Abstract：
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 co-primary 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.NRG Oncology RTOG 0415 is a randomized phase III noninferiority (NI) clinical trial comparing conventional fractionation (73.8 Gy in 41 fractions) radiotherapy (C-RT) with hypofractionation (H-RT; 70 Gy in 28) in patients with low-risk prostate cancer. The study included 1,092 protocol-eligible patients initially reported in 2016 with a median follow-up of 5.8 years. Updated results with median follow-up of 12.8 years are now presented. The estimated 12-year disease-free survival (DFS) is 56.1% (95% CI, 51.5 to 60.5) for C-RT and 61.8% (95% CI, 57.2 to 66.0) for H-RT. The DFS hazard ratio (H-RT/C-RT) is 0.85 (95% CI, 0.71 to 1.03), confirming NI (P < .001). Twelve-year cumulative incidence of biochemical failure (BF) was 17.0% (95% CI, 13.8 to 20.5) for C-RT and 9.9% (95% CI, 7.5 to 12.6) for H-RT. The HR (H-RT/C-RT) comparing biochemical recurrence between the two arms was 0.55 (95% CI, 0.39 to 0.78). Late grade ≥3 GI adverse event (AE) incidence is 3.2% (C-RT) versus 4.4% (H-RT), with relative risk (RR) for H-RT versus C-RT 1.39 (95% CI, 0.75 to 2.55). Late grade ≥3 genitourinary (GU) AE incidence is 3.4% (C-RT) versus 4.2% (H-RT), RR 1.26 (95% CI, 0.69 to 2.30). Long-term DFS is noninferior with H-RT compared with C-RT. BF is less with H-RT. No significant differences in late grade ≥3 GI/GU AEs were observed between assignments (ClinicalTrials.gov identifier: NCT00331773).
摘要：
临床试验通常包括在不同时间成熟的多个终点。初次报告,通常基于主要终点，当尚未获得关键计划的共同主要或次要分析时，可能会发布。临床试验更新提供了传播其他研究结果的机会，发表在JCO或其他地方，已经报告了主要终点。NRG肿瘤学RTOG0415是一项随机的III期非劣效性（NI）临床试验，比较了低风险前列腺癌患者的常规分割（41分73.8Gy）放疗（C-RT）和低分割（H-RT；28分70Gy）。该研究包括2016年最初报告的1,092名符合协议的患者，中位随访时间为5.8年。现在提供中位随访12.8年的最新结果。C-RT估计的12年无病生存率（DFS）为56.1％（95％CI，51.5至60.5），H-RT为61.8％（95％CI，57.2至66.0）。DFS风险比(H-RT/C-RT)为0.85(95%CI，0.71至1.03)，确认NI(P<.001)。生化衰竭（BF）的12年累积发生率C-RT为17.0%（95%CI，13.8~20.5），H-RT为9.9%（95%CI，7.5~12.6）。比较两组间生化复发的HR(H-RT/C-RT)为0.55(95%CI,0.39~0.78)。晚期≥3级GI不良事件（AE）发生率为3.2％（C-RT）对4.4％（H-RT），H-RT与C-RT的相对风险（RR）为1.39（95％CI，0.75至2.55）。晚期≥3级泌尿生殖系统（GU）AE发生率为3.4％（C-RT）与4.2％（H-RT），RR1.26（95%CI，0.69至2.30）。与C-RT相比，H-RT的长期DFS不差。BF与H-RT较少。在各分配之间，未观察到晚期≥3级GI/GUAE的显着差异（ClinicalTrials.gov标识符：NCT00331773）。
