Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned coprimary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.

The purpose of this update was to determine differences in patient-reported chronic toxicity and disease outcomes with intensity-modulated radiation therapy (IMRT) compared with conventional pelvic radiation. Patients with cervical and endometrial cancers who received postoperative pelvic radiation were randomly assigned to conventional radiation therapy (CRT) or IMRT. Toxicity and quality of life were assessed using Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events, Expanded Prostate Cancer Index Composite (EPIC) bowel and urinary domains, and Functional Assessment of Cancer Therapy–General. Between 2012 and 2015, 279 eligible patients were enrolled to the study with a median follow-up of 37.8 months. There were no differences in overall survival (P = .53), disease-free survival (P = .21), or locoregional failure (P = .81). One year after RT, patients in the CRT arm experienced more high-level diarrhea frequency (5.8% IMRT v 15.1% CRT, P = .042) and a greater number had to take antidiarrheal medication two or more times a day (1.2% IMRT v 8.6% CRT, P = .036). At 3 years, women in the CRT arm reported a decline in urinary function, whereas the IMRT arm continued to improve (mean change in EPIC urinary score = 0.5, standard deviation = 13.0, IMRT v –6.0, standard deviation = 14.3, CRT, P = .005). In conclusion, IMRT reduces patient-reported chronic GI and urinary toxicity with no difference in treatment efficacy at 3 years.

临床试验经常包括在不同时间成熟的多个终点。当关键计划的共同主要或次要分析尚未可用时，通常基于主要终点的初始报告可能会发布。临床试验更新提供了传播在JCO或其他地方发表的研究的额外结果的机会，这些研究的主要终点已经报告。

本次更新的目的是确定调强放射治疗 (IMRT) 与传统盆腔放射治疗相比，患者报告的慢性毒性和疾病结果的差异。接受术后盆腔放疗的宫颈癌和子宫内膜癌患者被随机分配接受常规放射治疗 (CRT) 或 IMRT。使用不良事件通用术语标准的患者报告结果版本、扩展前列腺癌综合指数 (EPIC) 肠道和泌尿领域以及癌症治疗功能评估（一般）来评估毒性和生活质量。2012年至2015年间，279名符合条件的患者参加了该研究，中位随访时间为37.8个月。总生存期 ( P = .53)、无病生存期 ( P = .21) 或局部失败 ( P = .81)没有差异。RT 一年后，CRT 组患者出现更高程度的腹泻频率（5.8% IMRT vs 15.1% CRT，P = 0.042），并且更多的患者必须每天服用两次或多次止泻药物（1.2% IMRT v 8.6% CRT，P = .036）。3 年时，CRT 组的女性报告泌尿功能下降，而 IMRT 组持续改善（EPIC 泌尿评分的平均变化 = 0.5，标准差 = 13.0，IMRT v –6.0，标准差 = 14.3，CRT，P = .005)。总之，IMRT 减少了患者报告的慢性胃肠道和泌尿道毒性，且 3 年治疗效果没有差异。