膀胱辅助放射治疗（BART）：一项III期多中心随机对照试验的急性和晚期毒性

Bladder Adjuvant Radiation Therapy (BART): Acute and Late Toxicity From a Phase III Multicenter Randomized Controlled Trial.

作者信息

Murthy Vedang, Maitre Priyamvada, Bakshi Ganesh, Pal Mahendra, Singh Maneesh, Sharma Rakesh, Gudipudi Duleep, Pujari Lincoln, Pandey Himanshu, Bandekar Bhavesh, Joseph Deepa, Krishnatry Rahul, Phurailatpam Reena, Kannan Sadhana, Arora Amandeep, Misra Ankit, Joshi Amit, Noronha Vanita, Prabhash Kumar, Menon Santosh, Prakash Gagan

机构信息

Department of Radiation Oncology, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, India.

出版信息

Int J Radiat Oncol Biol Phys. 2025 Mar 1;121(3):728-736. doi: 10.1016/j.ijrobp.2024.09.040. Epub 2024 Sep 29.

DOI:10.1016/j.ijrobp.2024.09.040

PMID:39353477

Abstract

PURPOSE

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).

METHODS AND MATERIALS

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.

RESULTS

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).

CONCLUSIONS

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.

摘要

目的

报告在高危肌层浸润性膀胱癌（MIBC）根治性膀胱切除术后进行膀胱辅助放疗（BART）的多中心III期随机试验中的毒性反应。

方法和材料

根治性膀胱切除术后具有≥1项高危特征（pT3 - 4、pN1 - 3、淋巴结检出数<10、切缘阳性或经新辅助化疗后降期至≥cT3）的非转移性尿路上皮MIBC患者，在4个中心按1:1随机分为观察组（Obs）或辅助放疗组（RT），按pN分期（N0、N+）和化疗情况（新辅助化疗、辅助化疗、无化疗）分层。对膀胱切除床和盆腔淋巴结进行造口保留影像引导调强放疗，剂量为50.4 Gy，分28次照射。按照不良事件通用术语标准v5.0，依据方案评估急性毒性（放疗/随机分组后≤3个月）和晚期毒性。随机分组后3个月内或6个月内进展的患者分别被排除在急性或晚期毒性分析之外。

结果

BART试验纳入了153例患者（观察组 = 76例，放疗组 = 77例）。约一半（49%）患者为pN+。近90%的患者接受了化疗（70%为新辅助化疗；最常用的是吉西他滨加顺铂）。在放疗组中，63/77例患者按方案完成了放疗，无因毒性反应导致放疗终止的情况。在可分析急性毒性的134例患者中，3级毒性反应无差异（观察组4.2% vs放疗组1.6%，P = 0.34）。放疗组2级反应更高（17.5% vs 1.1%，P < 0.001），主要为腹泻/肠炎或直肠炎。对中位随访27个月的104例患者（观察组 = 57例，放疗组 = 47例）分析晚期毒性。3 - 4级毒性反应约为10%（观察组10.5% vs放疗组8.4%，P = 0.62），两组累积晚期2级及以上毒性反应相似（17.5% vs 23.3%，P = 0.27）。