Department of Urology, Dongguk University Ilsan Medical Center, Dongguk University School of Medicine, Goyang, Korea.
Department of Urology, Center for Urologic Cancer, National Cancer Center, Goyang, Korea.
Investig Clin Urol. 2021 Jul;62(4):361-377. doi: 10.4111/icu.20200602. Epub 2021 May 27.
Intravesical bacillus Calmette-Guérin (BCG) immunotherapy has been the gold standard adjuvant treatment for intermediate- and high-risk non-muscle-invasive bladder cancer (NMIBC) after transurethral resection of bladder tumor (TURBT). BCG immunotherapy prevents disease recurrence and progression to muscle-invasive disease following TURBT. Although most patients initially respond well to intravesical BCG, considerable concern has been raised for patients with BCG failure who are refractory or recur in 6 months after their last BCG, which implies 'BCG-unresponsiveness'. Based on current clinical guidelines, early radical cystectomy (RC) is recommended to treat BCG-unresponsive NMIBC. However, due to the high risk of morbidity and mortality of RC and patients' desire to preserve their own bladder, there is a critical unmet need for alternative conservative treatments as bladder-sparing strategies in BCG-unresponsive patients. Trials for effective bladder-sparing treatments are ongoing, and several novel agents have been recently tested in the NMIBC setting. The goal of this review is to introduce and summarize recently reported novel and emerging drugs and ongoing clinical trials for BCG-unresponsive NMIBC.
经尿道膀胱肿瘤切除术 (TURBT) 后,膀胱内卡介苗 (BCG) 免疫疗法已成为中高危非肌肉浸润性膀胱癌 (NMIBC) 的金标准辅助治疗。BCG 免疫疗法可预防 TURBT 后疾病复发和进展为肌层浸润性疾病。尽管大多数患者最初对膀胱内 BCG 反应良好,但对于 BCG 治疗失败的患者,即最后一次 BCG 治疗后 6 个月内出现难治性或复发的患者,仍存在相当大的担忧,这意味着“BCG 无应答”。基于当前的临床指南,建议对 BCG 无应答的 NMIBC 进行早期根治性膀胱切除术 (RC)。然而,由于 RC 的发病率和死亡率高,以及患者保留自身膀胱的愿望,对于 BCG 无应答患者的替代保守治疗(作为保留膀胱的策略)存在着迫切的未满足需求。目前正在进行有效的保留膀胱治疗试验,最近已经在 NMIBC 环境中测试了几种新型药物。本综述的目的是介绍和总结最近报道的用于 BCG 无应答 NMIBC 的新型和新兴药物及正在进行的临床试验。