Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.
Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.
Urol Oncol. 2019 Mar;37(3):179.e9-179.e18. doi: 10.1016/j.urolonc.2018.10.019. Epub 2018 Nov 14.
We aimed at this study to test the value of immediate postoperative intravesical epirubicin instillation in intermediate and high-risk non-muscle-invasive bladder cancer patients.
After approval of Institutional Review Board, 260 patients were randomly allocated into 2 groups, including transurethral resection of bladder tumor (TURBT) alone in control group and TURBT plus immediate postoperative epirubicin (50 mg) in test group. Patients were monitored for postoperative complications. Adjuvant instillation therapy was administered according to risk categorization. Patients were followed every 3 months by cystourethroscopy and urine cytology. The primary end points were recurrence, progression, and/or death from cancer.
Of the 260 patients, 236 were eligible and followed for a mean of 29 months. The 2 study groups were comparable regarding perioperative baseline demographic criteria. There was no statistically significant difference between the 2 groups regarding recurrence rate (27.1% vs. 26.2%), interval to first recurrence (16.3 ± 6.6 vs. 16.4 ± 6.4 months) or progression rate to muscle invasion (8.5% vs. 5.9%). Site, size, and number of recurrences were also comparable between the 2 groups. Recurrences and progression-free survival were comparable between the 2 groups (Log-rank P = 0.88 and 0.47, respectively). Postoperative complications were all low-grade according to modified Dindo-Clavian system, with no significant difference in their rate between the 2 groups.
Immediate post-TURBT epirubicin instillation is ineffective in intermediate and high-risk non-muscle-invasive bladder cancer. It neither prolongs time to recurrence and/or progression nor reduces number of recurrences. We advocate strict specification of patient and tumor criteria in which immediate instillation is indicated.
本研究旨在检测即刻膀胱内表柔比星灌注在中高危非肌层浸润性膀胱癌患者中的应用价值。
在获得机构审查委员会批准后，将 260 例患者随机分为两组，对照组仅行经尿道膀胱肿瘤切除术（TURBT），实验组则在 TURBT 术后即刻行膀胱内表柔比星（50mg）灌注。观察术后并发症，根据危险分层进行辅助灌注治疗。通过膀胱镜和尿液细胞学检查每 3 个月对患者进行随访。主要终点为肿瘤复发、进展和/或死亡。
260 例患者中，236 例符合条件并随访平均 29 个月。两组患者在围手术期基线人口统计学特征方面具有可比性。两组患者的复发率（27.1% vs. 26.2%）、首次复发的时间间隔（16.3±6.6 个月 vs. 16.4±6.4 个月）或进展为肌层浸润的比率（8.5% vs. 5.9%）无统计学差异。两组患者的复发部位、大小和数目也相似。两组患者的复发和无进展生存率也相似（Log-rank P=0.88 和 0.47）。根据改良的 Dindo-Clavian 系统，术后并发症均为低级别，两组之间的发生率无显著差异。
即刻 TURBT 后表柔比星灌注对中高危非肌层浸润性膀胱癌无效，既不能延长复发和/或进展时间，也不能减少复发次数。我们主张严格规范即刻灌注适用的患者和肿瘤标准。
