膀胱保留治疗与根治性膀胱切除术在BCG未响应非肌层浸润性膀胱癌中的长期结局

Long-term outcomes of bladder-sparing therapy vs radical cystectomy in BCG-unresponsive non-muscle-invasive bladder cancer

BJU INTERNATIONAL

影响因子:4.4

分区:医学2区 / 泌尿学与肾脏学2区

发表日期:2025 Feb

作者: Jacob I Taylor, Ashish M Kamat, Michael A O'Donnell, Drupad Annapureddy, Jeffrey Howard, Wei Shen Tan, Ian McElree, Facundo Davaro, Kendrick Yim, Stephen Harrington, Elizabeth Dyer, Anna J Black, Pratik Kanabur, Mathieu Roumiguié, Seth Lerner, Peter C Black, Jay D Raman, Mark A Preston, Gary Steinberg, William Huang, Roger Li, Vignesh T Packiam, Solomon L Woldu, Yair Lotan

DOI: 10.1111/bju.16509

摘要

本研究旨在量化膀胱保留治疗（BST）在BCG未响应非肌层浸润性膀胱癌（NMIBC）患者中的肿瘤学风险，并与预设的根治性膀胱切除术（RC）进行比较。研究从10个国际站点的回顾性队列中收集了符合美国食品药品监督管理局（FDA）标准的BCG未响应NMIBC患者的预先设定数据要素。获伦理委员会批准后，纳入具有BCG未响应且符合FDA标准的患者。收集了接受预先RC或BST后的肿瘤学结局。BST方案包括再次手术或仅监测、重复BCG、膀胱内化疗、全身免疫治疗及临床试验。在578名患者中，28%接受预先RC，72%接受BST。中位（四分位间距）随访时间为50（20-69）个月。两组在无转移生存率、癌症特异性生存率或总生存率方面无统计学差异。在BST组中，37%和52%的患者在12和24个月时发生高等级复发，12和24个月时进展为肌层浸润性膀胱癌（MIBC）的比例分别为7%和13%。在BST组中，31.7%的患者接受了RC，淋巴结病变发现率为13%，而在预先RC组中为4%（P=0.030）。在特定患者队列中，初始BST在中期内提供了与预先RC相当的生存结局。复发和进展率随着时间增加，尤其是在接受额外BST治疗的患者中。

Abstract

To quantify the oncological risks of bladder-sparing therapy (BST) in patients with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) compared to upfront radical cystectomy (RC).Pre-specified data elements were collected from retrospective cohorts of patients with BCG-unresponsive NMIBC from 10 international sites. After Institutional Review Board approval, patients were included if they had BCG-unresponsive NMIBC meeting United States Food and Drug Administration criteria. Oncological outcomes were collected following upfront RC or BST. BST regimens included re-resection or surveillance only, repeat BCG, intravesical chemotherapy, systemic immunotherapy, and clinical trials.Among 578 patients, 28% underwent upfront RC and 72% received BST. The median (interquartile range) follow-up was 50 (20-69) months. There were no statistically significant differences in metastasis-free survival, cancer-specific survival, or overall survival between treatment groups. In the BST group, high-grade recurrence rates were 37% and 52% at 12 and 24 months and progression to MIBC was observed in 7% and 13% at 12 and 24 months, respectively. RC was performed in 31.7% in the BST group and nodal disease was found in 13% compared with 4% in upfront RC (P = 0.030).In a selected cohort of patients, initial BST offers comparable survival outcomes to upfront RC in the intermediate term. Rates of recurrence and progression increase over time especially in patients treated with additional lines of BST.