: Results of a Pilot Study." Blood 118, no. 21 (2011): 4839. http://dx.doi.org/10.1182/blood.v118.21.4839.4839.

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Abstract Abstract 4839 Background: As children with sickle cell disease (SCD) are at significant risk for neurocognitive complications, an automated and objective measure of neurocognitive functioning would address several challenges facing both clinical and research progress in SCD including longitudinal monitoring of deficits, cross-site comparability of neurocognitive tests in multicenter trials, and limited access to pediatric neuropsychologists. The Cambridge Automated Neuropsychological Testing Automated Battery (CANTAB) is a well-validated computerized test with significant normative data in individuals age 4 to 80 that has been used to monitor disease progression and treatment response in children and adults with a range of disorders but has not been used previously in SCD. Hypothesis: We hypothesize that the CANTAB system is a useful and viable tool for the neurocognitive evaluation of pediatric patients with SCD. We expect that the CANTAB testing will be well tolerated by SCD patients and parents, easy to administer in our comprehensive clinic, and generate valid results that correlate with both medical and psychological outcomes. Methods: 7 CANTAB tests which assess attention, executive function and memory were run on pediatric SCD patients during scheduled clinic visits. Parents completed the child behavior checklist (CBCL) which generates t-scores for children on internalizing, externalizing scales as well as DSM-oriented scales of affective, anxiety, pervasive developmental, attention and oppositional scales. Medical data including SCD genotype, average hemoglobin (hgb), hematocrit (hct), reticulocyte count (rct), lactate dehydrogenase and hospital utilization records (ER visits, # hospital visits in the last year) was collected. Demographic information and a total pain burden assessment were also collected. Results: 11 children with HbSS SCD were enrolled in the pilot study (table 1). All patients successfully completed the CANTAB testing without difficulty. Hgb and rct were associated with strategy score on spatial working memory and the latency score on the motor screening task. Hgb and rct also correlated with internalizing, externalizing, and total symptoms scores on the CBCL (table 2). Specifically lower hgb and higher rct were associated with increased CBCL scores. A regression model incorporating average hgb and total internalizing scores with spatial working memory as the dependent variable revealed a significant interaction between internalizing scores and hgb and a significant model p=.01 and r2 of 0.89 offering preliminary support for a multi-level model incorporating disease and child specific factors (table 2). The total pain burden score correlated error making in several tests including the delayed match to sample test (p=.01), spatial working memory test (p=.06), and Stockings of Cambridge task (p=.0038). The pain burden score was not associated with performance or latency on these tests indicating that pain burden may have a specific association with error making. Pain burden also correlated with the somatic measure on the CBCL (p=.01) indicating cross validation between the two measures. Conclusion: This pilot study demonstrates the feasibility and value of the CANTAB system in evaluating neurocognitive deficits in pediatric patients with SCD. These results can be assessed longitudinally following medical interventions. Furthermore, results indicate a multi-level model that includes medical factors, child specific factors, and demographics may be a more appropriate model to utilize in determining the etiology of neurocognitive deficits in SCD. Ongoing studies with an increased sample size will examine the association of neurocognitive function with SCD genotype, MRI, transcranial doppler studies, and family stress. SWM: Spatial working memory SOC: Stockings of Cambridge MOT: Motor Screening Test Disclosures: No relevant conflicts of interest to declare.

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Janowitz, Tobias, Edward Hywel Williams, Andrea Marshall, et al. "A new model for estimating glomerular filtration rate in patients with cancer." Journal of Clinical Oncology 35, no. 15_suppl (2017): e14074-e14074. http://dx.doi.org/10.1200/jco.2017.35.15_suppl.e14074.

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e14074 Background: The glomerular filtration rate (GFR) is essential for carboplatin chemotherapy dosing, however, the best method to estimate GFR in patients with cancer is unknown. We identify the most accurate and least biased method. Methods: Data on age, sex, height, weight, serum creatinine, and results for GFR from 51Cr-EDTA excretion measurements (51Cr-EDTA GFR) were obtained from Caucasian patients aged 18 years or older with histologically confirmed cancer diagnoses at the University of Cambridge Hospital NHS Trust, UK. We developed a new multivariable linear model for GFR using statistical regression analysis. 51Cr-EDTA GFR was compared to the estimated GFR (eGFR) from seven published and our new model using an internal validation data set and root-mean-squared-error (RMSE) and median residuals. A comparison of carboplatin dosing accuracy based on an absolute percentage error more than 20% (APE > 20%) was undertaken. Results: Between August 2006 and January 2013 data from 2,471 patients were obtained. The new model improved the eGFR accuracy (RMSE 15.00ml/min (95% CI 14.12-16.00)) compared to all published models. Body surface area (BSA) adjusted CKD-EPI was the most accurate published models for eGFR (RMSE 16.30ml/min (95% CI 15.34-17.38)) for the internal validation set. Importantly, the new model reduced the fraction of patients with a carboplatin dose APE > 20% to 14.17% in contrast to 18.62% for BSA adjusted CKD-EPI and 25.51% for the Cockcroft-Gault model. The results were externally validated. Conclusions: In a large data set, from patients with cancer, a new model improves eGFR and carboplatin dose calculations, when compared to BSA adjusted CKD-EPI, the model we identified as the best published model for determination of eGFR in patients with cancer.

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Janowitz, Tobias, Edward H. Williams, Andrea Marshall, et al. "New Model for Estimating Glomerular Filtration Rate in Patients With Cancer." Journal of Clinical Oncology 35, no. 24 (2017): 2798–805. http://dx.doi.org/10.1200/jco.2017.72.7578.

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Purpose The glomerular filtration rate (GFR) is essential for carboplatin chemotherapy dosing; however, the best method to estimate GFR in patients with cancer is unknown. We identify the most accurate and least biased method. Methods We obtained data on age, sex, height, weight, serum creatinine concentrations, and results for GFR from chromium-51 (51Cr) EDTA excretion measurements (51Cr-EDTA GFR) from white patients ≥ 18 years of age with histologically confirmed cancer diagnoses at the Cambridge University Hospital NHS Trust, United Kingdom. We developed a new multivariable linear model for GFR using statistical regression analysis. 51Cr-EDTA GFR was compared with the estimated GFR (eGFR) from seven published models and our new model, using the statistics root-mean-squared-error (RMSE) and median residual and on an internal and external validation data set. We performed a comparison of carboplatin dosing accuracy on the basis of an absolute percentage error > 20%. Results Between August 2006 and January 2013, data from 2,471 patients were obtained. The new model improved the eGFR accuracy (RMSE, 15.00 mL/min; 95% CI, 14.12 to 16.00 mL/min) compared with all published models. Body surface area (BSA)–adjusted chronic kidney disease epidemiology (CKD-EPI) was the most accurate published model for eGFR (RMSE, 16.30 mL/min; 95% CI, 15.34 to 17.38 mL/min) for the internal validation set. Importantly, the new model reduced the fraction of patients with a carboplatin dose absolute percentage error > 20% to 14.17% in contrast to 18.62% for the BSA-adjusted CKD-EPI and 25.51% for the Cockcroft-Gault formula. The results were externally validated. Conclusion In a large data set from patients with cancer, BSA-adjusted CKD-EPI is the most accurate published model to predict GFR. The new model improves this estimation and may present a new standard of care.

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Eggink, Esmé, Melanie Hafdi, Marieke P. Hoevenaar-Blom, et al. "Prevention of dementia using mobile phone applications (PRODEMOS): protocol for an international randomised controlled trial." BMJ Open 11, no. 6 (2021): e049762. http://dx.doi.org/10.1136/bmjopen-2021-049762.

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IntroductionProfiles of high risk for future dementia are well understood and are likely to concern mostly those in low-income and middle-income countries and people at greater disadvantage in high-income countries. Approximately 30%–40% of dementia cases have been estimated to be attributed to modifiable risk factors, including hypertension, smoking and sedentary lifestyle. Tailored interventions targeting these risk factors can potentially prevent or delay the onset of dementia. Mobile health (mHealth) improves accessibility of such prevention strategies in hard-to-reach populations while at the same time tailoring such approaches. In the current study, we will investigate the effectiveness and implementation of a coach-supported mHealth intervention, targeting dementia risk factors, to reduce dementia risk.Methods and analysisThe prevention of dementia using mobile phone applications (PRODEMOS) randomised controlled trial will follow an effectiveness–implementation hybrid design, taking place in the UK and China. People are eligible if they are 55–75 years old, of low socioeconomic status (UK) or from the general population (China); have ≥2 dementia risk factors; and own a smartphone. 2400 participants will be randomised to either a coach-supported, interactive mHealth platform, facilitating self-management of dementia risk factors, or a static control platform. The intervention and follow-up period will be 18 months. The primary effectiveness outcome is change in the previously validated Cardiovascular Risk Factors, Ageing and Incidence of Dementia dementia risk score. The main secondary outcomes include improvement of individual risk factors and cost-effectiveness. Implementation outcomes include acceptability, adoption, feasibility and sustainability of the intervention.Ethics and disseminationThe PRODEMOS trial is sponsored in the UK by the University of Cambridge and is granted ethical approval by the London—Brighton and Sussex Research Ethics Committee (reference: 20/LO/01440). In China, the trial is approved by the medical ethics committees of Capital Medical University, Beijing Tiantan Hospital, Beijing Geriatric Hospital, Chinese People’s Liberation Army General Hospital, Taishan Medical University and Xuanwu Hospital. Results will be published in a peer-reviewed journal.Trial registration numberISRCTN15986016.

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Folprecht, Gunnar, Daniela Ellen Aust, Arnaud Roth, et al. "Improving access to molecularly defined clinical trials for patients with colorectal cancer: The EORTC SPECTAcolor platform." Journal of Clinical Oncology 33, no. 3_suppl (2015): 575. http://dx.doi.org/10.1200/jco.2015.33.3_suppl.575.

