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1
D'Orangeville, L., D. Houle, B. Côté, L. Duchesne, and H. Morin. "Increased soil temperature and atmospheric N deposition have no effect on the N status and growth of a mature balsam fir forest." Biogeosciences 10, no. 7 (2013): 4627–39. http://dx.doi.org/10.5194/bg-10-4627-2013.
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Abstract. Nitrogen (N) is a major growth-limiting factor in boreal forest ecosystems. Increases of temperature and atmospheric N deposition are expected to affect forest growth directly and indirectly by increasing N availability due to higher rates of N mineralization. In order to understand the potential impacts of these changes, a mature balsam fir stand in Québec, Canada, was subjected during three consecutive growing seasons (2009–2011) to (i) experimentally increased soil temperature (4 °C) and earlier snowmelt (2–3 weeks) as well as (ii) increased inorganic N concentration in artificial precipitation (3 × current N concentrations using 15NH4-15NO3). Soil inorganic N was measured using buried ion-exchange membranes (PRS™ probes) and standard soil extractions. Dendrometers were used to monitor the variations in diameter growth and needles were analyzed annually for N to assess the nutritional response of trees. Results from the second (2010) and third (2011) year of treatment are reported. After three years of treatment, there was no significant increase in soil nitrate (NO3) or ammonium (NH4) availability either in the organic or in the mineral soil as measured with standard soil extractions. Similar results were obtained with ion-exchange membranes, except for NH4 in the forest floor, which increased by an average of 54% over the two years. No effect of treatments were observed on needle N or diameter growth, but an 8-day earlier peak in diameter growth was measured in heated plots in 2010. We attributed the limited effects of our treatments to the acute soil competition for available N at the site. As a result, the projected modifications of the forest N cycle and concomitant increased forest growth due to an earlier snowmelt, increased soil temperature and N deposition should be considered with caution in similar cold N-poor ecosystems.
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Herrick, Kirsten, Lauren 0'Connor, Sydney O'Connor, and Jill Reedy. "Temporal Eating Patterns Among U.S. Infants and Toddlers, NHANES 2011–2016." Current Developments in Nutrition 4, Supplement_2 (2020): 587. http://dx.doi.org/10.1093/cdn/nzaa047_007.
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Abstract Objectives As characterization of temporal eating patterns of U.S. infants and toddlers is limited, we aimed to explore eating frequency and interval, and to reveal relevant challenges related to investigation among this age group. Methods Using a single 24-hour recall from NHANES 2011–2016, we estimated eating frequency in categories (1–4, 5–7, 8–10, and ≥11 times per day) (%, Standard Error (SE)) and eating interval (mean, SE) in hours, by age group (0–5 months, 6–11 months, and 12–23 months) among infants and toddlers younger than 2 years old (n = 1704). Eating interval was defined as the last reported consumption time minus the first reported consumption time. SAS was used to incorporate weights and the complex survey design. We also explored describing the data by parent report of eating occasion (breakfast, lunch, dinner, supper, snack, etc.). Results Among children 0–23 months, 8% (SE 0.8), 54% (SE 1.3), 32% (SE 1.1), and 6% (SE 0.6) reported eating 1–4, 5–7, 8–10, and ≥11 times per day, respectively. The mean eating interval length decreased with increasing age category: 17.6 hours (SE 0.19), 15.6 hours (0.21), and 13.1 hours (SE 0.20), among infants and toddlers 0–5, 6–11, and 12–23 months (P < 0.001), respectively. Attempts to evaluate eating frequency by parent-reported eating occasion revealed misalignment of clock time with reported eating occasion. For example, a parent may report multiple eating occasions as “breakfast” in a given day between the hours of 6:00 AM and 10:00 PM, interspersed among other eating occasions reported as lunch, snack, or dinner. Conclusions There is a dearth of national data on the eating habits of infants and toddlers younger than 2 years, and even less is known about the temporal eating patterns for this group. We found that more than half of infants and toddlers reported 5–7 eating occasions on a given day and that toddlers 12–23 months had shorter eating intervals compared to infants 0–5 and 6–12 months. We also found some discordance with how eating occasions were reported among infants and toddlers, as the naming does not align with more typical classification that is used among older children and adults. Therefore, caution is advised when characterizing temporal eating patterns for this group. Funding Sources N/A
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Oki, Yasuhiro, Hubert Chuang, Beth Chasen, et al. "The Prognostic Value of Interim PET Scan in Patients with Classical Hodgkin Lymphoma." Blood 120, no. 21 (2012): 1529. http://dx.doi.org/10.1182/blood.v120.21.1529.1529.
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Abstract Abstract 1529 The interim PET scan has prognostic value in pts with cHL. Because the outcome of ptswho have positive interim PET scans was dismal in previous reports, multiple clinical trials are ongoing using the interim PET to guide treatment decisions, but these are mostly non-randomized studies. We performed a retrospective study analyzing the prognostic role of the interim PET scan for predicting event free survival (EFS) for early stage (I and II non-bulky) and advanced stage (II-bulky, III and IV) cHL treated with standard ABVD with or without radiation therapy. This study was approved by the institutional review board. Interim PET results (positive or negative) were collected from the clinical reports of PET scans which were based on visual interpretation. A total of 327 pts diagnosed between 01/2001 and 05/2011, and had interim PET scan after 2 (PET2; n=231) or 3 (PET3; n=96) cycles were reviewed. The median follow up duration of surviving pts was 45 months (range 2–130 months). For pts with advanced stage disease, 5-year EFS rates in PET2-negative (n=79) and PET2-positive (n=20) groups were 75% and 54%, respectively (p=0.027). For pts with low IPS scores (0–2), 5-year EFS rates in PET2-negative (n=60) and PET2-positive (n=15) groups were 77% and 53%, respectively (p=0.02). For pts with high IPS scores (3–7), 5-year EFS rates in PET2-negative (n=19) and PET2-positive (n=5) groups were 69% and 50%, respectively (p=0.76). In pts with early stage disease, 5-year EFS rates in PET2-negative (n=107) and PET2-positive (n=25) groups were 98% and 65%, respectively (p<0.01). PET3 had little prognostic value for EFS for pts with early stage or advanced stage diseases, though the number of pts analyzed was smaller. There have been significant changes in PET technology, methodology, and interpretation criteria. To minimize these factors, we next selected 118 pts whose PET2 were performed between 03/2008 and 05/2011. The PET scans from theres patients were blindly and independently re-reviewed without information on clinical outcome, by two nuclear radiologist based on Deauville criteria. For pts with advanced stage disease, 2-year EFS rates for pts with negative PET2 (n=47) and positive PET2 (n=5) scans were 68% and 60%, respectively (p=0.59). For pts with early stage diseases, 2-year EFS rates for pts with negative PET2 (n=55) and positive PET2 (n=11) scans were 98% and 47%, respectively (p<0.01). In conclusion, this study confirmed that PET2 results remain prognostic, not only for advanced stage disease but more significantly for early stage cHL. However, pts with advanced stage disease whose PET2 was positive had 5-year EFS of 54% (2001–2011), which seems far better than previous reports. Interim-PET guided treatment decisions are not currently recommended outside of clinical trials. Randomized trials will be required to determine whether change of therapy based on PET2 status will improve treatment outcome. Disclosures: Fanale: MedImmune: Research Funding.
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Sulardiono, Bambang o., Pujiono Wahyu Purnomo, and Haeruddin Haeruddin. "TINGKAT KESESUAIAN LINGKUNGAN PERAIRAN HABITAT TERIPANG (ECHINODERMATA : HOLOTHUROIDAE) DI KARIMUNJAWA (Environmental Suitability for Holothuroidea Habitat in Karimunjawa)." SAINTEK PERIKANAN : Indonesian Journal of Fisheries Science and Technology 12, no. 2 (2017): 93. http://dx.doi.org/10.14710/ijfst.12.2.93-97.
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ABSTRAK Ekosistem terumbu karang Karimunjawa menyediakan habitat yang baik bagi kehidupan dan perkembangbiakan teripang. Di sisi lain, peningkatan beban limbah organik baik bersumber dari daratan maupun dari lingkungan perairan itu sendiri diduga menyebabkan daya dukung untuk kehidupan teripang menurun. Berdasarkan hal tersebut, bagaimana kondisi lingkungan perairan ditinjau dari kesesuaian lingkungan perairan habitat teripang. Pengukuran data kualitas air diambil pada 5 stasiun pengamatan. Data arus berdasarkan data pasang surut terendah, yang diperoleh dari pengukuran data pasang surut stasiun LPWP Jepara periode 2010-2011, pengukuran data variabel kedalaman perairan (m), suhu (°C), salinitas (‰), dan pH secara in situ, serta pengukuran kandungan oksigen terlarut (mg/l) secara laboratoris. Analisis data tingkat kesesuaian lingkungan teripang didasarkan atas beberapa kriteria penting yang harus dipenuhi, yaitu kondisi lingkungan yang sesuai dengan standar kriteria kesesuaian, meliputi kisaran dibawah baku mutu dengan skor (1), kisaran toleransi dengan skor (2), dan kisaran optimal dengan skor 3. Selanjutnya dilakukan pembobotan setiap variabel dalam 3 kelas bobot yang diukur berdasarkan tingkat pengaruh masing-masing variable. Berdasarkan hasil perhitungan total skor (Y) dari 6 variabel kualitas perairan.diperoleh jumlah skor tertinggi 54 dan terendah 6, sedangkan berdasarkan nilai interval kelas kesesusian (I) sebesar 16. Hasil analisis skor per kelas adalah (a) 39–54 = Sesuai (S1), (b) 23–38 = Cukup Sesuai (S2), dan (c) 6–22 = Tidak Sesuai (N). Hasil analisis diperoleh informasi bahwa kondisi lingkungan perairan cukup sesuai bagi kehidupan teripang. Kata kunci: Kesesuaian, habitat, teripang ABSTRACT The Karimunjawa waters reef ecosystem provides a good habitat for the life and breeding of sea cucumbers. On the other hand, the increased burden of organic waste both from the mainland and from the water environment itself is thought to cause the carrying capacity for the life of sea cucumbers declined. Based on this, then how the condition of the aquatic environment in terms of the suitability of the marine environment habitat sea cucumbers. Measurement of water quality data was taken at 5 observation stations. Current data based on the lowest tidal data, obtained from the measurement of the tidal data of LPWP station Jepara period 2010-2011. Measurement of water depth variable (m), temperature (°C), salinity (‰), and pH in situ, and dissolved oxygen content (mg/l) in laboratory. The data analysis of the suitability level of sea cucumber is based on several important criteria that must be fulfilled, that is environmental condition in accordance with standard of conformity criterion, covering range below standard quality with score (1), tolerance range with score (2), and optimal range with score 3, Then weighted each variable in 3 weight classes measured by the influence level of each variable, Based on the result of total score calculation (Y) from 6 water quality variables. Based on the result of total score (Y) of 6 water quality variables. Obtained by the highest score 54 and lowest 6, whereas based on the value of interval of suitability class (I) of 16. The result of the score analysis per class is (a) 39–54 = Suitable (S1), (b) 23–38 = quite suitable (S2), and (c) 6–22 = Not Match (N). The result of the analysis obtained information that the condition of the aquatic environment is quite suitable for the life of sea cucumber. Keywords: Conformity, habitat, sea cucumber
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Urke, Helga Bjørnøy, Maurice B. Mittelmark, and Martín Valdivia. "Trends in stunting and overweight in Peruvian pre-schoolers from 1991 to 2011: findings from the Demographic and Health Surveys." Public Health Nutrition 17, no. 11 (2014): 2407–18. http://dx.doi.org/10.1017/s1368980014000275.
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AbstractObjectiveTo examine trends in stunting and overweight in Peruvian children, using 2006 WHO Multicentre Growth Reference Study criteria.DesignTrend analyses using nationally representative cross-sectional surveys from Demographic and Health Surveys (1991–2011). We performed logistic regression analyses of stunting and overweight trends in sociodemographic groups (sex, age, urban–rural residence, region, maternal education and household wealth), adjusted for sampling design effects (strata, clusters and sampling weights).SettingPeru.SubjectsChildren aged 0–59 months surveyed in 1991–92 (n 7999), 1996 (n 14 877), 2000 (n 11 754), 2007–08 (n 8232) and 2011 (n 8186).ResultsChild stunting declined (F(1, 5149) = 174·8, P ≤ 0·00) and child overweight was stable in the period 1991–2011 (F(1, 5147) = 0·4, P ≤ 0·54). Over the study period, levels of stunting were highest in rural compared with urban areas, the Andean and Amazon regions compared with the Coast, among children of low-educated mothers and among children living in households in the poorest wealth quintile. The trend in overweight rose among males in coastal areas (F(1, 2250) = 4·779, P ≤ 0·029) and among males in the richest wealth quintile (F(1, 1730) = 5·458, P ≤ 0·020).ConclusionsThe 2011 levels of stunting and overweight were eight times and three and a half times higher, respectively, than the expected levels from the 2006 WHO growth standards. The trend over the study period in stunting declined in most sociodemographic subgroups. The trend in overweight was stable in most sociodemographic subgroups.
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Moxon-Emre, Iska, Eric Bouffet, Michael D. Taylor, et al. "Impact of Craniospinal Dose, Boost Volume, and Neurologic Complications on Intellectual Outcome in Patients With Medulloblastoma." Journal of Clinical Oncology 32, no. 17 (2014): 1760–68. http://dx.doi.org/10.1200/jco.2013.52.3290.
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Purpose To examine the impact of radiation (ie, craniospinal irradiation [CSR] dose and boost volume) and complications (ie, hydrocephalus and other neurologic complications, including mutism) on patterns of change in intellectual functioning in medulloblastoma survivors. Patients and Methods We conducted a retrospective review of 113 patients treated for medulloblastoma between 1983 and 2011 who were seen for neuropsychological assessment, including longitudinal follow-up of intellectual function. Patients were treated with either standard-dose CSR with a posterior fossa (PF) boost (n = 51), standard-dose CSR plus tumor bed (TB) boost (n = 9), reduced-dose CSR plus PF boost (n = 28), or reduced-dose CSR plus TB boost (n = 23), with or without chemotherapy. A subset of patients developed hydrocephalus that required cerebrospinal fluid (CSF) diversion (n = 54) and/or other neurologic complications (n = 40), more than half of which were postoperative mutism (n = 25). Growth curve analysis was used to determine stability or change in intelligence scores over time. Results Patients treated with reduced-dose CSR plus TB boost showed stable intellectual trajectories, whereas patients treated with higher doses and larger boost volumes experienced intellectual declines. Presence of complications was associated with worse intellectual outcome; however, hydrocephalus requiring CSF diversion and mutism differed in their pattern of decline. Conclusion These results improve our understanding of factors that impair intellectual outcome in patients treated for medulloblastoma. Lower doses of CSR and smaller boost volumes seem to mitigate intellectual decline. Our findings validate the use of TB boost and suggest PF boost should be reconsidered.
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Korevaar, Daniël A., Eleanor A. Ochodo, Patrick M. M. Bossuyt, and Lotty Hooft. "Publication and Reporting of Test Accuracy Studies Registered in ClinicalTrials.gov." Clinical Chemistry 60, no. 4 (2014): 651–59. http://dx.doi.org/10.1373/clinchem.2013.218149.
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Abstract BACKGROUND Failure to publish and selective reporting are recognized problems in the biomedical literature, but their extent in the field of diagnostic testing is unknown. We aimed to identify nonpublication and discrepancies between registered records and publications among registered test accuracy studies. METHODS We identified studies evaluating a test's accuracy against a reference standard that were registered in ClinicalTrials.gov between January 2006 and December 2010. We included studies if their completion date was set before October 2011, allowing at least 18 months until publication. We searched PubMed, EMBASE, and Web of Science and contacted investigators for publications. RESULTS We included 418 studies, of which 224 (54%) had been published by mid-2013. Among studies that had been completed at least 30 months before our analyses, 45% were published within 30 months after their completion. Publication rates were high in studies registered after study completion (76%) and low for studies with an unknown (rather than completed) study status (36%). After we excluded these 2 categories, study duration was the only characteristic significantly associated with publication, with lower rates in studies lasting up to 1 year (39%) compared to studies of 13–24 months (62%) or longer (67%) (P = 0.01). In the 153 published studies that had been registered before completion, 49 (32%) showed discrepancies between the registry and publication regarding inclusion criteria (n = 19), test/threshold (n = 9), and outcomes (n = 32). CONCLUSIONS Failure to publish and selective reporting are prevalent in test accuracy studies. Their registration should be further promoted among researchers and journal editors.
