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Saif-Ur-Rahman, K. M., Kavita Kothari, Corinna Sadlier, et al. "Effect of COVID-19 vaccines for the treatment of people with post-COVID-19 condition: a rapid review." HRB Open Research 5 (October 25, 2022): 69. http://dx.doi.org/10.12688/hrbopenres.13638.1.
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Background: Vaccination for coronavirus disease 2019 (COVID-19) has demonstrated reduced risk of hospitalisation and death against more recent variants of COVID-19. Some studies suggested improvements in patients with post-COVID-19 condition (PCC) following vaccination. We systematically explored available evidence on the effect of COVID-19 vaccines for the treatment of people with PCC. Methods: We conducted a rapid review of the literature following systematic approaches. We searched Medline (OVID), EMBASE (Elsevier), ClinicalTrials.gov, and the International Clinical Trials Registry Platform (ICTRP) for randomised trials, non-randomised trials, controlled before-after studies, and interrupted time-series studies of the effect of COVID-19 vaccines for treating people with PCC. Two independent review authors screened citations. Two review authors extracted data independently. We had planned to assess the risk of bias and use the GRADE approach (Grading of Recommendations, Assessment, Development, and Evaluation) to assess the certainty of evidence if there were completed studies. Results: We identified two ongoing randomised controlled trials. Both trials examine the effectiveness of therapeutic vaccines on PCC. The anticipated completion date of the CIMAvax-EGFA trial is January 2023, and the completion date of the COVID-19 mRNA vaccine trial is not stated. Conclusions: There is currently an absence of high‐quality evidence evaluating the effectiveness of COVID-19 vaccines for treating people with post-COVID-19 condition. The absence of published studies and only two ongoing trials highlight the need for additional studies on the effectiveness of vaccines for PCC. We recommend that researchers consider PCC as per the definition provided by the World Health Organization and use the available core outcome set for PCC in deciding which outcomes to measure and report in the trials. PROPSERO registration: CRD42022330821 (20/06/2022)
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Saif-Ur-Rahman, K. M., Kavita Kothari, Corinna Sadlier, et al. "Effect of COVID-19 vaccines for the treatment of people with post-COVID-19 condition: a rapid review." HRB Open Research 5 (October 11, 2023): 69. http://dx.doi.org/10.12688/hrbopenres.13638.2.
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Background: Vaccination for coronavirus disease 2019 (COVID-19) has demonstrated reduced risk of hospitalisation and death against more recent variants of COVID-19. Some studies suggested improvements in patients with post-COVID-19 condition (PCC) following vaccination. We systematically explored available evidence on the effect of COVID-19 vaccines on the treatment of people with PCC. Methods: We conducted a rapid review of the literature following systematic approaches. We searched Medline (OVID), EMBASE (Elsevier), ClinicalTrials.gov, and the International Clinical Trials Registry Platform (ICTRP) for randomised trials, non-randomised trials, controlled before-after studies, and interrupted time-series studies of the effect of COVID-19 vaccines for treating people with PCC. Two independent review authors screened citations. Two review authors extracted data independently. We had planned to assess the risk of bias and use the GRADE approach (Grading of Recommendations, Assessment, Development, and Evaluation) to assess the certainty of evidence if there were completed studies. Results: We identified two ongoing randomised controlled trials. Both trials examine the effectiveness of therapeutic vaccines on PCC. The anticipated completion date of the CIMAvax-EGFA trial is January 2023, and the completion date of the COVID-19 mRNA vaccine trial is not stated. Conclusions: There is currently an absence of high‐quality evidence evaluating the effectiveness of COVID-19 vaccines for treating people with post-COVID-19 condition. The absence of published studies and only two ongoing trials highlight the need for additional studies on the effectiveness of vaccines for PCC. We recommend that researchers consider PCC as per the definition provided by the World Health Organization and use the available core outcome set for PCC in deciding which outcomes to measure and report in the trials. PROPSERO registration: CRD42022330821 (20/06/2022)
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Zaide, Glenn B., Renee Pekmezaris, Christian N. Nouryan, et al. "Ethnicity, race, and advance directives in an inpatient palliative care consultation service." Palliative and Supportive Care 11, no. 1 (2012): 5–11. http://dx.doi.org/10.1017/s1478951512000417.
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AbstractObjective:Although race and ethnic background are known to be important factors in the completion of advance directives, there is a dearth of literature specifically investigating the effect of race and ethnicity on advance directive completion rate after palliative care consultation (PCC).Method:A chart review of all patients seen by the PCC service in an academic hospital over a 9-month period was performed. Data were compiled using gender, race, ethnicity, religion, and primary diagnosis. For this study, advance directives were defined as: “Do Not Resuscitate” (DNR) and/or “Do Not Intubate” (DNI).Results:Of the 400 medical records reviewed, 57% of patients were female and 71.3% documented their religion as Christian. The most common documented diagnosis was cancer (39.5%). Forty-seven percent reported their race as white. White patients completed more advance directives than did nonwhite patients both before (25.67% vs. 12.68%) and after (59.36% vs. 40.84%) PCC. There was a significantly higher proportion of whites who signed an advance directive after a PCC than of nonwhites (p = 0.021); of the 139 whites who did not have an advance directive at admission, 63 signed an advance directive after a PCC compared with 186/60 nonwhites (45% vs. 32%, respectively, p = 0.021). Further analysis revealed that African Americans differed from whites in the likelihood of advance directive execution rates pre-PCC, but not post-PCC.Significance of results:This study demonstrates the impact of a PCC on the completion of advance directives, on both whites and nonwhites. The PCC Intervention significantly reduced differences between whites and African Americans in completing advance directives, which have been consistently documented in the end-of-life literature.
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Broekhuis, Thom, and Michael Corbey. "Trek lering uit uw investering! Over financiële projectmonitoring en post investment analysis." Maandblad voor Accountancy en Bedrijfseconomie 98, no. (4) (2024): 105–15. https://doi.org/10.5117/mab.98.120127.
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Dit artikel laat zien dat de theorie en de praktijk van investeringsselectie veel meer gericht zijn op de fases <i>tot en met</i> de investeringsbeslissing dan <i>erná</i>. Vervolgens worden de voor- en nadelen van het systematisch financieel monitoren, bijsturen en evalueren van <i>geaccepteerde</i> investeringsprojecten geïnventariseerd. De voordelen zijn het lerend vermogen, verbeterde investeringsbesluitvorming, identificatie van succesfactoren, en realiteitszin van de cashflow(s) voor huidige en toekomstige investeringen. De nadelen (complicaties) betreffen de capaciteit en kosten van het uitvoeren, projectselectie, cultuur, en het <i>disentanglement</i> probleem. Deze bevindingen zijn onderzocht in een casestudy bij telecombedrijf KPN en bevestigen de theorie, inclusief het belang van (1) betere besluitvorming ná, en (2) "lering trekken uit". KPN ziet het <i>disentanglement</i> probleem hierbij als het grootste obstakel.
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Nabong, Christopher, Monique Chang, Sujith Kalmadi, et al. "Abstract P2-08-05: Pembrolizumab (P) added to Neoadjuvant Chemotherapy (NACT) for Triple Negative Breast Cancer (TNBC) in a community practice setting: Real World Evidence (RWE) for the effectiveness of the KN -522 regimen." Clinical Cancer Research 31, no. 12_Supplement (2025): P2–08–05—P2–08–05. https://doi.org/10.1158/1557-3265.sabcs24-p2-08-05.
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Abstract Background: NACT with platinum is the standard of care approach for operable TNBC. The KN-522 trial (N Engl J Med 2022; 386:556-7), demonstrated superior outcomes with the addition of P to NACT (KN-522 regimen), the pathological complete response (pCR) was 65% and significantly superior to 51% NACT alone (NEJM 2022; 386:556-67). The event-free survival at 36 months was 85% in the P-NACT group, compared to 77% for placebo-NACT (p&lt;0.0001). The KN522 regimen was approved by the FDA in July 2021, with rapid uptake in community practices. However, RWE demonstrates an efficacy-effectiveness gap between reported outcomes in phase 3 clinical trials to practice, including TNBC. In the control arm of the KN-522 study, 51% of patients had a pCR rate with NACT (without P). RWE for NACT is much lower, with pCR rate of 22% (n=255) from MD Anderson Cancer Ctr, TX (JCO. 2008; 26: 1275-81), and a pCR rate of 24.5% (n=421) from the BC Cancer registry (JCO 2024; 42: 16_suppl: e23274). Methods: Ironwood Cancer & Research Centers , Phoenix, AZ (ironwoodcrc.com) is a large oncology practice (includes medical, radiation oncologists, and breast surgeons) in Phoenix, AZ. We reviewed medical records for all operable TNBC cases from August 2021 to May 2024. Eligible patients had pathologically documented TNBC, operable disease, received NACT+P and were scheduled for breast surgery in the time period. This project involved retrospective chart reviews and was deemed IRB review exempt. Results: Patient characteristics: N=93, all were female. Age 29-86 yrs (median 60). 40.9% were &gt; 65 yrs and 69.9% were post-menopausal. Performance status: ECOG 0 (54.8%), ECOG 1(12.9 %) and not determined before NACT (30.1%). Nodal status was positive in 41.9% and clinical staging was 1 (5.8%), 2 (54.8%) and 3 (39.8%). NACT+P was initiated in all 93 patients, following completion of NACT, 85 had surgery (91.4%). Lumpectomy was performed in 35.5% and mastectomy in 55.9%. The pCR rate (n=85) was 51.8%. Adjuvant therapy following surgery with P was given to 77.3% of patients. Most patients who received NACT+P met relevant selection criteria similar to the KN522 study. Conclusions: Our analysis is notable for having older patients, lower percentage of ECOG 0 and higher percentage of stage 3 disease compared to the KN522 study. Major differences in our population compared to the KN522 study are : Age &gt; 65 yrs (40 vs 11%), ECOG 0 (55 vs 87%) and stage 3 disease (39 vs 25%) respectively. The pCR (RWE) for NACT without P in TNBC is 22-25%. To the best of our knowledge, this analysis is the first RWE for the KN522 regimen. The pCR is doubled to 51.7% in our study with P+NACT, results support the community use of the KN522 regimen for operable TNBC patients. Citation Format: Christopher Nabong, Monique Chang, Sujith Kalmadi, Karen Ortiz- Cruz,, Victor Chiu, Anu Batra, Leslie Klein, Emily Ho, Edgar Hernandez, Theresa Chan, Rashmi Vaidya, Joesph Di Como, Ramesh K Ramanathan, Sumeet Mendonca. Pembrolizumab (P) added to Neoadjuvant Chemotherapy (NACT) for Triple Negative Breast Cancer (TNBC) in a community practice setting: Real World Evidence (RWE) for the effectiveness of the KN -522 regimen [abstract]. In: Proceedings of the San Antonio Breast Cancer Symposium 2024; 2024 Dec 10-13; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2025;31(12 Suppl):Abstract nr P2-08-05.
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Pham, Huan, Qiaoling Chen, Aldon Li, Adam Baghban, Anita Cheruvanky, and Graciela Faiad. "541. Comparing Patients with Severe COVID-19 Who Improve to the Point of Discharge Following an Abbreviated Course (< 5 Days) of Remdesivir (RDV) Versus a Standard Course (≥5 Days)." Open Forum Infectious Diseases 8, Supplement_1 (2021): S372. http://dx.doi.org/10.1093/ofid/ofab466.740.
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Abstract Background The COVID-19 pandemic has negatively affected our healthcare system. Our hospitals have reached maximum capacity on several occasions. Because of the need to make beds available to new patients, some patients with severe COVID-19 who were on low flow O2 supplementation have been discharged home prior to completion of the standard (≥ 5-day) RDV course. To date, data are limited regarding clinical outcomes on these patients. Because of this, we conducted a retrospective study to assess the clinical outcomes of patients who received an abbreviated treatment course of RDV. Methods Retrospective (chart review) study Subject population All nonpregnant adult patients who were hospitalized at Kaiser Permanente Riverside Medical Center and Kaiser Permanente Moreno Valley Medical Center in 2020 with severe COVID-19 who required low flow O2 supplement during hospitalization who received RDV and discharged from hospital alive. Severe COVID-19 = positive SARS-CoV-2 PCR + evidence of lung involvement on lung imaging (X-ray or CT) + O2 saturation ≤ 94% on room air or requirement of O2 supplement. Inclusion criteria Age ≥ 18 years; Hospitalized with severe COVID-19; Given RDV Exclusion criteria Pregnancy; O2 requirement &gt; 6 L including high flow and mechanical ventilation (noninvasive or invasive); discontinuation of RDV due to adverse effects Figure 1. Patient Section. Results Mortality rate: no difference (2.1% vs 1.8%, p=0.84). 30 day post-discharge ED visit: twice more likely in the abbreviated RDV group as compared to the group receiving the standard duration (16.1% vs 8.5%, p=0.03). 30 day readmission: almost 10 times more likely in the abbreviated RDV group as compared to the group receiving the standard duration (11.9% vs 1.2%, p=&lt; 0.001). Table 1. Patient's Characteristics Table 2. Clinical Outcomes. *8 Patients Who Died Within 30-Day from Discharge Were Excluded Conclusion Though there is no difference in 30 day mortality rate, the patients who received the abbreviated RDV course are twice more likely to have ER visit and 10 times more likely to have readmission within 30 day post discharge despite more patients in the abbreviated course receiving steroids. The findings suggest that completing an at least 5-day course of RDV may be beneficial even in patients who demonstrate a clinical response earlier in course. Disclosures All Authors: No reported disclosures
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Li, Guichao, Jennifer Y. Wo, Lawrence Scott Blaszkowsky, et al. "Preoperative chemoradiotherapy versus postoperative chemoradiotherapy for local advanced gastric or Siewert II/III GEJ cancer: A retrospective analysis." Journal of Clinical Oncology 36, no. 4_suppl (2018): 115. http://dx.doi.org/10.1200/jco.2018.36.4_suppl.115.