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575 Background: Molecular diagnostics can identify subgroups of colorectal and other cancers that are relevant for the mode of action of new anti-cancer agents. The efficient, GCP-conform and quality assured molecular screening to identify potential study patients is one of the major challenges for targeted drug development. The EORTC has implemented a new collaborative molecular screening platform in order to facilitate these next generation trials. Methods: SPECTAcolor (Screening Patients for Efficient Clinical Trial Access in advanced colorectal cancer) is a pan European network of institutions collaborating in centralized, high-throughput screening of tumor material from patients with colorectal cancer. After informed written consent, patients are screened for molecular alterations. Molecularly annotated patients can be offered so called “downstream” clinical trials. Results: Launched in September 2013, SPECTAcolor is now initiated in 19 clinical centers in 9 countries. As of 12 September 2014, 406 patients were enrolled exceeding the expected accrual target of 300 patients in the first year. Of these 406 patients, 293 patients had their tumor block shipped to the central biobank at the Dresden University Hospital for central quality and pathological review, and core analyses. Tumor samples are being additionally analyzed using next generation sequencing for 360 key cancer alterations in cooperation with the Sanger Institute (Cambridge, UK). In the first year, the blocks were analyzed for 5 baseline biomarkers. KRAS was wild type for exon 2, 3 and 4 in 151/284 pts (53%) and mutated 133 pts (47%; 114 pts in exon 2 (40%), 8 pts in exon 3, and 11 pts in exon 4). NRAS was tested in KRAS wild type pts only; mutations were found in 14 pts (4.9%; 6 pts in exon 2 and 8 pts in exon 3). BRAF mutations, all in exon 15, were found in 18 pts (7%). PI3K mutations occurred in 41 pts (15%; 13 in exon 20 and 28 in exon 9). IHC staining was showing deficient mismatch repair in 16 patients. Conclusions: SPECTAcolor is the first pan-European and EORTC screening platform. Its successful implementation proves that a logistically complex infrastructure to run next generation trials in a multinational setting is feasible.

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Minisini, A. M., P. Ermacora, S. Russo, et al. "Anticancer treatment and cognitive functions in elderly cancer patients: A prospective study." Journal of Clinical Oncology 24, no. 18_suppl (2006): 8543. http://dx.doi.org/10.1200/jco.2006.24.18_suppl.8543.

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8543 Background: It has been reported that anticancer treatment may alterate cognitive functions in cancer patients but very few prospective studied addressed this issue. Moreover, little is known about the cognitive impact of anticancer treatment in elderly cancer patients. We aimed at investigating the effect on cognitive functions of antiblastic chemotherapy and endocrine therapy in a consecutive series of elderly cancer outpatients. Methods: We evaluated cognitive functions by means of the Cambridge Cognitive Examination (CAMCOG) test and the Mini-Mental Scale Examination (MMSE) at baseline (before anticancer systemic treatment), after 3 months and after 6 months in cancer patients aged more than 65 years. Mood disturbances such as anxiety and depression were also evaluated (Hospital Anxiety and Depression Scale); comprehensive geriatric assessment and blood tests were performed at each evaluation. Results: Sixty patients were enrolled, 15 patients received chemotherapy (group 1), 13 patients received endocrine therapy (group 2) and 32 patients had neither chemotherapy nor endocrine therapy (group 3, control). Fifty-eight (97%) patients had no evidence of disease at the time of assessment. Median age was 71.5, 73 and 71 years in group 1, 2 and 3, respectively. At baseline, median Activities of Daily Living (ADL) score, Instrumental Activity of Daily Living (IADL) score, number of comorbidities and concomitant medications were 6, 8, 5, 1 in group 1, and 6, 8, 3, 2 in group 2, and 6, 8, 4, 2 in group 3, respectively. Median hemoglobin value was 12.9, 12.8, 13.3 g/dl in group 1, 2 and 3 respectively. At baseline, no significant unbalance was evident among groups. There was a statistically significant correlation between ADL or IADL score and CAMCOG total score (Spearman test, rho=0.4, p<0.05). Higher scolarity level was associated with higher CAMCOG total score. No deterioration of CAMCOG score was evident in group 1, 2 and 3 after 3 and 6 months (paired t-test p>.05); the separate analyses for the different items in CAMCOG test did not evidence any deterioration in time in the 3 groups. No worsening was seen in MMSE. Conclusions: Our study showed that anticancer treatment is not associated with rapid cognitive deterioration in elderly cancer patients. No significant financial relationships to disclose.

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Doherty, Gary, Deirdre Lynskey, Athena Matakidou, Kate Fife, and Tim Eisen. "A novel strategy for axitinib dosing in the treatment of metastatic renal cell carcinoma." Journal of Clinical Oncology 35, no. 6_suppl (2017): 464. http://dx.doi.org/10.1200/jco.2017.35.6_suppl.464.

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464 Background: The AXIS trial established axitinib as an effective second line treatment for patients with metastatic renal cell carcinoma (mRCC). The dosing schedule of axitinib in this trial begins at 5mg twice daily, with escalation of individual doses to 7mg and 10mg after consecutive 2 week intervals if tolerated. We observed significant drug-related toxicity using this dosing strategy, particularly after dose escalations, while clinical responses were often observed at the starting dose. We therefore switched to a pragmatic strategy where dose escalations were made only after disease progression or where a rapid response was deemed clinically pertinent. Methods: We performed a retrospective review of electronic health records and radiology of all patients with mRCC treated with axitinib for greater than 2 weeks at Addenbrooke’s Hospital, Cambridge, UK (a tertiary referral center), over a 40 month period to determine the clinical and radiological effects of dose escalations made according to the above strategy. Results: 42 patients fitting these criteria were identified; of these, 29 had at least one dose escalation event (DEE). A total of 58 DEEs were identified, with a median of 2 per patient, and the objective radiological consequences of 50 of these could be determined. The disease control rate (partial response or stable disease) after the first DEE instituted for disease progression was similar to that after the second DEE (68.8% versus 70%). 56% of all DEEs, and 62.5% of DEEs made as a result of disease progression, resulted in disease control. The median overall survival from the commencement of axitinib for all dose-escalated patients was 19.9 months, and 6.7 months for non-dose-escalated patients. The median survival for dose-escalated patients with a higher than median time on a prior tyrosine kinase inhibitor has not been reached at the time of data cut-off. The mean dose (for all patients) at 90 days after starting axitinib was 5.92 mg. Conclusions: These data suggest that dose escalation of axitinib after disease progression may be an effective dosing strategy for patients with mRCC, and may reduce toxicity through lower drug exposure. Our survival data compares favourably to the AXIS trial in a real practice population.

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Anagnostou, Katherine, Sabita Islam, Yvonne King, et al. "Study of induction of Tolerance to Oral Peanut: a randomised controlled trial of desensitisation using peanut oral immunotherapy in children (STOP II)." Efficacy and Mechanism Evaluation 1, no. 4 (2014): 1–56. http://dx.doi.org/10.3310/eme01040.

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BackgroundPeanut allergy is a common disease that causes severe and fatal food allergic reactions. Currently, the best treatment is avoidance as repeated reactions can occur. Quality of life (QoL) is reduced by fear of severe reactions and social limitations. Oral immunotherapy (OIT) is a novel treatment that may be an effective treatment for peanut allergy.ObjectivesTo determine the efficacy of peanut OIT in children.DesignA phase 2 randomised, controlled, crossover trial (open label).SettingSingle UK centre study.ParticipantsChildren aged 7–15 years with peanut allergy diagnosed by double-blind, placebo-controlled food challenge (DBPCFC). No children were excluded because of anaphylaxis or asthma.InterventionsDaily immunotherapy (2 mg, 5 mg, 12.5 mg, 25 mg, 50 mg, 100 mg, 200 mg, 400 mg and 800 mg of peanut protein) was administered as peanut flour (containing 50% peanut protein). Doses were increased at 2-weekly intervals to a maintenance dose of 800 mg of protein. The control group underwent peanut avoidance for 6 months during phase 1.Main outcome measureA peanut DBPCFC up to 1400 mg of peanut protein was performed in both groups at 6 months. The highest amount of peanut tolerated was the main outcome measure.RandomisationRandomised by online audited system to active or control group (1 : 1).BlindingThe intervention arm allocation was not blinded.MethodsWe assigned 99 participants aged 7–16 years with peanut allergy of all severities to active OIT or control (peanut avoidance/current standard of care). The primary outcome was desensitisation, defined as negative peanut challenge (1400 mg of protein DBPCFC) at 6 months (phase 1). Control participants underwent OIT during phase 2, followed by DBPCFC. Immunological parameters and disease-specific QoL scores were measured.ResultsThe primary outcome, desensitisation, was observed in 62% (24/39) of the active group and none (0/46) of the control group after phase 1 [95% confidence interval (CI) 45% to 78% vs. 0% to 9%;p < 0.001]; 84% (95% CI 70% to 93%) of the active group tolerated daily ingestion of 800 mg of protein (≈ five peanuts). Median increase in peanut threshold after OIT was 1345 mg (range 45–1400 mg;p < 0.001) or 2.5-fold (range 1.82–280-fold;p < 0.001). After phase 2, 54% (95% CI 35% to 72%) tolerated a 1400-mg challenge (≈ 10 peanuts) and 91% (95% CI 79% to 98%) tolerated a daily ingestion of 800 mg of protein. QoL scores improved (decreased) after OIT (median change –1.61;p < 0.001). Side effects were mostly mild with gastrointestinal symptoms being the most common: oral pruritus occurred after 6.3% of doses, wheeze occurred after 0.41% of doses (one-fifth of participants) and intramuscular epinephrine was required after 0.01% of doses (one participant).ConclusionIn children with peanut allergy of any severity, OIT successfully induced desensitisation in the majority, with a clinically meaningful increase in peanut threshold. QoL improved after intervention and there was a good safety profile. Immunological changes reflected clinical desensitisation. Peanut OIT should not be undertaken in non-specialist settings. Future work will include a phase 3 confirmatory study and studies of long-term tolerance; similar studies of other allergens are also required.Trial registrationCurrent Controlled Trials ISRCTN62416244.FundingThis project was awarded by the Efficacy and Mechanism Evaluation programme and is funded by the Medical Research Council (MRC) and managed by the National Institute for Health Research (NIHR) on behalf of the MRC–NIHR partnership, and jointly sponsored by the University of Cambridge and Addenbrooke’s Hospital [Cambridge University Hospital Foundation Trust (RD authorisation A091686)]. The project will be published in full inEfficacy and Mechanism Evaluation; Vol. 1, No. 4. See the NIHR Journals Library website for further project information.

