tbuckley/cabot-search huggingface dataset:
Phase I trial of nab-paclitaxel administered concurrently with radiotherapy in patients with locally advanced inoperable pancreatic adenocarcinoma (ART in LAP).
Authors: Amitesh Chandra Roy, Muhammad Nazim Abbas, Timothy Jay Price, Nimit Singhal, Sina Vatandoust, John Leung, Ganessan Kichenadasse, Bogda Koczwara, Shawgi Sukumaran, Rajiv Kumar, Richard John Woodman, Alison Richards, Alex Scott-Hoy, Christos Stelios Karapetis
Journal: Journal of Clinical Oncology (2020)

e16796 Background: Locally advanced pancreatic adenocarcinoma (LAPC) carries a poor prognosis with median overall survival of 12-18m. The optimal treatment is controversial. Nab-paclitaxel is active in advanced pancreatic cancer and has exhibited radio-sensitising anti-tumour efficacy. Methods: We conducted an investigator-initiated open-label, phase-I dose escalation trial of nab-paclitaxel with standard external beam radiotherapy (EBRT). All patients had biopsy-proven, untreated, localised, inoperable pancreatic adenocarcinoma; Patients received nab-paclitaxel on a weekly schedule for 6 weeks, concurrently with EBRT. A 3+3 cohort design was employed, with doses of nab-paclitaxel increasing from 25 mg/m2 (cohort 1), to 50 mg/m2 (cohort 2), 75 mg/m2 (cohort 3) and 100 mg/m2 (cohort 4). This principal objective of the trial was to establish the maximum tolerated dose (MTD) of nab-paclitaxel given concurrently with radiotherapy. Secondary objectives included safety and efficacy evaluation, including response rate, median PFS, median and 1- year OS. Results: Fourteen patients were recruited to the study, with a median age of 69 (range 40-86). 69% had a head or neck of pancreas tumour. Majority of patients had grade 1 or 2 toxicities with nausea (92%), fatigue (69%), diarrhoea (54%) and vomiting (54%) being the most common. Three patients were recruited in each of the first three cohorts, without any dose limiting toxicities (DLT). In cohort 4, DLT of febrile neutropenia and enterocolitis was observed in patient 1. The cohort was expanded with a subsequent DLT of febrile neutropenia and enterocolitis observed in patient 5. Both DLT events lead to death (grade 5). The MTD and recommended phase II study dose has been established as 75mg/ m2. The disease control (PR and SD) rate was 67%, median PFS 4.7 months (95% CI 2.5-27.5), 1 year OS 43% and median OS 11.4 months (95%CI 6.37-25.2). Conclusions: The combination of weekly nab-paclitaxel and fractionated radiation was generally well-tolerated at doses of nab-paclitaxel below 100 mg/m2. There were two treatment related DLTs leading to death in the nab-paclitaxel 100 mg/m2 cohort. The MTD and recommended phase II study dose for nab-paclitaxel combined with radiation therapy in the treatment of LAPC is 75mg/m2. Clinical trial information: ACTRN12613001013752 .
Effects of YOCAS yoga, cognitive behavioral therapy, and survivorship health education on insomnia: A URCC NCORP Research Base Phase III RCT in 740 cancer survivors.
Authors: Karen Michelle Mustian, Po-Ju Lin, Eva Culakova, Javier Bautista, Huiwen Xu, Supriya Gupta Mohile, Michelle Christine Janelsins, Luke Joseph Peppone, Amber Kleckner, Ian Kleckner, Kah Poh Loh, Richard Francis Dunne, Nikesha Gilmore, Alison Katherine Conlin, Kim Ong Gococo, Anthony John Jaslowski
Journal: Journal of Clinical Oncology (2020)

