Bladder Adjuvant Radiotherapy: Phase III Multicenter Randomized Controlled Trial of Adjuvant Radiotherapy or Observation for Postcystectomy Muscle-Invasive Bladder Cancer.

Methods

Patients with nonmetastatic urothelial MIBC at high risk after RC (any one of: T3-4, N1-3, margin positive, ≤10 nodes dissected) were randomly assigned 1:1 to adjuvant RT or observation (Obs), stratified by nodal involvement (yes/no) and chemotherapy (neoadjuvant/adjuvant/none).

在根治性膀胱切除术后被判定为高危的非转移性尿路上皮肌层浸润性膀胱癌患者（满足以下任一条件：T3-4，N1-3，切缘阳性，≤10个淋巴结被切除）被随机分配为1:1接受辅助放疗或观察，根据淋巴结受累情况（是/否）和化疗情况（新辅助/辅助/无）进行分层。

Stoma-sparing IG-IMRT 50.4Gy in 28 fractions was prescribed to the cystectomy bed and pelvic nodes.

为膀胱切除术床和盆腔淋巴结制定了无造口的IG-IMRT 50.4 Gy，分28次照射。

The primary end point was 2-year locoregional recurrence-free survival (LRFS), and the secondary end points were disease-free survival (DFS), bladder cancer-specific survival (BCSS), and overall survival(OS).

主要终点是2年无局部区域复发生存（LRFS），次要终点包括无病生存（DFS）、膀胱癌特异性生存（BCSS）和总生存（OS）。

Results

From June 2016 to May 2024, 153 patients were randomly assigned (Obs = 76, RT = 77), with 62% and 41% of patients having pT3-T4 and pN+ stages, respectively.

2016年6月至2024年5月期间，153名患者被随机分配（观察组76人，放疗组77人），其中62%的患者为pT3-T4期，41%的患者为pN+期。

Over 90% of the patients received systemic chemotherapy (71% neoadjuvant and 20% adjuvant), and none received immunotherapy.

超过90%的患者接受了全身化疗（71%为新辅助化疗，20%为辅助化疗），没有患者接受免疫治疗。

After a median follow-up of 47 months, the 2-year LRFS was significantly higher with adjuvant RT versus observation (87.1% v 76.0%, hazard ratio[HR], 0.43 [95% CI, 0.20 to 0.96], P = .04).

中位随访47个月后，与观察组相比，辅助放疗组的2年局部复发无病生存率显著更高（87.1%对比76.0%，风险比[HR]为0.43 [95% 置信区间，0.20至0.96]，P = .04）。

The DFS was 71.6% versus 58.7% (HR, 0.62 [95% CI, 0.36 to 1.05]), BCSS was 79.6% versus 65.0% (HR, 0.59 [95% CI, 0.33 to 1.10]), and OS was 70.4% versus 57.4% (HR, 0.78 [95% CI, 0.49 to 1.26]) for RT and Obs, respectively.

无病生存率(DFS)为71.6%对比58.7%（HR，0.62 [95% 置信区间，0.36至1.05]），乳腺癌特异性生存率(BCSS)为79.6%对比65.0%（HR，0.59 [95% 置信区间，0.33至1.10]），总生存(OS)为70.4%对比57.4%（HR，0.78 [95% 置信区间，0.49至1.26]），分别对应放疗组和观察组。

Conclusions

Adjuvant pelvic IMRT after radical cystectomy and perioperative chemotherapy suggests an improvement in locoregional control in patients with high risk urothelial MIBC with no additional severe toxicity.

在根治性膀胱切除术和围手术期化疗后进行辅助性盆腔IMRT，似乎可以改善高风险尿路上皮MIBC患者的局部区域控制，且没有增加严重的毒性。