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Lee, Matilda, Wan Qin Chong, Hon Lyn Tan, et al. "The chemo-brain effect in colorectal cancer patients." Journal of Clinical Oncology 38, no. 15_suppl (2020): e24095-e24095. http://dx.doi.org/10.1200/jco.2020.38.15_suppl.e24095.

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e24095 Background: The chemo-brain effect associated with systemic chemotherapy results in cognitive disturbances impacting the capacity to engage in tasks and quality of life (QOL). Patients with colorectal cancer (CRC) who receive adjuvant chemotherapy generally have long survival times. The long-term effect of chemotherapy on cognition is uncertain. We aimed to ascertain the frequency of long-term cognitive impairment using neuropsychological assessments and correlating with neuroimaging. Methods: In this prospective pilot study, patients (n=22) with stage II to III CRC between 45 to 75 years old, who were planned to receive adjuvant chemotherapy, were recruited. 3 visits were scheduled for each subject – pre-chemotherapy (V1), at 1 month post chemotherapy (V2), and at 6 months post chemotherapy (V3). Serial tests were performed – the Cambridge Neuropsychological Test Automated Battery (CANTAB), QOL questionnaires (Hospital Anxiety and Depression Scale (HADS), Perceived Deficits Questionnaire (PDQ), EORTC QLQ-C30, FACT-ES), 3 item pocket smell test, functional PET/MRI brain imaging, and blood biomarker studies. Results: 18/22 subjects (13 male, 5 female) had completed tests at all 3 visits; the median age was 62 years (range 51 – 69). 9/18 had an initial decline (median -0.033) of Rapid Visual Information processing (RVP) at V2; 3/9 showed improvement to baseline at V3. 8/18 had a persistent decline in RVP scores at V3 (median -0.054). This was associated with increased HADS depression scores (mean 3.63 at V2 vs 4.63 at V1), worsening attention scores (mean 4.38 at V3 and 3.63 at V1), prospective memory scores (mean 3.75 at V3 vs 3.38 at V1), and total scores (mean 14.63 at V3 vs 13.75 at V1) on the PDQ. 7/18 had an increase in Paired Associates Learning (PAL) errors (median +6) at V2. 3/7 improved to baseline at V3, while 4/7 continued to have a persistent decline. PAL scores were not associated with worsening retrospective or prospective PDQ memory scores, changes in HADS depression or EORTC QLQ-C30 scores. There was no difference in baseline CANTAB scores for patients reporting declining vs stable QLQ-C30 scores. Conclusions: Only half of patients with initial RVP A and PAL decline improved at 6 months post chemotherapy. Further efforts should be placed to identify those at risk of poor recovery, and develop strategies to manage the chemo-brain effect. The correlation of cognitive decline with neuroimaging will be presented in the final analysis.

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Edwardson, J. Michael. "Alan William Cuthbert. 7 May 1932—27 August 2016." Biographical Memoirs of Fellows of the Royal Society 68 (November 20, 2019): 131–49. http://dx.doi.org/10.1098/rsbm.2019.0036.

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Alan Cuthbert carried out ground-breaking work on epithelial ion transport. He used radiolabelled amiloride and benzamil to measure the sodium channel density in epithelia from frog skin and toad bladder, tissues that are good models for the distal section of the mammalian kidney tubule. This work shed important new light on how the properties of these channels are modified by hormones such as aldosterone and antidiuretic hormone, and increased our understanding of how diuretics affect kidney function. Later, he focused on the ion transport deficits that underlie cystic fibrosis (CF), and was a member of the team that showed that the ion transport defect could be corrected in CF transgenic mice by gene therapy. Alan was Sheild Professor of Pharmacology and Head of the Department of Pharmacology at the University of Cambridge from 1979 until his retirement in 1999. During this time he was instrumental in moving the Department from the Addenbrooke's Hospital site to a new building in the centre of town. He was also Master of Fitzwilliam College from 1991 until 1999. Alan made major contributions to pharmacology nationally and internationally, serving as chairman of the editorial board of the British Journal of Pharmacology for eight years, and as President of the Federation of European Pharmacological Societies for two years. In recognition of his contributions to the subject, the British Pharmacological Society awarded him their Wellcome Gold Medal in 2005. After his retirement, he continued his research in the Department of Medicine, pursuing novel pharmacological approaches to the treatment of CF.

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Atkins, Christopher, Richard Fordham, Allan B. Clark, Andrea Stockl, Andrew P. Jones, and Andrew M. Wilson. "Feasibility study of a randomised controlled trial to investigate the treatment of sarcoidosis-associated fatigue with methylphenidate (FaST-MP): a study protocol." BMJ Open 7, no. 12 (2017): e018532. http://dx.doi.org/10.1136/bmjopen-2017-018532.

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IntroductionFatigue is a frequent and troublesome manifestation of chronic sarcoidosis. This symptom can be debilitating and difficult to treat, with poor response to the treatment. Symptomatic management with neurostimulants, such as methylphenidate, is a possible treatment option. The use of such treatment strategies is not without precedent and has been trialled in cancer-related fatigue. Their use in sarcoidosis requires further evaluation before it can be recommended for clinical practice.Methods and analysisThe Fatigue and Sarcoidosis—Treatment with Methylphenidate study is a randomised, controlled, parallel-arm and feasibility trial of methylphenidate for the treatment of sarcoidosis-associated fatigue. Patients are eligible if they have a diagnosis of sarcoidosis, significant fatigue (measured using the Fatigue Assessment Scale) and have stable disease. Up to 30 participants will be randomly assigned to either methylphenidate (20 mg two times per day) or identical placebo in a 3:2 ratio for 24 weeks. The primary objective is to collect data determining the feasibility of a future study powered to determine the clinical efficacy of methylphenidate for sarcoidosis-associated fatigue. The trial is presently open and will continue until July 2018.Ethics and disseminationEthical approval for the study was granted by the Cambridge Central Research Ethics Committee on 21 June 2016 (reference 16/EE/0087) and was approved and sponsored by the Norfolk and Norwich University Hospital (reference 190280). Clinical Trial Authorisation (EudraCT number 2016-000342-60) from the Medicines and Healthcare products Regulatory Agency (MHRA) was granted on 19 April 2016. Results will be presented at relevant conferences and submitted to appropriate journals following trial closure and analysis.Trial registration numberNCT02643732; Pre-results.

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Smith, Brandon George, Charlotte Jane Whiffin, Ignatius N. Esene, et al. "Neurotrauma clinicians’ perspectives on the contextual challenges associated with long-term follow-up following traumatic brain injury in low-income and middle-income countries: a qualitative study protocol." BMJ Open 11, no. 3 (2021): e041442. http://dx.doi.org/10.1136/bmjopen-2020-041442.

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IntroductionTraumatic brain injury (TBI) is a global public health concern; however, low/middle-income countries (LMICs) face the greatest burden. The WHO recognises the significant differences between patient outcomes following injuries in high-income countries versus those in LMICs. Outcome data are not reliably recorded in LMICs and despite improved injury surveillance data, data on disability and long-term functional outcomes remain poorly recorded. Therefore, the full picture of outcome post-TBI in LMICs is largely unknown.Methods and analysisThis is a cross-sectional pragmatic qualitative study using individual semistructured interviews with clinicians who have experience of neurotrauma in LMICs. The aim of this study is to understand the contextual challenges associated with long-term follow-up of patients following TBI in LMICs. For the purpose of the study, we define ‘long-term’ as any data collected following discharge from hospital. We aim to conduct individual semistructured interviews with 24–48 neurosurgeons, beginning February 2020. Interviews will be recorded and transcribed verbatim. A reflexive thematic analysis will be conducted supported by NVivo software.Ethics and disseminationThe University of Cambridge Psychology Research Ethics Committee approved this study in February 2020. Ethical issues within this study include consent, confidentiality and anonymity, and data protection. Participants will provide informed consent and their contributions will be kept confidential. Participants will be free to withdraw at any time without penalty; however, their interview data can only be withdrawn up to 1 week after data collection. Findings generated from the study will be shared with relevant stakeholders such as the World Federation of Neurosurgical Societies and disseminated in conference presentations and journal publications.

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Dimopoulos, Meletios A., Francesca Gay, Fredrik H. Schjesvold, et al. "Maintenance Therapy with the Oral Proteasome Inhibitor (PI) Ixazomib Significantly Prolongs Progression-Free Survival (PFS) Following Autologous Stem Cell Transplantation (ASCT) in Patients with Newly Diagnosed Multiple Myeloma (NDMM): Phase 3 Tourmaline-MM3 Trial." Blood 132, Supplement 1 (2018): 301. http://dx.doi.org/10.1182/blood-2018-99-112079.

