5-FU/顺铂联合每日两次放疗 (FCT) 或吉西他滨联合每日一次放疗 (GD) 是保留膀胱治疗肌层浸润性膀胱癌 (MIBC) 的有效放化疗 (CRT) 方案。该试验评估了这些方案并证明了任一方案在 3 年时的疗效。随着进一步的随访，本文报告了长期结果。cT2-4a MIBC 患者被随机分配至 FCT 或 GD。患者接受了经尿道切除术和诱导 CRT 至 40 Gy。完全缓解 (CR) 的患者接受了 64 Gy 的巩固 CRT。其他人则进行了膀胱切除术。给予吉西他滨/顺铂辅助化疗。主要终点是无远处转移（FDM）。此更新的分析报告了 7 年的数据。还评估了毒性和疗效终点，包括膀胱完整无远处转移生存期（BI-DMFS）。从2008年12月至2014年4月，招募了70名患者； 66 例符合分析条件，每组 33 例。符合条件的健在患者的中位随访时间为 9.1 年。 7 年时，FCT 和 GD 的 FDM 分别为 65% 和 73%。 BI-DMFS 分别为 58% (95% CI: 41 - 76) 和 68% (95% CI: 51-84)。事后风险比为 0.75 (95% CI: 0.37-1.55)，显示治疗之间没有差异 (p=0.44)。 7 年总生存率为 48% 和 59%。 FCT 和 GD 分别进行了 4 例和 5 例膀胱切除术。在 FCT 组中，报告了 5 例 (16%)、1 例 (3%) 和 0 例 3、4 和 5 级晚期毒性。在 GD 组中，分别为 7 例（23%）、0 例和 0 例。两种方案在 7 年时均保持较高的 FDM 率。双臂的膀胱切除率较低，总生存率较高。晚期毒性率较低。吉西他滨和每日放疗或基于顺铂的治疗方案都是有效的膀胱保留疗法。版权所有 © 2024。由 Elsevier Inc. 出版。

5-FU/cisplatin and twice-daily radiation (FCT) or gemcitabine and once daily radiation (GD) are effective chemoradiation (CRT) regimens for bladder sparing treatment of muscle-invasive bladder cancer (MIBC). This trial evaluated these regimens and demonstrated efficacy with either regimen at 3 years. With further follow-up, longer term results are reported here.Patients with cT2-4a MIBC were randomized to FCT or GD. Patients had a transurethral resection and induction CRT to 40 Gy. Patients with a complete response (CR) received consolidation CRT to 64 Gy. Others had cystectomy. Adjuvant gemcitabine/cisplatin chemotherapy was administered. The primary endpoint was freedom from distant metastasis (FDM). This updated analysis reports 7-year data. Toxicity and efficacy endpoints, including bladder intact distant metastasis free survival (BI-DMFS) were also assessed.From 12/2008 to 4/2014, 70 patients were enrolled; 66 eligible for analysis, 33 per arm. Median follow-up was 9.1 years for eligible living patients. At 7 years, FDM was 65% and 73% for FCT and GD, respectively. BI-DMFS was 58% (95% CI: 41 - 76) and 68% (95% CI: 51-84), respectively. The post-hoc hazard ratio of 0.75 (95% CI: 0.37-1.55) showed no difference between treatments (p=0.44). Overall survival at 7 years was 48% and 59%. There were 4 and 5 cystectomies performed for FCT and GD, respectively. In the FCT arm, there were 5 (16%), 1 (3%) and 0 grade 3, 4 and 5 late toxicities reported. In the GD arm, there were 7 (23%), 0 and 0.Both regimens maintained high FDM rates at 7 years. Cystectomy rates were low and overall survival rates high on both arms. Late toxicity rates were low. Either gemcitabine and daily radiation or a cisplatin-based regimen are effective bladder sparing therapies.Copyright © 2024. Published by Elsevier Inc.