12005 Background: Insomnia, a prevalent and troublesome side effect experienced by cancer survivors, significantly impairs recovery and survival. We conducted a nationwide, multicenter, phase III, blinded, randomized controlled trial testing whether 1) yoga is superior to survivorship health education (SHE) and 2) yoga is non-inferior to cognitive behavioral therapy for insomnia (CBT-I) for treating insomnia in survivors. Methods: The trial was conducted via the University of Rochester Cancer Center NCI Community Oncology Research Program (URCC NCORP) Research Base. Participants were cancer survivors between 2-60 months post adjuvant therapy, with insomnia, no metastatic disease, and no yoga participation during the previous 3 months. Survivors were randomized into 1) YOCAS yoga (2x/wk; 75 min/sess for 4 wks with pranayama, asana, and dhyana, N = 251), 2) CBT-I (1x/wk, 90 min/sess for 8 wks with sleep hygiene, stimulus control, sleep restriction, and cognitive therapy, N = 238), or 3) SHE (2x/wk; 75 min/sess for 4 wks with ASCO-recommended survivorship education, N = 251). Insomnia was assessed pre- and post-intervention via the Insomnia Severity Index. Results: 740 eligible cancer survivors were enrolled (93% female, mean age = 56 + 11, 75% breast cancer). ANCOVAs with baseline values as covariates revealed YOCAS is significantly better than SHE for treating insomnia at post-intervention (CS = change score; CS mean diff = -1.43, SE = 0.42, p &lt; 0.01). Yoga participants demonstrated greater improvements in insomnia from pre- to post-intervention (CS = -3.61, SE = 0.30) compared to SHE participants (CS = -2.19, SE = 0.33, all p &lt; 0.01). Intent-to-treat analyses of non-inferiority (non-inferiority margin set at 1.15 a priori) showed YOCAS is inferior to CBT-I (CS mean diff = 3.52, CI = 2.55 - 4.50, p &lt; 0.01). However, analyses of non-inferiority using the optimal treatment effect in fully compliant survivors were inconclusive regarding whether YOCAS is non-inferior to CBT-I for treating insomnia (CS mean diff = 2.20, CI = 0.42 - 3.98, p = 0.09). Significantly more survivors withdrew from CBT-I and SHE due, in part, to disliking the interventions compared to YOCAS (30%, 25%, and 16%, respectively, p &lt; 0.01). Conclusions: YOCAS yoga is better than SHE and results are inconclusive as to whether yoga is non-inferior to CBT-I for treating insomnia among survivors. Clinicians should consider prescribing YOCAS and CBT-I for survivors reporting insomnia. Funding: NCI UG1CA189961, R01CA181064, T32CA102618. Clinical trial information: NCT02613364 .
Mental health care during female menopause
Authors: Yanling He
Journal: BMJ (2016)

妇女精神卫生中与女性生理周期有关的心理健康和疾病自然是关注的重点。女性更年期因其生理变化和社会环境的改变，而有着这阶段女性的心理特征和常见的心理问题。本文从生物-心理-社会的医学模式进行阐述，为全科医生提出健康教育重点和干预建议。
Family function and trait coping style relate with sleep quality in patients with primary insomnia
Authors: 张秀兰, 华潜棠, 张颖, 谢绣清
Journal: BMJ (2007)

目的 了解家庭生活事件、家庭功能等对原发性失眠症的影响.方法 向在社区卫生服务站就诊,持续3个月以上的原发性失眠者和无失眠者各56例发放家庭功能量表、匹茨堡睡眠质量指数量表和特质应对反应方式问卷.失眠者问卷回收48份,作为病例组;无失眠者问卷回收52份,作为对照组.对问卷进行分析.结果 病例组与对照组的睡眠质量差异有统计学意义(χ2=10.75,P＜0.05);两组的特质应对反应方式差异有统计学意义(χ2=4.03,P＜0.05);消极应对反应方式与睡眠质量的关联性,经卡方检验χ2=4.05,P＜0.05.两组的家庭功能差异无统计学意义(χ2=3.39,P＞0.05).结论 生活事件、家庭功能障碍是通过患者的特质应对反应方式影响患者睡眠质量的。
A few points on guideline for pulmonary function testing in primary care(2018)
Authors: Yuanlin Song, Jinping Zheng
Journal: BMJ (2019)

慢性气道疾病的诊断、治疗和管理离不开肺功能的操作和解读，双向转诊的实施需要以肺功能技术的基层普及和推广为基础。为了适应呼吸慢性病管理的需要，在基层社区开展肺功能检查，有必要制定适合基层医疗卫生机构的基层肺功能检查指南。
A Ib/II study of the combination of lenvatinib (L) and eribulin (E) in advanced liposarcoma (LPS) and leiomyosarcoma (LMS) (LEADER).
Authors: Tom Wei-Wu Chen, Chih-Wei Yu, Ruey-Long Hong, Chueh-Chuan Yen, Jhe-Cyuan Guo, San-Chi Chen, Jen-chieh Lee, Mei-Lu Chen, Hsin-Fang Chang, Meng-Chi Hsu, Ting-Fang Kung
Journal: Journal of Clinical Oncology (2020)