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Knauf, Wolfgang Ulrich, Wolfgang Abenhardt, Arnd Nusch, Renate Grugel, and Norbert Marschner. "Bendamustine-Rituximab (BR) Replaces R-CHOP As “Standard of Care” in the Treatment of Indolent Non-Hodgkin Lymphoma in German Hematology Outpatient Centres." Blood 120, no. 21 (2012): 3666. http://dx.doi.org/10.1182/blood.v120.21.3666.3666.
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Abstract Abstract 3666 Introduction With the FDA and EMA approval of Bendamustine a new treatment option has recently become available to patients (pts) with indolent (low-grade) non-Hodgkin lymphoma (iNHL). Clinical registries provide insight into real-life treatment of pts. They can help to answer the question whether patients may benefit from new research findings. Methods The clinical registry on lymphoid neoplasms (TLN Registry), conducted by iOMEDICO in collaboration with the Arbeitskreis Klinische Studien (AKS) and the Kompetenznetz Maligne Lymphome (KML), prospectively collects data on the treatment of pts with lymphoid B-cell neoplasms as administered in hematology outpatient centres in Germany. Pts are followed for 5 years. A broad set of data regarding patient and tumor characteristics, comorbidities, all systemic treatments, response rates, progression-free survival and overall survival are recorded. Since May 2009, 106 sites have actively recruited a total of 2579 pts. Results From the overall sample, 645 pts received systemic 1st-line treatment for indolent Non-Hodgkin lymphoma (iNHL). 53% of pts are male, mean age at time of primary diagnosis was 65 years (yrs) and at start of therapy 66 yrs. Tumor stage was 7% Stage I, 15% Stage II, 25% Stage III and 54% Stage IV. 61% of pts (n=387) were diagnosed with at least one comorbidity, mainly hypertension (33%) or diabetes (12%); the average Charlson Comorbity Index of 0.6 indicates that pts have few comorbities. Rituximab is part of the 1st-line treatment in 94% (n=606) of pts with iNHL. Bendamustine is part of the 1st-line treatment in 71% (n=455) of pts with iNHL. It is mostly applied in combination with Rituximab (BR, 66%, n=428). Further 2% (n=10) receive Bendamustin as monotherapy. Rituximab/Cyclophosphamide/Doxorubicin/Vincristine/Prednisone (R-CHOP) as 1st-line treatment is applied in 16% (n=105) of pts with iNHL. Pts receiving BR or R-CHOP differ. Pts characteristics indicate that BR is applied preferably in elderly pts (mean 67.3 vs. 60.9 yrs). However, BR is the preferred treatment also in pts younger than 66 yrs (60% vs. 23%). The use of BR has increased from 62% in 2009 to 68% in 2011, whereas the rate of R-CHOP has decreased from 19% in 2009 to 15% in 2011. Of all pts with iNHL, 121 have received 2nd-line treatment. Rituximab is part of the 2nd-line treatment in 84% (n=102) of pts with iNHL. Bendamustine is part of the 2nd-line treatment in 68% (n=82) of pts with iNHL. It is mostly applied in combination with Rituximab (BR, 60%, n=72). Further 7% (n=9) receive Bendamustin as monotherapy. R-CHOP as 2nd-line treatment is applied in 7% (n=9) of pts with iNHL. Conclusion BR is the most frequently used systemic treatment for pts with iNHL in German hematology outpatient centres. The use of BR has continuously increased since 2009. In contrast, the use of R-CHOP has decreased. This indicates that in Germany R-CHOP can no longer be considered as “standard of care” for pts with iNHL. These data also show that results from clinical trials are quickly implemented into daily practice. The impact of BR on quality of life and survival remains to be of central interest in the future. Disclosures: Knauf: Mundipharma GmbH: Honoraria, Membership on an entity's Board of Directors or advisory committees.
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D'Orangeville, L., D. Houle, B. Côté, L. Duchesne, and H. Morin. "Three years of increased soil temperature and atmospheric N deposition have no effect on the N status and growth of a mature balsam fir forest." Biogeosciences Discussions 10, no. 1 (2013): 1313–43. http://dx.doi.org/10.5194/bgd-10-1313-2013.
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Abstract. Nitrogen (N) is a major growth-limiting factor in boreal forest ecosystems. Increases of temperature and atmospheric N deposition are expected to affect forest growth directly and indirectly, by increasing N availability due to higher rates of N mineralization. In order to understand the potential impacts of these changes, a mature balsam fir stand in Québec, Canada, was subjected to (i) experimentally increased soil temperature (4 °C) and earlier snowmelt (2–3 weeks) as well as (ii) increased inorganic N concentration in artificial precipitation (3 × current N concentrations using 15NH4–15NO3). Soil inorganic N was measured using buried ion exchange membranes (PRS™-probes) and standard soil extractions. Dendrometers were used to monitor the variations in diameter growth and needles were analyzed annually for N to assess the nutritional response of trees. After three years of treatment, there was no significant increase in soil nitrate (NO3) or ammonium (NH4) availability either in the organic or in the mineral soil as measured with standard soil extractions. Similar results were obtained with ion exchange membranes, except for an average 54% increase in the forest floor available NH4. No effect of treatments were observed on needle N or diameter growth, but an eight-day earlier peak in diameter growth was measured in heated plots in 2010. We attributed the limited effects of our treatments to the acute soil competition for available N at the site. As a result, the projected modifications of the forest N cycle and concomitant increased forest growth due to an earlier snowmelt, increased soil temperature and N deposition should be considered with caution in similar cold N-poor ecosystems.
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Leal, Alexis D., Kunal C. Kadakia, Sherry Looker, et al. "Fosaprepitant-induced phlebitis: A focus on patients receiving doxorubicin/cyclophosphamide therapy." Journal of Clinical Oncology 31, no. 15_suppl (2013): e20605-e20605. http://dx.doi.org/10.1200/jco.2013.31.15_suppl.e20605.
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e20605 Background: Intravenous (IV) fosaprepitant is a potent antiemetic, commonly used in patients receiving chemotherapy. The purpose of this study was to investigate the incidence of IV fosaprepitant-associated infusion site adverse events (ISAEs) among a cohort of breast cancer patients receiving doxorubicin and cyclophosphamide (AC) chemotherapy at Mayo Rochester. Methods: A retrospective review of electronic medical record (EMR) data was performed for all patients who were initiated on AC chemotherapy from January 2011 to April 2012. Data collected from the EMR included baseline demographics, antiemetic regimen, documentation of ISAEs and type of IV access (peripheral vs. central). Descriptive statistics (mean and standard deviation or percentages) were summarized overall and by type of IV access and initially administered antiemetic. Results: 148 patients were included, with a median age of 54 years (range 28-76). 98 patients initially received IV fosaprepitant; 44 oral aprepitant; 6 neither. 132 (89%) initially had peripheral IV access and 16 (11%) had central venous access. Overall, 33 patients (34%) experienced an IV fosaprepitant associated ISAE including: erythema (n=22), pain (n=26), swelling (n=12), infusion site hives (n=5), extravasation (n=4), deep venous thrombosis (n=3), superficial thrombosis (n=7), phlebitis/thrombophlebitis (n=5), venous discoloration (n=1), venous engorgement (n=1), venous hardening/induration (n=4) and local scarring (n=1). Only 1 patient (2%) experienced an oral aprepitant associated ISAE, which was infusion site pain. This patient had previously had a fosaprepitant associated ISAE at the same site. All experienced ISAEs occurred in patients with peripheral IV access. Conclusions: The incidence and severity of ISAEs associated with IV fosaprepitant administration among a group of patients receiving doxorubicin/cyclophosphamide chemotherapy is significant and is appreciably higher than what has been noted in other reports. The higher incidence observed is likely related to the predominance of peripheral venous access used in the studied cohort.
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Kantarcioglu, Murat, Bahadir Caliskan, Hakan Demirci, et al. "The Efficacy of Mesenchymal Stem Cell Transplantation in Caustic Esophagus Injury: An Experimental Study." Stem Cells International 2014 (2014): 1–7. http://dx.doi.org/10.1155/2014/939674.
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Introduction.Ingestion of corrosive substances may lead to stricture formation in esophagus as a late complication. Full thickness injury seems to exterminate tissue stem cells of esophagus. Mesenchymal stem cells (MSCs) can differentiate into specific cell lineages and have the capacity of homing in sites of injury.Aim and Methods.We aimed to investigate the efficacy of MSC transplantation, on prevention of esophageal damage and stricture formation after caustic esophagus injury in rats. 54 rats were allocated into four groups; 4 rats were sacrificed for MSC production. Group 1, untreated controls (n: 10). Group 2, membrane labeled MSCs-treated rats (n: 20). Group 3, biodistribution of fluorodeoxyglucose labeled MSCs via positron emission tomography (PET) imaging (n: 10). Group 4, sham operated (n: 10). Standard caustic esophageal burns were created and MSCs were transplanted 24 hours after. All rats were sacrificed at the 21st days.Results.PET scan images revealed the homing behavior of MSCs to the injury site. The histopathology damage score was not significantly different from controls. However, we demonstrated Dil labeled epithelial and muscle cells which were originating from transplanted MSCs.Conclusion.MSC transplantation after caustic esophageal injury may be a helpful treatment modality; however, probably repeated infusions are needed.
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Metges, Jean-Philippe, Jean François Ramée, Roger Faroux, et al. "Efficacy and safety of FOLFIRINOX in patients with pancreatic metastatic cancer." Journal of Clinical Oncology 31, no. 4_suppl (2013): 248. http://dx.doi.org/10.1200/jco.2013.31.4_suppl.248.
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248 Background: Efficacy and safety of a combination chemotherapy regimen consisting of oxaliplatin, irinotecan, fluorouracil, and leucovorin (FOLFIRINOX) is one of the gold standard in metastatic pancreatic cancer as first-line therapy for patients with PS 0-1, good haematological and renal function and a subnormal bilirubin level. Pending approval, this treatment has been allowed in Brittany (B) and Pays de la Loire (PL) respecting these criteria. Methods: Observatory of Cancer B/PL is a network of 50 private/public cancer centers focused on good practice for cancer drugs use. Our aim is to evaluate the use of FOLFIRINOX between July 2010 and June 2013 in B/PL. Sex, age, successive chemotherapeutic regimens, toxicities, response rate, progression free survival (PFS) and overall survival (OS) have been studied. Results: Data of 79 patients, treated in 2010 (37%), in 2011 (54%) or early 2012 (9%) have been studied (44 men, median age 62 years [37-74]). 64 patients were metastatic when cancer was diagnosed. Principal site of metastases was liver (73%). 17 primary tumors were resected and 15 patients received an adjuvant chemotherapy (gemcitabine (n=14)).The median number of treatment cycles was 9 [1-24]. Objective response was observed in 29 patients (37%), disease stabilization in 18 patients (23%) and progression in 18 patients (23%). During treatment, 75% of patients had a dose adjustment and 30 % had one or more dose delays. 22 patients presented grade III/IV toxicity (almost neurotoxicity or haematologic). 42 patients had a second line of treatment (mainly gemcitabine) and 7 patients a third line. The median PFS and OS were respectively 174 days IC95% [125-216] and 309 days IC 95% [229-376]. Conclusions: Our preliminary results are relatively convenient with those of Conroy et al in 2011. A higher rate of response (37% vs 32%) has been found. Concerning PFS and OS, our results are clearly worst with 174 vs 195 days and 309 vs 338 days. Our results confirm the aggressiveness of this schedule with 75% of the patients requiring a dose adjustement. Analysis of all pancreatic metastatic patients treated by FOLFIRINOX in B/PL by the Observatory of Cancer allows to assess its good use in the real life.
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Shah, Manish A., Yelena Y. Janjigian, Ronald Stoller, et al. "Randomized Multicenter Phase II Study of Modified Docetaxel, Cisplatin, and Fluorouracil (DCF) Versus DCF Plus Growth Factor Support in Patients With Metastatic Gastric Adenocarcinoma: A Study of the US Gastric Cancer Consortium." Journal of Clinical Oncology 33, no. 33 (2015): 3874–79. http://dx.doi.org/10.1200/jco.2015.60.7465.
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Purpose Docetaxel, cisplatin, and fluorouracil (DCF) is a standard first-line three-drug chemotherapy regimen for advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma and is associated with significant toxicity. We examined the safety and efficacy of a modified DCF (mDCF) regimen in a randomized multicenter phase II study. Patients and Methods Previously untreated patients with metastatic gastric or GEJ adenocarcinoma were randomly assigned to receive either mDCF (fluorouracil 2,000 mg/m2 intravenously [IV] over 48 hours, docetaxel 40 mg/m2 IV on day 1, cisplatin 40 mg/m2 IV on day 3, every 2 weeks) or parent DCF (docetaxel 75 mg/m2, cisplatin 75 mg/m2, and fluorouracil 750 mg/m2 IV over 5 days with granulocyte colony-stimulating factor, every 3 weeks). The study had 90% power to differentiate between 6-month progression-free survival of 26% and 43%, with type I and II error rates of 10% each. An early stopping rule for toxicity was included, defined as grade 3 to 4 adverse event rate > 70% in the first 3 months. Results From November 2006 to June 2010, 85 evaluable patients were enrolled (male, n = 61; female, n = 24; median age, 58 years; Karnofsky performance status, 90%; GEJ, n = 28; gastric, 57). mDCF (n = 54) toxicity rates included 54% grade 3 to 4 toxicity (22% hospitalized) within the first 3 months and 76% grade 3 to 4 toxicity over the course of treatment. The DCF arm (n = 31) closed early because of toxicity, with rates of 71% grade 3 to 4 toxicity (52% hospitalized) within 3 months and 90% grade 3 to 4 toxicity over the course of treatment. Six-month PFS was 63% (95% CI, 48% to 75%) for mDCF and 53% (95% CI, 34% to 69%) for DCF. Median overall survival was improved for mDCF (18.8 v 12.6 months; P = .007). Conclusion mDCF is less toxic than parent DCF, even when supported with growth factors, and is associated with improved efficacy. mDCF should be considered a standard first-line option for patients with metastatic gastric or GEJ adenocarcinoma.
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Nishida, Aya, Hikari Ota, Kazuya Ishiwata, et al. "Comparative Outcomes of Reduced-Intensity and Myeloablative Conditioning in Unrelated Cord Blood Transplantation for Adult Standard-Risk Hematological Diseases." Blood 120, no. 21 (2012): 4498. http://dx.doi.org/10.1182/blood.v120.21.4498.4498.
