每天两次辐射的膀胱保存的长期结果，以及5-氟尿嘧啶/顺铂或每日辐射以及用于肌肉侵入性膀胱癌症的吉西他滨NRG/RTOG的报告：NRG/RTOG 0712：一项随机的2期2期试验
Long-Term Results of Bladder Preservation With Twice-Daily Radiation Plus 5-Fluorouracil/Cisplatin or Daily Radiation Plus Gemcitabine for Muscle-Invasive Bladder Cancer-Updated Report of NRG/RTOG 0712: A Randomized Phase 2 Trial
影响因子:6.50000
分区:医学1区 Top / 肿瘤学2区 核医学2区
发表日期:2025 Jan 01
作者:
John J Coen, Joseph P Rodgers, Philip J Saylor, Cheryl T Lee, Chin-Lee Wu, William Parker, Tim Lautenschlaeger, Anthony L Zietman, Jason Efstathiou, Ashesh B Jani, Omer Kucuk, Luis Souhami, Stephanie L Pugh, Howard M Sandler, William U Shipley
摘要
为了治疗肌肉侵入性膀胱癌的膀胱疗法治疗，每天两次辐射（FCT）或吉西他滨加每日辐射（GD）的5-氟尿嘧啶/顺铂是有效的化学辐射（CRT）方案。该试验评估了这些方案，并在3年时证明了两种方案的功效。随着进一步的随访，这里报告了长期的结果。CT2至CT4A肌肉侵入性膀胱癌的患者被随机分为FCT或GD。患者对40 Gy进行了尿道切除术和诱导CRT。具有完全反应的患者将CRT固结至64 Gy。其他人进行了膀胱切除术。辅助吉西他滨/顺铂化疗。主要终点是摆脱遥远转移（FDM）的自由。此更新的分析报告了7年数据。还评估了毒性和功效终点，包括膀胱直立转移生存期（BI-DMF）。从2008年12月到2014年4月，招募了70名患者；有66条有资格进行分析，每只手臂33。合格活着的患者的中位随访时间为9。1年。在7年时，FDM分别为FCT和GD，分别为73％。膀胱直立的无转移生存率分别为58％（95％CI，41-76）和68％（95％CI，51-84）。 HOCARD后比率为0.75（95％CI，0.37-1.55）显示治疗之间没有差异（p = .44）。 7年的总生存率为48％和59％。 FCT和GD分别进行了4个和5个膀胱切除术。在FCT臂中，分别报告了5（16％），1（3％）和0级3、4和5级晚期毒性。在GD臂中，分别报告了7（23％），0和0级3、4和5级晚期毒性。在7年时，双方方案的FDM率很高。膀胱切除率较低，两臂的总生存率均高。晚期毒性率很低。吉西他滨和每日辐射或基于顺铂的方案都是有效的膀胱疗法。
Abstract
For bladder-sparing treatment of muscle-invasive bladder cancer, 5-fluorouracil/cisplatin with twice-daily radiation (FCT) or gemcitabine plus daily radiation (GD) are effective chemoradiation (CRT) regimens. 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 to cT4a muscle-invasive bladder cancer were randomized to FCT or GD. Patients had a transurethral resection and induction CRT to 40 Gy. Patients with a complete response 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 December 2008 to April 2014, 70 patients were enrolled; 66 were 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. Bladder-intact distant metastasis-free survival 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 = .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, respectively. In the GD arm, there were 7 (23%), 0, and 0 grade 3, 4, and 5 late toxicities reported, respectively.Both regimens maintained high FDM rates at 7 years. Cystectomy rates were low and overall survival rates were high on both arms. Late toxicity rates were low. Either gemcitabine and daily radiation or a cisplatin-based regimen are effective bladder-sparing therapies.