Department of Urology, Haseki Training and Research Hospital, Istanbul, Turkey.
Urologia. 2023 Nov;90(4):631-635. doi: 10.1177/03915603231189022. Epub 2023 Jul 20.
Some patients with high-risk non-muscle-invasive bladder cancer (NMIBC) are unable to receive adequate BCG instillations due to intolerance. In this study we aimed to investigate the efficacy and tolerability of hyperthermic intravesical chemotherapy (HIVEC®) treatment using Mitomycin C (MMC) in BCG-intolerant NMIBC patients.
Retrospectively collected data from a total of 22 high-risk papillary NMIBC patients who received adjuvant HIVEC therapy for BCG intolerance were analyzed. The primary outcomes of the study were recurrence-free survival (RFS), time to recurrence, progression-free survival (PFS), and time to progression following initial TURB. Detection of histologically confirmed urothelial carcinoma during follow-up was considered as recurrence, while detection of muscle-invasive disease was defined as progression. The secondary outcome was adverse events of HIVEC treatment.
The median follow-up was 32.2 (IQR: 17.8-42.8) months. The RFS and PFS rates were 81.8% and 95.4%, respectively. The mean time to tumor recurrence and progression was 29.2 ± 14.3 and 16.7 months, respectively. Adverse events occurred in 50% of patients, and 95% of adverse events were mild to moderate.
This study demonstrated that adjuvant HIVEC with MMC is an effective and safe alternative bladder sparing treatment in BCG intolerant high risk papillary NMIBC patients.
一些高危非肌肉浸润性膀胱癌(NMIBC)患者由于不耐受而无法接受足够的卡介苗灌注治疗。本研究旨在探讨热膀胱内化疗(HIVEC®)联合丝裂霉素 C(MMC)治疗卡介苗不耐受高危 NMIBC 患者的疗效和耐受性。
回顾性分析了 22 例因卡介苗不耐受而接受辅助 HIVEC 治疗的高危乳头状 NMIBC 患者的数据。研究的主要结局是无复发生存率(RFS)、复发时间、无进展生存率(PFS)和初始 TURB 后进展时间。随访期间组织学证实的尿路上皮癌的检出被认为是复发,而肌肉浸润性疾病的检出被定义为进展。次要结局是 HIVEC 治疗的不良反应。
中位随访时间为 32.2(IQR:17.8-42.8)个月。RFS 和 PFS 率分别为 81.8%和 95.4%。肿瘤复发和进展的平均时间分别为 29.2±14.3 和 16.7 个月。50%的患者发生不良反应,95%的不良反应为轻至中度。
本研究表明,MMC 辅助 HIVEC 是卡介苗不耐受高危乳头状 NMIBC 患者膀胱保留治疗的一种有效且安全的替代方法。