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Abstract Introduction Maintenance therapy has been extensively explored as a strategy for prolonging the duration of disease control and potentially survival following ASCT. To date, only lenalidomide has been approved for this indication. However, lenalidomide maintenance is associated with the development of second primary malignancies and tolerability issues. PIs are a backbone of MM treatment, and bortezomib-based maintenance has shown promising activity post-ASCT, yet the benefit of PI-based maintenance has not been demonstrated in a phase 3 trial vs placebo. Moreover, the feasibility of bortezomib maintenance in routine clinical practice is limited due to tolerability and the need for regular parenteral administration. There is a need for an oral PI maintenance therapy that can be administered for a prolonged period, improve depth of response without cumulative or late-onset toxicity, and improve convenience for patients. Methods The phase 3, double-blind, placebo-controlled, multicenter TOURMALINE-MM3 study (NCT02181413) compared weekly ixazomib vs placebo maintenance in NDMM patients who had at least a partial response (≥PR) to induction therapy with a PI and/or immunomodulatory drug (IMiD) followed by single ASCT. Patients were randomized (3:2) to receive ixazomib or matched placebo on days 1, 8, and 15 of 28-day cycles for up to 2 years or until progressive disease (PD) or unacceptable toxicity. Randomization was stratified by induction regimen (PI without IMiD vs IMiD without PI vs PI+IMiD), pre-induction ISS stage (I vs II or III), and post-ASCT response (complete response [CR] or very good partial response [VGPR] vs PR). Patients were ineligible if they had received post-ASCT consolidation or tandem ASCT. The ixazomib dose was 3.0 mg during cycles 1-4, increasing to 4 mg from cycle 5 if tolerated during cycles 1-4. The primary endpoint was PFS per independent review committee (IRC), who were blinded to treatment assignment. The key secondary endpoint was OS. Here, we report data from the final analysis for PFS (data cut-off: April 16, 2018). Results 656 patients were randomized (395 ixazomib; 261 placebo). Patient demographics were balanced between groups; overall median age was 57 years (range, 24-73), 37% vs 63% had ISS I vs II or III, 59%/11%/30% had received PI without IMiD / IMiD without PI / PI+IMiD induction therapy, 34%/45%/21% had achieved CR / VGPR / PR following induction/ASCT, and 18% had high-risk cytogenetics [del(17p), t(4;14), or t(14;16)]. After a median follow-up of 31 months with 54% of PFS events, there was a 28% reduction in the risk of progression/death, corresponding to a 39% improvement in PFS with ixazomib vs placebo (median 26.5 vs 21.3 months; hazard ratio [HR] 0.72; 95% CI: 0.582, 0.890; p=0.002; Figure). In a landmark analysis from ASCT, PFS was 30.7 vs 24.9 months (HR 0.684; 95% CI: 0.551, 0.848; p<0.001). Median PFS2 and OS have not yet been reached in either arm. Ixazomib maintenance led to higher rates of deepened response compared with placebo (relative risk 1.41; 95% CI: 1.10, 1.80; p=0.004). Conversion from documented MRD positivity at study entry to MRD negativity occurred at a higher rate with ixazomib compared with placebo (12% vs 7%). PFS benefit was seen broadly across subgroups, including ISS III (HR 0.661), PI-exposed (HR 0.750), PI-naïve (HR 0.497), and patients with high-risk cytogenetics (HR 0.625). Discontinuation due to AEs was low (7% ixazomib vs 5% placebo). With ixazomib vs placebo, 42% vs 26% of patients had grade ≥3 AEs; 27% vs 20% had serious AEs; and 1 patient vs 0 died on treatment. Common grade ≥3 AEs were infections (15% vs 8%) including pneumonia (6% vs 4%), gastrointestinal disorders (6% vs 1%), neutropenia (5% vs 3%), and thrombocytopenia (5% vs <1%). Peripheral neuropathy rates were 19% vs 15% (<1% vs 0 grade 3). Rate of second primary malignancies was 3% in both arms. Global Quality of Life scores (EORTC QLQ-C30) on ixazomib were similar to placebo. Conclusions This study demonstrated a 28% reduction in the risk of progression/death, corresponding to a 39% improvement in PFS with ixazomib maintenance, with deepening of responses and increased conversions to MRD negativity over control, as well as a favorable safety profile, including an absence of risk of second primary malignancies and low rates of peripheral neuropathy, supporting ixazomib as a valuable option for maintenance therapy in responding patients post-ASCT. Figure. Figure. Disclosures Dimopoulos: Janssen: Honoraria; Takeda: Honoraria; Amgen: Honoraria; Celgene: Honoraria; Bristol-Myers Squibb: Honoraria. Gay:Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen Takeda Celgene, Amgen, BMS, and Roche: Other: Advisor; Janssen, Amgen, Takeda, Celgene, BMS: Honoraria; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees; Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees; Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees; Abbvie: Consultancy; Bristol Myers Squibb: Honoraria, Membership on an entity's Board of Directors or advisory committees; Roche: Membership on an entity's Board of Directors or advisory committees. Schjesvold:Oncopeptides: Consultancy; Abbvie: Honoraria; Novartis: Honoraria; Janssen: Consultancy, Honoraria, Research Funding; Adaptive: Consultancy; Bayer: Consultancy; Bristol Myers Squibb: Consultancy; Takeda: Consultancy, Honoraria; Celgene: Consultancy, Honoraria; Amgen: Consultancy, Honoraria, Research Funding. Beksac:Bristol Myers Squibb: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen Cilag: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Deva: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Hajek:Amgen: Consultancy, Honoraria, Research Funding; Bristol Myers Squibb: Consultancy, Honoraria; Takeda: Consultancy, Honoraria, Research Funding; Janssen: Consultancy, Honoraria, Research Funding; Celgene: Consultancy, Honoraria, Research Funding; Novartis: Research Funding. Weisel:Amgen, BMS, Celgene, Janssen, and Takeda: Honoraria; Amgen, BMS, Celgene, Janssen, Juno, Sanofi, and Takeda: Consultancy, Membership on an entity's Board of Directors or advisory committees; Amgen, Celgene, Janssen, and Sanofi: Research Funding. Goldschmidt:Novartis: Honoraria, Research Funding; Amgen: Consultancy, Research Funding; Adaptive Biotechnology: Consultancy; Sanofi: Consultancy, Research Funding; Takeda: Consultancy, Research Funding; Chugai: Honoraria, Research Funding; Bristol Myers Squibb: Consultancy, Honoraria, Research Funding; Celgene: Consultancy, Honoraria, Research Funding; Janssen: Consultancy, Honoraria, Research Funding; ArtTempi: Honoraria; Mundipharma: Research Funding. Maisnar:Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees; Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees; Bristol Myers Squibb: Membership on an entity's Board of Directors or advisory committees; Takeda: Membership on an entity's Board of Directors or advisory committees; Novartis: Honoraria. Moreau:Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees; Abbvie: Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees; Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees; Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees. Chng:Merck: Research Funding; Takeda: Consultancy, Honoraria, Other: Travel, accommodation, expenses; Amgen: Consultancy, Honoraria, Other: Travel, accommodation, expenses; Aslan: Research Funding; Janssen: Consultancy, Honoraria, Other: Travel, accommodation, expenses, Research Funding; Celgene: Consultancy, Honoraria, Other: Travel, accommodation, expenses, Research Funding. Kaiser:Janssen: Consultancy, Honoraria; Takeda: Consultancy, Other: Travel Support; Bristol-Myers Squibb: Consultancy, Other: Travel support; Chugai: Consultancy, Honoraria, Research Funding; Amgen: Consultancy, Honoraria; Celgene: Consultancy, Honoraria, Research Funding. Zweegman:Takeda: Membership on an entity's Board of Directors or advisory committees, Research Funding; Celgene Corp.: Membership on an entity's Board of Directors or advisory committees, Research Funding; Takeda: Membership on an entity's Board of Directors or advisory committees, Research Funding; Janssen: Membership on an entity's Board of Directors or advisory committees, Research Funding. Mateos:Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; GSK: Consultancy, Membership on an entity's Board of Directors or advisory committees; Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Abbvie: Consultancy, Membership on an entity's Board of Directors or advisory committees; Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; GSK: Consultancy, Membership on an entity's Board of Directors or advisory committees; Takeda: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees. Spencer:Celgene: Honoraria, Research Funding, Speakers Bureau; Janssen-Cilag: Honoraria, Research Funding, Speakers Bureau; Amgen: Honoraria, Research Funding; BMS: Research Funding; Takeda: Honoraria, Research Funding, Speakers Bureau; STA: Honoraria. Iida:Janssen: Consultancy, Honoraria, Research Funding; Kyowa-Hakko Kirin: Research Funding; Bristol Myers Squibb: Honoraria, Research Funding; Astellas: Research Funding; Chugai: Research Funding; Novartis: Honoraria, Research Funding; Celgene: Honoraria, Research Funding; Ono: Consultancy, Honoraria, Research Funding; Takeda: Consultancy, Honoraria, Research Funding; Toyama Chemical: Research Funding; MSD: Research Funding; Gilead: Research Funding; Teijin Pharma: Research Funding; Sanofi: Consultancy. Morgan:Takeda: Consultancy, Honoraria; Celgene: Consultancy, Honoraria, Research Funding; Janssen: Research Funding; Bristol-Myers Squibb: Consultancy, Honoraria. Teng:Millennium Pharmaceuticals, Inc., Cambridge, MA, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Employment. Suryanarayan:Millennium Pharmaceuticals, Inc., Cambridge, MA, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Employment. Skacel:Millennium Pharmaceuticals, Inc., Cambridge, MA, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Employment; Department of Hematology, Charles University General Hospital, Prague, Czech Republic: Other: Affiliation. Dash:Takeda Pharmaceuticals International Co.: Employment. Labotka:Millennium Pharmaceuticals, Inc., Cambridge, MA, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Employment.

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Keverne, E. B. "Sir Richard John Harrison. 8 October 1920 – 17 October 1999." Biographical Memoirs of Fellows of the Royal Society 51 (January 2005): 185–93. http://dx.doi.org/10.1098/rsbm.2005.0012.

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Richard Harrison was a convivial man, equally at ease having a drink with his friends discussing science issues, and as Chair of a relatively large Department of Anatomy directing teaching and research. After graduating in natural sciences at Cambridge and medicine from St Bartholemew's Hospital in 1944, Richard Harrison started his research in comparative reproduction on a variety of mammals. Horses, goats, deer, primates, seals and whales were just some of the species to which he dedicated his career as a comparative anatomist, but equally important was his strong interest in function. This was not the orthodox career of a medical doctor, but as he would frequently say, ‘ you can always tell a man who is from Bart's, but you cannot tell him very much’. We have to remember that horses and medicine were not, at that time, from the same stable, and the boundaries between anatomy and physiology were very distinct. Richard Harrison was early into the integration of structure and function and a pioneer of cross–disciplinary studies that are now so much a feature of modern anatomy departments.In 1946 Harrison moved to a lectureship in anatomy at Glasgow and there he received the degree of DSc in 1948. The early phases of his research on reproduction focused on the ovary and the placenta, a structure unique to mammals created from a uniquely mammalian tissue, trophectoderm, and developed de novo during each pregnancy. In 1949 he published his first of several Nature papers, this being on multiovular follicles in the ovaries of lower primates. His critical examination of the ovaries of some of the lower primates revealed the presence of several multiovular follicles and multinuclear oocytes, an unusual observation for primates. The majority of the multiple forms of follicles in all of the ovaries investigated showed either early or advanced signs of atresia. In many oocytes, in which the zona pellucida had not developed, small groups of granulosa cells had invaded the ooplasm. It is probable, he concluded, that multiovular follicles and multinuclear oocytes do represent atretic changes, although it had been reported for other species that they could reach maturity and ovulate. The findings from this study supported the view that was gaining favour at the time; namely, that in a mammal that produced only a single offspring in each pregnancy, many oocytes are potentially available for ovulation.