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115 Background: Radiation therapy has improved survival in gastric cancer in some randomized trials. However, post-operative fields have been difficult tolerate, and completion rates have been low. Preoperative therapy may afford the opportunity to radical therapy, and potentially improve the resectability in advanced patients. Methods: Patients with Siewert II/III GE junction or gastric cancer treated at Massachusetts General Hospital were evaluated with Institutional Review Board approval. Clinical parameters and prognostic factors including gender, age, clinical stage, pathological stage, radiation parameters, concurrent chemotherapy, non-radiation chemotherapy, toxicity and survival were included in the analysis. Results: From Jul 2005 to Jan 2017, we enrolled 88 patients had chemoradiotherapy (CRT) and surgery, 48 preoperative and 40 postoperative CRT patients. In the preoperative group, 16.7% (8/48) had nodes outside a standard D2 dissection range, and the pathologic complete regression (pCR) rate was 18.8% (9/48). Median preoperative and postoperative radiation dose was 50.4 Gy and 45 Gy. Two-drug regimen was the most commonly used preoperative concurrent chemotherapy: 60.5% and single drug was the most commonly used postoperative concurrent chemotherapy: 97.5%. Except concurrent chemotherapy, 25 preoperative CRT patients received induction FOLFOX (median 8 cycles); 9 postoperative CRT patients also received 5-FU and 23 received FOLFOX (or EOX) chemotherapy. The estimated 3-year relapse-free survival (RFS) and overall survival (OS) in the preoperative and postoperative group was 51% vs. 34.3% (p = 0.286), and 71.2% vs. 45.9% (p = 0.179), respectively. In preoperative CRT group, there was more hematological toxicity but less gastrointestinal toxicity than postoperative CRT group, more distant metastasis but less peritoneal recurrence rate. Conclusions: Compared to postoperative chemoradiotherapy, preoperative chemoradiotherapy option has the trend of better tolerance, higher RFS and OS in patients with local advanced gastric cancer. Different chemoradiotherapy strategy may lead to different recurrence patterns.
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Kutny, Matthew A., Todd A. Alonzo, Robert B. Gerbing, et al. "Results of a Phase III Trial Including Arsenic Trioxide Consolidation for Pediatric Patients with Acute Promyelocytic Leukemia (APL): A Report from the Children's Oncology Group Study AAML0631." Blood 126, no. 23 (2015): 219. http://dx.doi.org/10.1182/blood.v126.23.219.219.
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Abstract Results from cooperative group trials demonstrating the effectiveness of arsenic trioxide in the treatment of newly diagnosed APL have thus far been restricted to trials consisting of primarily adult patients. The Children's Oncology Group trial AAML0631 incorporated two cycles of arsenic trioxide (ATO) during consolidation with approximately 40% reduction in anthracycline dosing compared to the Italian AIDA0493 trial which has the largest cohort and best phase III results published for pediatric APL (Testi et al Blood 2005). Eligibility criteria included age ≥ 2 to < 22 years, de novo APL confirmed by PML-RARA PCR and no prior therapy. Diagnostic white blood cell count (WBC) determined risk group as standard risk (SR) for WBC < 10,000 and high risk (HR) for WBC ≥ 10,000. ATRA was given at the pediatric dose of 12.5 mg/m2/dose PO BID on days 1-30 of induction and days 1-14 of each consolidation course and each maintenance cycle. Other therapy was as follows: Induction- idarubicin 12 mg/m2/dose for 3 doses; Consolidation 1- 2 cycles of ATO 0.15 mg/kg/day IV 5 days each week for 5 weeks; Consolidation 2- cytarabine 1,000 mg/m2/dose IV q12 hours days 1-3, mitoxantrone 10 mg/m2/dose IV days 3, 4; Consolidation 3- idarubicin 5 mg/m2/dose IV days 1, 3, 5; Consolidation 4 (HR APL only)- cytarabine 1,000 mg/m2/dose IV q12 hours days 1-3, idarubicin 10 mg/m2/dose IV day 4; Maintenance (12 weeks/cycle for 9 cycles)- 6-mercaptopurine 50 mg/m2/day PO, methotrexate 25 mg/m2 PO once weekly. Intrathecal cytarabine was given once during each consolidation 2-4 and cycle 1 of maintenance. Between 3/2009 and 11/2012, 108 patients enrolled and 101 (66 SR and 35 HR) were evaluable for outcome (4 PML-RARA PCR negative, 3 local consent issues). Hematologic CR after induction (without central review) was 81%. The molecular (RQ-PCR) remission rate for those tested at end of Consolidation was 100%. For all patients, overall survival (OS) was 94% and event free survival (EFS) was 92% at 2 years. Comparing SR to HR, the OS was 98% vs. 86% (p=0.004) and EFS was 97% vs. 83% (p=0.014) (Figure 1). The predetermined statistical plan was to compare the EFS results to AIDA0493 which had 2 year EFS of 91% for SR and 79% for HR APL. Relapse risk on AAML0631 from end consolidation I (following ATO treatment) was 2% at 2 years and did not differ significantly between patients with SR vs. HR APL. Events on this trial included 3 relapses, 1 second malignant neoplasm (squamous cell carcinoma in situ) and 7 deaths (6 HR APL, 1 SR APL) including one death post-relapse. Four deaths during induction (all HR APL) included multiple etiologies, but coagulopathy was a factor in each. There were 2 post-induction on-therapy deaths: SR APL patient with accidental (non-chemotherapy) drug overdose during Consolidation 3 and HR APL patient with gram negative sepsis during Consolidation 2. Three relapses included: combined molecular bone marrow (detected by PCR) and CNS relapse in a SR APL patient during maintenance cycle 7 (24 months post diagnosis), combined hematologic bone marrow and CNS relapse in a HR APL patient during maintenance cycle 6 (23 months post diagnosis), and molecular bone marrow relapse in a HR APL patient after therapy completion (38 months post diagnosis) who later died of stem cell transplant complications. Both patients with molecular relapse had low level PML-RARA transcript detection (under 0.001 NCN) during maintenance beginning 1 and 16 months prior to relapse. No other patients had similar "borderline" results. While 28 patients had a diagnostic LP performed in pre-therapy evaluation, 7 patients met the protocol definition of CNS disease (CNS2 N=4, or CNS3 N=3). The 2 patients with relapse involving the CNS did not have CNS disease at diagnosis. Historically, AIDA0493 represents the largest (N=107) and best published outcomes for a major pediatric phase III trial in APL. The current trial of 101 pediatric patients achieved higher EFS rates in both SR and HR APL through incorporation of ATO while significantly reducing anthracycline doses. The reported CR rate was lower than historical comparisons, but this was likely due to difficulty in assessing differentiating and recovering bone marrow cells after APL induction. The excellent molecular remission rate at end of consolidation and the low relapse rate confirm the effectiveness of this therapy. These results strongly support use of ATO in pediatric patients with newly diagnosed APL. Disclosures Off Label Use: Arsenic Trioxide in pediatric patients with newly diagnosed APL. Gemtuzumab Ozogamicin in Pediatric AML..
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Jurkowski, Lauren, Aditya Varnam Shreenivas, Sakti Chakrabarti, et al. "Association of total neoadjuvant therapy with favorable clinical outcomes in patients with locally advanced esophageal and gastroesophageal junction adenocarcinomas (LA-GEJ CA)." Journal of Clinical Oncology 39, no. 3_suppl (2021): 231. http://dx.doi.org/10.1200/jco.2021.39.3_suppl.231.
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231 Background: Both peri-operative chemotherapy and neoadjuvant chemoradiation have been shown to improve outcomes in patients (pts) with LA-GEJ CA compared to surgery alone. Rates of post-operative chemotherapy delivery remain suboptimal. Total neo-adjuvant therapy (TNT) in LA-GEJ CA - induction chemotherapy (IC) followed by concurrent chemoradiation (CRT) - may improve systematic delivery of neoadjuvant therapy and result in favorable clinical outcomes. Methods: We retrospectively reviewed medical records of 135 pts with LA-GEJ CA at our institution between 2/2007 and 11/2019; pertinent clinical data were abstracted with Institutional Review Board approval. Patients treated with IC and curative-intent CRT with ≥40 Gy dose of radiation for adenocarcinoma were included in this analysis (N = 59). Doublet or triplet IC regimens utilizing 5-Flurouracil(5-FU), Cisplatin/Oxaliplatin and Docetaxel were commonly administered while combinations of Carboplatin +Paclitaxel or 5-FU + Oxaliplatin were used in CRT. Clinical complete response (CCR) was defined as metabolic imaging and endoscopic biopsies negative for residual malignancy after completion of TNT. Patients were followed from diagnosis to recurrence and overall survival. Survival probabilities were estimated using the Kaplan-Meier method and compared between groups using a log-rank test. Results: Out of 59 evaluable pts, 69% were clinical stage T3, 71% were node positive. 37 pts (63%) underwent surgery, R0 resection rate was 89% (33/37), pathologic complete response (pCR) rate was 19% (7/37). Among the pts who did not undergo surgery, 41% (9/22) opted to forego surgery since they attained a CCR. For the entire cohort, median Disease-Free Survival (mDFS), median Overall Survival (mOS), and 3-yr OS were 2.4 yrs, 4.7 yrs, and 67% respectively. Pts who did not undergo surgery had a mDFS, mOS, and 3-yr OS of 1.5 yrs, 4.2 yrs, and 59% respectively. Median DFS, mOS, and 3-yr OS of patients who underwent surgery were 3.5 yrs, 5.8 yrs and 72% respectively. Patients who achieved a CCR and opted to forego surgery (N = 9) had a 3 -yr DFS of 42% vs 83% for pts (N = 7) who demonstrated a pCR after curative intent tri-modality therapy. (P = 0.0099) Interestingly, the same group that achieved CCR and opted out of surgery had 3yr OS of 89% vs 83% of those who demonstrated a pCR (p = 0.0042). Conclusions: TNT for pts with LA-GEJ CA is associated with high rates of R0 resection as well as excellent DFS and OS compared to historical controls, warranting prospective evaluation. The remarkable DFS and OS in patients who opted to forego surgery due to achieving CCR is reflective of the local and systemic control rendered by this approach. Careful characterization and close longitudinal follow-up of patients who achieve CCR may help identify a subgroup of LA-GEJ CA pts who may benefit from surgery sparing approaches.
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Chanez, Brice, Jérome Guiramand, Vincent Niziers, et al. "Does radical surgery for gastric cancer after 70 years prolong survival?" Journal of Clinical Oncology 38, no. 15_suppl (2020): e16527-e16527. http://dx.doi.org/10.1200/jco.2020.38.15_suppl.e16527.
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e16527 Background: Gastric cancer (GC) occurs in 50% of case after 70 years old (y/o). Radical surgery or perioperative treatments have to be balanced with safety management in those potential frail patients. Methods: We perfomed a retrospective review of our single institution database to address the outcome of patient (pts) > 70y/o who underwent radical surgery for GC with or without neoadjuvant and adjuvant treatment. Results: From 2005 to 2019, 60 eligible patients (pts) have undergone radical surgery for resectable GC. Median age at diagnosis was 74.2y/o [70.3-92.8] and 82% were male. Initial echoendoscopy staged 12% of T1/T2 tumor versus 70% of T3/T4, whereas 60% were found with lymph node spreading (N+). 80% of pts were given neoadjuvant treatment: chemoradiation (58%), chemotherapy (45%) or radiation alone (1%). 1/4 pt received perioperative chemotherapy. Only one patient had post-operative radiation with FOLFOX and none had adjuvant radiation alone. Surgery procedure was total (27%) or sub-total (5%) gastrectomy, polar-oesogastrectomy with thoracotomy (18%) or without thoracotomy (50%). Post-operative mortality within 3 months was 5% (n = 3) including 2 pts in the first 30 days. For the global cohort, median overall survival (mOS) was 44.75 months and median progression free survival (mPFS) was 21.2 months. Patients who frontly underwent radical surgery (n = 15, 25%) had small disease with 13% pT0 and 60% of pT1 on final pathology. Only 27% had pT2/T3 but all had vascular and/or peri-nervous emboli. Two of them (13%) were pN+. The mOS was 60 months and mPFS 60 months in this cohort and 33% of pts end/was lost of follow up. Only one metastatic relapse was identifies and no local relapse. Six pts died (40%): 2 in the 30-days post surgery (13%), 3 (30%) from other cause than GC and 1 (7.5%) because of GC distant relapse. The cohort treated with neoadjuvant chemotherapy (n = 45, 75%) was given platinum and anthracycline-based regimen in 73% and 16% of cases, respectively. 1% received fluoropyrimidine +/- irinotecan. 53% associated radiation to neoadjuvant chemotherapy. After neoadjuvant treatment completion, 47% of downstaging (including 18% of pCR), 33% of stable stage and 15.5% of upstaging was observed and 40% of initial usN+ was pN0. After perioperative treatment, mOS was 31 months and mPFS was 18.9 months. Overall 44% experienced local and/or distant relapse. Conclusions: Age above 70y/o should not systematically exclude patient from neoadjuvant or perioperative treatment and radical surgery, which is feasible in selected population displaying long term result in focal and distant disease control.
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Chuk, Meredith, Emily McIntyre, Donald Small, and Patrick Brown. "Discordance of MLL-Rearranged (MLL-R) Infant ALL in Monozygotic Twins with Spontaneous Clearance of Preleukemic Clone in Unaffected Twin." Blood 112, no. 11 (2008): 2543. http://dx.doi.org/10.1182/blood.v112.11.2543.2543.
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Abstract The concordance rate for acute leukemia in infant monozygotic twins is estimated to be between 50 and 100%. The leukemic clone is thought to develop in one twin and transfer to the other twin via placental anastamoses. This hypothesis is supported by studies documenting identical, clonal, non-constitutional fusion sequences in concordant leukemias of monozygotic twins. For the ~80% of infant leukemias that are MLL-R+, the twin concordance rate is thought to be 100%, with a very short latency period between the diagnosis of the two twins. This suggests that either the MLL fusion is sufficient to cause leukemia, or it promotes the rapid acquisition of additional mutations required for the development of overt disease. We report a case of discordance in an infant monozygotic twin pair in which twin A presented with MLL-ENL+ ALL and twin B, who was transiently RT-PCR+ for MLL-ENL in bone marrow (BM) and blood, remains healthy 2.5 years later. Twin A was diagnosed at age 9 months (T=0) with CD10(−) pre-B ALL, cytogenetics t(11;19)(q23;p13.3), FISH+ for MLL-R, RT-PCR+ for MLL-ENL fusion transcript. Twin B was healthy with normal CBC and physical exam (PE). At T+7wks, twin B’s CBC and PE remained normal, but RT-PCR on peripheral blood mononuclear cells (PBMNC) was MLL-ENL+. Three weeks later (T+10wks), BM aspirate was also RT-PCR+ for MLL-ENL. Morphology, FISH and cytogenetics were normal, as were CBC and PE. Two weeks later (T+12wks), twin B developed neutropenia (WBC= 2,880/ml; ANC=461) and thrombocytopenia (29,000/ml) one week after a viral URI (fever, rhinorrhea, cough, diffuse erythematous rash). He had no lymphadenopathy or hepatosplenomegaly on PE. Review of his PB smear confirmed the cytopenias and revealed atypical lymphocytosis and activated monocytes compatible with a viral process, but no lymphoblasts. Large platelets were noted, suggesting a diagnosis of acute ITP. No treatment was given. Repeat CBC 2 days later showed recovery of counts with WBC of 6,390/ml (ANC=1150) and platelets of 117,000/ml. RT-PCR of PBMNC was negative for MLL-ENL; BM aspirate was not performed. One week later, CBC had normalized. Over the next 4 months, monthly CBC and PE were normal, and monthly RT-PCR of PBMNC were negative. Twin B remains healthy with no clinical or laboratory evidence of leukemia at T+2.5yrs. Twin A was treated according to COG protocol P9407. End-induction BM showed morphologic remission, normal cytogenetics and negative FISH, although RT-PCR remained MLL-ENL+. End-consolidation BM showed continued remission, and was negative for MLL-ENL by cytogenetics, FISH and RT-PCR. At the end of P9407 therapy, an additional 1 year of maintenance therapy was given (total duration of therapy = 2 years). Two months after completion of therapy (26 months from diagnosis), twin A experienced an isolated testicular relapse of CD10(−) pre-B ALL, MLL-ENL+. He received reinduction chemotherapy and testicular radiation and is currently receiving post-induction chemotherapy. To our knowledge, this is the first report of discordant MLL-R leukemia in infant monozygotic twins, and the first report of documented spontaneous clearance of a detectable preleukemic clone in a healthy “twin B”. There are reports of twins discordant for MLL-R leukemia, but placental status was either unknown, dichorionic, or the leukemia developed in the first twin at 5 years of age and was likely postnatally acquired. The temporal association of the disappearance of the preleukemic clone in twin B with an episode of viral-induced, self-limited thrombocytopenia and neutropenia suggests the possibility that the immune process that mediated the cytopenias may also have been responsible for clearance of the preleukemic clone. This report confirms prior reports that clonal MLL-R cells are shared between monozygotic twins. However, this case presents evidence against the hypothesis that MLL rearrangements (specifically the MLL-ENL fusion) are sufficient for the development of overt leukemia. It is possible that a viral-induced autoimmune reaction may have aborted the progression of twin B’s MLL-ENL+ preleukemic clone to overt leukemia by eradicating the clone prior to the acquisition of additional mutations. It is also possible that twin B’s preleukemic clone persists at a level beneath the sensitivity of our RT-PCR assay. A less speculative conclusion is that short latency concordance of infant MLL-R leukemia in monozygotic twins is not universal.