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Abstract Abstract 4498 Background: Unrelated cord blood transplantation (uCBT) using reduced-intensity conditioning (RIC) is increasingly used for older and medically unfit patients. Data on the efficiency of hematopoietic stem cell transplantation (HCT) after RIC in younger and standard-risk patients are limited relative to myeloablative conditioning (MAC). Objective and method: To compare the outocomes of RIC to MAC in uCBT for adult patients with standard-risk hematological diseases, we retrospectively reviewed medical records of 57 standard risk hematological disease patients who underwent first uCBT at Toranomon Hospital from Jan. 2005 to December.2011. The definition of standard risk disease is severe aplastic anemia (SAA), myelodysplastic syndrome (MDS) in RA, RARS, and RCMD, acute myeloid or lymphoid leukemia (AML, ALL) in complete remission (CR) 1 or 2, chronic myeloid leukemia (CML) in chronic phase, malignant lymphoma (ML) and adult T-cell leukemia (ATL) in CR. RIC and MAC are defined according to previously reported criteria. Result: The median age of the studied patients was 55 years (range; 26–70). Twenty nine of patients received RIC and 28 MAC. Eleven patients of SAA, 7 MDS, 17 AML, 12 ALL, 5 CML, 2 ML, and 3 ATL were included in this study. Median follow-up days of survivors was 299 (11–2522). Cumulative incidence of neutrophil engraftment was 89.2% and the median days of engraftment is 20 days (11–51). Cumulative incidence of grade 2 to 4 acute graft versus host disease (aGVHD) was 42.9%. The 5-year disease-free and overall survival (DFS and OS) rates were 49.1% and 42.6%, respectively. The 5-years OS was comparable between MAC and RIC (RIC= 52.1% versus MAC= 44.2%; P=0.90). The 5-years OS of the elderly patients >54 years (n=27, 47%) were significantly lower than that in the younger patients (n=30, 53%) (35.1% versus 63.7%; P=0.042). The 5-years transplant-related mortality (TRM) was comparable between MAC and RIC (RIC= 35.0% versus MAC= 28.6%; P=0.56). The relapse rate was also comparable in two groups (RIC=11.9% versus MAC=33.6%; P=0.2) Conclusion: This study showed that uCBT with RIC for standard risk disease patients with median age of 55 years old had the similar results as MAC regimens in the 5-years OS, DFS, TRM and relapse rate. Disclosures: No relevant conflicts of interest to declare.
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Silva, Andrisley Joaquim da, Fernando França da Cunha, Cassiano Garcia Roque, Monice Donatila Tavares da Silva, Diego Oliveira Ribeiro, and Manuel Rodrigues Carballal. "Replacement of liming and NPK fertilization with turkey litter in degraded areas grown with Urochloa decumbens." Semina: Ciências Agrárias 39, no. 2 (2018): 467. http://dx.doi.org/10.5433/1679-0359.2018v39n2p467.
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Soil fertility and acidity correction in recovering areas require high doses of correctives and fertilizers. Therefore, the use of low-cost products may be an alternative in infertile areas. The objective of this study was to evaluate the effect of soil fertilization and correction methods on the yield of degraded areas cultivated with Urochloa decumbens and soil chemical attributes. The study was conducted in Orthic Quartzarenic Neosol in Mineiros, Goiás, Brazil, from October 2011 to September 2013. The experiment included soil samples treated with 2 Mg ha-1 of dolomitic limestone, a standard fertilizer (45, 54, and 75 kg ha-1 of N, P, and K, respectively), or 3 Mg ha-1 of turkey litter, and a control sample without correction/fertilization. Each treatment included four replicates in a completely randomized block design. The experimental plots consisted of areas of 4.0 m2 (2.0 ?? 2.0 m). The dry matter yield of forage grass and the following soil chemical attributes were evaluated: organic matter, hydrogen potential (pH in CaCl2), phosphorus (resin), potassium, calcium, magnesium, cation exchange capacity (CEC), and base saturation. The data were subjected to analysis of variance, and the means were compared using Tukey’s test at a level of significance of 0.05. Fertilization did not affect the pH, potassium, and CEC of the soil. Fertilization with turkey litter increased the levels of organic matter, phosphorus, calcium, magnesium, and base saturation compared with soils subjected to standard fertilization or liming. Furthermore, soils fertilized with turkey litter presented higher dry matter yield of Urochloa decumbens compared with unfertilized soils or soils subjected to acidity correction by liming but were not significantly different from soils treated with standard fertilizers. Therefore, fertilization with 3 Mg ha-1 of turkey litter is recommended for improving degraded pastures.
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Kalinka-Warzocha, Ewa, Javier Gallego Plazas, Laurent Mineur, et al. "Chemotherapy (CT) treatment patterns and neutropenia management in gastric cancer patients (pts) receiving myelosuppressive chemotherapy in Europe." Journal of Clinical Oncology 31, no. 4_suppl (2013): 128. http://dx.doi.org/10.1200/jco.2013.31.4_suppl.128.
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128 Background: Granulocyte-colony stimulating factor (G-CSF) primary prophylaxis (PP) is recommended for pts undergoing CT who are at overall high risk for febrile neutropenia (FN). No single CT regimen is recognized as standard in gastric cancer and few regimens are represented in G-CSF guidelines. We therefore evaluated neutropenia management in pts receiving CT for gastric cancer. Methods: This was a multicentre prospective observational study that enrolled pts sequentially from 11/2009 to 06/2011. Adult gastric cancer pts (any stage) with ≥3 cycles of myelosuppressive CT scheduled and an investigator-assessed overall FN risk ≥20% were eligible. The primary outcome was the proportion of pts who received PP G-CSF (G-CSF in days 1-7 of cycle 1). Secondary outcomes included FN incidence, chemotherapy administration, and G-CSF use. Posthoc analyses investigated the subgroup who received DCF, including modifications from standard DCF (Van Cutsem. JCO. 2006), and the G-CSF support given up to the first FN (G-CSF prophylaxis given per label in each cycle up to that in which FN occurred). Results: Of 209 pts enrolled, 199 were eligible and their data analyzed. The mean (±SD) age was 62 (±12) years, 76% were male, 17% were ECOG 2 and none ECOG 3-4; 47% were treatment naïve. Planned CT was palliative in 74% of pts; overall, 27 different backbone regimens were planned (10 triplet, 12 doublet, 5 single drug regimens). The most common regimen used was DCF (54 pts, 27%), predominantly given as modified DCF (41 pts). Despite being assessed as high risk for FN, G-CSF PP was administered to only 35% of pts overall (n=70; 54 pegfilgrastim, 16 daily G-CSF) and to 69% of pts who received DCF. FN occurred in 14 pts (10%), 9 of whom received DCF. A large majority of FN pts (12/14, 86%) had not received prophylactic G-CSF per label up to the first FN occurrence; furthermore, 86% of FN pts did not receive G-CSF prophylaxis in the cycle following the FN event. Conclusions: The variety of CT used, frequent modifications to standard CT, and presence of pt risk factors makes FN risk estimation difficult in gastric cancer. Improved risk assessment and appropriate targeting of G-CSF PP to high risk pts is needed.
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Gomathi, K., IA Shaafie, K. Mummigatti, S. Shahid, and J. Sreedharan. "Biochemical Parameters in Women with Polycystic Ovary Syndrome in Ajman, UAE." Nepal Journal of Obstetrics and Gynaecology 6, no. 2 (2012): 7–10. http://dx.doi.org/10.3126/njog.v6i2.6748.
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Aims: Polycystic ovary syndrome (PCOS) is a common endocrine disorder affecting 5 -10% of women and is a major cause of anovulatory infertility. Prevalence varies among population based on genetic and environmental factors. Etiology of PCOS remains unknown but hyperandrogenism and insulin resistance have both been associated with PCOS. The aim of this study was to measure levels of Homocysteine and other biochemical parameters in women diagnosed with PCOS attending Gulf Medical College Hospital & Research Centre (GMCHRC), Ajman, UAE. Methods: Young women, aged between 18 and 35 years of age, diagnosed with PCOS (N =37), not on any treatment, attending GMCHRC were included in the study. Biochemical parameters were measured using standard procedures. Laboratory normal reference ranges were used for comparison. Results: 54 % of the women with PCOS were overweight or obese according to the Body mass index (BMI) and 51% had a waist circumference >88cm. Fasting and postprandial Glucose and Insulin levels and HOMA-IR were within the normal reference range indicating that no Insulin resistance was seen in these women. 40% of the women had a serum total Cholesterol level above 200 mg/dL, while Low Density Lipoprotein (LDL) Cholesterol was above and High Density Lipoprotein (HDL) cholesterol was lower than the desirable value. Serum Triacylglycerol was within the normal reference range. Serum Testosterone, Estradiol, Prolactin Thyroid Stimulating Hormone (TSH) and Plasma Homocysteine level were found to be within the normal reference ranges. Homocysteine levels correlated with Testosterone, total Cholesterol and LDL cholesterol levels. Conclusions: BMI was high in 54% of the women. No Insulin resistance was seen in these patients. Hormone levels and Homocysteine were within normal reference ranges. Dyslipidermia was observed. These findings differ from reports in literature where Insulin resistance, Hyperandrogenism and high Homocysteine levels have been associated with PCOS. NJOG 2011 Nov-Dec; 6 (2): 7-10 DOI: http://dx.doi.org/10.3126/njog.v6i2.6748
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Gerner, P., Andre Hörning, S. Kathemann, K. Willuweit, and S. Wirth. "Growth Abnormalities in Children with Chronic Hepatitis B or C." Advances in Virology 2012 (2012): 1–5. http://dx.doi.org/10.1155/2012/670316.
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Background. It has been suggested that chronic hepatitis B infection leads to growth impairment, but data are inconsistent and underlying factors are not defined.Methods. Children and adolescents with chronic hepatitis B (HBV) or C (HCV) were retrospectively evaluated for growth, weight, antiviral treatment, biochemical signs of liver inflammation, route of infection, and HBV DNA, respectively.Results. In all, 135 children (mean age 6.1 years, 81 male, 54 female) with HBV (n=78) or HCV (n=57) were studied. Route of infection was vertical in 50%, parenteral in 11%, and unknown in 39%. ALT levels were above 1.5 times above normal in 30% while 70% had normal/near normal transaminases. 80% were Caucasian, 14% Asian, 1% black, and 4% unknown. Mean baseline height measured in SDS was significantly lower in the study population than in noninfected children (boys −1.2, girls −0.4,P<0.01). 28 children were below 2 standard deviations of the norm while 5 were above 2 standard deviations. SDS measures in relation to individual factors were as follows: elevated ALT: boys −1.4, females −0.5 (P<0.01), ALT normal/near normal: boys +0.4, females +0.6; parenteral transmission: boys −3.3, girls −0.9 (P<0.01), vertical transmission: boys −0.2, females −0.2. Antiviral treatment itself or HBV-DNA load did not reach statistically significant differences.Conclusions. Chronic HBV or HCV may lead to compromised growth which is mostly influenced by liver inflammation. Our data may argue for early antiviral treatment in children with significant ALT elevation.
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Shultz, Sarah P., Jinsup Song, Andrew P. Kraszewski, et al. "An Investigation of Structure, Flexibility, and Function Variables that Discriminate Asymptomatic Foot Types." Journal of Applied Biomechanics 33, no. 3 (2017): 203–10. http://dx.doi.org/10.1123/jab.2016-0001.
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It has been suggested that foot type considers not only foot structure (high, normal, low arch), but also function (overpronation, normal, oversupination) and flexibility (reduced, normal, excessive). Therefore, this study used canonical regression analyses to assess which variables of foot structure, function, and flexibility can accurately discriminate between clinical foot type classifications. The feet of 61 asymptomatic, healthy adults (18–77 years) were classified as cavus (N = 24), rectus (N = 54), or planus (N = 44) using standard clinical measures. Custom jigs assessed foot structure and flexibility. Foot function was assessed using an emed-x plantar pressure measuring device. Canonical regression analyses were applied separately to extract essential structure, flexibility, and function variables. A third canonical regression analysis was performed on the extracted variables to identify a combined model. The initial combined model included 30 extracted variables; however 5 terminal variables (malleolar valgus index, arch height index while sitting, first metatarsophalangeal joint laxity while standing, pressure-time integral and maximum contact area of medial arch) were able to correctly predict 80.7% of foot types. These remaining variables focused on specific foot characteristics (hindfoot alignment, arch height, midfoot mechanics, Windlass mechanism) that could be essential to discriminating foot type.
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Kumar, Abhishek, Joseph Kamel Salama, and Matthew J. Boyer. "Utilization of local treatment modalities and surveillance in veterans with early stage renal cell carcinoma." Journal of Clinical Oncology 41, no. 6_suppl (2023): 643. http://dx.doi.org/10.1200/jco.2023.41.6_suppl.643.
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643 Background: Surgery represents the standard treatment for early stage renal cell carcinoma (RCC). For older patients, especially those with comorbidities including chronic kidney disease (CKD), there have been efforts made to spare renal function. The objective of this study was to evaluate the disease and treatment characteristics of Veterans with early stage RCC. Methods: We used the national Veterans Affairs’ Corporate Data Warehouse (CDW) database to identify patients diagnosed between 2000-2018 with early stage (cT1-2N0M0) RCC. Laboratory and diagnosis data were used to calculate creatinine clearance and Charlson comorbidity score. Chronic kidney disease (CKD) was defined as creatinine clearance < 60 milliliters per minute. The odds of receiving surveillance were evaluated with multivariable logistic regression. Results: Overall 19,555 Veterans with early stage RCC were included. The median age at diagnosis was 65, 90% range (48-82). 9,807 patients (50%) had at least 1 comorbidity and 4169 (21%) had multiple. Of 16,514 (84%) patients with available lab data, 1,359 (8%) patients had CKD. The treatments received were radical nephrectomy (RN) (N=4107, 21%), nephron sparing surgery (NSS) (N=5008, 26%), thermal ablation (N=489, 3%), and surveillance (N=9946, 51%). Compared to 2000-2010, from 2011-2018, there was a higher proportion of patients receiving NSS (29% vs. 20%, p < 0.01) and a lower proportion receiving surveillance (49% vs. 54%, p < 0.01). On multivariable logistic regression, predictors of receiving surveillance included older age (Odds Ratio [OR] 1.03 per year, p<0.01), T1 disease (OR 1.18, 95% CI 1.08-1.28), increasing number of comorbidities (OR 1.12 per comorbidity point, 95% CI 1.08-1.16), or CKD (OR 1.25, 95% CI 1.12-1.41). Compared to creatinine clearance before diagnosis, the median change in creatinine clearance at least 1 year after diagnosis was -46 for RN, -9 for NSS, -8 for ablation, and -24 for surveillance (p<0.01). Conclusions: A significant proportion of Veterans with early stage RCC undergo surveillance. Nephron sparing treatments are becoming increasingly common and are associated with more modest reductions in renal function than radical nephrectomy or surveillance. Further studies are warranted to assess the impact of surveillance on survival and cancer related outcomes.
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Murni, Andarias Makka, Julie Mae Pasuquin, and Christian Witt. "Site Specific Nutrient Management for Maize on Ultisols Lampung." JOURNAL OF TROPICAL SOILS 15, no. 1 (2018): 49. http://dx.doi.org/10.5400/jts.2010.v15i1.49-54.
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Site Specific Nutrient Management for Maize on Ultisols Lampung (A M Murni, JM Pasuquin, and C Witt): Lampung is the third major maize producing province in Indonesia after East Java and Central Java. In Lampung maize is cultivated mainly in upland areas with ultisols and only some cultivated on paddy field as a secondary crop in the dry season. The average maize yield in Lampung is still 3.4 Mg ha-1 bellow yield potential of 7-10 Mg ha-1. To increase the productivity of maize through site-specific nutrient management (SSNM), on-farm trials were conducted in five locations in Lampung i.e. four locations in Central Lampung District (Sidowaras, Binjai Ngagung, Watu Agung and Balai Rejo) and one location in South Lampung District (Trimulyo, Tegineneng Sub District) during the 2004/2005, 2005/2006 and 2006/2007 rainy seasons. The experimental setup followed a standard protocol at all sites and included nutrient omission plots (PK, NK, NP) to estimate indigenous nutrient supplies, an NPK plot to measure yield response to fertilizer application, and a farmers’ fertilizer practice (FFP) plot in each farmer’s field. An SSNM treatment plot was included in the second and third seasons. Each of the above treatments was paralleled by a plot with improved crop management practice (ICM), i.e. higher planting density, addition of lime, and addition of magnesium. Results showed that yield response to fertilizer N, P and K application in these sites were: N = 2.3-4.1 Mg ha-1; P = 0.6-2.0 Mg ha-1; K = 0.3-2.4 Mg ha-1. Attainable yield in the three seasons on average ranged from 7.6 Mg ha-1 to 10.6 Mg ha-1. Yield in the SSNM treatment (with or without ICM) was significantly higher than the FFP indicating great opportunities for farmers to increase productivity and profitability with improved nutrient and crop management.
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Bröckelmann, Paul J., Helen Goergen, Ulrich Keller, et al. "Nivolumab and AVD for Early-Stage Unfavorable Hodgkin Lymphoma (NIVAHL)." Blood 134, Supplement_1 (2019): 236. http://dx.doi.org/10.1182/blood-2019-122406.