11507 Background: For advanced LPS and LMS, the two most common histologies in soft tissue sarcoma, there are limited treatment options that readily balance efficacy and toxicity. Patients (pts) treated with E had an improved median overall survival (OS) in a phase III randomized study compared to dacarbazine but with an unsatisfactory 4% objective response rate (ORR). Early studies of L, a multi-targeted anti-angiogenic inhibitor, had suggested efficacy in sarcoma pts. We hypothesized that the combination of anti-angiogenic agent and chemotherapy could potentiate treatment benefit and aimed to explore the safety and efficacy of L + E in advanced LMS and LPS. Methods: LEADER was a single-arm phase Ib/II study for advanced adult LMS and LPS pts who had received no more than 2 lines of systemic chemotherapy. The phase Ib part (starting dose: L 18mg/day, E 1.1mg/m 2 ) had been reported and the recommended phase 2 dose (RP2D) was determined at L 14mg/day and E 1.1mg/m 2 D1, D8 every 21 days. The primary endpoint of the phase II part was ORR by RECIST 1.1, secondary endpoints included ORR by Choi criteria, progression-free survival (PFS), 6-month PFS rate, and OS. With α = 0.05 and 80% power, the pts needed for stage I and total of the Simon 2-stage design was 13 and 27 pts, respectively. Results: As of Jan 22, 2020, 20 pts (F/M 13/7) had been treated with at least one cycle of L + E; 14 were LMS (5 uterine, 9 non-uterine) and 6 were LPS (4 dedifferentiated, 2 myxoid round cell). The median age was 51 (range 29-73); the median lines of treatment(s) received before enrollment was 1 (range 0-3). 18 pts were evaluable for primary endpoint: the ORR by RECIST 1.1 was 27 % (5/18) (95% CI 10-53%). The ORR by Choi criteria was 67 % (12/18) (95% CI 41-87%). With 8 PFS events, the median PFS and 6-month PFS rate was 56 weeks (95% CI 25-not reached) and 72%, respectively. There were no OS events. The ORRs by RECIST 1.1 between different L starting doses were not significantly different (18mg 33% (2/6) vs 14mg 25% (3/12), p = 0.7). 15 pts experienced at-least one grade (gr) 3 or 4 adverse event (AE); gr 3 or 4 AEs occurred in &gt; 1 pts included (% of phase Ib, % of phase II pts) hypertension (n = 4) (67%, 0%); hand-foot-syndrome (n = 4) (50%, 7%), proteinuria (n = 3) (0%, 25%), febrile neutropenia (n = 2) (17% vs 5%), neutropenia (n = 6) (50% vs 25%). The RP2D was associated with overall lower gr3/4 AEs except for proteinuria. Conclusions: L + E had shown promising efficacy in advanced LMS and LPS. L at 14mg/day had a better AE profile without compromising activity. The exploratory biomarker study of LEADER is ongoing. Clinical trial information: NCT03526679 .
Final survival results from SPARTAN, a phase III study of apalutamide (APA) versus placebo (PBO) in patients (pts) with nonmetastatic castration-resistant prostate cancer (nmCRPC).
Authors: Eric Jay Small, Fred Saad, Simon Chowdhury, Stephane Oudard, Boris A. Hadaschik, Julie N Graff, David Olmos, Paul N. Mainwaring, Ji Youl Lee, Hiroji Uemura, Peter De Porre, Andressa Smith, Sabine Doris Brookman-May, Susan Li, Ke Zhang, Oliver Brendan Rooney, Angela Lopez-Gitlitz, Matthew Raymond Smith
Journal: Journal of Clinical Oncology (2020)