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Luiten, Ernest, Tallal Younis, Aydah Al-Awadhi, and Hussam Mousa. "Abstract P4-07-08: Targeted Axillary Dissection using magnetic seed placement in the axilla (mag-TAD) combined w/ dual tracer sentinel node procedure after neo-adjuvant systemic therapy (NST) in primary node pos breast cancer. Real-world evidence study in the UAE." Clinical Cancer Research 31, no. 12_Supplement (2025): P4–07–08—P4–07–08. https://doi.org/10.1158/1557-3265.sabcs24-p4-07-08.
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Abstract Targeted Axillary Dissection using magnetic seed placement in the axilla (mag-TAD) combined with dual tracer sentinel node procedure after neo-adjuvant systemic therapy (NST) in primary node positive breast cancer. A real-world evidence study of patients treated in a tertiary breast center in the United Arab Emirates (UAE). Introduction: Patients with primary node positive breast (BC) are most often treated with NST followed by breast surgery and axillary lymph node dissection (ALND). Axillary pCR is achieved in up to 80% post NST1 . Less invasive axillary surgery as opposed to ALND is a promising surgical strategy post NST to detect remnant nodal disease while reducing morbidity and preserving oncologic safety. In a large Dutch clinical trial targeted axillary dissection (TAD) was associated with a 3.5% False Negative Rate (FNR) and a 92.8% Negative Predictive Value (NPV)2. A recent multicenter retrospective cohort study showed that in patients found to be ypNo - either sentinel lymph node biopsy (SLNB) or TAD - axillary recurrence following omission of completion-ALND was low (1.0%)3. Implementation of TAD is increasing in western parts of the world. The performance of TAD relative to ALND outside clinical trials, however, remains unknown, particularly in jurisdictions such as the United Arab Emirates (UAE) where BCs are characterized by younger age of onset, poorer biological features and more advanced disease stages4. Methods: A retrospective cohort analysis was done, involving patients with primary node-positive BC treated with NST followed by mag-TAD plus ALND from August 2021 until March 2024 at the Breast Surgery Department of Tawam Hospital. A magnetic seed was inserted in the biopsy proven clipped primary positive node preceding surgery. Following completion of NST, surgery was carried out by a single breast surgeon, experienced in TAD. Dual tracer sentinel node procedure was carried out using either Technetium (Tc-99) or a magnetic tracer and combined with Patent Blue injection. (Neo-)Adjuvant treatment decisions were taken in accordance with NCCN guidelines. The performance of mag-TAD relative to mag-TAD plus ALND was examined. Results: 60 patients with node positive BC underwent mag-TAD following NST. Completion ALND was omitted in 6 patients and mag-TAD yielded inconclusive results in 1 patient due to incorrect placement outside a lymph node (1.7%). Of the remaining 53, ALND was carried out during the same (n=52) or second (n=1) surgery. All patients received neo-adjuvant chemotherapy +/- targeted therapy, except for 1 patient (neo-adjuvant endocrine). Median age was 50 year (range 30-68). Clinical T-stage was cT1-2 in 56.6% (n=30) vs cT3-4 in 43.4% (n=23) while clinical N-stage was cN1 in 83.0% (n=44) vs cN2-3 in 17.0% (n=9). Breast conserving surgery was performed in 45 out of 53 patients (84.9%). Of these, 2 (4.4%) had incomplete resection necessitating additional resection in 1 patient while the other opted for completion mastectomy. Of the 53 patients, 52.8% (n=28) had HER2 positive expression and 11.3% (n=6) had triple negative disease. The median number of lymph nodes removed by mag-TAD and the consecutive ALND was 4 (range 1-16) and 10 (range 1-18) nodes, respectively. Axillary pCR was achieved in 20 out of 53 patients (37.7%). In 2 out of 22 patients with mag-TAD ypNo, a positive lymph node was found in the ALND. In 21 out of 31 patients (67.7%) with mag-TAD ypN+, additional positive nodes were found in the ALND; median 2 (range 1-11). The mag-TAD was associated with FNR 6% (95% CI: 2 - 23 %) and NPV 91% (95% CI: 72-98%). Conclusion: In this RWE study – unique in the GCC - involving patients with high-risk node-positive BC, mag-TAD was feasible in our population with a high success rate and comparable FNR and NPV to those observed in the relevant clinical trial2. Recurrence and survival analyses will be planned. Further confirmatory studies in other jurisdictions in the region, with larger sample sizes, are warranted to confirm the favorable performance of mag-TAD observed in this single center study. 1) van den Ende NS, Nguyen AH, Jager A et al. Triple-Negative Breast Cancer and Predictive Markers of Response to Neoadjuvant Chemotherapy: A Systematic Review. Int J Mol Sci. 2023 Feb 3;24(3):2969. doi: 10.3390/ijms24032969. PMID: 36769287; PMCID: PMC9918290. 2) Simons JM, van Nijnatten TJA, van der Pol CC et al. Diagnostic Accuracy of Radioactive Iodine Seed Placement in the Axilla With Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Node-Positive Breast Cancer. .JAMA Surg. 2022 Nov 1;157(11):991-999. doi: 10.1001/jamasurg.2022.3907.PMID: 36069889 3) Montagna G, Mrdutt MM, Sun SX et al. Omission of axillary dissection following nodal downstaging with neoadjuvant chemotherapy. JAMA Oncol. Published online April 25, 2024. doi:10,001/jamaoncol.2024.0578 4) Al-Shamsi HO, Abdelwahed N, Al-Awadhi A et al. Breast Cancer in the United Arab Emirates. JCO Glob Oncol. 2023 Jan;9:e2200247. doi: 10.1200/GO.22.00247.PMID: 36608306 Citation Format: Ernest Luiten, Tallal Younis, Aydah Al-Awadhi, Hussam Mousa. Targeted Axillary Dissection using magnetic seed placement in the axilla (mag-TAD) combined w/ dual tracer sentinel node procedure after neo-adjuvant systemic therapy (NST) in primary node pos breast cancer. Real-world evidence study in the UAE [abstract]. In: Proceedings of the San Antonio Breast Cancer Symposium 2024; 2024 Dec 10-13; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2025;31(12 Suppl):Abstract nr P4-07-08.
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Karkouti, Keyvan, Jeannie Callum, Justyna Bartoszko, et al. "Protocol for a phase 3, randomised, active-control study of four-factor prothrombin complex concentrate versus frozen plasma in bleeding adult cardiac surgery patients requiring coagulation factor replacement: the LEX-211 (FARES-II) trial." BMJ Open 14, no. 8 (2024): e091381. http://dx.doi.org/10.1136/bmjopen-2024-091381.
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IntroductionReduced thrombin generation is an important component of post cardiopulmonary bypass (CPB) coagulopathy. To replenish coagulation factors and enhance thrombin generation in bleeding surgical patients, frozen plasma (FP) and four-factor prothrombin complex concentrate (4F-PCC) are used. However, the efficacy–safety balance of 4F-PCC relative to FP in cardiac surgery is unconfirmed.Methods and analysisLEX-211 (FARES-II) is an active-control, randomised, phase 3 study comparing two coagulation factor replacement therapies in bleeding adult cardiac surgical patients at 12 hospitals in Canada and the USA. The primary objective is to determine whether 4F-PCC (Octaplex/Balfaxar, Octapharma) is clinically non-inferior to FP for haemostatic effectiveness. Inclusion criteria are any index (elective or non-elective) cardiac surgery employing CPB and coagulation factor replacement with 4F-PCC or FP ordered in the operating room for bleeding management. Patients will be randomised to receive 1500 or 2000 international units of 4F-PCC or 3 or 4 units of FP, depending on body weight. The primary endpoint of haemostatic treatment response is ‘effective’ if no additional haemostatic intervention is required from 60 min to 24 hours after the first initiation of 4F-PCC or FP; or ‘ineffective’ if any other haemostatic intervention (including a second dose of study drug) is required. An estimated 410 evaluable patients will be required to demonstrate non-inferiority (one-sided α of 0.025, power ≥90%, non-inferiority margin 0.10). Secondary outcomes include transfusions, bleeding-related clinical endpoints, coagulation parameters and safety.Ethics and disseminationThe trial has been approved by the institutional review boards of all participating centres. Trial completion is anticipated at the end of 2024, and results will be disseminated via publications in peer-reviewed journals and conference presentations in 2025. The results will advance our understanding of coagulation management in bleeding surgical patients, potentially reducing the need for allogeneic blood products and improving outcomes in surgical patients.Trial registration numberNCT05523297.
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Singhvi, Surendra S. "Post‐completion review for capital projects." Planning Review 14, no. 3 (1986): 37–39. http://dx.doi.org/10.1108/eb054147.
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Stock, Wendy, Ben Sanford, Gerard Lozanski, et al. "Alemtuzumab can be Incorporated Into Front-Line Therapy of Adult Acute Lymphoblastic Leukemia (ALL): Final Phase I Results of a Cancer and Leukemia Group B Study (CALGB 10102)." Blood 114, no. 22 (2009): 838. http://dx.doi.org/10.1182/blood.v114.22.838.838.
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Abstract Abstract 838 Eradication of minimal residual disease (MRD) during the first months of ALL treatment is associated with improved disease-free survival (DFS). We hypothesized that alemtuzumab, a humanized anti-CD52 monoclonal antibody, might be an effective, novel agent for eradication of MRD. In CALGB 10102, we tested dose escalation of alemtuzumab in sequential cohorts of CD52+ cases to a target dose of 30 mg administered SC 3 times/week for 4 weeks (12 doses) during post-remission therapy. Dose limiting toxicity (DLT) was defined as the inability to proceed with protocol treatment within 6 weeks after the last dose of alemtuzumab. Eligible patients (pts) had ≥10% lymphoblast CD52 expression at diagnosis determined in a CALGB reference laboratory. Antimicrobial prophylaxis for cytomegalovirus (CMV) and Pneumocystis carinii was mandated. The 10102 therapy consisted of 6 monthly chemotherapy modules followed by maintenance therapy for a total of 2 years (Stock et al. ASH 2005, abstr 145); 299 untreated ALL pts were eligible and enrolled from 2003–2007. We previously reported (Lozanski et al. ASH 2007, abstr 2386) that 70% were CD52+ and eligible to receive Alemtuzumab (70% of B-cell ALL; 53% of T-cell ALL; 100% of Ph+ cases). Results: Twenty-four pts in remission (CR1) received Alemtuzumab as their fourth treatment module during the Phase I portion of the study. The median age was 37 years (18-77 years); 18 (80%) had B-cell ALL; 5 (19%) had T-cell ALL. 17/24 cases had evaluable cytogenetics after central review: 5 had favorable, 8 intermediate-risk, 2 poor-risk cytogenetics (neither were Ph+), and 2 were not classifiable (miscellaneous abnormalities). Non-hematologic toxicities were mild. SC alemtuzumab was well tolerated. Grade 3-4 myelosuppression was reported during 4 weeks of alemtuzumab treatment in 4 pts; 2 pts had Grade 3-4 lymphopenia. 4 pts had DLT: subsequent treatment was delayed in 2 due to transient CMV viremia; 1 developed Staph aureus empyema; and 1 had prolonged myelosuppression but did not receive G-CSF support as recommended by the protocol. 3 pts relapsed with ALL immediately following completion of the alemtuzumab module. Serial assessment of MRD using quantitative clone-specific PCR was possible in 11/24 cases. There was a median 1-log decrease in MRD during alemtuzumab therapy in the 20 and 30 mg cohorts. However, there was a 2-log rise during alemtuzumab therapy in one pt who relapsed 6 weeks later. Pharmacokinetic analysis revealed rising alemtuzumab serum levels during treatment in all dose cohorts, and levels were still detectable in some pts 10 weeks after completing alemtuzumab. During subsequent post-remission therapy, 8 pts developed CMV viremia, 2 had Herpes simplex infections, and 3 had Herpes zoster reactivation. There was not a significant correlation between serum alemtuzumab level and change in MRD or risk of viral infection. The median follow-up time for the 14 surviving pts is 51 months (49-54 months). Median DFS is 53 months (95% CI, 39 – not reached); median overall survival is 55 months (95% CI, 42- not reached). Conclusions: CD52 is expressed in the majority of adult ALL cases. Addition of alemtuzumab to front-line therapy is feasible and provides reduction in MRD, but is associated with viral infections. Dose escalation of alemtuzmab was not associated with DLT. Based on these results, the 30 mg dose of alemtuzumab was explored in an additional 70 patients in the Phase II portion of the study. The encouraging DFS results reported here require confirmation from longer follow-up of the larger Phase II cohort of patients. Disclosures: Stock: Genzyme: Research Funding. Off Label Use: The testing of alemtuzumab for treatment of ALL in adults. Lozanski:Genzyme: Research Funding. Vij:CELGENE: Honoraria, Research Funding, Speakers Bureau. Powell:Antisoma: Research Funding. Sher:invivoscribe: Employment. Richards:Genzyme: Employment. Sung:genzyme: Employment.
