报告高危肌层浸润性膀胱癌 (MIBC) 根治性膀胱切除术和化疗后膀胱辅助放射治疗 (BART) 的多中心 III 期随机试验的毒性。根治后具有 ≥ 1 个高危特征的非转移性尿路上皮 MIBC 患者膀胱切除术 - pT3-4、pN1-3、淋巴结产量 <10、切缘阳性或≥cT3 通过新辅助化疗降期 - 在 4 个中心按 1:1 随机分配至观察 (Obs) 或辅助放射治疗 (RT)，按 pN 分层分期（N0、N）和化疗（新辅助、辅助、无）。保留造口的图像引导调强 RT 50.4 Gy 28# 被指定用于膀胱切除床和盆腔淋巴结。使用不良事件通用术语标准 v5.0 根据方案评估急性毒性（≤ 3 个月的 RT/随机化）和晚期毒性。随机分组后 3 个月或 6 个月内出现进展的患者分别被排除在急性或晚期毒性分析之外。BART 试验招募了 153 名患者（观测值 = 76，RT = 77）。大约一半 (49%) 患有 pN 。近 90% 接受化疗（70% 新辅助治疗；最常见的是吉西他滨加顺铂）。在 RT 组中，63/77 的患者按照方案完成了 RT，没有发生与毒性相关的 RT 终止。在可分析急性毒性的 134 名患者中，3 级没有观察到差异（观察值 4.2% 对比 RT 1.6%，P = .34）。 RT 的 2 级效应更高（17.5% vs 1.1%，P < .001），主要是腹泻/肠炎或直肠炎。 104 名患者（Obs = 57，RT = 47）的晚期毒性可分析，中位随访时间为 27 个月。 3 至 4 级毒性约为 10%（Obs 10.5% vs RT 8.4%，P = .62），两组的累积晚期 2 级毒性相似（17.5% vs 23.3%，P = .27）。对于高危尿路上皮 MIBC 进行辅助放疗的最大试验，严重急性和晚期毒性较低，与观察或放射治疗相似。等待肿瘤学结果。版权所有 © 2024 Elsevier Inc. 保留所有权利。

To report toxicity from the multicenter phase III randomized trial of Bladder Adjuvant Radiation Therapy (BART) after radical cystectomy and chemotherapy in high-risk muscle-invasive bladder cancer (MIBC).Patients with nonmetastatic urothelial MIBC with ≥1 high-risk feature after radical cystectomy- pT3-4, pN1-3, nodal yield <10, positive margin, or ≥cT3 downstaged with neoadjuvant chemotherapy- were randomized 1:1 to observation (Obs) or adjuvant radiation therapy (RT) at 4 centers, stratified by pN stage (N0, N+) and chemotherapy (neoadjuvant, adjuvant, none). Stoma-sparing image guided intensity modulated RT 50.4 Gy in 28# was prescribed to the cystectomy bed and pelvic nodes. Acute toxicity (≤3 months of RT/randomization) and late toxicity were assessed per protocol using Common Terminology Criteria for Adverse Event v5.0. Patients progressing within 3 or 6 months of randomization were excluded from acute or late toxicity analysis, respectively.The BART trial enrolled 153 patients (Obs = 76, RT = 77). About half (49%) had pN+. Nearly 90% received chemotherapy (70% neoadjuvant; most commonly gemcitabine plus cisplatin). In the RT arm, 63/77 completed RT per protocol with no toxicity-related RT termination. Of the 134 patients analyzable for acute toxicity, no difference was observed in grade 3 (Obs 4.2% vs RT 1.6%, P = .34). Grade 2 effects were higher with RT (17.5% vs 1.1%, P < .001), mainly diarrhea/enteritis or proctitis. Late toxicity was analyzable for 104 patients (Obs = 57, RT = 47) with a median follow-up of 27 months. Grades 3 to 4 toxicity were about 10% (Obs 10.5% vs RT 8.4%, P = .62), and cumulative late grade 2+ toxicity was similar in both groups (17.5% vs 23.3%, P = .27).In the largest trial of adjuvant RT for high-risk urothelial MIBC, severe acute and late toxicity were low and similar with obervation or radiation therapy. The oncological outcomes are awaited.Copyright © 2024 Elsevier Inc. All rights reserved.