5516 Background: SPARTAN evaluated APA vs PBO in pts with nmCRPC and a prostate-specific antigen doubling time of ≤ 10 mo receiving androgen deprivation therapy (ADT). At primary end point analysis of metastasis-free survival (MFS), APA significantly improved median MFS by 2 yrs, as well as time to metastasis, progression-free survival, and time to symptomatic progression vs PBO (Smith, et al. NEJM 2018); overall survival (OS) results were immature. SPARTAN was unblinded upon meeting the primary end point; pts still on PBO were allowed to cross over to APA. Final survival results are reported herein. Methods: 1207 nmCRPC pts were randomized 2:1 to APA (240 mg QD) or PBO plus ongoing ADT. At progression, pts could receive open-label sponsor-provided abiraterone acetate + prednisone. After the primary efficacy end point (MFS) was met, 76 PBO pts (19%) crossed over to APA. OS and time to cytotoxic chemotherapy (TTCx) were tested by group sequential testing procedure with O’Brien-Fleming (OBF)-type alpha spending function. Time-to-event end points were analyzed by Kaplan-Meier method and Cox model. A sensitivity analysis for OS, accounting for crossover using a naïve censoring approach, was conducted. Results: With follow-up of 52.0 mo, 428 (of 427 required) OS events had occurred. Median treatment duration: APA, 32.9 mo; PBO, 11.5 mo. Median OS was significantly longer with APA + ADT vs PBO + ADT (73.9 vs 59.9 mo), (hazard ratio [HR], 0.784, Table). APA significantly lengthened TTCx (HR, 0.629). Discontinuation rates (APA vs PBO) due to progressive disease were 42.7% vs 73.9%, and due to adverse events (AE) 15.2% vs 8.4%. Safety was consistent with previous reports; grade 3/4 treatment-emergent (TE) AEs of special interest were rash 5.2%, fractures 4.9%, falls 2.7%, ischemic heart disease 2.6%, hypothyroidism 0%, and seizures 0%. 1 TEAE leading to death (myocardial infarction) was considered potentially APA related. Conclusions: In pts with nmCRPC, APA + ADT significantly improved OS compared with PBO + ADT, with median OS &gt; 6 yr in the APA + ADT group and 14 mo improvement over PBO + ADT. Benefit from APA was observed despite a 19% crossover from PBO. The safety profile of APA was consistent with prior interim analyses. Clinical trial information: NCT01946204 . [Table: see text]
社区获得性耐甲氧西林金黄色葡萄球菌致颅内感染一例
Authors: 袁红娟, 卫京平
Journal: BMJ (2009)

患者男,54岁,主因发热伴恶心呕吐3 d,嗜睡1 d于2008年10月14日凌晨入院.既往体健,有糖尿病家族史.入院前3 d无明显诱因出现发热,最高达39.4℃,伴寒战、恶心、非喷射状呕吐、轻度咳嗽、少许白痰,于当地医院静脉滴注头孢噻肟钠2 g,12 h一次,连续3 d。
Phase Ib trial combining rapid determination of drug-drug interaction (DDI) followed by a dose finding period to assess safety and preliminary efficacy of fimepinostat plus venetoclax in patients with aggressive B-cell lymphoma.
Authors: Tycel Jovelle Phillips, Sven De Vos, Jason Westin, Stefan K. Barta, Jonathon Brett Cohen, Krish Patel, Sonali M. Smith, John M. Pagel, Vikram Kansra, Dena Grayson, Anas Younes, Connie Lee Batlevi
Journal: Journal of Clinical Oncology (2020)