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Shrikhande, Shailesh V., Bhawna Sirohi, Alok Gupta, et al. "Is greater downstaging achieved if surgery is delayed beyond 8 weeks in patients with locally advanced (LA) rectal cancer?" Journal of Clinical Oncology 32, no. 3_suppl (2014): 660. http://dx.doi.org/10.1200/jco.2014.32.3_suppl.660.
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660 Background: Neoadjuvant Chemoradiotherapy (NACTRT) improves local recurrence rate in LA rectal cancer with no survival benefit. Pathological complete response (pCR) and better tumour regression grade (TRG) is associated with improved outcome. Debate is ongoing as to what is the best time to operate—if greater downstaging can be achieved by a longer interval to surgery and have an impact on sphincter saving surgery rates. In this study, we have correlated the pCR rate and TRG post completion of NACTRT with timing of surgery (TD). Methods: This is a retrospective study of prospective database of patients with LA adenocarcinoma of rectum treated from Jan 2012 to May 2013. 89 pts who completed NACTRT (50Gy/25 fractions with capecitabine 825 mg/m2BD) followed by surgical resection were included. For response evaluation patients were divided into two groups, group 1 (TD < 60 days, n=34) and 2 (TD > 60 days, n=55). Results: Of 89 pts (median age 48 y (22-76), 64 M/25F; 16/89 (18%) had signet ring histology) 93% pts underwent R0 resection; 7% R1 resection. Response to NACTRT was CR in 8 pts, PR in 65 (73%) pts and 15 SD, 1 not assessed. Median time from completion of NACTRT to surgery was 64 d (32-141). Median number LN resected were 11 (1-50). Overall, 25 (28%) pts achieved pCR; 6/89 (7%) pts had positive circumferential resection margin. 25 (74%) patients in group 1 compared to 28 (51%) pts in group 2 underwent sphincter preserving surgery (P=0.045). Eight (24%) pts in group 1 and 17 (31%) in group 2 achieved pCR (P=0.479). The median TRG in group 1 was 2.5 and in group 2 was 2 (P=NS). In pts who achieved pCR, median TD was 67 d compared to 63 d in pts who did not achieve pCR. Of the 16 pts with signet histology 4(25%) had pCR compared to 21(29%) in those with non-signet histology (P=NS). Conclusions: We conclude that the timing of surgery is not an important variable post completion of NACTRT and our data suggests that it's possible that earlier surgery may be better for organ conservation. There is no incremental benefit of delaying the surgery though this needs to be confirmed in a prospective randomised trial.
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Stock, Wendy, Richard Harvey, Barry Moser, et al. "Minimal Residual Disease (MRD) and Risk of Relapse in Acute Promyelocytic Leukemia (APL): Insights from the North American Intergroup Phase III Trial C9710." Blood 108, no. 11 (2006): 494. http://dx.doi.org/10.1182/blood.v108.11.494.494.
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Abstract MRD results during and following treatment (Rx) of APL have become an important predictor of clinical outcome and are beginning to be used to guide Rx for this highly curable leukemia, but important questions remain. Some studies suggest that low/intermediate (LI)-risk patients (pts), as defined by the Sanz criteria, who achieve a negative PCR result after intensive consolidation Rx have a very low risk of relapse and may not require maintenance Rx, while those with MRD might benefit from hematopoietic stem cell transplantation. However, these data are controversial. We studied whether a single quantitative MRD test obtained immediately after completion of C9710 consolidation Rx (with all-trans retinoic acid, daunorubicin, with or without arsenic trioxide) predicted relapse and could be used to guide further Rx. Real-time quantitative RT-PCR( RQ-PCR) was used to measure PML-RARα in bone marrow (BM) and blood (B) of 43 pts treated on C9710. All 43 pts were in first complete remission after completion of consolidation Rx when MRD was measured, but all of them later relapsed during, or after completion of maintenance Rx. By Sanz criteria, 14/43 were high risk and 29/43 LI-risk at diagnosis. 29 had S-isoform, 12 had L-isoform, and 2 had V-isoform. Median time from MRD assessment to relapse was 253 days (range: 44–1231). RQ-PCR results were expressed as a normalized quotient (NQ) of PML-RARα/GAPDH or ABL control. The sensitivity of the assay was 1 in 104–5. A NQ of &gt;10−5 was found in the prior intergroup study, INT0129, to be strongly associated with risk of relapse and was set as the threshold for considering a result “positive”. MRD with NQ &gt;10−5 was detected in only 4 of 43 (9%) pts after completion of consolidation Rx. 8 others had detectable PML-RARα transcript but had NQs &lt; 10−5. The remaining 31 pts had no evidence of MRD. There was excellent concordance between MRD measurements in 26 paired B and BM NQ values and a strong correlation between NQ values in B and BM using either GAPDH or ABL controls (p = 0.0001 and p &lt;0.0001, respectively). To determine whether a more sensitive assay might identify a higher percentage of pts with MRD, we also evaluated the post-consolidation samples in 19 of these pts using a qualitative nested RT-PCR assay with a sensitivity of detection of 1 in 106. We found 13 of 19 (68%) pts had detectable MRD. In conclusion, RQ-PCR analysis of MRD using a threshold NQ of &gt;10−5 at a single post-consolidation Rx timepoint did not predict relapse of APL in pts on C9710. Setting a lower NQ threshold for the RQ-PCR assay or using a more sensitive, but qualitative PCR assay improved the detection rate; however, neither approach identified all pts destined to relapse, nor has the prognostic value of a positive result using the more sensitive assay been determined. Based on these results, we caution against the use of a single MRD test at the end of consolidation Rx to determine further Rx. Ongoing analysis of serial samples obtained during and following completion of Rx might provide further insights into optimal timing and frequency of MRD measurements needed to identify APL pts at high risk of relapse.
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Wamithi, S. "Cross-Sectional Survey on Prevalence of Attention Deficit Hyperactivity Disorder Symptoms at A Tertiary Care Health Facility in Nairobi." Paediatrics & Child Health 21, Supplement_5 (2016): e66a-e67. http://dx.doi.org/10.1093/pch/21.supp5.e66a.
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Abstract BACKGROUND: Attention deficit hyperactivity disorder is considered the most common childhoodneurobehavioral disorder worldwide with well documented adverse consequences in adolescence and adulthood, yet 60-80% of cases go undiagnosed. Routinescreening for the condition is not practiced in most pediatric outpatient services andlittle information exists on factors associated with the condition in developingcountries. OBJECTIVES: This was a questionnaire based cross-sectional survey whose primary objective was to determine prevalence of attention deficit hyperactivity disorder (ADHD) symptoms in children aged 6-12 years attending the Accidents and Emergency unit of a tertiary care hospital in Nairobi. Secondary objectives were to (i) ascertain if physical injury and poor academic performance were associated with ADHD, (ii) compare diagnostic utility of parent-filled Vanderbilt Assessment Scale (VAS) against Statistical Manual of Mental Disorders-IV (DSM-IV) as the gold reference and (iii) establish if there exists an association between ADHD symptoms cluster and comorbid conditions. DESIGN/METHODS: The study was undertaken at the paediatric accidents and emergency (A&E) section of the Aga Khan University Hospital (AKUHN) between March and June 2012. AKUHN is a private, not for profit, tertiary health care facility based in Nairobi, Kenya. Paediatrics A&E offers a 24-hour service provided by paediatric residents and senior house officers under the supervision of paediatric registrars. Children aged 6-12 years were enrolled provided guardians demonstrated ability to read and write in English. A written signed informed consent was also required from the primary care provider. Children on methylphenidate, antidepressants or behavioral therapy and those with neurological disorders, hearing and visual impairments or need for emergency care were excluded. Those who consented were clinically evaluated and treated for the ailments that brought them to hospital prior to completion of the self-administered study questionnaire. Sample size was estimated at 240 based on estimated ADHD prevalence of 6% reported by Kashala et al from a neighboring country with similar socio-economic setting as Kenya. Study approval was obtained from the Aga Khan University Hospital Scientific and Ethical Review Committees. Enrolling of children was done after written consent from parents or primary guardians as required by the institutional review board for children under the age of 18 years. It was made clear that recruitment was entirely voluntary and that refusal to participate would not in any way compromise provision of care. Study records were secured in a locked cabinet to safeguard confidentiality. Study was carried out using a two-stage ascertainment procedure. Children were evaluated for eligibility after registration at the reception between 9am to 8pm during week days. A maximum of 10 participants were recruited on any given day to minimize burden in the department and to hopefully capture a wider spectrum of medical conditions. Details about the study were explained to the parents by the principal investigator or the research assistant after patients had been seen by the clinician for the presenting problem. Information necessary for DSM-IV classification was obtained from parents who also completed VAS form. Care providers of study children were requested to complete the risk assessment form with assistance provided as needed. It contained questions about school performance such as repetition of class and average end of term marks which was categorized as; below 25%, 25-50%, 50-75% or above 75%. A grade above 50% was considered as acceptable performance. Only injuries for which medical treatment was sought were considered for inclusion and categorized into burns,fractures and open wounds. Information on causes of injuries was classified under falls, fight, car accident and others. Completion of an assessment form took approximately 15 minutes after which questionnaire was scored and tabulated before providing feedback to parents. Data were entered in Microsoft Excel® and analysis done using STATA®Version 11 (StataCorp). Prevalence of ADHD symptoms was calculated using the number of positive cases as numerator and study population as denominator. Chi square or Fischer’s exact test were used as appropriate to compare categorical variables with P-value below 0.05 considered significant. Wilcoxon test was used for ordinal data. Odds ratios (OR) were used to determine association between ADHD symptoms and categorical variables and 95% confidence interval (CI) to determine precision around individual estimates. RESULTS: Prevalence of cluster of symptoms consistent with ADHD was 6.3% (95% CI; 3.72-10.33) in 240 children studied. Those affected were more likely to repeat classes than the asymptomatic (OR 20.2; 95%CI 4.02-100.43). Additionally, 67% of the symptomatic had previously experienced burns and 37% post-traumatic open wounds. The odds of having an injury in the symptomatic was 2.9 (95%CI; 1.01-8.42) compared to the asymptomatic. Using DSM-IV as the reference, VAS had a low sensitivity of 66.7% (95%; CI 39.03-87.12) but specificity of 99.0% (95%CI; 96.1-99.2). Its positive predictive value was 83.0% (95%CI; 50.4-97.3) and the negative predictive value 98.0% (CI 95.1-99.1). Positive and negative likelihood ratios were 75(95%CI; 18.3-311.2) and 0.3 (95%; CI 0.21-0.73) respectively. Oppositional defiant disorder symptoms, anxiety, depression and conduct problems were not significantly associated with ADHD cluster of symptoms. CONCLUSION: A relatively high prevalence of symptoms associated with ADHD was found inchildren visiting the Paediatric Accidents and Emergency department. Symptomaticchildren had also experienced more poor school performance. These findings makea strong case for introduction of a policy on routine screening for ADHD in pediatricoutpatient service in a similar setting. Positive history of injury, especially burns, and poor academic performance is associated with symptoms of ADHD which should trigger need forfurther evaluation for ADHD and appropriate referral. Even though easier toadminister than DSM-IV, Vanderbilt assessment scale has low sensitivity hence itwould not be appropriate for use in ADHD screening. However, in view of its highspecificity and ease of administration, it could be used as an alternative confirmatorytest to determine who among clinically symptomatic patients would require referral to a psychiatrist for further evaluation and management.
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Overmayer, Ryan, Francisco Tavares, and Matthew William Driller. "Acute Post-Exercise Recovery Strategies in Cycling: A Review." Journal of Science and Cycling 7, no. 3 (2018): 11–44. http://dx.doi.org/10.28985/181231.jsc.04.
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Cycling events often include multiple races a day or racing over consecutive days. Congested competition schedules and increased training load have led to the implementation of recovery strategies; with the goal of alleviating post-exercise fatigue and enhancing subsequent performance. This review aims to review the efficacy of recovery strategies used following different cycling events. Compression garments have been shown to improve subsequent 30s – 30min mean cycling power and 5-min max cycling power, while cold water immersion may improve 5-15s sprint cycling power output, 1-15min time trial (TT) total work performed and mean power output in hot and humid conditions. Cold water immersion was also more beneficial than active recovery at improving total work performed. Contrast water therapy could increase 15s – 15min TT work performed and sprint mean and peak power output. Similarly, active recovery has been shown to improve power measures and time to completion. Conversely, hot water immersion appears to be detrimental to sprint power output and TT power output over consecutive days. Thermoneutral water immersion appears beneficial for improving average cycling speed and time to completion during a 20-km TT, where humidification therapy and sports massage are beneficial at improving sprint and middle duration time trial performance. A combination of recovery strategies appear more beneficial than stand-alone strategies and various combinations should be explored further.
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Severskaya, N. V., D. V. Erygin, Yu V. Aleksandrov, N. G. Minaeva, N. Yu Dvinskikh, and N. Yu Novikov. "Carcinoembryonic antigen BEFORE AND AFTER neoadjuvant chemoradiotherapy IN PREDICTION OF pathological complete response in patients with locally advanced rectal cancer." Siberian journal of oncology 17, no. 5 (2018): 60–66. http://dx.doi.org/10.21294/1814-4861-2018-17-5-60-66.
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Carcinoembryonic antigen (CEA) is widely used to evaluate the effectiveness of treatment in patients with rectal cancer.The aim of the studywas to investigate whether the CEA levels measured before and after neoadjuvant chemoradiotherapy (nCRT) can be used to predict pathological complete response (pCR) in patients with locally advanced rectal cancer.Material and methods.179 patients with locally advanced rectal cancer were treated with nCRT followed by surgical treatment. The serum CEA level was measured before and 610 weeks after the completion of nCRT. Preand post nCRT CEA levels were compared with pCR. The factors associated with pCR were studied.Results.pCR after nCRT was achieved in 12 % (22/179) patients. The incidence of pCR was higher in patients with normal (<5 ng/mL) pre-treatment CEA level (20 %vs8 %, p=0.019). In patients with the elevated pre-treatment CEA level (> 5 ng/mL), there were no significant differences in the incidence of pCR between cases with normalization and without normalization of CEA level after treatment (p=0.08). The maximum likelihood of pCR determined by the ROC curve was <2.8 ng/mL with pre-treatment CEA (31 %) and <1.8 ng/mL with post-treatment CEA (23 %). Well differentiated tumors (G1) had higher likelihood of pCR (46%) in patients with low pre-treatment CEA (<2.8 ng/mL).Conclusion.Low CEA before and after nCRT is a predictor of pCR. Well differentiated tumors increase the probability of pCR after nCRT.
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Loparev, Vladimir N., Karen McCaustland, Brian P. Holloway, Philip R. Krause, Michiko Takayama, and D. Scott Schmid. "Rapid Genotyping of Varicella-Zoster Virus Vaccine and Wild-Type Strains with Fluorophore-Labeled Hybridization Probes." Journal of Clinical Microbiology 38, no. 12 (2000): 4315–19. http://dx.doi.org/10.1128/jcm.38.12.4315-4319.2000.
