Miller Avital M, Passy Adina H, Sherry Alexander D, Kouzy Ramez, Abi Jaoude Joseph, Lin Timothy A, Kupferman Gabrielle S, Beck Esther J, Msaouel Pavlos, Ludmir Ethan B
Department of Radiation Oncology, Division of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.
Department of Radiation Oncology, Stanford University, Stanford, CA.
JCO Oncol Pract. 2025 Jul;21(7):979-988. doi: 10.1200/OP-24-00735. Epub 2025 Jan 8.
This study aimed to determine complete toxicity reporting (CTR), and the use of subjective toxicity-minimizing language (TML) among phase III oncology trials.
Two-arm superiority-design phase III oncology trials published from 2002 to 2020 were reviewed for toxicity data. CTR was defined as reporting total adverse events (TAEs), total serious adverse events (SAEs), total deaths, and study therapy discontinuations because of toxicity. Guideline concordance was defined according to guidelines published in the (defined as reporting total SAEs, total deaths, and study therapy discontinuations because of toxicity). TML was defined as a set of terms that subjectively downplay the harm of therapies.
A total of 407 trials enrolling 322,645 patients were included. Most (51%, n = 207) reported SAEs, 88% (n = 358) reported total deaths, and 84% (n = 340) reported study therapy discontinuation because of toxicity. Although 55% of trials (n = 223) reported TAEs, only 32% (n = 131; 95% credible interval, 28 to 37) fit the criteria for CTR. CTR was more common in trials with industry sponsorship (37%) than with cooperative group sponsorship (4%). All 131 trials where CTR was observed were industry-sponsored, and only 3% (4/131) were cooperative group-sponsored trials. TML was used in 46% of trials (n = 186; 95% credible interval, 41 to 51), with no trial-related factors (including sponsorship source) associated with the odds of TML use.
Toxicity in phase III oncology clinical trials is often incompletely reported and is frequently minimized in its interpretation. Industry-sponsored trials more comprehensively report toxicity than do cooperative group-sponsored trials. CTR may improve patients' and oncologists' understanding of new treatments; thus, a more standardized approach to reporting toxicity data is needed.
本研究旨在确定III期肿瘤学试验中的完整毒性报告（CTR）以及主观毒性最小化语言（TML）的使用情况。
回顾2002年至2020年发表的双臂优效性设计III期肿瘤学试验的毒性数据。CTR定义为报告总不良事件（TAE）、总严重不良事件（SAE）、总死亡人数以及因毒性导致的研究治疗中断情况。指南一致性根据（此处原文缺失具体指南名称）中发布的指南定义（定义为报告总SAE、总死亡人数以及因毒性导致的研究治疗中断情况）。TML定义为一组主观淡化治疗危害的术语。
共纳入407项试验，涉及322,645名患者。大多数试验（51%，n = 207）报告了SAE，88%（n = 358）报告了总死亡人数，84%（n = 340）报告了因毒性导致的研究治疗中断情况。尽管55%的试验（n = 223）报告了TAE，但只有32%（n = 131；95%可信区间，28至37）符合CTR标准。CTR在行业赞助的试验（37%）中比在合作组赞助的试验（4%）中更常见。观察到CTR的所有131项试验均由行业赞助，只有3%（4/131）是合作组赞助的试验。46%的试验（n = 186；95%可信区间，41至51）使用了TML，且没有与TML使用几率相关的试验相关因素（包括赞助来源）。
III期肿瘤学临床试验中的毒性报告往往不完整，且在解读中常常被最小化。行业赞助的试验比合作组赞助的试验更全面地报告毒性。CTR可能会提高患者和肿瘤学家对新治疗方法的理解；因此，需要一种更标准化的方法来报告毒性数据。