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Background The anti-PD1 antibody nivolumab is approved for relapsed or refractory classical Hodgkin lymphoma (cHL) showing high overall response rates (ORR) and a favorable safety profile. However, complete response (CR) is rare in this setting, and most patients develop progressive disease. To evaluate the efficacy of combined nivolumab and doxorubicin, vinblastine and dacarbazine (AVD) as 1st-line treatment for early-stage unfavorable cHL, we conducted the GHSG NIVAHL trial. Methods NIVAHL is a prospective, randomized, investigator-sponsored single-stage phase II trial that enrolled treatment-naïve early-stage unfavorable cHL patients between 18 and 60 years at 35 German centers (NCT03004833). In arm A, patients received 240mg nivolumab and AVD at standard doses on day 1 and 15 of each 28-day cycle for a total of four cycles (4xNivoAVD). In arm B, the same treatment was administered sequentially, starting with 4x nivolumab in 2-weekly intervals, followed by 2xNivoAVD and 2xAVD. Both groups received 30Gy involved-site radiotherapy (IS-RT). Primary endpoint is the centrally reviewed PET/CT-based CR rate after completion of protocol therapy including IS-RT. 55 patients per group were enrolled in order to exclude a CR rate ≤80% with a power of 90% on a one-sided alpha level of 2.5% each. Secondary endpoints will be analyzed descriptively and include treatment-related morbidity (TRMorbidity), progression-free (PFS), overall survival (OS), response at interim and final restaging as well as patient-reported outcomes. Sequential biopsies, blood and microbiome samples were collected for correlative studies. Results Between 04/2017 and 10/2018, a total of 110 patients were enrolled with one patient disqualified due to alteration of HL diagnosis by central pathology review (N=109, group A n=55, group B n=54). The median age of the predominantly female patients (60%) was 27 years. Stage II was present in 95% of cases with ≥3 involved areas as most common risk factor (69%), followed by elevated ESR (48%), large mediastinal mass (20%) and extranodal disease (13%). Mean duration of chemoimmunotherapy was 15 (standard deviation (SD) 3) weeks and 22 (SD 6) weeks with a mean relative dose intensity of 87.4 (SD 15.9)% and 85.8 (SD 24.2)% in groups A and B, respectively. Severe protocol deviations occurred in 4 patients in group A and 5 in group B. Reasons were toxicity (n=5), patient's wish (n=2), incorrect allocation to early-stage unfavorable risk group (n=1) and progressive disease (n=1). Another 2 patients refused to receive IS-RT. Any adverse events (AEs) were reported for 98% of patients. AEs ≥°3 were observed in 73% and 78%, respectively, and serious AEs occurred in 38% and 28% of patients in groups A and B, respectively. TRMorbidity defined as organ toxicity ≥°3 or anemia, thrombocytopenia or infection °4 was documented in 16% and 22% of patients; all of these were organ toxicities predominantly of liver and gastrointestinal tract, with 19/21 events occurring during the first 2 treatment cycles. Data on ongoing or late toxicities is limited by short follow-up. Until 07/2019, 4 cases of persistent hypothyroidism have been reported. At the 1st interim restaging after 2xNivoAVD and 4x nivolumab, the ORR was 100% (54/54) and 96% (49/51), with a CR rate of 85% and 53% in groups A and B, respectively. Interim remission status was not assessed in 1 and 3 patients, respectively, due to treatment discontinuation after incorrect allocation to early-stage unfavorable risk group (n=1) or toxicity (n=3). After completion of systemic therapy, ORR was 100% (54/54) and 98% (50/51) with a CR rate of 81% and 86%, respectively. One patient in group B developed histologically proven primary progressive HL during nivolumab monotherapy while no other case of progressive or relapsed disease or death has been documented so far. The centrally reviewed CR rate at the end of treatment will be reported at the meeting. Additionally, initial data from currently ongoing histopathologic and immunologic studies will also be presented. Conclusion Concomitant and sequential therapy with nivolumab and AVD is feasible with acceptable toxicity. In early-stage unfavorable cHL, concomitant Nivo-AVD induces a high early CR rate. The interim CR rate observed with 4x nivolumab monotherapy is higher than previously reported in relapsed or advanced-stage disease. The primary endpoint and initial PFS data will be reported at the meeting. Disclosures Bröckelmann: Bristol-Myers Squibb: Honoraria, Other: Travel Support, Research Funding; Takeda: Consultancy, Honoraria, Other: Travel Support, Research Funding; MSD Sharpe & Dohme: Research Funding. Kerkhoff:EUSA: Honoraria; Hexal: Honoraria; Celgene: Honoraria, Other: Travel Support; Roche: Honoraria; Novartis: Honoraria. Hüttmann:University Hospital Essen: Employment; Takeda: Honoraria; Gilead: Honoraria. Zimmermann:Takeda: Honoraria, Other: Travel Expenses; Novartis: Other: Travel Expenses; MSD: Other: Travel Expenses; BMS: Other: Travel Expenses. von Tresckow:MSD Sharpe & Dohme: Consultancy, Honoraria, Research Funding; Novartis: Consultancy, Honoraria, Research Funding; Takeda: Consultancy, Honoraria, Research Funding; Pfizer: Honoraria; Roche: Honoraria; Amgen: Honoraria. Klapper:Roche, Takeda, Amgen, Regeneron: Honoraria, Research Funding. Borchmann:Novartis: Honoraria, Research Funding. OffLabel Disclosure: Nivolumab 240mg i.v. 2-weekly for 1st-line treatment of classical Hodgkin lymphoma.
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Tekgunduz, Emre, Seval Akpinar, Sinem Civriz Bozdag, et al. "Effectiveness of Defibrotide in the Prevention of VOD Among Patients Receiving Allogeneic Hematopoetic Cell Transplantation: A Retrospective Single Center Experience." Blood 120, no. 21 (2012): 4508. http://dx.doi.org/10.1182/blood.v120.21.4508.4508.
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Abstract Abstract 4508 Introduction: Hepatic venooclusive disease (VOD), is one of the major regimen related early complications of hematopoietic cell transplantation (HCT). The incidence of VOD ranges between 3% to 54% in different series. Mortality rates also differ according to severity of the disease and defibrotide treatment. We aimed to assess the impact of defibrotide prophylaxis on the incidence of VOD in our center by day 30 after allogeneic HST (allo-HCT). Material Method: We retrospectively analyzed 87 consecutive patients who had received allo-HCT with different diagnosis of hematological diseases in our transplantation unit between January 2009 and August 2012 in two groups acoording two VOD prophylaxis they received. The first (standard group; n: 59) and second (defibrotide group; n: 28) groups of patients were treated with allo-HST during January 2009-October 2011 and November 2011-August 2012 (n:28), respectively. Patient characteristics are summarized in Table 1. All of the patients had enoxaparin (as long as Plt ≥ 30000/mm3 and absence of bleeding), ursodeoxycolic acid and N-acetylsistein prophylaxis. Twenty eight of the patients in the second group received upfront defibrotide 10 mg/kg/day i.v between posttransplantation days 1 and 14 in addition to standard VOD prophylaxis approach. If the patients were diagnosed as VOD, defibrotide dose was increased to 25 mg/kg/day i.v in the prophylaxsis group. Fifty nine of the patients belonging to standard group did not have the opportunity to get defibrotide for prophylaxis or treatment due to drug supply. Diagnosis and classification of severity was defined according to Seattle criteria. None of the patients had hepatic biopsy for histopathological diagnosis mainly because of the thrombocytopenia/coagulopaty associated bleeding risk. Results: Nine of eighty seven (10%) patients diagnosed as VOD; only one of these patients was in the defibrotide group. Less patients were diagnosed as VOD in the defibrotide (8/59; 3.5%) compared to standard prophlaxis (1/28;13%) group (p=0,153). Number of patients who were diagnosed with mild/moderate/severe VOD were 2/3/4,respectively. The median day of VOD diagnosis was posttransplantation day 9(2–19). The median of maximum bilirubin level was 5 (2,1–24). Seven of nine (77%) patients died during the follow up. Eight patients in standard who were diagnosed with VOD could not be treated with the defibrotide as the drug was unavailable during this time period in our country. The only patient with VOD in second group received primary defibrotide prophylaxis and the dose of the drug was increased to treatment dosage when VOD was diagnosed. Venooclusive disease of the two alive patients resolved completely without defibrotide treatment. Hypoxemia and O2 requirement was observed in four patients. The median diuretic (furosemide; IV) requirement for weight gain of the patients was found to be lower for patients in defibrotide arm (160 mg; (0–4280 mg)) compared to standard prophylaxis arm (280 mg; (20–6500 mg)) (p=0,196). Discussion–Conclusion: There are several factors that can effect VOD incidence during allogeneic stem cell transplantation. Myeloablative conditioning, previous liver disease, poor performance status, and alternative donors are the variables with higher impact on VOD development. Our patient groups were not statistically different according to the conditioning regimen, number of transplantations and previous hepatic disease status. Zheng et al reported the incidence of VOD with or without defibrotide prophylaxis as 13,7% and 4.4%, respectively. Although our results are similar to this report we did not observed a significant difference in terms of VOD between the two groups. The majority of our patients had either moderate or severe disease and mortality was very high in the group without defibrotide prophylaxis; as a consequence of inability to reach to defibrotide. In conclusion, defibrotide seems to be a very promising agent to reduce VOD incidence by prophylactic usage. Disclosures: No relevant conflicts of interest to declare.
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Eng, Cathy, Jane Rogers, George J. Chang, et al. "Choice of chemotherapy in the treatment of metastatic squamous cell carcinoma of the anal canal." Journal of Clinical Oncology 30, no. 15_suppl (2012): 4060. http://dx.doi.org/10.1200/jco.2012.30.15_suppl.4060.
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4060 Background: Metastatic squamous cell carcinoma (SCCA) of the anal canal is an uncommon malignancy with no standard approach. The reported median overall survival (OS) is 9-12 months (M) following 5-FU + cisplatin (FC)-based therapy. The aim of this study is to evaluate first-line chemotherapy approaches in this patient (pt) population. Methods: A retrospective analysis was conducted of 428 pts with metastatic SCCA of the anal canal identified from the MDACC tumor registry between 1/1/2000 - 5/31/2011. Electronic medical records were reviewed for histology, date of diagnosis and/or recurrence, site of metastasis, type of therapy provided, response rate (RR), progression-free survival (PFS), OS, and lines of salvage therapy. All eligible pts were required to be treatment-naïve for metastatic disease and have radiographic imaging at MDACC. Waiver of informed consent was obtained. Results: 99 pts fulfilled all criteria; 10 were lost to follow-up; 12 did not initiate chemotherapy. 77 pts were evaluable; M: F = 20:57; median age = 55 years (range: 37 - 82); HIV(+) = 5% (4/77); prior chemoXRT with curative intent: 70% (54/77), complete response (CR): 87% (47/54), median time to development of metastatic disease =17M. 29% (22/77) presented with metastatic disease. Sites of disease included distant lymph nodes (41%); liver (45 %); lung (25%); bone (15%); and brain (8%). The median follow up was 37M. 73% (56/77) of patients were treated with platinum-based therapy; 51% (n=39) received FC and 22% (n= 17) received carboplatin + paclitaxel (CP). The median PFS was 6M; FC trended better than CP for PFS (7M vs. 5M, p<0.067). The overall median OS = 29M. 40% (31/77) of pts received neoadjuvant first-line therapy followed by metastasectomy (68%), XRT (26%), or both (6%); resulting in a median OS = 35M. Conclusions: Metastatic SCCA of the anal canal is a malignancy in which 5-FU+cisplatin is a commonly used regimen. Our analysis suggests FC results in improved PFS over CP but is underpowered supporting further analysis. The short median PFS with front-line chemotherapy, and yet longer OS reflects the challenges in treating this patient population and the importance of multidisciplinary management in select cases.
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Barthelemy, Philippe, Karine Bassot, Florence Joly, et al. "Adjuvant treatment of early-stage HER2+ elderly breast cancer patients: A retrospective, multicenter French study." Journal of Clinical Oncology 30, no. 15_suppl (2012): 636. http://dx.doi.org/10.1200/jco.2012.30.15_suppl.636.
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636 Background: Trastuzumab (T) is the standard of care for the adjuvant treatment of early stage, HER2+ breast cancer (BC). However, few data are available for elderly HER2+ breast cancer patients in this setting. In this current study, the patterns of care for elderly HER2+ early stage BC in 7 French cancer centres was evaluated. Methods: Medical records of all consecutive early stage HER2+ BC patients over 70 years old treated between 2006 and 2011 among participating centres were retrospectively reviewed. Specific factors such as age, comorbidities, tumor stage, grade, ER/PR and HER2 status, treatment characteristics, follow-up and cardiotoxicity data were analysed. Results: One hundred and two patients were identified, median age 75.4 (range 70-95). Elderly patients presented mostly (57%) large tumors (pT ≥2), and positive lymph node involvement (n=61). Trastuzumab-based adjuvant treatment was administered in 62% of patients (n=63). 54% of patients (n=55) received adjuvant chemotherapy whereas five patients received neoadjuvant chemotherapy. Chemotherapy without T was administered in 2 additional patients. Anthracyclines (A)-Taxanes (Ta) combination-based chemotherapy was given in 27% of patients (n=16), whereas 38% received a Ta-based chemotherapy (n=23), 35% (n=19) an A-based chemotherapy. Five patients received single-agent T. Treatment delays for T were required in 37% of patients (n=23) among whom 15 and 8 permanently or temporarily stopped T, respectively. The most frequent reason for interrupting or delaying therapy was cardiotoxicity (n=12) as well as patients refusal (n=7). A ≥ 10% decrease in LVEF was observed in 18/63 (29%) of patients, among whom T was stopped in 12. After a median 33 months follow-up, the median progression-free survival was not reached in patients receiving T-based therapy. The 2 and 3-year PFS rate were 94 and 89.5%, respectively. Conclusions: In routine practice only 62% of elderly early stage HER2+ BC patients are treated with a neoadjuvant or adjuvant T-based regimen. However, less than 50% of all patients completed their therapy. A-based chemotherapy was administered in around 60% of treated patients, and could explain cardiotoxicity in this setting.
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Ramanathan, Ramesh K., Peter Lee, John E. Seng, et al. "Phase II study of induction therapy with gemcitabine and nab-paclitaxel followed by consolidation with mFOLFIRINOX in patients with metastatic pancreatic cancer." Journal of Clinical Oncology 32, no. 3_suppl (2014): 224. http://dx.doi.org/10.1200/jco.2014.32.3_suppl.224.
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224 Background: FOLFIRINOX or NabP-Gem are now standard mPC regimens.The optimal sequence is not known.This phase II study evaluated the feasibility of NabP-Gem followed by FOLFIRINOX. Methods: Eligible pts had evidence of untreated mPC, ECOG 0-1 and adequate organ function. Pts received Nab-P (125 mg/m2) and Gem (1000 mg/ m2) weekly x 3 (Induction ) every 4 weeks for upto 6 cycles. FOLFIRINOX, q2 weeks (Consolidation regimen) was initiated after 6 cycles of the Induction regimen, or earlier in case of progression, and given for a maximum of 6 months (12 cycles). mFOLFIRINOX (NEJM, 364:1817-25: 2011) has been modified with growth factor prophylaxis and omission of bolus 5FU. One endpoint is to increase 1 year survival to > 70%, (n=30, 95% CI is +/- 20%). Results: Accrual goals have been met (n=31). The M/F ratio is 55%/45%, median is 66 years. In 23 pts with elevated baseline CA19-9 levels treated with NabP-Gem, 83% had a > 90% decrease. The response rate with the NabP-Gem regimen is 43%. Selected therapy related Grade > 3 adverse events during the course of both NabP-Gem and FOLFIRINOX therapy are: neutropenia (39%), fatigue (32%), anemia (19%), thrombocytopenia (16%), thromboembolic events (3%), peripheral neuropathy (16%), leukopenia (16%), nausea (3%), vomiting (3%), diarrhea (7%), and neutropenic fever (3%). During the course of NabP-Gem, 14 dose reductions and four dose delays were seen. Two pts had early progression at cycle 4 or less and were switched to the Consolidation regimen. Seventy one % (22/31) of pts went on to receive FOLFIRINOX (4 pts still on study), 4 received FOLFIRI, and one pt received FOLFOX as Consolidation therapy. One-year survival is projected to be 50-60%. Conclusions: The induction NabP-Gem regimen shows evidence of substantial activity similar to published reports (JCO.29:4548-54: 2011). The induction-consolidation strategy is feasible in selected patients. Cumulative side effects predominantly fatigue and neuropathy will require appropriate dose reductions or treatment breaks. (Supported by the Seena Magowitz foundation). Clinical trial information: NCT01488552.
