Department of Urology, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, California, USA.
Curr Opin Urol. 2024 Nov 1;34(6):489-494. doi: 10.1097/MOU.0000000000001213. Epub 2024 Aug 19.
Several novel therapies approved by the Food and Drug Administration (FDA) and explosion of clinical trials have changed the landscape Bacillus Calmette-Guérin (BCG)-unresponsive nonmuscle invasive bladder cancer (NMIBC). Given the recent advancements in bladder sparing options, the role of radical cystectomy (RC) in BCG-unresponsive NMIBC remains a subject of debate.
All three novel agents currently approved by the FDA for BCG-unresponsive NMIBC have strict indication [carcinoma in situ (CIS)], low response rate, and short response duration. Some promising new agents are awaiting results and/or FDA approval. RC still provides the best oncologic control and acceptable quality of life, and potentially represents the most cost-effective option.
It is an exciting time for the urologic oncology community to see the FDA approvals of some of the novel bladder sparing therapies and expansion of ongoing clinical trials. Yet, RC should still be considered as the gold standard of BCG-unresponsive NMIBC. We also must be cautious and selective in recommending bladder sparing options for patients with BCG-unresponsive NMIBC.
美国食品和药物管理局(FDA)批准的几种新型疗法和临床试验的激增改变了卡介苗(BCG)无反应性非肌肉浸润性膀胱癌(NMIBC)的治疗格局。鉴于目前在保留膀胱方面的进展,根治性膀胱切除术(RC)在 BCG 无反应性 NMIBC 中的作用仍然存在争议。
目前 FDA 批准用于 BCG 无反应性 NMIBC 的三种新型药物均有严格的适应证[原位癌(CIS)]、低反应率和短反应持续时间。一些有前途的新药物正在等待结果和/或 FDA 批准。RC 仍然提供最佳的肿瘤控制和可接受的生活质量,并且可能是最具成本效益的选择。
对于泌尿外科肿瘤学界来说,看到一些新型保留膀胱疗法获得 FDA 批准以及正在进行的临床试验不断扩大,这是一个令人兴奋的时刻。然而,RC 仍应被视为 BCG 无反应性 NMIBC 的金标准。我们在为 BCG 无反应性 NMIBC 患者推荐保留膀胱的方案时也必须谨慎和有选择性。