8056 Background: Fimepinostat (F), a dual inhibitor of PI3K (α, β, δ) and HDACs type 1/2, causes suppression of MYC levels (Shulman et al., 2017). A pooled analysis of diffuse large B-cell lymphoma (DLBCL) pts treated with F in two Ph 1/2 trials revealed an objective response rate in evaluable/ITT MYC-altered DLBCL pts of 29%/23%, respectively (Landsburg et al., 2018). Based on compelling preclinical activity of F in combination with venetoclax (V) (a Bcl2 inhibitor), we initiated a Ph 1b/2 study of F + V in pts with relapsed or refractory (R/R) DLBCL or high-grade B-cell lymphoma (HGBL), with or without MYC alteration. V is metabolized primarily by CYP3A, and preclinical studies showed that F may inhibit CYP3A4 (IC 50 of 13.58 and 0.28 µM for midazolam and testosterone, respectively), suggesting F could cause DDI with V. Methods: Cohorts of patients received increasing dose levels of F administered on a 5-days-on/2-days-off (5/2) schedule in combination with daily V in 21-day cycles (Cohort 1: F 30 mg QD 5/2 + V 400 mg QD; Cohort 2: F 60 mg QD, 5/2 + V 400 mg QD; Cohort 3: F 60 mg QD 5/2 + V 800 mg QD). A potential DDI was assessed during Cycle 0 (Table), where PK for V (10 mg) monotherapy was compared to that for V (10 mg) in the presence of F. Patient PK samples were collected, analyzed and reviewed in &lt; 10 days to determine the final ramp-up dose level of V. Results: As of 1-Feb-2020, 16 pts have been enrolled in 2 dose cohorts. Intensive PK analysis of 13 pts showed only mild (≤ 2-fold) to no increase in V exposure in the presence of F. In Cohort 1 (n = 6), the mean AUC increased 1.6-fold, and mean C max by 1.5-fold. In Cohort 2 (n = 7), no increase in mean AUC (0.9-fold) or C max (1.0-fold) was observed. Accordingly, all pts ramped up V to 100% of the target dose (400 mg) upon entering Cycle 1; rapid escalation of V was well tolerated. DLT was observed in 1 pt (Grade 3 diarrhea) in Cohort 2. Overall, 75% of TEAEs have been mild or moderate (Grade 1/2), and most were of limited duration. 11 pts (69%) experienced SAEs; 4 pts (25%) had SAEs considered related to either F or V. Conclusions: Real-time PK evaluation showed that F had only a mild to no DDI with V. F + V is well tolerated at clinically active dose levels, and evaluation of higher dose-level cohorts was ongoing. Enrollment in Cohort 2 remains on-going. Clinical trial information: NCT01742988 . [Table: see text]
A phase Ib trial of neoadjuvant/adjuvant durvalumab +/- tremelimumab in locally advanced renal cell carcinoma (RCC).
Authors: Moshe Chaim Ornstein, Joseph Zabell, Laura S. Wood, Brian Hobbs, Sarah Devonshire, Allison Martin, Kimberly D. Allman, Arpit Rao, Timothy D. Gilligan, Steven Campbell, Venkatesh Krishnamurthi, Brian I. Rini
Journal: Journal of Clinical Oncology (2020)

5021 Background: Effective neoadjuvant and adjuvant therapies are lacking in locally advanced RCC. Given robust activity of checkpoint inhibitors in mRCC, a phase Ib trial of perioperative Durvalumab (D) +/- Tremelimumab (T) in locally advanced RCC was conducted (NCT02762006). Methods: Pts with radiographic evidence of high risk localized RCC (clinical stage T2b-4 and/or N1, M0 disease), adequate performance status, and adequate laboratory values were eligible. Primary objective was safety and feasibility of neoadjuvant/adjuvant D +/- T. Results: Twenty-nine pts were enrolled. Cohorts, regimens, and immune-related adverse events (irAE) are detailed in the table. In total, 79% male, median age 61 (range, 42-84), 8%/88%/4% clinical T2/T3/T4, 27% positive clinical lymph nodes (LN+), and median time from neoadjuvant dose to surgery was 7 days. On surgical pathology: 5%/14%/77%/5% pathologic T1/T2/T3/T4, and 13% LN+. Median time from treatment to first grade (Gr) &gt;3 irAE or any Gr irAE requiring corticosteroids was 99 days (range, 32-207). There were no treatment-related delays to nephrectomy or surgical complications. Although not meeting the protocol-defined MTD, given higher than expected irAEs, the study was suspended. Conclusions: Perioperative durvalumab in locally advanced RCC appears safe. The addition of tremelimumab is associated with higher rates of toxicity. Updated toxicity will be presented. Clinical trial information: NCT02762006 . [Table: see text]
Safety and preliminary antitumor activity of the transforming growth factor beta (TGF-β) receptor I kinase inhibitor, vactosertib, in combination with paclitaxel in patients with metastatic gastric adenocarcinoma.
Authors: Minkyu Jung, Choong-Kun Lee, Hyo Song Kim, Chan-Young Ock, Bae Jin Bum, Jin Lee, Dong Woo Kang, Sunjin Hwang, Seong-Jin Kim, Hyun Cheol Chung, Sun Young Rha
Journal: Journal of Clinical Oncology (2020)