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Fu, Weijun, Jin Lu, Jie Jin, et al. "Overall Survival (OS) Benefit of Oral Ixazomib in Combination with Lenalidomide and Dexamethasone (IRd) Vs Lenalidomide and Dexamethasone (Rd) in Asian Patients (pts) with Relapsed and/or Refractory Multiple Myeloma (RRMM): Pooled-Analysis from the Tourmaline-MM1 and the China Continuation Studies." Blood 132, Supplement 1 (2018): 5637. http://dx.doi.org/10.1182/blood-2018-99-116844.

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Abstract Introduction: Ixazomib (Ninlaro) is the first orally administered proteasome inhibitor (PI) approved in more than 50 countries worldwide, including China. The TOURMALINE-MM1 study was a large randomized, double-blind, global registration study assessing treatment with either ixazomib or placebo added to lenalidomide and dexamethasone. The China Continuation Study (CCS) was a separate regional expansion of the global study that used the same study design. (Panel A) In the global study, IRd treatment extended progression-free survival (PFS), the primary endpoint, by 35% (HR=0.74) vs Rd. Here we report results of a pooled analysis of data from a subgroup of Asian patients enrolled in these two studies. Demographics and Methods: Asian patients from China (n=6 from the global study; n=115 from the CCS), Singapore (n=6), South Korea (n=6), and 3 non-Asian countries (n=5) were included in this pooled analysis. Overall response rate (ORR) was based on the International Myeloma Working Group criteria. The median OS and PFS were calculated using the Kaplan-Meier method. Comparative analysis of treatment groups used stratified log rank tests and the Cox proportional hazard regression model. Safety assessments were based on treatment-emergent adverse events (TEAEs), changes in laboratory parameters, and 12-lead electrocardiogram results. Results: Data from 138 pts were analyzed (67 IRd; 71 Rd). Baseline characteristics were balanced between the treatment groups; overall median age was 61 (range, 30-80) years, 67% of pts were < 65 years; 97% of pts had Eastern Cooperative Oncology Group Performance Scores 0-1; 37% had International Staging System (ISS) stages II/III; and 72% had lytic bone disease. The median number of prior treatments was 2, with 82% exposed to thalidomide of which 61% were thalidomide refractory, 61% were exposed to bortezomib, and 48% exposed to both drugs. The ORR was 57% in the IRd group vs 37% in the Rd group. Median OS was 25.8 mos and 15.8 mos in the IRd and Rd treatment groups, respectively (HR=0.346). (Panel B). OS also was longer with IRd therapy regardless of prior exposure to bortezomib (HR=0.322) or thalidomide (HR=0.317) as well as in pts with thalidomide refractory tumors (HR=0.273). (Panel C). The median PFS was 7.3 mos and 4.6 mos in the IRd and Rd treatment groups, respectively (HR=0.559). Longer PFS was also observed with IRd treatment in pts with prior exposure to bortezomib (HR=0.467) or thalidomide (HR= 0.580) as well as pts with thalidomide refractory tumors (HR= 0.631). The rates of drug-related TEAEs (IRd, 96%; Rd, 97%), serious TEAEs (IRd, 37%; Rd, 34%), Grade 3/4 TEAEs (IRd, 74%; Rd, 73%) and discontinuations due to AEs (IRd, 12%; Rd, 13%) were similar in both treatment groups. Grade 3/4 TEAEs reported in ≥10% of either treatment group were anemia (IRd, 14%; Rd, 31%), lower respiratory infection (IRd, 23%; Rd, 21%), neutrophil count decrease (IRd, 13%; Rd, 16%), platelet count decrease (IRd, 15%; Rd, 13%), neutropenia (IRd, 17%; Rd, 9%), thrombocytopenia (IRd 11%; Rd 6%). There was no increased cardiotoxicity, renal toxicity, hepatoxicity or secondary primary malignancy in the IRd group. Conclusions: Asian pts with RRMM treated with oral IRd showed superior OS and PFS vs those treated with Rd. The benefit was consistent regardless of prior exposure to thalidomide and bortezomib. The addition of ixazomib to Rd was well-tolerated, and no new safety signals were identified. The safety profile of IRd was consistent with the safety findings of the large global study (Moreau P, Masszi T, Grzasko N, et al. for the TOURMALINE-MM1 Study group. N Engl J Med. 2016;374:1621-1634.) Disclosures Jin: College of Medicine, Zhejiang University: Employment; The National Natural Science Foundation of China: Research Funding. Chng:Amgen: Consultancy, Honoraria, Other: Travel, accommodation, expenses; Janssen: Consultancy, Honoraria, Other: Travel, accommodation, expenses, Research Funding; Celgene: Consultancy, Honoraria, Other: Travel, accommodation, expenses, Research Funding; Merck: Research Funding; Aslan: Research Funding; Takeda: Consultancy, Honoraria, Other: Travel, accommodation, expenses. Goh:Johnson & Johnson: Consultancy, Honoraria; Bristol-Myers-Squibb: Consultancy, Honoraria; Pfizer: Consultancy, Honoraria; Sanofi-Aventis: Consultancy, Honoraria; Astellas: Consultancy, Honoraria; Gilead: Consultancy, Honoraria; Amgen: Consultancy, Honoraria; Novartis: Consultancy, Honoraria. Wu:Takeda Pharmaceuticals: Employment. Wang:Millennium Pharmaceuticals, a wholly owned subsidiary of Takeda: Employment. Liu:Millennium Pharmaceuticals, Inc., Cambridge, MA, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Employment. Skacel:Millennium Pharmaceuticals, Inc., Cambridge, MA, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Employment; Department of Hematology, Charles University General Hospital, Prague, Czech Republic: Other: Affiliation. Wan:Takeda Pharmaceuticals International Co.: Employment. Berg:Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Employment.

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Crompton, D. W. T. "Parr Tate, 1901–1985." Parasitology 93, no. 2 (1986): 249–50. http://dx.doi.org/10.1017/s0031182000051416.

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SUMMARYDuring my third year as an undergraduate reading Zoology at Cambridge, I found a relatively large parasite inside one of the Asellus aquaticus that had been allocated to me for the afternoon's practical work. After we had failed to identify even the group of animals to which it belonged, someone suggested that I should take my find to The Molteno Institute on the Downing Site. There I was ushered into Room 3 where I first met Dr Tate. After listening to my account he looked at my specimen and said, ‘Now just one second …’ in his rich Irish accent. As I later came to know, so much of his teaching or advice began with that highly characteristic phrase. He told me that I had found an acanthocephalan worm in its intermediate host, and when I returned some days later to tell him the results of my search of the literature, he suggested that I should work on the Acanthocephala under his supervision for the Ph.D. Degree after my graduation. I never regretted for one moment my decision to take up his offer. He maintained close contact with me, as he did with all his former research students, and the last letter I received from him was dated 16 September 1985, written just a few weeks before his death on 7 November 1985 in hospital in Cork. During the 24 years of our association I was never on Christian-name terms with him. He was always ‘Dr Tate’ or, when talking with equally close mutual associates like Donald Lee, David Molyneux, John Barrett, Vaughan Southgate or Roger Tatchell, we referred to him as ‘P.T.’. He had great integrity and fairness in all that he did and an ability of seeming to know exactly what you were thinking. These attributes, coupled with his extraordinarily wide parasitological knowledge, generated our respect. He also had a delightful sense of fun and even his sarcasm was kind and gentle. Our children loved him and his steady supply of sweets for those who visited him in Room 3 and the book tokens that came without fail every Christmas were expressions of his kindness.

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Hajek, Roman, Evangelos Terpos, Hans C. Lee, et al. "Ixazomib Plus Lenalidomide-Dexamethasone (IRd) in Relapsed/Refractory Multiple Myeloma (MM) Patients (Pts) - Effectiveness in Routine Clinical Practice Is Similar to the Efficacy in the Phase 3 Tourmaline-MM1 Trial: A Pooled Analysis from the Insight MM Observational Study and the Czech Registry of Monoclonal Gammopathies (RMG)." Blood 132, Supplement 1 (2018): 1971. http://dx.doi.org/10.1182/blood-2018-99-113441.