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We developed a single-tube rapid method for the detection and differentiation of varicella-zoster virus (VZV) vaccine and wild-type strains that combines rapid-cycle PCR with wild-type-specific fluorescent probe melting profiles for product genotyping. A region including the polymorphic site in VZV open reading frame (ORF) 62 was amplified in the presence of two fluorescence-labeled hybridization probes. During the annealing step of the thermal cycling, both probes bound to their complementary sequences in the amplicon, resulting in resonance energy transfer, thus providing real-time fluorescence monitoring of PCR. Continuous acquisition of fluorescence data during a melting curve analysis at the completion of PCR revealed that loss of fluorescence occurred in a strain-specific manner as the detection probe, which was fully complementary to the wild-type VZV ORF 62 region, melted off the template. Use of this method allowed genotyping of samples within minutes after the completion of PCR, eliminating the need for post-PCR sample manipulation. In addition to reducing the time required to produce a result, this method substantially reduces the risk of contamination of the final product as well as the risk of sample tracking errors. The genotypes of 79 VZV-positive samples determined by this fluorescent resonance energy transfer (FRET) method were identical to the genotypes obtained by conventional PCR and restriction fragment length polymorphism analysis. The genotyping of VZV strains by the FRET method is a rapid and reliable method that is suitable for typing and that is also practical for use for the processing of large numbers of specimens.
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Grandal, Beatriz, Clémence Evrevin, Enora Laas, et al. "Impact of BRCA Mutation Status on Tumor Infiltrating Lymphocytes (TILs), Response to Treatment, and Prognosis in Breast Cancer Patients Treated with Neoadjuvant Chemotherapy." Cancers 12, no. 12 (2020): 3681. http://dx.doi.org/10.3390/cancers12123681.
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Introduction: Five to 10% of breast cancers (BCs) occur in a genetic predisposition context (mainly BRCA pathogenic variant). Nevertheless, little is known about immune tumor infiltration, response to neoadjuvant chemotherapy (NAC), pathologic complete response (pCR) and adverse events according to BRCA status. Material and Methods: Out of 1199 invasive BC patients treated with NAC between 2002 and 2012, we identified 267 patients tested for a germline BRCA pathogenic variant. We evaluated pre-NAC and post-NAC immune infiltration (TILs). Response to chemotherapy was assessed by pCR rates. Association of clinical and pathological factors with TILs, pCR and survival was assessed by univariate and multivariate analyses. Results: Among 1199 BC patients: 46 were BRCA-deficient and 221 BRCA-proficient or wild type (WT). At NAC completion, pCR was observed in 84/266 (31%) patients and pCR rates were significantly higher in BRCA-deficient BC (p = 0.001), and this association remained statistically significant only in the luminal BC subtype (p = 0.006). The interaction test between BC subtype and BRCA status was nearly significant (Pinteraction = 0.056). Pre and post-NAC TILs were not significantly different between BRCA-deficient and BRCA-proficient carriers; however, in the luminal BC group, post-NAC TILs were significantly higher in BRCA-deficient BC. Survival analysis were not different between BRCA-carriers and non-carriers. Conclusions: BRCA mutation status is associated with higher pCR rates and post-NAC TILs in patients with luminal BC. BRCA-carriers with luminal BCs may represent a subset of patients deriving higher benefit from NAC. Second line therapies, including immunotherapy after NAC, could be of interest in non-responders to NAC.
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Pietrantonio, Filippo, Maria Di Bartolomeo, Chiara Bampo, et al. "Role of FDG-PET as predictive biomarker of pathologic complete response (pCR) in locally advanced rectal cancer (LARC) treated with capecitabine-based neoadjuvant chemoradiation (NACR)." Journal of Clinical Oncology 30, no. 15_suppl (2012): e21118-e21118. http://dx.doi.org/10.1200/jco.2012.30.15_suppl.e21118.
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e21118 Background: A favourable outcome is associated with pCR in LARC treated with NACR; pCR prediction through functional imaging may help the prospective evaluation of management strategies alternative to standard surgery. The aim of this prospective study was to identify whether FDG-PET activity and early/late response predicted independently pCR. Methods: Patients with histologically diagnosed cT3-4 and/or N+ primary rectal cancer were treated homogeneously with NACR (simultaneous boost technique radiotherapy 54 Gy on GTV/24 fractions plus capecitabine 1650 mg/mq/day) and total mesorectal excision 7-8 weeks later. FDG-PET uptake, expressed as maximum standardized uptake value, was obtained at baseline (SUV-1), at interim (2 weeks after treatment start: SUV-2) and 6 weeks after NARC completion (SUV-3) and was calculated as percentage difference (Δ-SUV). The role of SUV-1, SUV-2, SUV-3, Δ-SUV(1-2) and Δ-SUV(1-3) for pCR prediction was assessed using logistic regression analysis; ROC analysis was performed to identify the optimal thresholds. Results: The study enrolled 30 pts (median age 59 yrs; 12M:18F) treated from January 2009 to November 2011 at Istituto Nazionale Tumori of Milan. All underwent FDG-PET at baseline and post-NACR and 80% consented to an interim assessment; one patient was excluded due to surgery refusal. pCR rate was 28%. Among all parameters, only post-NACR SUV (mean 4 +/- 1.7 for pCR vs 8.7 +/-5.8 for non-pCR; P=0.001 by Mann-Whitney test) showed significant association with pCR at univariate analysis (P=0.03). At multivariate analysis including baseline SUV, post-NACR SUV, Δ-SUV, age (≤ or >65 yrs), sex (F or M) and pre-treatment stage (N- or N+/cT3 or cT4), only female sex and post-NACR SUV predicted independently pCR (both P=0.01). With ROC analysis, a post-NACR SUV threshold <5.5 had 88% sensitivity and 81% specificity, with 83% overall accuracy. Conclusions: The SUV cut-off of 5.5, explained by inflammatory modifications, could limit the applicability in clinical practice assuming values ≤2.5 for negativity. However, FDG-PET SUV post-NACR may serve as useful predictive biomarker in LARC.
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Sandri, Orana, Sarah Holdsworth, and Ian Thomas. "Assessing graduate sustainability capability post-degree completion." International Journal of Sustainability in Higher Education 19, no. 1 (2018): 2–14. http://dx.doi.org/10.1108/ijshe-08-2016-0160.
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Purpose The purpose of this paper is to highlight both the need for measurement of graduate capabilities post-degree completion and the challenges posed by such a task. Higher education institutions provide an important site of learning that can equip future professionals with capabilities to manage and respond to complex sustainability challenges in their careers. Measurement of graduate uptake and application of sustainability capabilities is an important part of advancing sustainability curriculum and pedagogy to educate the twenty-first century sustainability capable graduates. Design/methodology/approach This paper explores the nature of capabilities and reviews existing approaches to capability assessment. Findings The nature of capabilities and their assessment post-degree completion pose a number of challenges for the development of assessment and measurement tools, which is why sustainability capability assessment methods are deserving of specific research attention. Research limitations/implications The assessment and application of capability in graduates’ professional contexts are an important part of closing the loop between learning and teaching in higher education and professional application of this learning. It is imperative that more research be undertaken on the methodology of graduate assessment, given the need to understand graduate learning outcomes as they apply in professional settings for graduate employability, promoting sustainability and developing effective sustainability pedagogy. Practical implications Given that there is significant overlap between employability skills, generic graduate attributes and sustainability capabilities, this paper has relevance beyond the measurement of sustainability capability to the measurement of uptake and professional application of generic capabilities more broadly. Social implications The measurement of graduate capability offers potential to enhance learning for sustainability. Measurement of graduate capabilities is a critical part of closing the loop between workplace expectations, graduate learning outcomes, learning and teaching and curriculum development during degree programs. Originality/value The review provided in this paper highlights a critical gap in research on methodologies to undertake measurement of workplace application of graduate capability. The paper explores considerations for measurement of graduate learning outcomes, specifically the difference between measuring competencies, skills and capability and the necessity for the measurement of the latter in the context of sustainability education for future professionals.
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Krönke, Jan, Richard F. Schlenk, Kai-Ole Jensen, et al. "Monitoring of Minimal Residual Disease in NPM1-Mutated Acute Myeloid Leukemia: A Study From the German-Austrian Acute Myeloid Leukemia Study Group." Journal of Clinical Oncology 29, no. 19 (2011): 2709–16. http://dx.doi.org/10.1200/jco.2011.35.0371.
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Purpose To evaluate the prognostic value of minimal residual disease (MRD) in patients with acute myeloid leukemia (AML) with NPM1 mutation (NPM1mut). Patients and Method RNA-based real-time quantitative polymerase chain reaction (RQ-PCR) specific for the detection of six different NPM1mut types was applied to 1,682 samples (bone marrow, n = 1,272; blood, n = 410) serially obtained from 245 intensively treated younger adult patients who were 16 to 60 years old. Results NPM1mut transcript levels as a continuous variable were significantly associated with prognosis after each treatment cycle. Achievement of RQ-PCR negativity after double induction therapy identified patients with a low cumulative incidence of relapse (CIR; 6.5% after 4 years) compared with RQ-PCR–positive patients (53.0%; P < .001); this translated into significant differences in overall survival (90% v 51%, respectively; P = .001). After completion of therapy, CIR was 15.7% in RQ-PCR–negative patients compared with 66.5% in RQ-PCR–positive patients (P < .001). Multivariable analyses after double induction and after completion of consolidation therapy revealed higher NPM1mut transcript levels as a significant factor for a higher risk of relapse and death. Serial post-treatment assessment of MRD allowed early detection of relapse in patients exceeding more than 200 NPM1mut/104 ABL copies. Conclusion We defined clinically relevant time points for NPM1mut MRD assessment that allow for the identification of patients with AML who are at high risk of relapse. Monitoring of NPM1mut transcript levels should be incorporated in future clinical trials to guide therapeutic decisions.
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Roeland, Eric, Katie Kanter, Jennifer Yon-Li Wo, et al. "Preliminary analysis of total neoadjuvant therapy for patients with locally advanced gastric (G) and gastroesophageal (GE) adenocarcinoma." Journal of Clinical Oncology 38, no. 4_suppl (2020): 393. http://dx.doi.org/10.1200/jco.2020.38.4_suppl.393.
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393 Background: Nearly half of patients with G/GE cancer do not receive or complete post-operative chemotherapy and/or chemoradiation (CRT). Total neoadjuvant therapy (TNT) is as an emerging alternate treatment strategy. We have previously reported a 28% pCR with FOLFIRINOX followed by CRT. However, TNT outcomes with FLOT or FOLFOX followed by CRT are lacking. Methods: We retrospectively analyzed patients after resection of locally advanced G/GE after receiving TNT. Patient received neoadjuvant FOLFOX or FLOT x 8 cycles, CRT (G 45 Gy, GE 50.4 Gy) with concurrent chemotherapy (5FU, carboplatin/paclitaxel). The primary aim was to explore TNT completion rates. Secondary aims included pCR and toxicity. We performed descriptive statistics, t-test, chi-squared, and Fisher’s exact tests as appropriate. Results: From 12/2015 to 8/2019, 57.1% (40/70) completed TNT and resection (15.7% active treatment, 15.7% progressive disease, 11% treated elsewhere). Median age was 66.0 (range:27-79) and 73% male. Tumor locations included 57.5% G, 30.0% GE, and 12.5% overlapping. Neoadjuvant chemotherapy included FLOT 22.5% (n = 9) or FOLFOX 77.5% (n = 31). Overall we found a 25% pCR without significant differences between type of neoadjuvant chemotherapy. Conclusions: TNT followed by resection is feasible with acceptable rates of treatment completion and toxicity. Notable limitations include the retrospective analysis, small sample size, and heterogenous treatment. The pCR rate is promising and warrants further prospective study to optimize TNT approaches. [Table: see text]
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Kip, Peter, Thijs J. Sluiter, Jodene K. Moore, et al. "Short-Term Pre-Operative Protein Caloric Restriction in Elective Vascular Surgery Patients: A Randomized Clinical Trial." Nutrients 13, no. 11 (2021): 4024. http://dx.doi.org/10.3390/nu13114024.
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(1) Background: Vascular surgery operations are hampered by high failure rates and frequent occurrence of peri-operative cardiovascular complications. In pre-clinical studies, pre-operative restriction of proteins and/or calories (PCR) has been shown to limit ischemia-reperfusion damage, slow intimal hyperplasia, and improve metabolic fitness. However, whether these dietary regimens are feasible and safe in the vascular surgery patient population remains unknown. (2) Methods: We performed a randomized controlled trial in patients scheduled for any elective open vascular procedure. Participants were randomized in a 3:2 ratio to either four days of outpatient pre-operative PCR (30% calorie, 70% protein restriction) or their regular ad-libitum diet. Blood was drawn at baseline, pre-operative, and post-operative day 1 timepoints. A leukocyte subset flow cytometry panel was performed at these timepoints. Subcutaneous/perivascular adipose tissue was sampled and analyzed. Follow-up was one year post-op. (3) Results: 19 patients were enrolled, of whom 11 completed the study. No diet-related reasons for non-completion were reported, and there was no intervention group crossover. The PCR diet induced weight loss and BMI decrease without malnutrition. Insulin sensitivity was improved after four days of PCR (p = 0.05). Between diet groups, there were similar rates of re-intervention, wound infection, and cardiovascular complications. Leukocyte populations were maintained after four days of PCR. (4) Conclusions: Pre-operative PCR is safe and feasible in elective vascular surgery patients.
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Giacchetti, Sylvie, Lilith Faucheux, Charlotte Gardair, et al. "Negative Relationship between Post-Treatment Stromal Tumor-Infiltrating Lymphocyte (TIL) and Survival in Triple-Negative Breast Cancer Patients Treated with Dose-Dense Dose-Intense NeoAdjuvant Chemotherapy." Cancers 14, no. 5 (2022): 1331. http://dx.doi.org/10.3390/cancers14051331.
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Background: Patients with triple-negative breast cancers (TNBC) have a poor prognosis unless a pathological complete response (pCR) is achieved after neoadjuvant chemotherapy (NAC). Few studies have analyzed changes in TIL levels following dose-dense dose-intense (dd-di) NAC. Patients and methods: From 2009 to 2018, 117 patients with TNBC received dd-di NAC at our institution. We aimed to identify factors associated with pre- and post-NAC TIL levels, and oncological outcomes relapse-free survival (RFS), and overall survival (OS). Results: Median pre-NAC and post-NAC TIL levels were 15% and 3%, respectively. Change in TIL levels with treatment was significantly correlated with metabolic response (SUV) and pCR. High post-NAC TIL levels were associated with a weak metabolic response after two cycles of NAC, with the presence of residual disease and nodal involvement at NAC completion. In multivariate analyses, high post-NAC TIL levels independently predicted poor RFS and poor OS (HR = 1.4 per 10% increment, 95%CI (1.1; 1.9) p = 0.014 and HR = 1.8 per 10% increment 95%CI (1.3–2.3), p < 0.0001, respectively). Conclusion: Our results suggest that TNBC patients with TIL enrichment after NAC are at higher risk of relapse. These patients are potential candidates for adjuvant treatment, such as immunotherapy, in clinical trials.