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Doss, E. Lauren, Linden Doss, Ying Han, et al. "Risk Factors for Glaucoma Suspicion in Healthy Young Asian and Caucasian Americans." Journal of Ophthalmology 2014 (2014): 1–6. http://dx.doi.org/10.1155/2014/726760.
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Purpose.To determine the prevalence of certain risk factors for glaucoma in a healthy, young population and to compare these risk factors between Asian Americans and Caucasians.Methods.120 healthy graduate students (mean age24.8±3.0years) underwent a comprehensive ophthalmic examination. Regression analyses controlling for age, sex, and refraction, comparing glaucoma risk factors in Asians (n=54) and Caucasians (n=41), were performed. Outcome variables included family history, intraocular pressure (IOP), spherical equivalent, central corneal thickness (CCT), mean deviation (MD) and pattern standard deviation (PSD), and disc and retinal nerve fiber layer (RNFL) parameters.Results.61% of subjects were female; the mean spherical equivalent was-3.81±3.2 D; and the mean axial length (AL) was25.1±1.7 mm. Regression analysis showed race affected spherical equivalent (P<0.001), AL (P=0.0073), IOP (P<0.001), and cup to disc area ratio (CDAR) (P=0.012). Family history, CCT, MD, and PSD did not vary between Asians and Caucasians (P>0.05). In this study, we found Asian Americans, compared to Caucasians, had2.95±0.64 D greater myopia; greater IOP by2.74±0.62 mmHg; and larger CDAR by0.12±0.046.Conclusions.In our study population, young, healthy Asian Americans had greater myopia, IOP, and CDAR as compared to Caucasians, suggesting that racial variations can be important when diagnosing glaucoma.
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Eckenschwiller, Manuel, Hanns Ackermann, Wolf O. Bechstein, and Frank Grünwald. "Accuracy of Hepatobiliary Scintigraphy after Liver Transplantation and Liver Resection." International Journal of Molecular Imaging 2016 (August 3, 2016): 1–8. http://dx.doi.org/10.1155/2016/7857849.
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Background and Aims. Biliary complications are the most frequent complications after common liver surgeries. In this study, accuracy of hepatobiliary scintigraphy (HBS) and impact of hyperbilirubinemia were evaluated. Methods. Between November 2007 and February 2016, 131 patients underwent hepatobiliary scintigraphy after having liver surgery. 39 patients with 42 scans after LTX (n=13) or hepatic resection (n=26) were evaluated in the study; 27 were male, with mean age 60 years. The subjects underwent hepatobiliary scintigraphy with Tc-99m labeled Mebrofenin. The results were compared to ERCP as gold standard performed within one month after HBS. We calculated sensitivity, specificity, PPV, and NPV. We compared LTX patients to patients with other liver surgeries. Furthermore the influence of hyperbilirubinemia on HBS scans was evaluated. Results. HBS always provided the correct diagnosis in cases of bile leak in the liver-resected group (14/14). Overall diagnostic accuracy was 76% (19/25) in this group and 54% (7/13) in the LTX group. False negative (FN) diagnoses occurred more often among LTX patients (p=0.011). Hyperbilirubinemia (>5 mg/dL) significantly influenced the excretion function of the liver, prolonging HBS’s time-activity-curve (p=0.001). Conclusions. Hepatobiliary scintigraphy is a reliable tool to detect biliary complications, but reduced accuracy must be considered after LTX.
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Khoshbin, Amir, Graeme Hoit, Lauren Leone Nowak, et al. "The association of preoperative blood markers with postoperative readmissions following arthroplasty." Bone & Joint Open 2, no. 6 (2021): 388–96. http://dx.doi.org/10.1302/2633-1462.26.bjo-2021-0020.
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Aims While preoperative bloodwork is routinely ordered, its value in determining which patients are at risk of postoperative readmission following total knee arthroplasty (TKA) and total hip arthroplasty (THA) is unclear. The objective of this study was to determine which routinely ordered preoperative blood markers have the strongest association with acute hospital readmission for patients undergoing elective TKA and THA. Methods Two population-based retrospective cohorts were assembled for all adult primary elective TKA (n = 137,969) and THA (n = 78,532) patients between 2011 to 2018 across 678 North American hospitals using the American College of Surgeons National Quality Improvement Programme (ACS-NSQIP) registry. Six routinely ordered preoperative blood markers - albumin, haematocrit, platelet count, white blood cell count (WBC), estimated glomerular filtration rate (eGFR), and sodium level - were queried. The association between preoperative blood marker values and all-cause readmission within 30 days of surgery was compared using univariable analysis and multivariable logistic regression adjusted for relevant patient and treatment factors. Results The mean TKA age was 66.6 years (SD 9.6) with 62% being females (n = 85,163/137,969), while in the THA cohort the mean age was 64.7 years (SD 11.4) with 54% being female (n = 42,637/78,532). In both cohorts, preoperative hypoalbuminemia (< 35 g/l) was associated with a 1.5- and 1.8-times increased odds of 30-day readmission following TKA and THA, respectively. In TKA patients, decreased eGFR demonstrated the strongest association with acute readmission with a standardized odds ratio of 0.75 per two standard deviations increase (p < 0.0001). Conclusion In this population level cohort analysis of arthroplasty patients, low albumin demonstrated the strongest association with acute readmission in comparison to five other commonly ordered preoperative blood markers. Identification and optimization of preoperative hypoalbuminemia could help healthcare providers recognize and address at-risk patients undergoing TKA and THA. This is the most comprehensive and rigorous examination of the association between preoperative blood markers and readmission for TKA and THA patients to date. Cite this article: Bone Jt Open 2021;2(6):388–396.
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CHEN, Yi-dong, Jin FENG, Tong FANG, Ming YANG, Xiao-guang QIU, and Tao JIANG. "Effect of intensity-modulated radiotherapy versus three-dimensional conformal radiotherapy on clinical outcomes in patients with glioblastoma multiforme." Chinese Medical Journal 126, no. 12 (2013): 2320–24. http://dx.doi.org/10.3760/cma.j.issn.0366-6999.20130218.
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Background Few studies were reported on the comparison of clinical outcomes between intensity-modulated radiotherapy (IMRT) and three-dimensional conformal radiotherapy (3D-CRT) in the treatment of glioblastoma multiforme (GBM). This study aimed to determine whether IMRT improves clinical outcomes compared with 3D-CRT in patients with GBM. Methods The records of 54 patients with newly-diagnosed GBM from July 2009 to December 2010 were reviewed. The patients underwent postoperative IMRT or 3D-CRT with concurrent and adjuvant temozolomide. Kaplan-Meier method and log rank test were used to estimate differences of patients' survival. Results The median follow-up was 13 months. Of the 54 patients, fifty (92.6%) completed the combined modality treatment. The 1-year overall survival rate (OS) was 79.6%. The pattern of failure was predominantly local. A comparative analysis revealed that no statistical difference was observed between the IMRT group (n=21) and the 3D-CRT group (n=33) for 1-year OS (89.6% vs. 75.8%, P=0.795), or 1-year progression-free survival (PFS) (61.0% vs. 45.5%, P=0.867). In dosimetric comparison, IMRT seemed to allow better sparing of organs at risk than 3D-CRT did (P=0.050, P=0.055). However, there was no significant difference for toxicities of irradiation between the IMRT group and the 3D-CRT group. Conclusions Our preliminary results suggested that delivering standard radiation doses by IMRT is unlikely to improve local control or overall survival for GBM compared with 3D-CRT. Given this lack of survival benefit and increased costs of IMRT, the utilization of IMRT treatment for GBM needs to be carefully rationalized.
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Bories, Pierre, Naïs Prade, Stéphanie Lagarde, et al. "TP53 Mutations Negatively Impact Survival of Acute Myeloid Leukemia Patients Treated with Standard Doses of Azacitidine." Blood 132, Supplement 1 (2018): 2745. http://dx.doi.org/10.1182/blood-2018-99-117219.
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Abstract Validated therapies for older pts with AML could rely on intensive or low-intensity strategies. Patient selection for these options remains controversial. There is currently no validated biomarker which can been used to guide therapeutic decision. TP53 mutations which are known to negatively impact AML pts outcome when treated with ICT, have been recently described as a positive prognosis factor for blast clearance with a 10-days regimen of decitabine (Welch, NEJM 2016). To date, it remains unclear whether AML pts with TP53 mutation represent a clinically homogeneous group. Several classification systems of p53 mutant, derived from in vitro or in vivo data, have been validated in solid tumors and aggressive lymphomas as predictors of p53 mutant functional impact or patient outcome. We retrospectively evaluated the impact of TP53 mutational status on the outcome of a real-world cohort of pts, treated frontline with standard doses of azacitidine (AZA). We further hypothesized that functional characterization of TP53 mutations could define a subgroup of pts with specific outcome with AZA From Jan 2007 to Dec 2016, we identified 279 AML pts enrolled in the regional cancer network ONCOMIP registry, treated frontline with AZA. Median age was 76 yrs (45-93), karyotype was adverse in 135 pts (49.1%), including 54 pts with -17 or del17p (19.4%). AML was secondary to MDS in 71 pts (25.4%), to MPN in 24 (8.6%) and therapy related in 46 pts (16.5%). Pts received a median of 6 cycles (1-67). Overall, 54 pts obtained CR/CRi (19.4%) and median OS was 10.6 months (95%CI ,9.7-12.1). For 224 pts with an available bone marrow baseline DNA sample, TP53 mutations were screened with next-generation sequencing on an Illumina® MiSeq sequencer. Sequencing results were filtered with the IARC TP53 mutations database and a variant allele frequency (VAF) >10%, strengthening the specificity of the data of this cohort. Of the 224 analyzed cases, 55 cases (24.6%) contained TP53 mutations. Response rates did not significantly differ between TP53mut (21.8% CR/CRi) and TP53wt (17.8% CR/CRi, p=.50) nor between pts with TP53mut and/or -17/del17p (19.1% CR/CRi) and pts without TP53 abnormality (18.6%CR/CRi, p=.93). Median OS was 7.9 months in pts with TP53mut and 12.6 months in TP53wt (p<.0001). With regards to the group of 109 pts with adverse karyotype, response rates did not significantly differ between TP53mut pts (20.8% CR/CRi) and TP53wt (14.3%, p=.37) and median OS was 7.9 months for TP53mut pts versus 9.6 for TP53wt pts (p=.02) Among the 55 pts with TP53mut, 53pts had adverse cytogenetics (96.4%), 16 pts had secondary AML to MDS or MPN (29.1%) and 13 had t-AML (23.6%). This subgroup included 49 cases (89%) with single TP53 mutation (missense n=42, nonsense n= 3, frameshift n=4) and 6 cases (11%) with 2 mutations (2 pts with missense and frameshift mutations and 4 pts with 2 missense mutation). We further characterized TP53mut pts with 3 validated classification systems. Due to dominant negative effect of TP53 mutation, for pts with >1 TP53 mutation, we selected the mutation with the predicted highest impact: 15 pts had disruptive mutations (i.e. missense mutation in L2/L3 helix of the DNA binding domain or truncating mutation) versus 40 pts with non-disruptive mutations (Poeta M, NEJM 2007), which was not associated with clinical response (25% in CR/CRi vs 27.9% in failure; p=1.00) nor with 6mOS (46.7% vs 55%, respectively; p=.79)Mutant p53 transactivation activity assessed with a 0-100 evolutionary score (Neskey D, Cancer Research 2015), was not associated with response (median score of 79.3[28-90] in CR/CRi vs 73.3 [49-96] in failure, p=1.00) nor with OS (HR 1.01; 95% CI, 0.99-1.03, p=.51).Relative fitness score (on a log2 scale) which was recently reported as a proxy of p53 mutant in vitro and in vivo cell proliferation advantage (Kotler E, Molecular cell 2018) was not associated with response (median score in CR/CRi of 0.094 [-0.79-0.58] vs 0.094 [-2.52-0.84] in failure, p=.68) nor with OS (HR 0.75; 95% CI, 0.45-1.22, p=.24) Overall, the response rate was not influenced by the TP53mut status, but median OS was negatively impacted by the TP53mut status in the entire cohort and in the sub-group of pts with adverse karyotype. None of the mutant p53 classification systems validated in other neoplasms succeed in identifying a subset of AML pts who specifically benefit from AZA suggesting a rather homogenous functional impact of TP53 mutations in this setting Disclosures Fornecker: Takeda: Honoraria; Servier: Honoraria.
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Sizemore, Connie A., Karen Manion, Lawrence Morris, Asad Bashey, H. Kent Holland, and Scott R. Solomon. "Total Outpatient Care for Myeloablative Unrelated Donor Hematopoietic Cell Transplantation: A Safe and Effective Alternative to Standard In-Patient Care." Blood 116, no. 21 (2010): 3525. http://dx.doi.org/10.1182/blood.v116.21.3525.3525.
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Abstract Abstract 3525 Total Outpatient Care for Myeloablative Unrelated Donor Hematopoietic Cell Transplantation: A Safe and Effective Alternative to Standard In-Patient Care Myeloablative unrelated donor allogeneic stem cell transplantation (UD-SCT) is associated with a high risk of transplant related toxicity, traditionally requiring patients to remain hospitalized from administration of the high-dose preparative regimen until recovery from the cytopenic phase. We previously published a comprehensive outpatient approach for the management of patients undergoing matched sibling donors myeloablative allogeneic stem cell transplant, showing comparable clinical outcomes to those reported for an inpatient approach (Solomon et al, Bone Marrow Transplantation 2010). Given the higher morbidity and mortality associated with UD-SCT, we analyzed the feasibility of outpatient management with this group of patients. For the current study, we reviewed the clinical outcomes of 59 consecutive myeloablative UD-SCT recipients, performed as outpatient procedures, at our institution between March 2005 and March 2010. Patients received their stem cell infusion on the inpatient unit but were not scheduled to stay overnight. Expectant admissions occurred for complications more safely managed in the hospital (febrile neutropenia, mucositis, uncontrolled nausea/vomiting). Fifty-nine consecutive patients who underwent outpatient myeloablative UD-SCT (10/10 locus matched n=46, 9/10 locus matched n=11, and 8/10 locus matched n= 2). Patient characteristics were: median age 50 years (range 19–75); diagnoses AML= 30, ALL=14, CML= 5, MDS=6, MPS=3 and CLL=1; CIBMTR disease risk- high risk (54%), intermediate risk (15%) or low risk (31%); preparative regimen- busulfan (16mg/kg or equivalent) (66%) or TBI ≥ 12 Gy (44%) based. Peripheral blood was the stem cell source for 56 patients and bone marrow for 3. Excluding the 8 patients admitted to receive Thymoglobulin®, only four patients (7%) required hospital admission during their preparative regimen for reasons of GI toxicity (1), drug rash (1), DVT (1) or cerebral aneurysm (1). Forty-eight patients (81%) were discharged from the hospital either the day of or day after stem cell infusion. The median time from stem cell infusion to the first readmission was Day +6 (range 3–23). Mucositis was the primary cause of readmission, occurring in 19 patients. Significant post transplant infections requiring admission prior to day +30 included neutropenic fever (8), staphylococcus epidermidis bacteria (6), RSV (1), CMV (1), clostridium difficile (1) or serratia marcescens (1). The median hospital length of stay (LOS) from the start of the preparative regimen through Day +30 was 12 days (range 1–31 days). Median times to neutrophil and platelet engraftment were 14 and 19 days, respectively. Acute (grade II-IV) and chronic graft versus host disease occurred in 57% and 68% of patients, respectively. Cumulative rates of 100 day and 1 year non-relapse mortality were 5% and 9%, respectively. With a median follow-up of 2.4 years (range 0.5–5.3), the estimated 1, 2, and 3 year overall survival were 76%, 60%, and 54%, respectively. In summary, we show that outpatient myeloablative UD-SCT with expectant inpatient management for treatment related toxicities can be done safely in an unselected group of patients. In spite of the high risk features of the transplant population (advanced age, high risk disease), outpatient UD-SCT was associated with low transplant related morbiditiy and mortality, and favorable transplant outcomes. This approach significantly decreases the length of inpatient hospitalization for UD-SCT, with the potential to free-up inpatient resources, improve quality of life, and decrease costs. Disclosures: No relevant conflicts of interest to declare.