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Abstract Background Ixazomib (ixa), the first oral proteasome inhibitor, is approved in combination with lenalidomide (len)-dexamethasone in >50 countries globally, including the US and EU, for the treatment of relapsed/refractory MM (RRMM) pts who have received ≥1 prior therapy. Outcomes and tolerability in routine clinical practice often differ from data reported in clinical trials for novel-agent-based MM therapies; however, data directly comparing efficacy in clinical trials with effectiveness in routine clinical practice of new MM agents and regimens are currently limited. To evaluate the effectiveness of IRd in RRMM pts in routine clinical practice, we performed a pooled analysis of individual pt-level data for IRd-treated RRMM pts from the ongoing INSIGHT MM (NCT02761187) study and from the Czech RMG. INSIGHT MM is the largest global, prospective, observational MM study conducted to date, which is currently enrolling ~4200 adult pts with newly diagnosed MM or RRMM from Europe (EUR), the US, Asia, and Latin America. The Czech RMG was established by the Czech Myeloma Group in 2007 and comprises clinical data for >6000 MM pts enrolled at 19 Czech and 4 Slovak centers. Methods RRMM pts with 1-3 (INSIGHT MM) or ≥1 (RMG) prior therapies who had been treated with IRd were identified. INSIGHT MM pts required prospectively collected data on IRd therapy; pts who received another regimen or additional treatment within the same line of therapy as IRd were excluded. RMG pts from Czech centers who received IRd were included using the same eligibility criteria as the INSIGHT MM study. Individual pt-level data on demographics, disease characteristics, treatment history, effectiveness, and safety for IRd-treated RRMM pts from INSIGHT MM and the Czech RMG were integrated and analyzed. Best response and PFS were determined as per the assessment of the treating physician or local investigator, utilizing IMWG criteria. Descriptive analyses were performed on the integrated data as well as on data from INSIGHT MM and from the Czech RMG. PFS, TTNT, DOT, and OS were estimated using Kaplan Meier methodology. Results Overall, 163 IRd-treated RRMM pts from 9 countries were included in the analysis (50 INSIGHT MM, 113 Czech RMG); of these, 146 (90%) were from EUR, 16 (10%) from the US, and 1 (1%) from Taiwan. Median age was 67 (range 39-84) yrs, with 23 (14%) pts aged >75 yrs; 86 (53%) pts were male. At initial diagnosis, 38%/36%/26% of pts had ISS Stage I/II/III disease; median time from diagnosis to initiation of IRd treatment was 42.6 mos; 71% of pts had ECOG PS ≥1. Most pts (65%) had IgG MM, and 14% had extramedullary disease. Overall, 50%/30%/20% of pts received IRd as 2nd/3rd/≥4th-line therapy. The most common reasons for starting IRd therapy were relapse/progression (90%), including bone lesions (53%), and anemia (14%). Overall, 61% of pts had received prior stem cell transplant; prior therapies included bortezomib (bor) in 89% of pts, thalidomide (thal) in 42%, len in 21%, carfilzomib (car) in 11%, daratumumab (dara) in 3%, and pomalidomide (pom) in 2%. Median DOT was 14.0 mos; 101 (62%) pts were on treatment at data cut-off. Data on best response to therapy were available for 105 pts; among these, ORR (partial response or better) was 74%, with 31% ≥VGPR (Table); ORR with IRd as 2nd/3rd/≥4th-line therapy was 91%/57%/47%, including 41%/25%/11% ≥VGPR. Median time to first response was 1.1 mos for Czech RMG pts; median time to best response was 3.7 mos for INSIGHT MM pts. Overall, median PFS was 20.9 (95% CI: 13.0-28.7) mos, with a 12-mo rate of 65% (Table). Median PFS with 2nd/3rd/4th/>4th-line therapy was NR/23.2/14.2/5.1 mos. Median TTNT was 26.2 (95% CI: 9.6-42.8) mos, with a 12-mo rate of 73% (Table). Overall, 37 (23%) pts received subsequent therapies including bor (24%), pom (24%), thal (16%), dara (16%), car (14%), or len (8%). Median OS was not reached, with 81% of pts alive at 12 mos (Table). Ixa and len dose reductions were required in 15% and 30% of pts, respectively, with 11% and 21% of pts, respectively, requiring dose reductions due to AEs (Table). Conclusions These findings show that the effectiveness of IRd in routine clinical practice, including an ORR of 74% and a median PFS of 20.9 mos, is comparable to the efficacy of IRd reported in the TOURMALINE-MM1 trial (ORR 78%, median PFS 20.6 mos). IRd is well tolerated in RRMM pts treated in routine clinical practice, with low rates of dose reductions due to AEs for ixa (11%) and len (21%). Table. Table. Disclosures Hajek: Bristol-Myers Squibb: Consultancy, Honoraria, Research Funding; Celgene: Consultancy, Honoraria, Research Funding; Takeda: Consultancy, Honoraria, Research Funding; Janssen: Consultancy, Honoraria, Research Funding; Amgen: Consultancy, Honoraria, Research Funding. Terpos:Novartis: Honoraria; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees; Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel Grant, Patents & Royalties; Genesis: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel Grant, Research Funding; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel Grant, Patents & Royalties; Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel Grant, Research Funding. Lee:Celgene: Consultancy, Membership on an entity's Board of Directors or advisory committees; Adaptive Biotechnologies Corporation: Consultancy; Amgen: Consultancy, Membership on an entity's Board of Directors or advisory committees; Chugai Biopharmaceuticals: Consultancy; Takeda Oncology: Consultancy, Membership on an entity's Board of Directors or advisory committees; Kite Pharma: Consultancy, Membership on an entity's Board of Directors or advisory committees. Chari:Celgene: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Adaptive Biotechnology: Membership on an entity's Board of Directors or advisory committees; Novartis: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Amgen: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Takeda: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Janssen: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Bristol Myers Squibb: Consultancy; Pharmacyclics: Research Funding; Seattle Genetics: Membership on an entity's Board of Directors or advisory committees; The Binding Site: Consultancy; Array Biopharma: Research Funding. Costello:Poseida Therapeutics, Inc.: Research Funding; Takeda: Consultancy; Celgene: Consultancy. Puig:Takeda: Consultancy, Honoraria; Celgene: Honoraria, Research Funding; Janssen: Consultancy, Honoraria, Research Funding. Leleu:Celgene: Honoraria, Other: steering committee membership ; Janssen: Honoraria, Other; BMS: Honoraria, Other: steering committee membership ; Merk: Honoraria, Other: steering committee membership ; Takeda: Honoraria, Other: steering committee membership ; Amgen: Honoraria, Other: steering committee membership ; Sanofi: Honoraria, Other: steering committee membership steering committee membership ; Novartis: Honoraria, Other: steering committee membership ; Roche: Honoraria; Gilead: Honoraria; Incyte: Honoraria, Other: steering committee membership ; Karyopharm: Honoraria. Berdeja:Celgene: Research Funding; Sanofi: Research Funding; Glenmark: Research Funding; Bristol-Myers Squibb: Research Funding; Amgen: Research Funding; Takeda: Research Funding; Janssen: Research Funding; Novartis: Research Funding; Genentech: Research Funding; Bluebird: Research Funding; Teva: Research Funding; Poseida Therapeutics, Inc.: Research Funding. Davies:Takeda: Consultancy, Membership on an entity's Board of Directors or advisory committees; Janssen: Consultancy, Honoraria; Abbvie: Consultancy; Amgen: Consultancy, Membership on an entity's Board of Directors or advisory committees; MMRF: Honoraria; ASH: Honoraria; TRM Oncology: Honoraria; Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees. Weisel:Amgen, BMS, Celgene, Janssen, and Takeda: Honoraria; Amgen, Celgene, Janssen, and Sanofi: Research Funding; Amgen, BMS, Celgene, Janssen, Juno, Sanofi, and Takeda: Consultancy, Membership on an entity's Board of Directors or advisory committees. Usmani:Abbvie, Amgen, Celgene, Genmab, Merck, MundiPharma, Janssen, Seattle Genetics: Consultancy; Amgen, BMS, Celgene, Janssen, Merck, Pharmacyclics,Sanofi, Seattle Genetics, Takeda: Research Funding. Hungria:Janssen: Honoraria; Amgen: Honoraria; Takeda: Honoraria; Celgene: Honoraria. Boccadoro:Amgen: Honoraria, Research Funding; Sanofi: Honoraria, Research Funding; Janssen: Honoraria, Research Funding; Novartis: Honoraria, Research Funding; AbbVie: Honoraria; Bristol-Myers Squibb: Honoraria, Research Funding; Mundipharma: Research Funding; Celgene: Honoraria, Research Funding. Rifkin:McKesson: Equity Ownership; Boehringer Ingelheim: Consultancy; EMD Serono: Consultancy; Celgene: Consultancy; Takeda: Consultancy; Sandoz: Consultancy; Amgen: Consultancy. Zonder:Takeda: Honoraria; Pharmacyclics: Other: DSMC; Alnylam: Honoraria; Coelum: Honoraria; BMS: Research Funding; Janssen: Honoraria; Celgene: Consultancy, Honoraria. Cook:Amgen, Bristol-Myers Squibb, GlycoMimetics, Celgene, Janssen and Takeda and Sanofi: Honoraria; Celgene, Janssen and Takeda: Research Funding. Ren:Takeda Pharmaceuticals International Co.: Employment. Cacioppo:Millennium Pharmaceuticals, Inc., Cambridge, MA, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Employment. Skacel:Millennium Pharmaceuticals, Inc., Cambridge, MA, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Employment; Department of Hematology, Charles University General Hospital, Prague, Czech Republic: Other: Affiliation. Stull:Millennium Pharmaceuticals, Inc., Cambridge, MA, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Employment. Maisnar:Janssen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Takeda: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; BMS: Membership on an entity's Board of Directors or advisory committees.

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Zeman, Adam. "18 The eye’s mind: perspectives on visual imagery." Journal of Neurology, Neurosurgery & Psychiatry 91, no. 8 (2020): e8.1-e8. http://dx.doi.org/10.1136/jnnp-2020-bnpa.18.

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Prof. Zeman trained in Medicine at Oxford University Medical School, after a first degree in Philosophy and Psychology, and later in Neurology in Oxford, at The National Hospital for Neurology in Queen Square, London and Addenbrooke’s Hospital, Cambridge. He moved to Edinburgh in 1996, as a Consultant and Senior Lecturer (later Reader) in the Department of Clinical Neurosciences and to the Peninsula Medical School (now University of Exeter Medical School) in September 2005 as Professor of Cognitive and Behavioural Neurology. His specialised clinical work is in cognitive and behavioural neurology, including neurological disorders of sleep.His main research interests are disorders of visual imagery and forms of amnesia occurring in epilepsy. He has an active background interest in the science and philosophy of consciousness, publishing a wide-ranging review of the field in Brain (2001; 124:1263–1289) and an accessible introduction to the subject for a general readership (Consciousness: a user’s guide, Yale University Press, 2002). In 2008 he published an introduction to neurology for the general reader, A Portrait of the Brain (Yale UP), and in 2012, Epilepsy and Memory (OUP) with Narinder Kapur and Marilyn Jones-Gotman. From 2007–2010 he was Chairman of the British Neuropsychiatry Association. He launched and continues to direct its training course in neuropsychiatry.For most of us visual imagery is a conspicuous ingredient of the imaginative experience which allows us to escape from the here and now into the past, the future and the worlds conceived by science and art. But there appears to be wide inter-individual variation in the vividness of visual imagery. Although the British psychologist Galton together with the Parisian neurologist Charcot and his psychiatrist colleague Cotard - recognised that some individuals may lack wakeful imagery entirely, the existence of ‘extreme imagery’ has been oddly neglected since this early work. In 2015 we coined the term ‘aphantasia’ to describe the lack of the mind’s eye, describing 21 individuals who reported a lifelong inability to visualise (Cortex, 2015;73:378–80). Since then we have heard from around 14,000 people, most reporting lifelong aphantasia, or its converse hyperphantasia, but also less common ‘acquired’ imagery loss resulting from brain injury or psychological disorder. Preliminary analyses suggests association between vividness extremes, occupational preference and reported abilities in face recognition and autobiographical memory. Many people with lifelong aphantasia nevertheless dream visually. Imagery in other modalities is variably affected. Extreme imagery appears to run in families more often than would be expected by chance. I will describe the findings of our recent pilot study of neuropsychological and brain imaging signatures of extreme imagery, and place our study of a- and hyper-phantasia in the context of the Eye’s Mind project, an interdisciplinary collaboration funded by the AHRC (http://medicine.exeter.ac.uk/research/neuroscience/theeyesmind/). In addition to our work on extreme imagery, we have reviewed the intellectual history of visual imagery (MacKisack et al, Frontiers in Psychology, 515:1–16. doi: 10.3389/fpsyg.2016.00515), undertaken a recent ALE meta-analysis of functional imaging studies of visualisation (Winlove et al, Cortex, 20182018; 105:4–25) and organised an exhibition of work by artists with extreme imagery vividness (Extreme Imagination: inside the mind’s eye Exeter University Press, 2018.)