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Slutzky-Goldberg, Iris, Hagay Slutzky, Colin Gorfil, and Ami Smidt. "Restoration of Endodontically Treated Teeth Review and Treatment Recommendations." International Journal of Dentistry 2009 (2009): 1–9. http://dx.doi.org/10.1155/2009/150251.
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Coronal restorations and posts can positively influence the long-term prognosis of teeth following root canal therapy. Final sealing the canal by placing an appropriate post and core will minimize leakage of oral fluids and bacteria into the periradicular area and is recommended as soon as possible after completion of root canal filling. Glass ionomer or MTA placed over the residual root canal filling after post space preparation may be effective to prevent bacterial leakage. A ferrule of 1-2 mm of tooth tissue coronal to the finish line of the crown significantly improves the fracture resistance of the tooth and is more important than the type of the material the core and post are made of.
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Desiato, Vincenzo, Alan S. Rosman, Elliot Newman, Russell S. Berman, H. Leon Pachter, and Marcovalerio Melis. "Changes in apparent diffusion coefficient evaluated with diffusion-weighted MRI to predict complete pathologic response after neoadjuvant therapy for rectal cancer: Literature review and meta-analysis." Journal of Clinical Oncology 34, no. 4_suppl (2016): 503. http://dx.doi.org/10.1200/jco.2016.34.4_suppl.503.
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503 Background: A complete pathological response (pCR) is observed in 9-38% of all patients undergoing neo-adjuvant chemo-radiation therapy (CRT) for locally advanced rectal cancer (ARC). Imaging techniques that can reliably assess CRT results may enhance identification of those pCR patients for which surgery may potentially be avoided. Recently, several studies have suggested that diffusion-weighted magnetic resonance imaging (DW-MRI) may predict pathologic response by measuring tumor apparent diffusion coefficient (ADC). ADC can be measured before (pre-ADC) and/or after CRT (post-ADC). Both pre- and post-ADC, as well as the variation between pre- and post-ADC (Δ-ADC) can be used to assess pCR. We aimed to assess the reliability of ADC at predicting pCR in ARC patients treated with CRT. To determine the most effective ADC timing to evaluate pCR. Methods: A systematic review of available literature was conducted to compare all the studies of DW-MRI for identification of pCR after CRT for ARC. For each parameter (pre-ADC, post-ADC and D-ADC) we pooled sensitivity and specificity and calculated the area (AUC) under the summary receiver operating characteristics (sROC) curve. Results: We found 10 prospective and 8 retrospective studies examining correlation of ADC and CRT results. Overall, pCR rate was 25%. Pooled sensitivity, specificity, and AUC were: 0.743, 0.755, and 0.841 for pre-ADC; 0.745, 0.706, and 0.782 for post-ADC; and 0.832, 0.806, and 0.895 for D-ADC. Conclusions: Our meta-analysis confirms that at least 25% of patients with ARC experiences pCR after CRT. DW-MRI is a promising technique for assessment of CRT results and D-ADC appears to be the most effective parameter for prediction of pCR.
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Singh, Gurbind, Mohanashankar A M, Shaji R. Velayudhan та ін. "Assessment of Transduction of CD34+ Human Hematopoietic Stem Cells from Patients with Severe Hemophilia-Α with Lentiviral Vector Carrying a High Expression FVIII Transgene (CD68-ET3-LV)". Blood 142, Supplement 1 (2023): 481. http://dx.doi.org/10.1182/blood-2023-188513.
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Background: Alternative strategies are needed for the large number of people with hemophilia who are ineligible for AAV based gene therapy due to age or high levels of anti-AAV neutralizing antibodies. High inter-individual variability of expression and ill sustained factor levels are also challenges with AAV based gene therapy for hemophilia A, in particular. We have developed a third-generation lentiviral vector mediated hematopoietic stem cell-based gene therapy for hemophilia A. (Doering et al Human Gene Therapy 2018; 29: 1183-1201) This vector (CD68-ET3-LV) has a high expression FVIII transgene with a CD68 promoter targeting expression in monocytic cells predominantly. We report here successful transduction of severe hemophilia A patient derived human hematopoietic stem cells with this vector. Methods: Mobilized peripheral blood stem cells were collected by apheresis from three patients with severe hemophilia A without inhibitors who also received prophylactic clotting factor replacement therapy during this period. CD34+ hematopoietic stem cells (HSCs) were enriched on the CliniMACS Plus® system (Miltenyi Biotec, Bergish Gladbach, Germany) using the CliniMACS CD34® reagent system. Purified HSC were then transduced with this CD68-ET3-LV as follows - HSCs cultured on retronectin coated surfaces in xenofree media with cytokines were exposed to clinical grade CD68-ET3-LV vector in two ways - a double transduction protocol without any enhancer and a single transduction with an enhancer. After completion of this step, the product was assessed for viability and vector copy number (VCN) by trypan blue labelling and Q-PCR performed on genomic DNA from CFU cells, respectively. Transduced HSCs were also assessed for their engraftment potential. CD68-ET3-LV vector transduced HSC (1x10 6) were transplanted into NBSGW mice via tail vein injection. Engraftment was assessed at 16 weeks after transplantation. This protocol was approved by the Institutional Review Board of the Christian Medical College, Vellore, India. Results: G-CSF (10 ug/kg/day) based peripheral blood stem cell mobilization was well tolerated by all participants. The apheresis procedures which were done with plasma FVIII levels in the normal range after prophylactic replacement therapy were unremarkable. The total collection of mobilized CD34+ cells from the three donors was 268±80.5x10 6 CD34+ cells. An aliquot of 2x10 6 CD34+ cells/ml was used in the transduction experiments. The data on viability and vector copy number post transduction shown in the tables 1 and 2 confirm that viability was not affected by the manipulation of these HSCs in both double and single transduction methods. The vector copy number (VCN) in the genomic DNA obtained from CFU cells collected from CD34+ HSCs cultured in MethoCult H4434™ (Stem Cell Technologies™, Vancouver, Canada) varied from 0.62 to 1.21 in double transduction (n=3) and nearly doubled in the single transduction method with an enhancer to VCNs of 1.5 and 2.4 in two samples tested. Transplantation studies in NBSGW mice showed successful engraftment of human CD34+ HSCs with a mean engraftment of 80.99 ± 4.2% of CD45+ multilineage hematopoietic cells in the bone marrow 16 weeks after transplantation. Conclusion: To the best of our knowledge, this is the first report of transduction of mobilized peripheral blood CD34+ HSCs from patients with severe hemophilia A using a clinical grade lentiviral vector with a high expression FVIII transgene. These data establish feasibility and safety of the procedure. The transduction protocol showed good efficiency with very high viability, significant VCN and good engraftment of these gene modified human HSCs in a mouse model. These protocols are currently being evaluated in a first in human phase 1 clinical trial of gene therapy for severe hemophilia A without inhibitors.
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Kheder, Ed, Lijo Saji, Ali Zalpour, Samuel Swanson, and Sreedhar Mandayam. "Improving admission medication reconciliation at a tertiary cancer center." Journal of Clinical Oncology 39, no. 15_suppl (2021): e18686-e18686. http://dx.doi.org/10.1200/jco.2021.39.15_suppl.e18686.
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e18686 Background: Accurate medication reconciliation (MedRec) is a pivotal step ensuring patient safety during transition of care, yet one of the most challenging aspects in healthcare quality and safety. Inaccurate MedRec leads to 40 % of medications errors, 20% of which results in harm. Our aim is to increase rate of accurate MedRec completion at MD Anderson Cancer Center (MDACC), within 24 hours of admission, from 85% to >95% through Best Possible Medication History (BPMH) Methods: During pre-intervention phase, we audited medication review and reconciliation of 50 randomly selected patients within 24 hours from admission to MDACC. Our intervention included: conducting several brain-storming sessions with nursing staff, providers, pharmacists; creating fish bone diagram and process maps; designing educational presentations for nursing staff on how to practice BPMH; educating providers on how to complete medication reconciliation within 24 hours of admissions; assigning nursing champions; and sending email reminders to provider on a daily basis. We audited another 50 patients post intervention. In our project, BPMH accuracy was measured by percentage of patients with zero discrepancies (incorrect dosage, frequency or route; extra medication; discontinued medication not removed from list). Significance was tested for BPMH completion, and MedRec completion using a Binomial Test, while significance for number of discrepancies and audit completion time was tested using a Two Sample t-Test. Results: We collected data on 50 patients pre and 50 post intervention. Our results indicate statistically significant improvement in MedRec rate (100%), reduction of number of discrepancies and audit completion time. Conclusions: Medication review and reconciliation are multi-phased processes. Nurses, Pharmacists and medical providers are the cornerstone of accurate and complete MedRec. Reminder emails to medical providers played a key role in MedRec rate improvement. Additional root cause analysis is needed to further address the medication review completion process in our institution.[Table: see text]
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Murray, Marie E., Jamie C. Barner, Nathan D. Pope, and Mark D. Comfort. "Impact and Feasibility of Implementing a Systematic Approach for Medication Therapy Management in the Community Pharmacy Setting: A Pilot Study." Journal of Pharmacy Practice 32, no. 6 (2018): 664–70. http://dx.doi.org/10.1177/0897190018779847.
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Objective: To determine how implementing a systematic medication therapy management (MTM) process impacted MTM completion rates. Methods: This process improvement pilot included 4 grocery store-based community pharmacy sites. Site staff were trained on a systematic process to integrate OutcomesMTM opportunities into pharmacy workflow. Technicians prepared MTM paperwork, including a standardized comprehensive medication review (CMR) worksheet, which pharmacists used to deliver the service at the counsel window. The primary outcome was the change in CMR completion rate from pre- to post implementation, with each site serving as its own control. Secondary outcomes were change in targeted intervention program (TIP) completion rate and survey results assessing barriers and feasibility. Results: The mean CMR completion rate improved from 2.7% ± 5.4% to 23.2% ± 7.7% ( P < .10). The mean TIP completion rate improved from 3.4% ± 4.2% to 24.9% ± 19.2% ( P < 0.10) pre- to post-implementation. Survey results indicated that pharmacists were satisfied with this; the most significant barriers were time spent contacting prescribers, documentation, and claim submission. Conclusion: Implementing this systematic approach to providing MTM into the pharmacy workflow may lead to an improvement in CMR completion rate. However, the sample size is small, and the results and process may not be generalizable to other sites.
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Marcelino, Carolina Soares, Vitor Emanuel de Souza Gomes, and Luís Marangoni Júnior. "Post-Consumer Recycled PET: A Comprehensive Review of Food and Beverage Packaging Safety in Brazil." Polymers 17, no. 5 (2025): 594. https://doi.org/10.3390/polym17050594.
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Polyethylene terephthalate (PET) is widely used in the food and beverage packaging sector due to its chemical and mechanical properties. Although PET is a fossil-based polymer, its recyclability significantly contributes to reducing the environmental impacts caused by excessive plastic consumption. However, the growing demand for post-consumer recycled PET (PET-PCR) food packaging has raised concerns about the efficiency of decontamination processes involved in recycling this material. This review initially addresses PET synthesis processes, highlighting injection stretch blow molding as the predominant technique for packaging production. It then discusses reverse logistics as a strategy to promote sustainability through the recovery of post-consumer packaging, such as plastic bottles. This review examines mechanical and chemical recycling methods used in PET-PCR production, food safety requirements including positive lists of permitted substances, contaminant migration limits, non-intentionally added substances (NIASs), and updated criteria for the National Health Surveillance Agency (ANVISA) of food-grade PET-PCR resins. Finally, the review explores future prospects for using PET-PCR in the food and beverage packaging sector, assessing its environmental impacts and potential technological advancements to enhance its sustainability and safety.
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Wagen, Brooke, Simisola Kuye, Rajvi Patel, et al. "A Resident-Led Quality Improvement Initiative to Increase End-of-Life Planning in Primary Care." Journal of Graduate Medical Education 16, no. 5 (2024): 596–600. http://dx.doi.org/10.4300/jgme-d-24-00271.1.
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ABSTRACT Background Despite many benefits of end-of-life (EOL) planning, only 1 in 3 adults has EOL documentation, with low rates in resident primary care clinics as well. Objective To increase clinic completion of life-sustaining treatment (LST) notes and advance directives (AD) for veterans at highest risk for death. Methods The setting was a Veterans Affairs (VA) internal medicine primary care clinic. All clinic residents in the 2021-2022 academic year and all clinic patients identified through a VA risk-stratification tool as highest risk for death were included. Baseline AD and LST completion rates were determined through manual chart review. Our interventions included 2 hours of teaching to increase resident knowledge of EOL planning and a systematic process improvement to complete EOL planning appointments. Outcomes assessed included anonymous resident pre- and post-surveys of self-assessed knowledge and comfort with EOL conversations, as well as rates of LST and AD completion determined through serial chart review. Results In the 2021-2022 academic year, 22 residents (100%) and 54 patients were included. Post-intervention surveys (n=22, 100%) showed improved self-assessed knowledge of EOL concepts and comfort with patient discussions (median Likert increase 3 to 4). The number of residents who completed an EOL planning visit increased from 9 of 22 (41%) to 15 (68%). LST completion increased from 9 of 54 (17%) to 29 (54%), and AD completion increased from 18 of 54 (33%) to 33 (61%). Conclusions A brief teaching intervention to prepare residents for comprehensive EOL visits combined with process improvement to offer EOL planning visits improved self-reported knowledge and comfort and completion of EOL visits.
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Gallagher, Robert E., Esther L. Schachter-Tokarz, Dan A. Jones, and Elihu H. Estey. "Assessment of Minimal Residual Disease (MRD) by Qualitative RT-PCR (Q-PCR) vs Real-Time Quantitative RT-PCR (RQ-PCR) in a Phase II Study of Acute Promyelocytic Leukemia (APL)." Blood 106, no. 11 (2005): 3262. http://dx.doi.org/10.1182/blood.v106.11.3262.3262.