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Pai, Raghav, Rishi Modh, Rebecca H. Lamoureux, et al. "Image Quality and Patient-Specific Organ Doses in Stone Protocol CT: A Comparison of Traditional CT to Low Dose CT with Iterative Reconstruction." BioMed Research International 2018 (September 27, 2018): 1–6. http://dx.doi.org/10.1155/2018/5120974.
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Objective. To compare organ specific radiation dose and image quality in kidney stone patients scanned with standard CT reconstructed with filtered back projection (FBP-CT) to those scanned with low dose CT reconstructed with iterative techniques (IR-CT). Materials and Methods. Over a one-year study period, adult kidney stone patients were retrospectively netted to capture the use of noncontrasted, stone protocol CT in one of six institutional scanners (four FBP and two IR). To limit potential CT-unit use bias, scans were included only from days when all six scanners were functioning. Organ dose was calculated using volumetric CT dose index and patient effective body diameter through validated conversion equations derived from previous cadaveric, dosimetry studies. Board-certified radiologists, blinded to CT algorithm type, assessed stone characteristics, study noise, and image quality of both techniques. Results. FBP-CT (n=250) and IR-CT (n=90) groups were similar in regard to gender, race, body mass index (mean BMI = 30.3), and stone burden detected (mean size 5.4 ± 1.2 mm). Mean organ-specific dose (OSD) was 54-62% lower across all organs for IR-CT compared to FBP-CT with particularly reduced doses (up to 4.6-fold) noted in patients with normal BMI range. No differences were noted in radiological assessment of image quality or noise between the cohorts, and intrarater agreement was highly correlated for noise (AC2=0.873) and quality (AC2=0.874) between blinded radiologists. Conclusions. Image quality and stone burden assessment were maintained between standard FBP and low dose IR groups, but IR-CT decreased mean OSD by 50%. Both urologists and radiologists should advocate for low dose CT, utilizing reconstructive protocols like IR, to reduce radiation exposure in their stone formers who undergo multiple CTs.
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Giebel, Sebastian, Myriam Labopin, Norbert Claude Gorin, et al. "Autologous HSCT for Ph-Positive Adult Acute Lymphoblastic Leukemia: A Curative Option in the Era of Tyrosine Kinase Inhibitors? an Analysis From the Acute Leukemia Working Party of the EBMT." Blood 120, no. 21 (2012): 233. http://dx.doi.org/10.1182/blood.v120.21.233.233.
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Abstract Abstract 233 Outcome of patients with Ph-positive acute lymphoblastic leukemia (Ph+ ALL) improved markedly with the introduction of tyrosine kinase inhibitors (TKIs) used in combination with chemotherapy. However, despite very high rate of complete remissions the possibility of cure with conventional-dose treatment remains questionable. Hence, allogeneic hematopoietic stem cell transplantation (HSCT) is still considered a standard of care. Patients lacking appropriate donor are usually treated with TKI-based maintenance. Autologous HSCT could be an alternative approach, however, due to “negative” results of a series of prospective studies run in XX. century its use has been limited. The goal of the current analysis was to retrospectively analyze if results of autoHSCT for Ph+ ALL changed over time. Results of 171 autologous transplantations performed in the first complete remission between 1996–2010 and reported to the EBMT registry have been analyzed. Median patient age was 48.3 (19–65) years. Conditioning regimen was based on either TBI (63%) or chemotherapy (37%). Peripheral blood was used as a source of stem cells in 84% cases. With the median follow-up of 2 years, in the whole study group, the probability of the overall survival (OS) at 2 years was 45% (+/−4%) and leukemia-free survival (LFS) was 32% (+/−4%). The cumulative incidence of relapse (RI) and non-relapse mortality (NRM) was 54% (+/−4%) and 13% (+/−3%), respectively. LFS rates were comparable for TBI and chemotherapy-based conditioning (34% vs. 29%, p=0.53). As well, the source of stem cells had no impact on LFS (32% for PB vs. 33% for BM, p=0.91). The 2 year probability of LFS increased from 22% for transplants performed between 1996–2000 (n=70) to 32% between 2001–2006 (n=61) and 54% between 2007–2010 (n=40), p<0.001 (Fig). In respective periods the RI decreased from 65% to 47% and 46% (p=0.01), while NRM was 11%, 21% and 0% (p=0.03). In a multivariate analysis the year of transplantation (<2007 vs. 2007–2010) was the only factor independently influencing the risk of treatment failure (HR=2.98, 95%CI, 1.54–5.79; p=0.001). We conclude that results of autologous HSCT for Ph+ ALL improved markedly in recent period with more than half of patients being alive and leukemia-free at 2 years. Therefore, it appears than in the era of TKIs autologous HSCT may be considered potentially curative option. The advantage is probably associated with more profound responses achieved with TKIs, which, however requires confirmation in a separate analysis. As well, the role of post-transplant maintenance remains to be determined. Disclosures: No relevant conflicts of interest to declare.
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Auricchio, Pasquale, Emre Tanay, Christopher Kieninger, Jörg Köninger, and Tobias Meile. "Re-Do Surgery after Sleeve Gastrectomy: A Single Center Comparison between Roux-en-Y Gastric Bypass and One Anastomosis Gastric Bypass." Surgeries 3, no. 2 (2022): 126–33. http://dx.doi.org/10.3390/surgeries3020014.
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Introduction: According to the high rate of patients requiring a Re-Do surgery after a primary Sleeve Gastrectomy, due to failure on weight loss, this study proposes a comparison between RYGB and OAGB as a secondary intervention for morbidly obese patients. Methods: A retrospective review of patients who underwent revisional surgery to convert SG to RYGB or OAGB at our institution from November 2011 to November 2019 was performed. Results: A subset of sixty-three patients with previous SG underwent revisional surgery due to failure of the primary intervention. The OAGB group (n = 17) had a mean BMI at the time of the sleeve of 62 kg/m2 and a mean BMI of 50.7 kg/m2, the length of the Omega was 139.35 cm. The RYGB (n = 46) group showed a mean BMI of 47 kg/m2 at the time of the sleeve and a BMI of 34.8 kg/m2 at the time of the revision. The RYGB was performed according to the 70/120 cm standard for all the patients. One patient also had a revision from secondary OAGB to RYGB due to persistent biliary reflux, in this case the biliary branch was settled at 150 cm and the alimentary at 50 cm. Conclusions: The outcomes in the OAGB group showed a 29%WL and a 47%EWL (out of a 17%WL and 28%EWL at the time of the sleeve), on the other side the RYGB group reached a 33%WL and 72%EWL (out of a 25%WL and a 54%EWL at the time of the sleeve). According to our data we assume that RYGB is more effective in terms of weight loss as a revisional surgery after sleeve
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Lim, Charles Henry, Daniel Yokom, Di Maria Jiang, et al. "Outcomes for advanced HER2-positive gastroesophageal cancer by anatomical location: Experience from the Princess Margaret Cancer Centre." Journal of Clinical Oncology 36, no. 4_suppl (2018): 131. http://dx.doi.org/10.1200/jco.2018.36.4_suppl.131.
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131 Background: The landmark ToGA trial established trastuzumab (T) based therapy as the standard of care for advanced HER2+ gastric and gastroesophageal junction cancer. However, outcomes for T based therapy for HER2+ esophageal cancer have not been well characterized. Methods: We conducted a retrospective analysis of patients (pts) with HER2+ gastroesophageal cancer receiving T based therapy at our institution from 2011-2016. Distal esophagus ( < 35 cm) and Siewert type I/II tumours were defined as esophageal (E). Siewert type III and stomach tumours were defined as gastric (G). Trained abstractors collected pt demographics and treatment details. Overall survival (OS) and progression-free survival (PFS) were calculated from the date of first T treatment. Chi-square tests, t-tests and Cox proportional hazards models were applied where appropriate. Results: We identified 87 pts with advanced HER2+ disease. 62% (n = 54) had de novo metastatic (M1) disease. 57 patients were treated with T based therapy, with median age 57 years (IQR 48-67), 91% baseline performance status 0-1, 19% female, and 7% Asian. 63% (n = 36) had E and 37% (n = 21) had G primary tumours. 67% (n = 38) presented with M1 disease. 33% (n = 19) underwent surgery with curative intent and received T based therapy at recurrence. Baseline characteristics were balanced between the E and G groups. Survival data were available for 51 patients. The E and G groups did not have significant differences in PFS (median 9.5 vs. 9.1 months, HR 0.89 (95% CI 0.44-1.80), p = 0.74) or in OS (median 15.8 vs. 14.2 months, HR 0.88 (95% CI 0.42-1.82), p = 0.73). 63% (n = 36) were treated with subsequent systemic therapy after progression on T, with 23 receiving one line, 9 receiving two lines and 4 receiving three additional lines of treatment. The number subsequent therapies received was similar between E and G groups. Conclusions: Although patients with distal esophagus tumours were not included in the ToGA trial, our analysis suggests that patients with E and G tumours had similar outcomes. Our contemporary cohort had comparable survival outcomes relative to patients receiving T in the ToGA trial (median PFS = 6.7 months, median OS = 13.8 months).
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Guru, Pramod, Tarun Singh, Melissa Passe, Kianoush Kashani, Gregory Schears, and Rahul Kashyap. "Derivation and validation of a search algorithm to retrospectively identify CRRT initiation in the ECMO patients." Applied Clinical Informatics 07, no. 02 (2016): 596–603. http://dx.doi.org/10.4338/aci-2015-12-ra-0183.
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SummaryThe role of extracorporeal membrane oxygenation (ECMO) in refractory cardiorespiratory failure is gaining momentum with recent advancements in technology. However, the need for dialysis modes such as continuous renal replacement therapy (CRRT) has also increased in the management for acute kidney injury. Establishing the exact timing of CRRT initiation in these patients from the electronic medical record is vital for automated data extraction for research and quality improvement efforts.We aimed to derive and validate an automated Electronic Health Records (EHR) search strategy for CRRT initiation in patients receiving ECMO.We screened 488 patients who received ECMO and a total of 213 patients underwent CRRT. We evaluated random 120 patients, 60 for derivation and 60 for validation cohorts. Following implementation of eligibility criteria, the algorithm was derived in 55 out of 120 ECMO/CRRT patients. The search algorithm was developed using first-time chart entry of ‘access pressure drop’ at CRRT initiation. The algorithm was then validated in an independent subset of 52 patients from the same time period. The overall agreement between electronic search algorithm and a comprehensive manual medical record review in the derivation and validation subsets, using ‘access pressure drop’ as the reference standard, was compared to assess CRRT initiation time.In the derivation subset (N=55), the automated electronic search strategy achieved an excellent agreement with manual search (D =0.99, 54 were identified electronically, and 55 upon manual review). There was no time difference observed in 49/54(89%) patients, while in the remaining 5 (9%) patients time difference was within 15 minutes. In the validation cohort (N=52), agreement was 100 % (D = 1.0, both methods identified 52 patients). Out of 52 patients, 47 (90%) had no time difference between the methods, for the remaining 5 (10%) patients, differences were within 15 minutes.The use of an electronic search strategy resulted in determining an accurate CRRT initiation time among ECMO patients.
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Gaya, Anna, Jordina Rovira, Cristina Moreno, et al. "At-Home Management of Adult Patients Following Consolidation Chemotherapy for Acute Myeloid Leukemia." Blood 124, no. 21 (2014): 3692. http://dx.doi.org/10.1182/blood.v124.21.3692.3692.
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Abstract Background: Consolidation chemotherapy for adult patients with acute myeloid leukemia (AML) who have achieved a complete response after induction treatment is associated with prolonged, severe neutropenia and a high incidence of infections. In our center, patients were historically followed up during the neutropenic period at the day care unit, usually every 2 or 3 days, where they had routine laboratory tests, blood transfusions, central venous catheter management and medical checkups. Since this strategy was associated with a high incidence of febrile episodes that lead to hospital readmissions with some patients dying due to infectious complications, we designed a specific program for patients with AML receiving consolidation therapy including a specialized at-home management. Patients and Methods: Since March 2011, all consecutive patients with AML without significant co-morbidities or active febrile complications who received consolidation chemotherapy and lived within 60 minutes of the hospital were included in the at-home program (AHP). During the neutropenic period, a specialized nurse took care of every patient daily, either visiting the patient at home or by phone. A record of the vital signs, routine laboratory tests, central venous catheter management and administration of intravenous medication was kept regularly by the nurse. Antibiotic prophylaxis consisted of oral levofloxacin (500 mg daily), oral posaconazole (200 mg, three times per day) and intravenous ceftriaxone during the neutropenic (<0.5 x109/L) period. The hematologist in charge coordinated the assistance from the hospital. Most complications, mainly febrile episodes, were managed directly 24 hours a day at the Hematology Department instead of the Emergency Unit. If the patient remained hemodynamically stable without focal infection, treatment was continued at-home. The results of the AHP were compared with a historical cohort of patients (2006-2011) who received the same chemotherapy scheme but were managed at day care unit with the standard outpatient program. Results: Up until February 2014, 29 out of 31 (94%) patients were included in the AHP, with a total of 60 episodes. Only 2 patients were excluded from the program, one because of lack of informed consent and the other due to an active febrile complication. The control group consisted of 40 out of 42 (98%) patients (56 episodes in total), who received consolidation treatment following the standard outpatient from May 2004 to March 2011. Median duration of severe neutropenia was of 11 (4-34) days in the AHP group compared with 18 (2-55) days in the control group (p<0.001), with no differences in the duration of the severe thrombocytopenia. In the AHP group, febrile episodes were documented in 17 (28%) episodes and only in 3 of them hospital readmission was necessary (5%). No deaths occurred in the AHP group during the study period. Eighty-two per cent of patients in the control group presented with fever and all of them were readmitted (p<0.001), with a median duration of hospitalization of 16 (0-34) days per episode, that supposed a total of 744 days. Three (5%) patients died from infections during the neutropenic period in the historical control group. Conclusion: At-home management after administration of consolidation therapy in adult patients diagnosed with AML is feasible in most patients. It is associated to a lower incidence of febrile complications and readmissions, contributing to increase safety for patients and optimizing hospital resources. Table Control Group(N= 56) AHP Group(N= 60) p Period of inclusion May/04-Mar/11 Mar/11-Feb/14 - Patients, n 40 29 - Included/candidate patients, n (%) 40/42 (98%) 29/31 (94%) - Episodes, n 56 60 - Included/candidate episodes, n (%) 54/57 (95%) 60/63 (95%) - Gender (M/F) 21/19 8/21 0.05 Age, median (range), years 52 (16-68) 56 (19-71) n.s. Neutropenia duration, median (range), days 18 (2-55) 11 (4-34) <0.001 Thrombocytopenia duration, median (range), days 24 (2-150) 18 (7-221) 0.3 Febrile episode, n (%) 46 (82%) 17 (28%) <0.001 Fever duration, median (range), days 2 (1-24) 2 (1-4) 0.006 Readmission, n (%) 46 (82%) 3 (5%) <0.001 Hospitalization duration if readmission, median (range), days 16 (0-34) days 0 (0-18) <0.001 Total days of hospitalization 744 36 - Death, n (%) 3 0 0.09 Disclosures No relevant conflicts of interest to declare.