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Tufail, Adnan, Venediktos V. Kapetanakis, Sebastian Salas-Vega, et al. "An observational study to assess if automated diabetic retinopathy image assessment software can replace one or more steps of manual imaging grading and to determine their cost-effectiveness." Health Technology Assessment 20, no. 92 (2016): 1–72. http://dx.doi.org/10.3310/hta20920.

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Background Diabetic retinopathy screening in England involves labour-intensive manual grading of retinal images. Automated retinal image analysis systems (ARIASs) may offer an alternative to manual grading. Objectives To determine the screening performance and cost-effectiveness of ARIASs to replace level 1 human graders or pre-screen with ARIASs in the NHS diabetic eye screening programme (DESP). To examine technical issues associated with implementation. Design Observational retrospective measurement comparison study with a real-time evaluation of technical issues and a decision-analytic model to evaluate cost-effectiveness. Setting A NHS DESP. Participants Consecutive diabetic patients who attended a routine annual NHS DESP visit. Interventions Retinal images were manually graded and processed by three ARIASs: iGradingM (version 1.1; originally Medalytix Group Ltd, Manchester, UK, but purchased by Digital Healthcare, Cambridge, UK, at the initiation of the study, purchased in turn by EMIS Health, Leeds, UK, after conclusion of the study), Retmarker (version 0.8.2, Retmarker Ltd, Coimbra, Portugal) and EyeArt (Eyenuk Inc., Woodland Hills, CA, USA). The final manual grade was used as the reference standard. Arbitration on a subset of discrepancies between manual grading and the use of an ARIAS by a reading centre masked to all grading was used to create a reference standard manual grade modified by arbitration. Main outcome measures Screening performance (sensitivity, specificity, false-positive rate and likelihood ratios) and diagnostic accuracy [95% confidence intervals (CIs)] of ARIASs. A secondary analysis explored the influence of camera type and patients’ ethnicity, age and sex on screening performance. Economic analysis estimated the cost per appropriate screening outcome identified. Results A total of 20,258 patients with 102,856 images were entered into the study. The sensitivity point estimates of the ARIASs were as follows: EyeArt 94.7% (95% CI 94.2% to 95.2%) for any retinopathy, 93.8% (95% CI 92.9% to 94.6%) for referable retinopathy and 99.6% (95% CI 97.0% to 99.9%) for proliferative retinopathy; and Retmarker 73.0% (95% CI 72.0% to 74.0%) for any retinopathy, 85.0% (95% CI 83.6% to 86.2%) for referable retinopathy and 97.9% (95% CI 94.9 to 99.1%) for proliferative retinopathy. iGradingM classified all images as either ‘disease’ or ‘ungradable’, limiting further iGradingM analysis. The sensitivity and false-positive rates for EyeArt were not affected by ethnicity, sex or camera type but sensitivity declined marginally with increasing patient age. The screening performance of Retmarker appeared to vary with patient’s age, ethnicity and camera type. Both EyeArt and Retmarker were cost saving relative to manual grading either as a replacement for level 1 human grading or used prior to level 1 human grading, although the latter was less cost-effective. A threshold analysis testing the highest ARIAS cost per patient before which ARIASs became more expensive per appropriate outcome than human grading, when used to replace level 1 grader, was Retmarker £3.82 and EyeArt £2.71 per patient. Limitations The non-randomised study design limited the health economic analysis but the same retinal images were processed by all ARIASs in this measurement comparison study. Conclusions Retmarker and EyeArt achieved acceptable sensitivity for referable retinopathy and false-positive rates (compared with human graders as reference standard) and appear to be cost-effective alternatives to a purely manual grading approach. Future work is required to develop technical specifications to optimise deployment and address potential governance issues. Funding The National Institute for Health Research (NIHR) Health Technology Assessment programme, a Fight for Sight Grant (Hirsch grant award) and the Department of Health’s NIHR Biomedical Research Centre for Ophthalmology at Moorfields Eye Hospital and the University College London Institute of Ophthalmology.

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Palmer, Stephen. "Reviews : Doing Research in General Dental Practice: A Practical Manual for General Dental Prac titioners By P J Holloway and H V Worthington Eden Bianchi Press ISBN 1 898 274 17 7 £5.00 per copy (which includes p&p) available from Mrs Helen Draper, Oral Health and Dev elopment, University Dental Hospital, Higher Cambridge Street, Manchester M15 6FH, UK. Cheques to be made payable to the University of Manchester." Health Education Journal 60, no. 1 (2001): 93. http://dx.doi.org/10.1177/001789690106000109.

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Debernardi, Silvana, Harrison O’Brien, Asma S. Algahmdi, et al. "A combination of urinary biomarker panel and PancRISK score for earlier detection of pancreatic cancer: A case–control study." PLOS Medicine 17, no. 12 (2020): e1003489. http://dx.doi.org/10.1371/journal.pmed.1003489.

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Background Pancreatic ductal adenocarcinoma (PDAC) is one of the deadliest cancers, with around 9% of patients surviving >5 years. Asymptomatic in its initial stages, PDAC is mostly diagnosed late, when already a locally advanced or metastatic disease, as there are no useful biomarkers for detection in its early stages, when surgery can be curative. We have previously described a promising biomarker panel (LYVE1, REG1A, and TFF1) for earlier detection of PDAC in urine. Here, we aimed to establish the accuracy of an improved panel, including REG1B instead of REG1A, and an algorithm for data interpretation, the PancRISK score, in additional retrospectively collected urine specimens. We also assessed the complementarity of this panel with CA19-9 and explored the daily variation and stability of the biomarkers and their performance in common urinary tract cancers. Methods and findings Clinical specimens were obtained from multiple centres: Barts Pancreas Tissue Bank, University College London, University of Liverpool, Spanish National Cancer Research Center, Cambridge University Hospital, and University of Belgrade. The biomarker panel was assayed on 590 urine specimens: 183 control samples, 208 benign hepatobiliary disease samples (of which 119 were chronic pancreatitis), and 199 PDAC samples (102 stage I–II and 97 stage III–IV); 50.7% were from female individuals. PDAC samples were collected from patients before treatment. The samples were assayed using commercially available ELISAs. Statistical analyses were performed using non-parametric Kruskal–Wallis tests adjusted for multiple comparisons, and multiple logistic regression. Training and validation datasets for controls and PDAC samples were obtained after random division of the whole available dataset in a 1:1 ratio. The substitution of REG1A with REG1B enhanced the performance of the panel to detect resectable PDAC. In a comparison of controls and PDAC stage I–II samples, the areas under the receiver operating characteristic curve (AUCs) increased from 0.900 (95% CI 0.843–0.957) and 0.926 (95% CI 0.843–1.000) in the training (50% of the dataset) and validation sets, respectively, to 0.936 in both the training (95% CI 0.903–0.969) and the validation (95% CI 0.888–0.984) datasets for the new panel including REG1B. This improved panel showed both sensitivity (SN) and specificity (SP) to be >85%. Plasma CA19-9 enhanced the performance of this panel in discriminating PDAC I–II patients from controls, with AUC = 0.992 (95% CI 0.983–1.000), SN = 0.963 (95% CI 0.913–1.000), and SP = 0.967 (95% CI 0.924–1.000). We demonstrate that the biomarkers do not show significant daily variation, and that they are stable for up to 5 days at room temperature. The main limitation of our study is the low number of stage I–IIA PDAC samples (n = 27) and lack of samples from individuals with hereditary predisposition to PDAC, for which specimens collected from control individuals were used as a proxy. Conclusions We have successfully validated our urinary biomarker panel, which was improved by substituting REG1A with REG1B. At a pre-selected cutoff of >80% SN and SP for the affiliated PancRISK score, we demonstrate a clinically applicable risk stratification tool with a binary output for risk of developing PDAC (‘elevated’ or ‘normal’). PancRISK provides a step towards precision surveillance for PDAC patients, which we will test in a prospective clinical study, UroPanc.

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Reinius, Marika, Saif S. Ahmad, Charles Crawley, Michael V. Williams, Jennie Wimperis, and George A. Follows. "High-Dose Methotrexate In The Treatment Of Primary Testicular Lymphoma." Blood 122, no. 21 (2013): 5108. http://dx.doi.org/10.1182/blood.v122.21.5108.5108.