e16505 Background: Recent studies demonstrated that TGF-β signaling attenuation in combination with paclitaxel inhibits epithelial-to-mesenchymal transition and cancer stem-like cells features, especially in diffuse type. We are reporting dose finding part in phase 1b study evaluating the combination of vactosertib, a highly selective and potent TGF-β inhibitor, with paclitaxel as a second line treatment in patients with metastatic gastric adenocarcinoma (GA). Methods: Eligible patients (pts) are ≥19 years old, have ECOG status ≤1, and have progressed on the first line treatment of metastatic GA treated with the combination therapy of fluoropyrimidine and platinum, or trastuzumab containing combination therapy in HER2-positive GA. The primary objective is to assess the safety and recommended phase 2 dose (RP2D) of vactosertib given 5 days on/2 days off in combination with weekly paclitaxel 80 mg/m 2 . Three dose levels of vactosertib (100, 200, and 300 mg BID) were tested. Results: As of Jan. 25, 2020, 12 pts were enrolled to the study (6, 3, and 3 pts in 100, 200, and 300 mg BID, respectively) and finished the safety evaluation. Median age was 50 (range, 39-65), 50% were male, and 75% had gastrectomy (4 pts with subtotal gastrectomy; 5 pts with total gastrectomy). At all cohorts, no dose limiting toxicity was observed. The most frequently reported treatment related adverse events (AEs) were anemia (50.0%), anorexia (41.6%), fatigue (33.3%), and urticaria (33.3%). AEs were mostly grade 1 or 2 and manageable. One case of grade 3 anorexia was reported as a treatment-related severe adverse event. Among 6 evaluable patients in 200/300 mg BID cohorts, the best responses to treatment were partial response in 1 patient; 57% decrease from baseline, 16.7% of overall response rate, and 83.3% of disease control rate at 12 weeks. Median progression free survival of the RP2D cohort has not been reached yet. Updated safety, PK, efficacy and biomarker data will be presented at the meeting. Conclusions: The combination of vactosertib plus paclitaxel has been well tolerated. The anti-tumor activity of this combination in patients with metastatic GA is now under exploration in the phase 2a part of the study. Clinical trial information: NCT03698825 .
Community health care providers:challenge and strategies
Authors: Li-juan Wang
Journal: BMJ (2008)

We conducted a questionnaire survey among 36 community health care providers at Jingansi Health Center to learn their status quo.Our results showed that talented person aged less than 35 only accounted for 1/10.97%of the young physicians wished to have more continuous medical education and improved working environment.Proper working regulation,personnel resource management and payment system might help attract,train and retain more qualified persons,improve personnel quality,and achieve sustainable development of community health centers.

Key words: 
Community health servicesLPersonnel quality
Effectiveness of adjuvant FOLFOX versus 5FU for colon cancer treatment in community oncology practice using a hybrid study approach.
Authors: Jennifer Leigh Lund, Michael Webster-Clark, Alexander P Keil, Daniel Westreich, Til Sturmer, Hanna Kelly Sanoff
Journal: Journal of Clinical Oncology (2020)

7067 Background: Treatment effects may differ between trials and community settings, in part due to underrepresentation of certain patient subgroups in trials. We used a hybrid approach combining clinical trial and real-world data to compare the effectiveness of adjuvant FOLFOX vs 5FU for stage II-III colon cancer in community oncology practice. Methods: We used Multicenter International Study of Oxaliplatin/5FU-LV in the Adjuvant Treatment of Colon Cancer (MOSAIC) combined with patients who met trial eligibility criteria within US Oncology from 1/1/2008-5/31/2019. In the combined data, we used logistic regression to estimate the probability of trial enrollment as a function of age, sex, substage, body mass index (BMI), and performance status. We estimated inverse odds of sampling weights and weighted MOSAIC participants to reflect three US Oncology populations: 1) patients meeting trial eligibility, 2) stage III patients, and 3) stage III patients initiating FOLFOX. Within the weighted trial populations, we estimated mortality hazard ratios (HRs) and bootstrapped 95% confidence intervals (CIs) comparing FOLFOX with 5FU. Results: There were 2246 MOSAIC participants and 9335 US Oncology patients. MOSAIC participants were younger, had more stage II cancer, lower BMI, and worse performance status compared with US Oncology patients. After weighting MOSAIC participants to reflect the US Oncology populations, the HRs were attenuated (Table) compared with the original MOSAIC estimate (HR = 0.84; 0.71,1.00). Conclusions: When differences between trial and clinical populations exist and response to therapy varies across subgroups, treatment efficacy can differ from clinical effectiveness. Compared with trial results, we found that effectiveness of FOLFOX versus 5FU was attenuated in community oncology practice. [Table: see text]