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Naing, Aung, Funda Meric-Bernstam, Bettzy Stephen, et al. "Phase 2 study of pembrolizumab in patients with advanced rare cancers." Journal for ImmunoTherapy of Cancer 8, no. 1 (2020): e000347. http://dx.doi.org/10.1136/jitc-2019-000347.
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BackgroundPatients with advanced rare cancers have poor prognosis and few treatment options. As immunotherapy is effective across multiple cancer types, we aimed to assess pembrolizumab (programmed cell death 1 (PD-1) inhibitor) in patients with advanced rare cancers.MethodsIn this open-label, phase 2 trial, patients with advanced rare cancers whose tumors had progressed on standard therapies, if available, within the previous 6 months were enrolled in nine tumor-specific cohorts and a 10th cohort for other rare histologies. Pembrolizumab 200 mg was administered intravenously every 21 days. The primary endpoint was non-progression rate (NPR) at 27 weeks; secondary endpoints were safety and tolerability, objective response rate (ORR), and clinical benefit rate (CBR).ResultsA total of 127 patients treated between August 15, 2016 and July 27, 2018 were included in this analysis. At the time of data cut-off, the NPR at 27 weeks was 28% (95% CI, 19% to 37%). A confirmed objective response (OR) was seen in 15 of 110 (14%) evaluable patients (complete response in one and partial response in 14). CBR, defined as the percentage of patients with an OR or stable disease ≥4 months, was 38% (n=42). Treatment was ongoing in 11 of 15 patients with OR at last follow-up. In the cohort with squamous cell carcinoma (SCC) of the skin, the NPR at 27 weeks was 36%, ORR 31%, and CBR 38%. In patients with adrenocortical carcinoma (ACC), NPR at 27 weeks was 31%, ORR 15%, and CBR 54%. In the patients with carcinoma of unknown primary (CUP), NPR at 27 weeks was 33%, ORR 23%, and CBR 54%. In the paraganglioma–pheochromocytoma cohort, NPR at 27 weeks was 43%, ORR 0%, and CBR 75%. Treatment-related adverse events (TRAEs) occurred in 66 of 127 (52%) patients, and 12 (9%) had grade ≥3 TRAEs. The most common TRAEs were fatigue (n=25) and rash (n=17). There were six deaths, all of which were unrelated to the study drug.ConclusionsThe favorable toxicity profile and antitumor activity seen in patients with SCC of skin, ACC, CUP, and paraganglioma–pheochromocytoma supports further evaluation of pembrolizumab in this patient population.Trial registration numberNCT02721732
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Jaoude, Dory Abou, Joseph A. Moore, Matthew B. Moore, Philip Twumasi-Ankrah, Elizabeth Ablah, and Dennis F. Moore. "Glioblastoma and Increased Survival with Longer Chemotherapy Duration." Kansas Journal of Medicine 12, no. 3 (2019): 65–69. http://dx.doi.org/10.17161/kjm.v12i3.11795.
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Introduction
 The five-year survival rate for patients with glioblastoma (GBM) is low at approximately 4.7%. Radiotherapy plus concomitant and adjuvant temozolomide (TMZ) remains the standard of care. The optimal duration of therapy with TMZ is unknown. This study sought to evaluate the survival benefit of two years of treatment.
 Methods
 This was a retrospective chart review of all patients diagnosed with GBM and treated with TMZ for up to two years between January 1, 2002 and December 31, 2011. The Kaplan-Meier method with log-rank test was used to estimate the progression-free survival (PFS) and the overall survival (OS). The results were compared to historical controls and data from previous clinical trials of patients treated up to one year.
 Results
 Data from 56 patients with confirmed GBM were evaluated. The OS probability was 54% (SE = 0.068) at one year, 28.3% (SE = 0.064) at two years, 17.8% (SE = 0.059) at three years, and 4% (SE = 0.041) at five years. Seven patients (12.5%) were treated with TMZ for two years. Their median time-to-progression was 28 months (95% CI = 5.0 - 28.0), and they had an increased survival probability at three years compared to other patients (log-rank test χ2 (1, N = 56) = 19.2, p < 0.0001).
 Conclusions
 There may be an advantage for a longer duration of TMZ therapy among patients with GBM, but the sample size was too small for generalization. A multicenter prospective study is needed to dentify optimal duration of TMZ therapy.
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Tupitsyn, N. N., T. M. Dzhumanazarov, A. D. Palladina, A. K. Alakhverdiyev, S. V. Chulkova, and P. V. Kononets. "IMMUNOLOGICAL PARAMETERS OF BONE MARROW IN NON-SMALL CELL LUNG CANCER." Russian Journal of Biotherapy 19, no. 2 (2020): 47–54. http://dx.doi.org/10.17650/1726-9784-2019-19-2-47-54.
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Introduction Generation of most immunocompetent cells takes place in bone marrow Bone marrow. As well, bone marrow is a peripheral lymphoid organ where antitumor effector cells and memory cells are present. The aim of the work is to estimate peripheral lymphoid cell subpopulations in bone marrow of lung cancer patients. Materials and methods Study has been done in 68 pts with lung cancer: squamous cell cancer (n = 28), adenocarcinoma (n = 38), other forms (n = 2). In all cases standard diagnostic and staging procedures were performed, as well as morphological (myelogram) and immunological study of bone marrow lymphocyte subpopulations. Multicolor Flow cytomtry was used for study of bone marrow lymphocyte populations. We studied T-cells and its subpopulations, B-cells, NK-cells, perforin-positive cells, and CD27-positive cells. Results Squamous cell lung cancer was characterized by higher content of bone marrow mature T-cells (CD3), and CD8 lymphocytes. More typical for adenocarcinoma was mature B-cell reaction (CD20). Effector (perforin-positive) populations of lymphocytes also were related to histological type of cancer: for adenocarcinoma presence of CD4-positive cytotoxic lymphocytes and CD27-expression on effector cells. Perforin-containing lymphoid cells were in opposite correlation to erythrocaryocytes. Conclusion Subpopulational lymphocyte content of bone marrow is related to histological variant of cancer and erythropoiesis in lung cancer patients.
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Sheskier, Rachel, Alen Sajan, Priyanka Mathias, and Vafa Tabatabaie. "Plasmapheresis as First Line Therapy for Thyrotoxicosis in a Critically Ill Patient." Journal of the Endocrine Society 5, Supplement_1 (2021): A948. http://dx.doi.org/10.1210/jendso/bvab048.1937.
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Abstract Introduction: The role of plasmapheresis (TPE) in thyrotoxicosis management is not well established. Its use may be determined on an individualized basis (1). We report a case of a critically ill patient where TPE was utilized as first-line therapy for refractory thyrotoxicosis. Clinical Case: A 33-year-old woman with Graves’ disease complicated by medication non-adherence presented with rapidly ascending paralysis and bulbar weakness. Primary work up was consistent with acute inflammatory demyelinating polyneuropathy (AIDP) based on EMG findings of motor fiber polyneuropathy with demyelinating features. Laboratory evaluation revealed uncontrolled hyperthyroidism (TSH &lt;0.05 uU/mL, N 0.3-4.2 uU/mL; fT4 3.9 ng/dL, N 0.6-1.5 ng/dL; tT3 318, N 60-160 ng/dL). Initially, there was low concern for thyrotoxicosis based on a Burch-Wartofsky score of 15 (2). Standard dose methimazole and aggressive beta-blockade were initiated. Hospital course was complicated by hypoxic respiratory failure due to progressive paralysis requiring intubation and septic shock from Klebsiella pneumonia requiring initiation of pressors and broad-spectrum antibiotics. Biochemical evaluation showed increasing fT4 (3.8 ng/dL) and tT3 (419 ng/dL) levels. Burch-Wartofsky score increased to 55, consistent with a thyrotoxic crisis. Due to the patient’s critical condition, TPE was rapidly initiated along with standard therapy for thyrotoxic crisis (high dose methimazole, esmolol drip, stress dose corticosteroids, cholestyramine, and potassium iodide) as a bridge to definitive management with thyroidectomy. Rapid clinical improvement with a decline in fT4 levels (3.8 to 2.1 ng/dL) was noted after initiation of TPE with normalization in fT4 (1.5 ng/dL) and tT3 (54 ng/dL) after three sessions. Thyroidectomy was pursued after clinical stabilization. Surgical pathology showed diffuse papillary hyperplasia consistent with Graves’ disease. Due to persistent respiratory failure, the patient underwent tracheostomy placement. Repeat EMG revealed severe myopathic dysfunction without demyelinating features favoring a diagnosis of acute thyrotoxic myopathy over AIDP. Patient was ultimately discharged to a long term acute care facility due to slow neurological recovery. Conclusion: TPE should be considered as first line management in conjunction with conventional medical therapy in critically ill patients with thyrotoxicosis as a bridge to thyroidectomy due to rapid time to effect and patient stabilization. References: (1) Padmanabhan A, et al. J Clin Apher. 2019 Jun;34(3):171-354. (2) Bahn Chair RS, et al. Thyroid. 2011 Jun;21(6):593-646.
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Kurosawa, Saiko, Hiroki Yamaguchi, Takuhiro Yamaguchi, et al. "Decision Analysis of Allogeneic Hematopoietic Stem Cell Transplantation Versus Chemotherapy in Cytogenetically Standard-Risk Acute Myeloid Leukemia in First Complete Remission: The Impact of FLT3-ITD Profile." Blood 124, no. 21 (2014): 1221. http://dx.doi.org/10.1182/blood.v124.21.1221.1221.
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Abstract Background Recent studies have shown that mutations in internal tandem duplication (ITD) of the FLT3 gene (FLT3-ITD) influence prognosis of cytogenetically normal AML. Our previous decision analysis (Kurosawa et al, Blood 2011) showed that, for patients with cytogenetically standard-risk AML in first complete remission (CR1), allogeneic hematopoietic cell transplantation (HCT) provided better survival with and without a quality-of-life (QOL) adjustment. In this study, we undertook a decision analysis to determine a favored treatment strategy for patients with cytogenetically standard-risk AML in CR1 depending on FLT3-ITD profile. Patients and Methods Inclusion criteria comprised patients aged 16 to 70 years who were diagnosed with intermediate- or unknown-risk AML according to the Southwest Oncology Group cytogenetic classification, and achieved CR1. We collected bone marrow or peripheral blood samples obtained at diagnosis for patients registered, and retrospectively analyzed mutations of FLT3-ITD using DNA extracted from the specimens. We constructed a Markov decision model to reflect outcomes of HCT and chemotherapy in CR1 with three Markov health states; (1) alive after HCT, (2) alive after chemotherapy, or (3) dead. After the decision node of HCT, we added a branch to consider patients who had relapse before receiving HCT in CR1. Cycle length was 3 months and the analyses were performed for 40 cycles, 10 years. Transition probabilities between health states were calculated from the underlying survival rate of the cohort registered. Results were obtained as life expectancy (LE) and QOL-adjusted life expectancy (QALE). We conducted another cross-sectional study to investigate patient-reported QOL from those treated for acute leukemia. Adjusted means of EQ-5D index were adapted from the study as utility estimates that reflect QOL after HCT or chemotherapy (overall mean: post HCT overall, 0.74; post HCT with GVHD, 0.67; post chemotherapy overall, 0.70), and were allowed to change over time (<1 years, 1-2 years, 2-5 years, and 6 years or later from CR1). The analyses were performed using TreeAge Pro software package (TreeAge Software, Williamstown, MA), Stata version 13 (Stata Corp., College Station, TX), and SPSS software (SPSS Inc). Results Among 541 patients registered in the database, mutations in FLT3-ITD were successfully tested in 332 patients (61%). The median age of patients was 52 years and the median follow up was 37 months among survivors. FLT3-ITD mutations were found in 60 patients (18%). Eighty-five patients received allogeneic HCT in CR1 and the other 247 patients were treated with chemotherapy alone during the period of CR1. Patients who received HCT were significantly younger (median age, 41 vs 54 years), more frequently received 2 courses of induction therapy and had dysplasia at diagnosis compared to those who were treated with chemotherapy. In FLT3-positive and FLT3-negative patients, similar proportions of patients received HCT in CR1 (23%, N=14 vs 26%, N=71). In 10-year observation, LE and QALE were 5.9 and 5.1 years, respectively, for total patients. For FLT3-positive patients, allogeneic HCT in CR1 improved LE and QALE by 22 and 17 months, respectively (Table). QALE benefit of HCT was still apparent when we used utility estimates for post HCT with GVHD. Sensitivity analyses across the range of plausible utility estimates (HCT, 0.63-0.83; chemotherapy, 0.64-0.75) did not change the conclusion. For FLT-3 negative patients, HCT benefit was less than 1 year for LE and QALE. Sensitivity analyses showed that chemotherapy would be the preferred strategy when utility estimates for chemotherapy was higher than 0.7. An analysis of FLT3-negative patients stratified by age indicated that HCT in CR1 provided better LE and QALE than chemotherapy alone for patients aged 55 years or older (LE: 77 vs 57; QALE: 54 vs 38 months). In contrast, HCT did not improve LE (74 vs 79 months) or QALE (52 vs 54 months) compared to chemotherapy alone in younger patients with FLT3-negative AML. Conclusion For patients with FLT3-ITD-positive, cytogenetically standard-risk AML, allogeneic HCT in CR1 offered overall and QOL-adjusted survival benefit. For patients without FLT3-ITD, survival benefit of HCT in CR1 was less apparent. Disclosures No relevant conflicts of interest to declare.
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Nakvasina, Elena N., Alexey G. Volkov, and Nadezhda A. Prozherina. "Provenance experiment with spruce (Picea abies (L.) Karst. and Picea obovata (Ledeb.)) in the North of Russia (Arkhangelsk region)." Folia Forestalia Polonica 59, no. 3 (2017): 219–30. http://dx.doi.org/10.1515/ffp-2017-0023.
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Abstract This research presents the variability in the survival and growth for 27 provenances of spruce (Picea abies (L.) Karst. and Picea obovata (Ledeb.)). All the tests were carried out in Russia, Arkhangelsk region, 62º 54’ N, 40º 24’ E, in the northernmost site of the State Geographic Network, established in 1977. For the research on the spruce provenances, standard methods for studying the geographic variation of the main forest-forming species were used. Growth rates of provenances were correlated with their geographical coordinates and climatic characteristics. Data was expressed in standard deviation units to select the best in growth provenances. Despite the significant differences in the location of the original stands (up to 12º N and 37º E), variability in survival, height and diameter is low (coefficient of variation is 12.2–19. 0%). Obtained data indicated that provenances’ growth is correlated on longitude of the location rather than on the latitude. Diameter and average height of provenances significantly depend on annual rainfall. The height of provenance is mostly dependent on the location of the initial habitats and their climatic characteristics. It is also related to the length of the growing season and the air temperature (annual average and in January). Groups of the provenances of the best and the worst growth were distinguished. The group of the best ones on the integral indicator (volume stand) includes provenances of the western origin represented by P. abies and its immediate hybrids – Karelia (3), Vologda (24), Leningrad (5), Pskov (7) and Moscow (29) Regions – and provenances of the eastern one represented by P. obovata – Komi (26) and Perm (38) Region. High plasticity of spruce (P. abies (L.) Karst. × P. obovata (Ledeb.)), growing within the Russian Plain, in sufficiently favourable conditions of middle taiga subzone (Arkhangelsk Region, Russia) was proved.
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Mulic, Aida, Inga B. Árnadòttir, Torbjòrg Jensdottir, and Simen E. Kopperud. "Opinions and Treatment Decisions for Dental Erosive Wear: A Questionnaire Survey among Icelandic Dentists." International Journal of Dentistry 2018 (November 1, 2018): 1–9. http://dx.doi.org/10.1155/2018/8572371.