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Abstract Assessment of MRD in APL by Q-PCR analysis for the presence or absence of PML-RARα mRNA after the completion of consolidation therapy in treatment regimens employing all-trans retinoic acid (ATRA) and chemotherapy (CT) has provided a reasonably accurate but not infallible prognostic test for disease recurrence (DR). This assessment has been made at detection sensitivity levels up to 1 in 104, which is considered to have optimal predictive value, since non-quantified lower levels of PML-RARα mRNA may not be relevant to clinical outcome. In the current study, we compared the results of Q-PCR (touchdown PCR for 40 cycles followed by post-PCR blot hybridization with a RARα chemiluminescent probe) to results from RQ-PCR in 15 patients on a Phase II clinical trial designed to eliminate CT (low-risk/LR patients, WBC <10K) or minimize CT (high-risk/HR patients, WBC >10K), using combined ATRA and arsenic trioxide therapy. All patients achieved complete remission (CR) and have been followed for a median of 1.2 years. DR occurred in 0/8 LR, 0/1 unclassified and 2/6 HR patients. At CR, all Q-PCR and RQ-PCR assays were positive. For RQ-PCR, the normalized quotient (NQ) value of PML-RARα, i.e., the PML-RARα copy number divided by the housekeeping gene glyceraldehyde-3′-phosphate dehydrogenase (GAPDH) copy number, ranged widely from 1.5 x 10−6 to 7.0 x 10−3. Post-CR follow-up data were: Patient Group Number Q-PCR+ RQ-PCR+ NQ Range LR/Unclassified 9 0/24 16/24 9 x 10−9 – 1 x 10−7 HR/no DR 4 0/23 8/23 2 x 10−9 – 3 x 10−7 HR/DR 2 1/7 5/7 1 x 10−8 – 5 x 10−5 For the 2 HR/DR patients, the last pre-DR results were, respectively: Q-PCR, positive and negative; RQ-PCR, NQ = 5 x 10−5 and NQ = 2.3 x 10−7. In overall comparisons to RQ-PCR results, all Q-PCR assays were positive for NQ >10−5, 3/4 were positive in the NQ 10−6 to 10−5 range, and all were negative for NQ <10−6. Additionally, dilution-reconstruction experiments confirmed the stochastic nature of PCR assays near the detection limit and indicated that RQ-PCR was about 10-fold more sensitive than Q-PCR. Although larger studies are needed, our results suggest that HR patients who are Q-PCR-negative but RQ-PCR-positive in the >10−7 – <10−5 range at a critical post-CR checkpoint may be at increased risk of DR and, more generally, they suggest that the results of RQ-PCR testing at a critical checkpoint can be used in combination with clinical risk assessment to stratify the intensity of subsequent MRD monitoring in individual patients.
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Ten Ham-Baloyi, Wilma, and Portia Jordan. "Systematic review as a research method in postgraduate nursing education." Health SA Gesondheid 21 (October 11, 2016): 120–28. http://dx.doi.org/10.4102/hsag.v21i0.942.
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In South Africa, there appears to be poor understanding about using a systematic review as an acceptable research method in post-graduate nursing education. The lack of understanding may result in research supervisors being unable to guide post-graduate students, such as masters and doctoral students, in using the systematic review methodology in the completion of an academic qualification. Furthermore, they might not be able to assist post-graduate students in completing their studies, or conducting studies, in particular systematic reviews, which are of high quality. Valuable opportunities can thus be missed that might add to the body of knowledge to inform and improve research, education, and clinical practice. This article may set the field for an informed debate on systematic reviews as a useful and acceptable research method to be used by post-graduate nursing students in South Africa. We conclude that a systematic review could be a useful and acceptable method for research in post-graduate nursing education. However, the method's benefits and disadvantages should be considered before a post-graduate student embarks on such a journey.
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Nelson, Heather Joyce, Twana Lee-Ann Cox-White, and Beverlee Ann Ziefflie. "Indigenous students: Barriers and success strategies-A review of existing literature." Journal of Nursing Education and Practice 9, no. 3 (2018): 70. http://dx.doi.org/10.5430/jnep.v9n3p70.
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There are many factors that effect the post-secondary completion rate of Indigenous students. The Indigenous student completion rate is a reflection of the number of students entering post-secondary education but is significantly affected by withdrawal rates (institutional withdrawals and student voluntary withdrawals). In the Saskatchewan Polytechnic School of Nursing, the Indigenous student withdrawal rate was 4.2% higher than the total nursing student population. Lower success rates among Indigenous students is a concerning issue in nursing programs. Continuing to operate programs and teach in the same fashion is not improving success rates. The Truth and Reconciliation Commission of Canada: Calls to Action (2012) highlighted the need to examine strategies and develop policies to enhance Indigenous student success. To this end, recent literature was reviewed to determine trends among Indigenous nursing students, their struggles, and more importantly, the successful strategies currently being implemented. Indigenous peoples are not a homogenous group; rather, they are a mosaic of cultures, languages and nations. The authors examined the literature to determine key factors that enabled or prevented the success of post-secondary Indigenous students. Twenty-one articles on current research regarding Indigenous student success facilitators and barriers were examined. These articles encompassed research from Canada, the United States, Australia and New Zealand. The purpose of this literature review was to identify themes and gaps, drive positive change in education, and guide future research. The research team found four common themes: academic preparedness, cultural safety, intrinsic student factors, and student support.
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Dee, Scott, John Deen, and Carlos Pijoan. "Evaluation of an industry-based sanitation protocol for full-size transport vehicles contaminated with porcine reproductive and respiratory syndrome virus." Journal of Swine Health and Production 14, no. 6 (2006): 307–11. http://dx.doi.org/10.54846/jshap/489.
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Objective: To test a protocol for sanitation of full-size commercial transport vehicles contaminated with porcine reproductive and respiratory syndrome virus (PRRSV), utilizing conditions found on commercial swine production units. Conditions included use of cold water for washing (21°C), application of a commercial disinfectant via a low-pressure foamer, and rapid completion of ≤ 2 hours. Materials and methods: Fifteen sites in a trailer were experimentally contaminated with IngelVac PRRS MLV vaccine (Boehringer Ingelheim Vetmedica Inc, St Joseph, Missouri; total of 5 × 105 median tissue culture infectious doses per site). Ten replicates were conducted. The presence or absence of PRRSV RNA was evaluated by polymerase chain reaction (PCR) testing of swabs taken from the trailer’s interior before treatment and 120 minutes post treatment. Swabs that were PCR-positive were then evaluated for viable PRRSV by swine bioassay. Treatment consisted of washing with cold water then disinfecting with a 1% solution of modified potassium monopersulfate applied via low-pressure foaming. The trailer was not dried. Results: In 10 of 150 samples collected across the 10 replicates, PRRSV RNA was detected 120 minutes post treatment. Differences in the percentages of PCR-positive swabs collected at 0 and 120 minutes post treatment in treatment and control replicates were significant (P < .001; Fisher’s exact test). Viable virus was not detected by swine bioassay. Implication: High-pressure washing of transport trailers, followed by 120 minutes exposure to 1% modified potassium monopersulfate applied with a hydrofoamer, will most likely eliminate residual infectious PRRSV
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Zulkifli, Umi Amirah, Mohd Saidin Misnan, Hamizah Liyana Tajul Ariffin, and Naqiyatul Amirah Mohd Said. "Comparative Analysis of Defects After Completion Clauses in PWD 203A and PAM 2018." International Journal of Research and Innovation in Social Science VIII, no. X (2024): 2531–52. http://dx.doi.org/10.47772/ijriss.2024.8100211.
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This study presents a comparative analysis of the defects after completion clauses in PWD 203A and PAM 2018 standard form contracts, commonly utilized in the Malaysian construction sector. The research aims to examine the implications of contractual variations on defect management and project outcomes, addressing an identified gap in current understanding. This is review paper and conducted a systematic literature review and thematic analysis of relevant clauses to examine the key differences and similarities between these contract forms in their approach to post-completion defects. The research objectives include identifying and analyzing the stipulated clauses, highlighting key differences and similarities, and evaluating potential implications for project stakeholders. Findings revealed significant variations in defect definitions, liability periods, and rectification procedures between PWD 203A and PAM 2018. These differences have substantial implications for risk allocation, project management strategies, and dispute resolution processes. The study enhances the existing information by elucidating the legislative framework regulating post-completion defects in Malaysia and provides significant insights for industry professionals and policymakers. The research underscores the importance of careful contract selection and tailored defect management strategies to enhance project outcomes and stakeholder satisfaction in the Malaysian construction sector.
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Teoh, Victoria, Fiona MacNeill, Nicola Roche, et al. "Image-guided vacuum-assisted biopsy to assess pathologic complete response in breast cancer patients with exceptional response to neoadjuvant chemotherapy." Journal of Global Oncology 5, suppl (2019): 39. http://dx.doi.org/10.1200/jgo.2019.5.suppl.39.
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39 Background: Image-guided vacuum-assisted biopsy (VAB) is increasingly used after completion of neoadjuvant chemotherapy (NAC) to assess residual disease in the breast, facilitate risk-adaptive surgery and potentially identify exceptional responders who may not require surgical intervention. The aim of this analysis was to investigate the diagnostic performance of a standardized post-NAC VAB protocol, developed following retrospective analysis of institutional data (1). Methods: Prospective cohort study of patients with HER2 positive and triple negative (TN) invasive ductal carcinoma, treated with NAC, who had partial/complete imaging response and underwent post-NAC VAB to aid surgical planning between 02/2018 and 06/2019. The aim of VAB was to sample the site of residual imaging abnormality (breast residuum <2cm) previously marked by clip insertion. Pathologic complete response (pCR) was defined as no residual disease in the breast (ypT0). Diagnostic accuracy of VAB was calculated using final surgical pathology as the reference standard. Simple descriptive statistics were performed. Results: 26 eligible patients underwent post-NAC VAB. This was representative in 23 cases. The overall pCR rate was 46.2% (42.1% for HER2 positive, 57.1% for TN phenotypes). The post-NAC VAB false negative rate (FNR) was 9.1% (95% CI: 0-26.1) and the negative predictive value (NPV) was 90.91% (95% CI: 60.27-98.51) with an overall accuracy of 86.96% (95% CI: 66.41-97.22). Conclusions: This data suggests that post-NAC VAB may reliably predict pCR in patients with HER2 positive and TN invasive ductal carcinoma with good response to NAC. Further technical refinements in VAB technique, standardization in patient selection and prospective trials are warranted to further explore the role of post-NAC VAB in supporting minimal or no surgery trials. References 1. Tasoulis MK, Roche N, Rusby JE, Pope R, Allen S, Downey K, Nerurkar A, Osin P, Wilson R, MacNeill F. Post neoadjuvant chemotherapy vacuum assisted biopsy in breast cancer: Can it determine pathologic complete response before surgery? J Clin Oncol 2018;36 (Supplement): abstr 567.
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Sterpi, Michelle, Yungtai Lo, Susan Fineberg, Harjot Gill, and Della Makower. "Abstract P5-11-20: Impact of Immune-Related Adverse Events on Response to Neoadjuvant Chemoimmunotherapy in Triple Negative Breast Cancer." Clinical Cancer Research 31, no. 12_Supplement (2025): P5–11–20—P5–11–20. https://doi.org/10.1158/1557-3265.sabcs24-p5-11-20.
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Abstract Background: Addition of the PD-1 inhibitor pembrolizumab to neoadjuvant chemotherapy improves pathologic complete response (pCR) rates and event-free survival in triple-negative breast cancer (TNBC). Immunotherapy may lead to immune-related adverse events (irAE), which can be life-threatening and permanent. Presence of tumor-infiltrating lymphocytes (TILs) in TNBC is also associated with improved prognosis and treatment response. Little data exists regarding associations between irAE and pCR, and between TILs and irAE, in TNBC. This study evaluates associations between irAE, clinicopathologic factors (including TILs), and pCR after neoadjuvant chemoimmunotherapy (NCIT) in a diverse single-institution cohort of TNBC patients (pts). Methods: Pts who received NCIT at our institution between 2021 and 2023 were identified from pharmacy database. Details of tumor stage, NCIT treatment, response to therapy, and presence or absence of irAE were obtained by chart review. IrAE were graded using Common Terminology Criteria for adverse events (CTCAE). Stromal TILs were estimated within the borders of the invasive carcinoma as per International TILs Working Group guidelines. Associations of age, race, ethnicity, tumor size (T stage), node involvement (N stage), grade, HER2 IHC status, TILs, and completion of planned NCIT with irAE incidence and pCR were assessed by Wilcoxon rank-sum tests for continuous variables and chi-square or Fisher’s exact tests for categorical variables. P-values &lt;0.05 were considered statistically significant. Results: 46 pts were treated with NCIT [27 (58.7%) Black; 14 (30.4%) Hispanic]. Median age was 60.5 (range 33-88). All NCIT regimens included pembrolizumab and a taxane. 35 pts (76.1%) received doxorubicin, and 25 (54.3%) received carboplatin. 31 (67.4%) pts received 80% or more of their planned NCIT regimen. Reasons for early discontinuation were chemotherapy toxicity (8 pts), irAE (4), progression of disease (POD) (2), unknown (1). 13 pts (28.2%) developed at least 1 irAE, including hypothyroidism (3 pts), rash (3), adrenal insufficiency (2), hepatitis (2), arthritis (2), myositis, pneumonitis, pericarditis, panniculitis, and encephalitis (1 each). irAE was Grade 1-2 in 6 pts, Grade 3 in 5 pts, Grade 4 in 1 pt, and Grade 5 in 1 pt. 41 pts underwent surgery. Reasons for no surgery were POD (2 pts, included in response analysis), fatal irAE (1 pt), pt refusal (1 pt), and unknown (1 pt). Of 43 evaluable pts, 24 (55.8%) achieved pCR. Development of irAE (p=0.039), younger age (p=0.028), and Hispanic ethnicity (p=0.005) were associated with pCR. Black pts were less likely to achieve pCR compared to non-Black pts (p=0.003). T and N stage, tumor grade, HER2 IHC status, and completion of planned NCIT were not associated with pCR. TILs were associated with achievement of pCR (p=0.002), but not with presence of irAE (p=0.341). No associations between irAE and age, race, ethnicity, T or N stage, tumor grade, HER2 IHC status, and completion of planned NCIT were seen.Conclusion: In this diverse cohort of TNBC pts, TILs and irAE, as well as age, race, and ethnicity, were associated with achievement of pCR to NCIT, while tumor stage and grade, and completion of planned NCIT, were not. No predictive factors for development of irAE were seen. Citation Format: Michelle Sterpi, Yungtai Lo, Susan Fineberg, Harjot Gill, Della Makower. Impact of Immune-Related Adverse Events on Response to Neoadjuvant Chemoimmunotherapy in Triple Negative Breast Cancer [abstract]. In: Proceedings of the San Antonio Breast Cancer Symposium 2024; 2024 Dec 10-13; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2025;31(12 Suppl):Abstract nr P5-11-20.
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Srinivasan, Roshini, Samuel N. Rodgers-Melnick, Rachael L. Rivard, et al. "Implementing paper-based patient-reported outcome collection within outpatient integrative health and medicine." PLOS ONE 19, no. 5 (2024): e0303985. http://dx.doi.org/10.1371/journal.pone.0303985.
