Overall side effect assessment of oxaliplatin toxicity in rectal cancer patients in NRG oncology/NSABP R04.

IF 3.3 3区 医学 Q1 HEALTH CARE SCIENCES & SERVICES
Quality of Life Research Pub Date : 2024-11-01 Epub Date: 2024-07-30 DOI:10.1007/s11136-024-03746-5
John Devin Peipert, Jessica Roydhouse, Mourad Tighiouart, Norah Lynn Henry, Sungjin Kim, Ron D Hays, Andre Rogatko, Greg Yothers, Patricia A Ganz
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引用次数: 0

Abstract

Purpose: Regulatory guidance suggests capturing patient-reported overall side effect impact in cancer trials. We examined whether the Functional Assessment of Cancer Therapy (FACT) GP5 item ("I am bothered by side effects of treatment") post-neoadjuvant chemotherapy/radiotherapy differed between oxaliplatin vs. non- oxaliplatin arms in the National Surgical Adjuvant Breast and Bowel Project (NSABP) R-04 trial of stage II-III rectal cancer patients.

Methods: The R-04 neoadjuvant trial compared local-regional tumor control between patients randomized to receive 5-fluorouracil or capecitabine with radiation, with or without oxaliplatin (4 treatment arms). Participants completed surveys at baseline and immediately after chemoradiotherapy. GP5 has a 5-point response scale: "Not at all" (0), "A little bit" (1), "Somewhat" (2), "Quite a bit" (3), and "Very much" (4). Logistic regression compared the odds of reporting moderate-high side effect impact (GP5 2-4) between patients receiving oxaliplatin or not after chemoradiotherapy, controlling for relevant patient characteristics. We examined associations between GP5 and other patient-reported outcomes reflecting side effects.

Results: Analyses were performed among 1132 study participants. Participants receiving oxaliplatin were 1.58 times (95% CI: 1.22-2.05) more likely to report moderate-high side effect bother at post-chemotherapy/radiation. In both arms, worse overall side effect impact was associated with patient-reported diarrhea, nausea, vomiting, and peripheral sensory neuropathy (p < 0.01 for all).

Conclusion: This secondary analysis of R-04 found that GP5 distinguished between patients receiving oxaliplatin or not as part of their post-neoadjuvant chemoradiotherapy, adding patient-centric evidence on the reduced tolerability of oxaliplatin and demonstrating that GP5 is sensitive to known toxicity differences between treatments.

Clinicaltrials: GOV: NCT00058474.

Abstract Image

NRG 肿瘤学/NSABP R04 对直肠癌患者奥沙利铂毒性的总体副作用评估。
目的:监管指南建议在癌症试验中收集患者报告的总体副作用影响。我们研究了国家乳腺和肠道外科辅助治疗项目(NSABP)R-04 试验中 II-III 期直肠癌患者接受新辅助化疗/放疗后,奥沙利铂与非奥沙利铂治疗组的癌症治疗功能评估(FACT)GP5 项目("我被治疗的副作用困扰")是否存在差异:R-04新辅助治疗试验比较了随机接受5-氟尿嘧啶或卡培他滨与放射治疗、奥沙利铂或非奥沙利铂治疗(4个治疗组)的患者的局部区域肿瘤控制情况。参与者在基线和化疗放疗后立即完成了调查。GP5 采用 5 点反应量表:"完全没有"(0)、"有一点"(1)、"有一点"(2)、"有一点"(3)和 "非常多"(4)。逻辑回归比较了化放疗后接受或未接受奥沙利铂治疗的患者报告中度-高度副作用影响(GP5 2-4)的几率,并控制了相关的患者特征。我们研究了 GP5 与其他反映副作用的患者报告结果之间的关联:我们对 1132 名研究参与者进行了分析。接受奥沙利铂治疗的患者在化疗/放疗后报告中度-高度副作用困扰的可能性是接受奥沙利铂治疗的患者的1.58倍(95% CI:1.22-2.05)。在两组患者中,总体副作用影响较差与患者报告的腹泻、恶心、呕吐和外周感觉神经病变有关(P 结论):R-04的这项二次分析发现,GP5可区分患者是否在新辅助化放疗后接受了奥沙利铂治疗,从而为奥沙利铂耐受性降低提供了以患者为中心的证据,并证明GP5对治疗方法之间已知的毒性差异很敏感:GOV:NCT00058474。
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来源期刊
Quality of Life Research
Quality of Life Research 医学-公共卫生、环境卫生与职业卫生
CiteScore
6.50
自引率
8.60%
发文量
224
审稿时长
3-8 weeks
期刊介绍: Quality of Life Research is an international, multidisciplinary journal devoted to the rapid communication of original research, theoretical articles and methodological reports related to the field of quality of life, in all the health sciences. The journal also offers editorials, literature, book and software reviews, correspondence and abstracts of conferences. Quality of life has become a prominent issue in biometry, philosophy, social science, clinical medicine, health services and outcomes research. The journal''s scope reflects the wide application of quality of life assessment and research in the biological and social sciences. All original work is subject to peer review for originality, scientific quality and relevance to a broad readership. This is an official journal of the International Society of Quality of Life Research.
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