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Abstract Background Primary testicular lymphoma (PTL) presents in most cases, histologically, as a diffuse large B-cell lymphoma. PTL has a propensity for metastases to the central nervous system (CNS) cited as 20% at 5 years. Bilateral testicular involvement is seen in 35% of cases. Treatment commonly consists of orchidectomy followed by Rituximab- cyclophosphamide, doxorubicin, vincristine and prednisolone (R-CHOP), intrathecal methotrexate (IT-MTX) and prophylactic radiotherapy to the contralateral testis. Administration of systemic high-dose MTX (HD-MTX), at 3 g/m2, has been proposed as an approach to improve CNS parenchymal penetration and may prevent the need for scrotal irradiation. From 2005 within the Anglia Cancer Network, HD-MTX was incorporated into standard treatment for patients with PTL, who were fit enough to receive high dose therapy. Here we report outcomes from the 2 largest lymphoma centres within the network. Method A retrospective review was carried out using medical records of patients with PTL treated with HD-MTX at Cambridge University Hospitals (CUH) and Norfolk and Norwich University Hospital (NNUH), UK, from 2005 onwards. Histological diagnoses were made via orchidectomy or testicular biopsy. Factors reviewed included: age, stage, ECOG performance status, presence of B symptoms and IPI score at diagnosis, treatment regimen, grade 3/4 toxicity and clinical outcome. Stage IV disease was excluded as it cannot be distinguished from a non-testicular primary. Results 10 patients were identified who met the search criteria. 6 were treated at CUH and 4 at NNUH. Median age at diagnosis was 61.5 (49-71). All patients presented with scrotal swelling and 30% had bilateral tumours. ECOG PS was 0 (90%) and 1 (10%). 80% had stage IE disease and 20% stage IIE (paraaortic). Median IPI was 1. Patients were planned to receive 6 cycles of R-CHOP21 with 3-6 cycles IT-MTX with 3 cycles HD-MTX (3 g/m2) administered between or after R-CHOP21. Patients at NNUH only also received radiotherapy at 30 Gy in 15 fractions to the contralateral testis +/- PA nodes if stage IIE disease. One NNUH patient did not receive IT-MTX and one CUH patient only received 2 cycles HD-MTX for logistical reasons. No grade 3 or 4 toxicities were noted. At time of submission with a median follow-up of 4.27 years, only 1 patient has relapsed within the bone marrow. He died of systemic disease but was not shown to have CNS relapse. One patient died of a non-PTL related cause. 8 patients remain in ongoing first remission. No cases of CNS or testicular relapse have been noted in our 10 patients including the 6 patients who did not receive scrotal irradiation. One patient at CUH with bilateral disease was diagnosed on biopsies alone. He underwent unilateral orchidectomy after completing systemic treatment demonstrating a complete response, despite no radiotherapy. He declined a second orchidectomy and remains relapse free at 5.91 years follow-up. Conclusion Treating PTL with HD-MTX, IT-MTX and R-CHOP has shown encouraging clinical outcomes in terms of treatment tolerability and disease-free survival at a median follow-up of 4.27 years. Accepting the small numbers, the absence of CNS relapse with this follow-up suggests prophylactic efficacy of HD-MTX. The finding that disease was eliminated in an in situ testis following treatment is also significant, given the standard practice of contralateral testicular irradiation. These results highlight the need for further prospective research to determine the role of HD-MTX in the management of PTL. Disclosures: No relevant conflicts of interest to declare.

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Sharples, Linda, Matthew Glover, Abigail Clutterbuck-James, et al. "Clinical effectiveness and cost-effectiveness results from the randomised controlled Trial of Oral Mandibular Advancement Devices for Obstructive sleep apnoea–hypopnoea (TOMADO) and long-term economic analysis of oral devices and continuous positive airway pressure." Health Technology Assessment 18, no. 67 (2014): 1–296. http://dx.doi.org/10.3310/hta18670.

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BackgroundObstructive sleep apnoea–hypopnoea (OSAH) causes excessive daytime sleepiness (EDS), impairs quality of life (QoL) and increases cardiovascular disease and road traffic accident risks. Continuous positive airway pressure (CPAP) treatment is clinically effective but undermined by intolerance, and its cost-effectiveness is borderline in milder cases. Mandibular advancement devices (MADs) are another option, but evidence is lacking regarding their clinical effectiveness and cost-effectiveness in milder disease.Objectives(1) Conduct a randomised controlled trial (RCT) examining the clinical effectiveness and cost-effectiveness of MADs against no treatment in mild to moderate OSAH. (2) Update systematic reviews and an existing health economic decision model with data from the Trial of Oral Mandibular Advancement Devices for Obstructive sleep apnoea–hypopnoea (TOMADO) and newly published results to better inform long-term clinical effectiveness and cost-effectiveness of MADs and CPAP in mild to moderate OSAH.TOMADOA crossover RCT comparing clinical effectiveness and cost-effectiveness of three MADs: self-moulded [SleepPro 1™ (SP1); Meditas Ltd, Winchester, UK]; semibespoke [SleepPro 2™ (SP2); Meditas Ltd, Winchester, UK]; and fully bespoke [bespoke MAD (bMAD); NHS Oral-Maxillofacial Laboratory, Addenbrooke’s Hospital, Cambridge, UK] against no treatment, in 90 adults with mild to moderate OSAH. All devices improved primary outcome [apnoea–hypopnoea index (AHI)] compared with no treatment: relative risk 0.74 [95% confidence interval (CI) 0.62 to 0.89] for SP1; relative risk 0.67 (95% CI 0.59 to 0.76) for SP2; and relative risk 0.64 (95% CI 0.55 to 0.76) for bMAD (p < 0.001). Differences between MADs were not significant. Sleepiness [as measured by the Epworth Sleepiness Scale (ESS)] was scored 1.51 [95% CI 0.73 to 2.29 (SP1)] to 2.37 [95% CI 1.53 to 3.22 (bMAD)] lower than no treatment (p < 0.001), with SP2 and bMAD significantly better than SP1. All MADs improved disease-specific QoL. Compliance was lower for SP1, which was unpopular at trial exit. At 4 weeks, all devices were cost-effective at £20,000/quality-adjusted life-year (QALY), with SP2 the best value below £39,800/QALY.Meta-analysisA MEDLINE, EMBASE and Science Citation Index search updating two existing systematic reviews (one from November 2006 and the other from June 2008) to August 2013 identified 77 RCTs in adult OSAH patients comparing MAD with conservative management (CM), MADs with CPAP or CPAP with CM. MADs and CPAP significantly improved AHI [MAD −9.3/hour (p < 0.001); CPAP −25.4/hour (p < 0.001)]. Effect difference between CPAP and MADs was 7.0/hour (p < 0.001), favouring CPAP. No trials compared CPAP with MADs in mild OSAH. MAD and CPAP reduced the ESS score similarly [MAD 1.6 (p < 0.001); CPAP 1.6 (p < 0.001)].Long-term cost-effectivenessAn existing model assessed lifetime cost–utility of MAD and CPAP in mild to moderate OSAH, using the revised meta-analysis to update input values. The TOMADO provided utility estimates, mapping ESS score to European Quality of Life-5 Dimensions three-level version for device cost–utility. Using SP2 as the standard device, MADs produced higher mean costs and mean QALYs than CM [incremental cost-effectiveness ratio (ICER) £6687/QALY]. From a willingness to pay (WTP) of £15,367/QALY, CPAP is cost-effective, although the likelihood of MADs (p = 0.48) and CPAP (p = 0.49) being cost-effective is very similar. Both were better than CM, but there was much uncertainty in the choice between CPAP and MAD (at a WTP £20,000/QALY, the probability of being the most cost-effective was 47% for MAD and 52% for CPAP). When SP2 lifespan increased to 18 months, the ICER for CPAP compared with MAD became £44,066. The ICER for SP1 compared with CM was £1552, and for bMAD compared with CM the ICER was £13,836. The ICER for CPAP compared with SP1 was £89,182, but CPAP produced lower mean costs and higher mean QALYs than bMAD. Differential compliance rates for CPAP reduces cost-effectiveness so MADs become less costly and more clinically effective with CPAP compliance 90% of SP2.ConclusionsMandibular advancement devices are clinically effective and cost-effective in mild to moderate OSAH. A semi-bespoke MAD is the appropriate first choice in most patients in the short term. Future work should explore whether or not adjustable MADs give additional clinical and cost benefits. Further data on longer-term cardiovascular risk and its risk factors would reduce uncertainty in the health economic model and improve precision of effectiveness estimates.Trial registrationThis trial is registered as ISRCTN02309506.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 18, No. 67. See the NIHR Journals Library website for further project information.

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Trump, Donald. "Commentary on: “Randomized, controlled, double-blind, cross-over trial assessing treatment preference for pazopanib versus sunitinib in patients with metastatic renal cell carcinoma: PISCES study.” Escudier B, Porta C, Bono P, Powles T, Eisen T, Sternberg CN, Gschwend JE, De Giorgi U, Parikh O, Hawkins R, Sevin E, Négrier S, Khan S, Diaz J, Redhu S, Mehmud F, Cella D. Bernard Escudier, Institut Gustave Roussy, Villejuif; Emmanuel Sevin, Centre François Baclesse, Caen; Sylvie Négrier, Leon Berard Cancer Center, Lyon, France; Camillo Porta, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Policlinico S. Matteo, Pavia; Cora N Sternberg, San Camillo Forlanini Hospital, Rome; Ugo De Giorgi, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, Italy; Petri Bono, Helsinki University Central Hospital, Helsinki, Finland; Thomas Powles, Barts Experimental Cancer Medicine Centre, Barts Cancer Institute, Queen Mary University of London, London; Tim Eisen, Cambridge University Health Partners, Cambridge; Omi Parikh, Royal Preston Hospital, Lancashire; Robert Hawkins, Christie Cancer Research UK, Manchester; Sadya Khan, Jose Diaz, and Faisal Mehmud, GlaxoSmithKline, Uxbridge, United Kingdom; Jürgen E Gschwend, Klinikum Rechts der Isar der Technischen Universität München, Munich, Germany; Suman Redhu, GlaxoSmithKline, Collegeville, PA; David Cella, Northwestern University Feinberg School of Medicine, Chicago, IL." Urologic Oncology: Seminars and Original Investigations 34, no. 5 (2016): 251. http://dx.doi.org/10.1016/j.urolonc.2015.03.015.

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"Language learning." Language Teaching 39, no. 4 (2006): 272–84. http://dx.doi.org/10.1017/s0261444806223851.

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