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Objective To investigate the feasibility of pre- and post-encounter patient-reported outcome (PRO) measure collection within an outpatient integrative health and medicine (IHM) clinic and to characterize factors associated with successful completion. Methods We conducted a retrospective review of 27,464 outpatient IHM encounters including 9,520 chiropractic; 8,237 acupuncture; 5,847 massage; 2,345 IHM consultation; and 1,515 osteopathic manipulation treatment encounters at four clinics offering IHM over 18 months. Patients were asked to complete paper questionnaires rating pain, anxiety, and stress from 0–10 immediately pre- and post-encounter. Generalized linear mixed effect regression models were used to examine the relationship between demographic, clinical, and operational covariates and completing (1) pre-encounter and (2) paired (i.e., pre and post) PROs. Results Patients (N = 5587, mean age 49 years, 74% white, 77% female) generally presented for musculoskeletal conditions (81.7%), with a chief complaint of pain (55.1%). 21,852 (79.6%) encounters were among patients who completed pre-encounter PROs; 11,709/21,852 (53.6%) completed subsequent post-encounter PROs. Odds of PRO completion were more impacted by provider, operational, and clinical-level factors than patient factors. Covariates associated with increased odds of pre-encounter PRO completion included being female, having additional IHM encounters, and having a pain or anxiety complaint. Covariates associated with increased odds of paired PRO completion included being aged 31–40 vs. 51–60 years and having additional IHM encounters. Conclusion Implementing a paper-based PRO collection system in outpatient IHM is feasible; however, collecting post-encounter PROs was challenging. Future endeavors should leverage the electronic health record and patient portals to optimize PRO collection and engage patients and clinical providers.
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Rutherford, Katrina, Janya McCalman, and Roxanne Bainbridge. "The Post-Schooling Transitions of Remote Indigenous Secondary School Graduates: A Systematic Scoping Review of Support Strategies." Australian and International Journal of Rural Education 29, no. 2 (2019): 8–25. http://dx.doi.org/10.47381/aijre.v29i2.222.
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School completion has been hailed by many as the ‘holy grail’ of Indigenous education, and 42% remote-living Indigenous students now attain year 12 completion each year. But for a range of complex reasons, only 60% of these graduates translate this achievement into further engagement in study, training or employment. This systematic literature review examined the evidence for strategies that support the post-schooling transitions of these students. Adhering to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) framework, it examinedthe scope and quality of the existing evidence and appliedqualitative meta-synthesis to elucidate the conditions that enable or hinder, and strategies that support post-schooling transitions. Findings suggested that lower rates of post-schooling study or employment uptake are influenced by: historical misalignment of education approaches with community values and aspirations; limited opportunities in remote communities; and other socio-economic factors. Strategies were found to bemost effective when cross-sectoral education/employment and community partnerships were formed, and remote communities were integralin the planning and implementation process. Strategies to improve transitions included: embedding Indigenous and Western knowledge systems in education, task-based learning, explicitly addressing students’ language needs, providing immersion experiences such as in universities, and mentoring programs to widen students’ aspirations. However, the evidence-base remains weak and further research is needed to understand the impact of strategies on students’ aspirations and their immediate and long-term post-schooling transitions.
 
 Keywords: remote; Indigenous; transition; post-secondary; pathways; aspiration
 
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McMurran, A. E. L., R. Blundell, and V. Kim. "Predictors of post-thyroidectomy hypocalcaemia: a systematic and narrative review." Journal of Laryngology & Otology 134, no. 6 (2020): 541–52. http://dx.doi.org/10.1017/s0022215120001024.
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AbstractObjectiveHypocalcaemia is the most common complication after total or completion thyroidectomy. This study assesses recent evidence on predictive factors for post-thyroidectomy hypocalcaemia in order to identify the patients affected and aid prevention.MethodTwo authors independently assessed articles and extracted data to provide a narrative synthesis. This study was an updated systematic search and narrative review regarding predictors of post-thyroidectomy hypocalcaemia using the Ovid Medline, Embase, Cochrane and Cinahl databases. Results were limited to papers published from January 2012 to August 2019.ResultsSixty-three observational studies with a total of 210 401 patients met the inclusion criteria. The median incidence was 27.5 per cent for transient biochemical hypocalcaemia, 12.5 per cent for symptomatic hypocalcaemia and 2.2 per cent for permanent hypocalcaemia. The most frequent statistically significant predictor of hypocalcaemia was peri-operative parathyroid hormone level. Symptomatic hypocalcaemia and permanent hypocalcaemia were seen more frequently in patients undergoing concomitant neck dissection.ConclusionMany factors have been studied for their link to post-thyroidectomy hypocalcaemia, and this study assesses the recent evidence presented in each case.
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Yap, Ching Seng, Mor Yang Ong, and Rizal Ahmad. "Online Product Review, Product Knowledge, Attitude, and Online Purchase Behavior." International Journal of E-Business Research 13, no. 3 (2017): 33–52. http://dx.doi.org/10.4018/ijebr.2017070103.
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This case study aims to investigate buyers' post-purchase behavior on feedback ratings. From the data collected from eBay, the statistical analysis shows that the average time length that buyers post their feedback after auctions completion is 15.5 days. New sellers and experienced sellers have different chances to receive feedback. New sellers are more likely to receive negative feedback over positive feedback. The distribution of the feedback types (negative, neutral and positive) does not match that of their associated monetary volumes. This case study also demonstrates that inexperienced eBay buyers are more likely to post negative feedback ratings than experienced ones. New and used products attract different ratings in the three feedback types. With word cloud and word frequency analysis, the authors identify common issues associated with each of the three types of feedback. The paper also discusses the managerial implications and recommendations based on these findings.
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Watanabe, Jun, Yoshinori Kagawa, Koji Ando, et al. "Circulating tumor DNA for predicting complete response to total neoadjuvant therapy in locally advanced rectal cancer: ENSEMBLE-2." Journal of Clinical Oncology 43, no. 4_suppl (2025): 284. https://doi.org/10.1200/jco.2025.43.4_suppl.284.
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284 Background: Total neoadjuvant therapy (TNT) has dramatically shifted the paradigm in the treatment of locally advanced rectal cancer (LARC), prolonging survival with high rates of pathologic complete response (pCR) and introducing non-operative management (NOM). However, no predictive biomarkers of TNT efficacy, the regrowth of NOM, or prognosis have been developed. Circulating tumor DNA (ctDNA) is a minimally invasive biomarker used to detect molecular residual disease (MRD) and predict recurrence in colon cancer after curative resection. The effectiveness of ctDNA MRD status as a predictive biomarker for TNT was evaluated in the Phase II TNT study, ENSEMBLE-2 (jRCTs071210143), conducted in Japan. Methods: Patients with LARC undergoing TNT were enrolled in ENSEMBLE-2. Protocol treatment was defined as total mesorectal excision (TME) following long course chemoradiotherapy (LCCRT: 50.4Gy, capecitabine) plus four cycles of CAPOX. NOM was allowed if a clinical complete response (cCR) was achieved in the evaluation after TNT. ctDNA MRD was measured by Signatera (Natera, Inc.) at the following time points: baseline, after LCCRT, after TNT, post operative 4w, 12w, 24, 36 and 48w in the GALAXY trial (UMIN000039205). Results: A total of 28 patients were enrolled in the study. Treatment was discontinued at the patient's request in one case. After completing TNT, TME and NOM were performed in 21 (77.8%) and 6 (21.4%) patients, respectively. ctDNA positivity rates were 96.4. % (27/28) at baseline, 14.8% (4/27) after LCCRT, and 34.6 % (9/26) after TNT. Post-LCCRT ctDNA status was not significantly associated with cCR + near CR (nCR) vs. incomplete clinical response (iCR), pCR vs. non-pCR (p=0.065 and p=0.539, respectively). In contrast, ctDNA status after TNT was significantly associated with cCR + nCR vs. iCR (p=0.028), as well as pCR vs. non-pCR (p=0.038). Conclusions: Our study indicates that post TNT ctDNA status may be a predictive biomarker for TNT response in LARC patients. ctDNA negativity upon completion of neoadjuvant treatment may indicate a favorable response. Clinical trial information: jRCTs071210143 . Correlation with ctDNA, clinical response, treatment after TNT and pathological response. After LCCRT p value After TNT p value Clinical ResponsecCR + nCR vs. iCR (ctDNA -/+) cCR + nCR 18 / 1 0.065 cCR + nCR 15 / 4 0.028 iCR 5 / 3 iCR 2 / 5 Treatment after TNTNOM vs. TME (ctDNA -/+) TME 17 / 3 0.438 TME 11 / 9 0.063 NOM 6 / 0 NOM 6 / 0 Pathological response after TMEpCR vs. non pCR (ctDNA -/+) pCR 5 / 0 0.539 pCR 5 / 0 0.038 non pCR 12 / 3 non pCR 6 / 9 Fisher's exact test was used to statistically examine the correlation between ctDNA MRD status and the factors at each timing.
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Graham, Helen, Kathy Prue-Owens, Jess Kirby, and Mythreyi Ramesh. "Systematic Review of Interventions Designed to Maintain or Increase Physical Activity Post-Cardiac Rehabilitation Phase II." Rehabilitation Process and Outcome 9 (January 2020): 117957272094183. http://dx.doi.org/10.1177/1179572720941833.
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Background: Cardiovascular disease (CVD) continues to be the No. 1 cause of death in the United States and globally, and individuals with a history of a cardiac event are at increased risk for a repeat event. Physical inactivity creates health problems for individuals with chronic heart disease. Evidence shows that physical activity (PA), as a central component of cardiac rehabilitation phase II (CRII), decreases hospital readmission and mortality. Yet, individual adherence to PA tends to decline several months following CRII completion. Objective: The purpose of this review was to evaluate current literature for interventions designed to assist individuals diagnosed with myocardial infarction (MI), coronary artery bypass graft (CABG), coronary artery disease (CAD), and percutaneous coronary intervention (PCI) to maintain or increase PA post-CRII. Methods: A systematic search of 5 electronic databases including hand-searched articles between 2000 and 2019. Key Medical Subject Headings (MeSH) search terms included cardiac rehabilitation, intervention, exercise or PA, outcomes, compliance, adherence, or maintenance. Only interventions implemented following CRII program completion were included for review. Results: Based on the inclusion criteria, the search yielded 19 randomized control trials retained for descriptive analysis. Interventions were categorized into 3 domains. The intervention designs varied widely in terms of duration of the intervention and the length of time to outcome measurement. Most interventions were short-term with only 2 studies offering a long-term intervention of greater than 1 year. Interventions using a theoretical approach most often included a cognitive-behavioral model. Conclusions: Interventions offered shortly after completion of CRII may help cardiac patients maintain PA and reduce the risk of experiencing additional cardiac events; however, more quality research is needed. Additional research to examine PA maintenance in older adults (70 years and older) would be valuable based on the increase in average lifespan. Studies with larger and more diverse samples, and less variation in methods and outcomes would greatly increase the ability to conduct a high-quality meta-analysis.
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Lima, C. A., V. Huntress, and E. W. Overström. "90 ENDOGENOUS MODIFICATIONS OF AURORA B AND AURORA C KINASE EXPRESSION IN MOUSE OOCYTES AND EARLY EMBRYOS." Reproduction, Fertility and Development 21, no. 1 (2009): 146. http://dx.doi.org/10.1071/rdv21n1ab90.
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The Aurora (Aur) proteins are a family of serine/threonine kinases that play fundamental roles in controlling M-phase progression. Previous reports have shown that AurB is vital for proper completion of karyokinesis and cytokinesis in somatic cells. The role of AurC in somatic cells has been found to be much less significant, whereas it appears to play an important role in spermatogenesis. The role of these Aur proteins is not well characterized in mouse oocytes and early embryos. The objective of this study was to assess changes of AurB and AurC mRNA and protein expression in mouse oocytes and early embryos as development progresses through the activation of the zygotic genome. Oocytes and embryos were collected from the oviducts of hormone-stimulated CF-1 mice. After culturing for varying amounts of time, cumulus-denuded samples were either fixed for immunofluorescence microscopy studies or lysed for analysis of mRNA levels through the use of reverse transcription-PCR (RT-PCR). Samples were processed for immunofluorescence using markers of spindle morphology (tubulin) and AurB. Analysis of relative levels of AurB and AurC mRNA were assessed by RT-PCR methods. Marked differences were observed in the localization of AurB when unfertilized oocytes or prezygotic genome activation (ZGA) embryos were compared with post-ZGA samples. There was no evidence of AurB protein localized to the mitotic spindle or resultant midbody in oocyte and early embryo samples. Embryos fixed post-ZGA demonstrated AurB localization, as is conventionally found in somatic cells. The AurB protein was found co-localized with DNA in metaphase stage blastomeres and associated with the midbody in blastomeres near completion of cytokinesis. Relative levels of AurB mRNA were not found to be significantly different when pre- and post-ZGA samples were compared. A significant decrease in relative levels of AurC mRNA was observed in fertilized pre-ZGA samples when compared with unfertilized oocyte counterparts. These observations demonstrate significant differences in the status of AurB and AurC mRNA levels and protein localization in mouse oocytes and early embryos when compared with somatic cells. Given earlier reports showing the vital role of AurC in spermatogenesis, the elevated levels of AurC mRNA observed in prefertilization oocytes may be indicative of a similar role of AurC during oogenesis. Elucidating temporal and localization details of Aur expression is vital to gaining further understanding of cell-cycle regulation in oogenesis and early embryogenesis.
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Sarmiento, Juan-Pablo, Philip Gelman, Gustavo Jordão, and Patricia Bittner. "Post-project review in urban disaster risk reduction." Disaster Prevention and Management: An International Journal 26, no. 2 (2017): 148–61. http://dx.doi.org/10.1108/dpm-10-2016-0205.
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Purpose The purpose of this paper is to provide an analysis of a post-project review (PPR) method designed to verify the accomplishments of urban disaster risk reduction-neighborhood approach (DRR-NA) projects after at least one year of project closeout. The PPR revisited the essential processes identified during project implementation and analyzed the sustainability of project gains. Design/methodology/approach The first section focuses on a literature review of the evaluation methods after project implementation, and the second describes the urban risk PPR design, its implementation, and findings. Findings The proposed framework for the PPR was clear and uniform and at the same time offered the necessary flexibility to adapt to the different DRR-NA projects and contexts. The PPR methodology sought to determine the conditions of the physical works, social and environmental gains, and progress in institutional arrangements associated with the NA projects. Factors that contribute and impede success in DRR-NA projects were identified. Practical implications Allowing at least one year between the completion of the NA projects and the PPR is both convenient and challenging. On the positive side, this approach allows for the verification of project outcomes after an extended period of time. However, there are also challenges, such as the need to seek additional financial resources to carry out the review; generate new contractual mechanisms; and assign human resources to review a project already closed. Originality/value The changes introduced into the PPR methodology to obtain a participative and self-conducted process resulted in a truly collective learning experience, becoming an act of accountability and social commitment.