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Dental erosive wear (DEW) is common among children and adolescents, and a survey of Icelandic children showed that 30.7% of 15-year-olds were diagnosed with the condition. Objective. To gain knowledge about dental practitioners’ experiences, opinions, and treatment decisions. Materials and Methods. A precoded questionnaire, previously used among Norwegian dentists, was sent electronically to all dentists in Iceland (n = 341). Results. The response rate was 64.2%, and 58% of dentists were male. More than half of the clinicians (54%) thought that prevalence had increased the last 10–15 years, and 67% reported it to be more common in male. Most (96%) recorded presence of DEW, but only 4% used a detailed scoring system. Lesions were mostly on occlusal surfaces of first mandibular molars (73%), on palatal in upper anterior teeth (61%), and on occlusal of maxillary first molars (36%). Most dentists (74%) reported a probable cause, e.g., high consumption of carbonated beverages (98%), acidic juices (68%), sport drinks (58%), reflux (54%), and eating disorders (20%). Dietary history was often recorded by 38%, and 65% never measured saliva. Most of the dentists (88%) treated patients themselves, and half of them preferred prevention with high fluoride and resin sealants. While some dentists wanted to restore teeth more invasively, most considered to restore with a filling. Conclusion. Icelandic dentists seem to be well educated for diagnosis and treatment of dental erosion, and dentists are aware of a minimally invasive approach. Clinical Significance. It is challenging for dentists to make the best treatment decision for patients with DEW, both in a short perspective and long perspective. At present, little is known about their knowledge and treatment approach, and there is no standard treatment which can be recommended. Therefore, the present study investigated dental practitioners’ treatment decisions, as well as knowledge, experiences, and awareness of DEW.
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Kumar, Anil, Ankita Pal, Mani Kalaivani, Nandita Gupta, and Vandana Jain. "Etiology of short stature in Indian children and an assessment of the growth hormone-insulin-like growth factor axis in children with idiopathic short stature." Journal of Pediatric Endocrinology and Metabolism 31, no. 9 (2018): 1009–17. http://dx.doi.org/10.1515/jpem-2017-0352.
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Abstract Background Our objectives were to evaluate the etiology of short stature, assess the prevalence of idiopathic short stature (ISS) and assess the growth hormone (GH)-insulin-like growth factor (IGF) axis in children with ISS. Methods A stepwise diagnostic evaluation was done in 394 children aged 4–16 years with short stature. Children with no definitive etiology were labeled as ISS. In these children, baseline IGF-1, IGF binding protein-3 (IGFBP-3) and stimulated IGF-1 after administration of GH for 4 days were measured. Results Hypothyroidism (in 18.1%) and ISS (in 15.5%) were the commonest causes of short stature. In children with ISS (n=61), the mean baseline and stimulated IGF-1 standard deviation scores (SDSs) were −1.2±1.0 and −0.3±1.4, respectively, with levels below −2 SDS in 13 (21%) and six (10%) children, respectively. In 33 (54%) of the ISS patients, response to GH was suboptimal (increment in the IGF-1 level <40%). There was no difference in the mean peak GH, IGFBP-3 and baseline and stimulated IGF-1 levels between children with familial and non-familial ISS. A significant positive correlation of height SDS with baseline IGF-1 SDS (r=0.28, p=0.026), stimulated IGF-1 SDS (r=0.32, p=0.010) and ΔIGF-1 SDS (r=0.26, p=0.036) was observed in children with ISS. Conclusions Hypothyroidism and ISS were the commonest etiologies for short stature. The baseline IGF-1 was below −2 SDS in 21% and the increment after GH stimulation was suboptimal in 54% of children, indicating that a substantial proportion of children with ISS had an impaired GH-IGF axis.
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Estari, Mamidala, and Paindla Prasad. "Phytochemical and Chromatographic Studies in the Leaves Extract of Acalypha Indica." International Interdisciplinary Research Journal 4, no. 1 (2014): 1750182. https://doi.org/10.5281/zenodo.7213379.
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<strong>ABSTRACT</strong> Acalypha indica is herb found in tropical countries. This plant used traditionally for treats various diseases. In the present study we carried out phytochemical analysis and TLC profiling were performed on different solvent extractions like n-hexane, chloroform, ethyl acetate, acetone and methanol of Acalypha indica leaves extracts. Fresh matured leaves were collected and shade dried. The leaves powder was successively extracted with different solvents. This study involves the preliminary screening of phytochemical and the qualitative thin layer chromatographic separation of secondary metabolites from the leaves of Acalypha indica. TLC profiling of the Acalypha indica was carried out using sequential extracts of solvents with varying polarity; n-hexane, ethyl acetate and acetic acid respectively. Qualitative phytochemical analysis of this plant confirm the presence of various phytochemical like alkaloids, carbohydrates, glycosides, saponins, proteins, tannins, phenols, amino acids, and starch in their leaf extracts. The TLC chromatograms constituted different coloured phytochemical compounds with different Rf values. It can be conveniently used to evaluate the quality of different area samples. For TLC, new solvent system developed for the best separation of the phytoconstituents present in the extracts. <strong>KEYWORDS</strong>: Acalypha indica, Phytochemicals, TLC, Plant extracts, Retention factor (Rf) <strong>References:</strong> Amin Mir M, Sawhney S.S, Jassal M M S. (2013), Qualitative and quantitative analysis of phttochemicals of taraxacum officinale.001-005. 2. Bauer RW, Caius JF, Mhaskar KS. (1923). The correlation between chemical composition and antihelmintics and their therapeutic values in connection with the Hookworm. 11:103-110. 3. Bourdy G, Walter A. (1992); Maternity and medicinal plants in Vanuatu. 37:179- 196. Chandra Mohan S., Dinakar S., Anand T., Elayaraja R. And Sathiya priya B., (2012). Phytochemical, GC-MS analysis and Anti bacterial activity of a medicinal plant Acalypha indica, 1050-1054. Chopra RN, Nayar SI, Chopra IC. (1956).Glossary of Indian Medical plants. 6. Chopra R. N., Nayar S. L., Chopra IC. (2006), Glossary of Indian Medicinal Plants, National Institute of Science Communication and Information Resources, page no.54. Das AK Ahmed F, Biswas NN, Dev S, Masud MM.(2005); Diuretic activity of Acalypha indica.4:1-2. De S, Dey Y. N., Ghosh A. K. (2010), Phytochemical investigation and chromatographic evaluation of the different extracts of tuber of Amorphaallus paeonifolius, 150-157. Govindarajan M., Jebanesan A., Reetha D, Amsath. R., Pushpanathan T and Samidurai K. (2008). Anti bacterial activity of Acalypha indica. 12:299-302. 11. Gupta R.K. (2010), Medicinal & Aromatic plants, CBS publishers &distributors116-117. Hiremath SP, Badami S, Swamy HKS, Biradar JS. (1993). Antimicrobial activity of various extracts of Acalypha indica. 33:75-77. John De Britto A, Steena Roshan Sebastian and Mary Sujin, (2011).Phytochemical analysis of medicinal Plants of Lamiaceae, 001-006. 14. Khare C P. Indian medicinal plants, Springer, (2007), Gupta. A. K., N. Tondon, M. Sharma. Quality Standards of Indian Medicinal Plants. 128. 15. Kirtikar K.R, Basu B.D, (2006), Indian Medicinal Plants, International book distributors, 2,856-860. Lingaiah M and Nagaraja Rao P. An ethnobotanical survey of medicinal plants used by traditional healers of Adilabad district, Andhra Pradesh, India. Biolife. 1(1):17-23, 2013. Manisha Masin, Tanushree Banerjee, Bhasker Banerjee and Anita PAL,(2011).Antidiabetic activity of Acalypha indica on normal and alloxan induced diabetic rats;51-54. Mohana Vamsi N, Venkata Sunil kumar M, Kodandaram N, Padmanbha Reddy Y, (2008).Evalution of anti-inflammatory activity of Acalypha indica. 7:89- 91. Nadkarni K.M. (2009), Indian Materia Medica, Bombay Popular PrakashamVol.1, 285-286. 20. Pongtip Sithisarn et al. (2006); Medicinal Principles Practice 15: 219-222. Prasad Paindla, Rajendra Chary Vijayagiri and Estari Mamidala (2013), Ethnobotanical survey in different mandals of Adilabad district, Andhra Pradesh, India, International Journal of Sciences. 77-82. Prashant Tiwari and Bimlesh kumar, Mandeep kaur, Gurpreet kaur, Harleen kaur (2011), Phytochemical screening and extraction. 98-106. Rajendra Chary Vijayagiri and Estari Mamidala. Preliminary phytochemical and in vitro anti-diabetic activity of Ficus racemosa (L.) stems bark extract. Online International Interdisciplinary Research Journal, Voll-III, Nov 2013. 134-141. Rajendra Prasad Gujjeti and Estari Mamidala. Phytochemical Screening and Thin Layer Chromatographic Studies of Aerva lanata root extract. International Journal of Innovative Research in Science, Engineering and Technology. 2(10), 2013. 5725-5730. Ruchi GM, Majekodunmi, Ramia, Gouri BV, Hussain A, Suad khamis SB. (2007), Antioxidant capacity of some edibile and wound healing plants in Oman. 101:465-470. Singh DAP, Raman M, Saradha V, Jayabharathi P, Kumar VRS, (2004); Acarcidal Property of kuppaimemeni (Acalypha indica) against natural Psoroptes cuniculi infestion in broiler Rabbits. 74(10):1003-1006. Suresh Reddy J, Rajeswara Rao P, Mada SR.(2002); Wound healing effects of Heliotropium indicum, Plumbago zeylanicum and Acalypha indica in rats. 79:249-251. Wagner H and Bladt S. (2004). Plant drug analysis-A thin layer chromatography atlas, 2nd Ed., 29. Yan-Ling Wang et al. (2010); J Medicinal Plants Research. 4(4): 304-308.
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Gleeson, Jack Patrick, Abdullah Alhusaini, Philip O'Halloran, et al. "Identifying factors to predict benefit from bevacizumab in progressive glioblastoma multiforme (GBM)." Journal of Clinical Oncology 35, no. 15_suppl (2017): e13515-e13515. http://dx.doi.org/10.1200/jco.2017.35.15_suppl.e13515.
Full textAbstract:
e13515 Background: Bevacizumab (BEV) has demonstrated activity in GBM, but the benefits have not been clearly defined in prospective randomised phase III trials. Some patients continue BEV for extended periods but little is known about predictors of clinical benefit. It has been suggested that a less intensive dose schedule might offer similar benefits. Methods: In a retrospective analysis of a National Neuro-Oncology centre database we examined biomarkers of BEV benefit on overall survival (OS), including age at diagnosis, time from diagnosis to BEV start, MGMT methylation and IDH-1 status. We compared those who derived clinical benefit (OS of ≥6-months) to those with limited clinical benefit (OS <6 months). At our Institution, there is variable practice between Neuro-Oncologists in terms of BEV dose schedule. In this homogeneous patient population, we examined whether OS was similar for patients who received standard BEV dosing (10mg/kg q 2wks or 15mg/kg q 3wks) or reduced intensity BEV (5mg/kg q 2wks or 7.5mg/kg q 3wks). Results: Between January 1st 2010 and Dec 31st 2016, 170 patients received BEV for progressive GBM. Median OS was 5.5 months (Range: 0.5-54). OS was 42%, 18% and 2% at 6-, 12- and 24-months, respectively. No significant predictors of clinical benefit were identified (table). Importantly, median OS was similar for patients who received standard (N=94) vs. reduced intensity (N=76) BEV (5.2 vs. 5.6mo respectively), p=0.74. Conclusions: In this large cohort of patients, we did not identify predictors of benefit from BEV. OS was similar in patients who received standard or reduced intensity BEV. Given the cost of BEV, these results have important implications for value in cancer care. [Table: see text]
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Sattoe, Jane N. T., Mariëlle A. C. Peeters, Jannie Haitsma, AnneLoes van Staa, Victorien M. Wolters, and Johanna C. Escher. "Value of an outpatient transition clinic for young people with inflammatory bowel disease: a mixed-methods evaluation." BMJ Open 10, no. 1 (2020): e033535. http://dx.doi.org/10.1136/bmjopen-2019-033535.
Full textAbstract:
ObjectiveDeveloping and evaluating effective transition interventions for young people (16–25 years) with inflammatory bowel disease (IBD) is a high priority. While transition clinics (TCs) have been recommended, little is known about their operating structures and outcomes. This study aimed to gain insight into the value of a TC compared with direct handover care.DesignControlled mixed-methods evaluation of process outcomes, clinical outcomes and patient-reported outcomes.SettingTwo outpatient IBD clinics in the Netherlands.ParticipantsData collection included: semistructured interviews with professionals (n=8), observations during consultations with young people (5×4 hours), medical chart reviews of patients transferred 2 to 4 years prior to data collection (n=56 in TC group; n=54 in control group) and patient questionnaires (n=14 in TC group; n=19 in control group).OutcomesData were collected on service structures and daily routines of the TC, experienced barriers, facilitators and benefits, healthcare use, clinical outcomes, self-management outcomes and experiences and satisfaction of young people with IBD.ResultsAt the TC, multidisciplinary team meetings and alignment of care between paediatric and adult care providers were standard practice. Non-medical topics received more attention during consultations with young people at the TC. Barriers experienced by professionals were time restrictions, planning difficulties, limited involvement of adult care providers and insufficient financial coverage. Facilitators experienced were high professional motivation and a high case load. Over the year before transfer, young people at the TC had more planned consultations (p=0.015, Cohen’s d=0.47). They showed a positive trend in better transfer experiences and more satisfaction. Those in direct handover care more often experienced a relapse before transfer (p=0.003) and had more missed consultations (p=0.034, Cohen’s d=−0.43) after transfer.ConclusionA TC offer opportunities to improve transitional care, but organisational and financial barriers need to be addressed before guidelines and consensus statements in healthcare policy and daily practice can be effectively implemented.
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Molina, Thierry Jo, Danielle Canioni, Christiane Copie-Bergman, et al. "R-ACVBP Benefits to Younger Patients with Non-Germinal Centre Diffuse Large B-Cell Lymphoma As Compared to R-CHOP in the GELA Trial LNH03-2B." Blood 118, no. 21 (2011): 2632. http://dx.doi.org/10.1182/blood.v118.21.2632.2632.
Full textAbstract:
Abstract Abstract 2632 Hans algorithm using immunohistochemistry correlates well with gene expression data in Diffuse large B-cell lymphomas (DLBCL) (Meyer PN, 2011) and has demonstrated in some studies clear survival differences in favor of germinal-centre (GC) vs non-germinal centre (n-GC) B-cell among DLBCL treated with R-CHOP. We undertook an immunohistochemical study among patients aged 18 to 59 years with aaIPI 1 included in the GELA trial LNH 03-2B that compared R-ACVBP intensified immunochemotherapy to standard R-CHOP. This trial demonstrated an improvement of EFS, PFS and overall survival (OS) of patients treated with R-ACVBP (C Recher et al, in press). Our goal was to evaluate survival of patients with GC and n-GC DLBCL according to treatment regimens. We analyzed by immunohistochemistry the expression of CD10, BCL6 and MUM1 and classified patients as GC or n-GC according to the Hans algorithm. Among the 380 patients enrolled in this study, 229 patients were available for Hans algorithm classification. There was no differences considering clinical characteristics of these 229 patients (age, sex, B symptoms, PS, Stage, LDH, number of extranodal sites, bulky mass, bone marrow involvement) compared to the whole LNH03-2B population. 175 DLBCL cases were present on a tissue microarray (TMA) and 54 other cases were analyzed using unstained slides. 101 patients were classified as GC and 128 as n-GC. 107 patients were treated by R-ACVBP and 122 by R-CHOP. EFS, PFS and OS were not different between the GC and n-GC profile among the whole population (P=.82, P=.90, P=.68, respectively). There was no statistical difference in EFS, PFS and OS between R-ACVBP and R-CHOP in GC patients (P=.78; P=.84, P=.33, respectively). Interestingly, EFS, PFS and OS were significantly much longer among n-GC patients treated by R-ACVBP compared to R-CHOP (P=.02; P=.007, P=.007, respectively). Results were similar considering only TMA population (P=.02, P=.001, P=.001, respectively). This subgroup analysis suggests that the survival benefit related to R-ACVBP over R-CHOP in the LNH 03-2B is in large part linked to a survival improvement in the n-GC population. This algorithm, easy to apply on routine paraffin-embedded tissue, might be useful in the future to select patients that can primarily benefit from this intensive regimen. Disclosures: No relevant conflicts of interest to declare.