Department of Urology, Hirosaki University Graduate School of Medicine, 5 Zaifu-chou, Hirosaki, 036-8562, Japan.
Department of Advanced Transplant and Regenerative Medicine, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.
Med Oncol. 2018 Feb 26;35(4):41. doi: 10.1007/s12032-018-1102-y.
The clinical benefits of bacillus Calmette-Guérin (BCG) therapy for the management of upper urinary tract carcinoma in situ (CIS) remain unclear. We aimed to compare the efficacy and safety of BCG therapy for upper urinary tract CIS with those of radical nephroureterectomy (RNU). Of 490 patients with upper urinary tract carcinoma, we retrospectively reviewed the post-treatment course of 58 patients with upper urinary tract CIS who underwent either RNU (RNU group) or BCG therapy (BCG group). Efficacy and safety were compared between the RNU and BCG groups. Inverse probability treatment-weighted (IPTW)-adjusted multivariate Cox regression analysis was performed to identify the influence of BCG therapy on prognosis. The RNU and BCG groups included 20 and 38 patients, respectively. No significant difference was found in patients' background, including age, sex, and performance status, between the groups. The reason underlying the selection of BCG therapy was bilateral CIS of the upper urinary tract (50%), solitary kidney (26%), unwillingness to undergo RNU (13%), and ineligibility for surgery (11%). The cytology became negative in 30 (79%) out of 38 patients after a 6-week course of BCG therapy, and 17 (57%) out of 30 patients remained negative. BCG-related adverse events (AEs) were observed in 92% of patients. The most common AE was cystitis (76%), followed by fever (50%). No significant differences were found in the progression-free, cancer-specific, and overall survivals between the RNU and BCG groups. IPTW-adjusted multivariate analysis revealed that BCG therapy did not worsen the prognosis of these patients. The limitations of our study were its retrospective design and small sample size. In conclusion, BCG therapy for upper urinary tract CIS might be a useful alternative for patient ineligible for RNU under careful observation for AEs.
卡介苗（BCG）治疗在上尿路原位癌（CIS）中的临床获益尚不清楚。我们旨在比较 BCG 治疗与根治性肾输尿管切除术（RNU）在上尿路 CIS 中的疗效和安全性。在 490 例上尿路癌患者中，我们回顾性分析了 58 例接受 RNU（RNU 组）或 BCG 治疗（BCG 组）的上尿路 CIS 患者的治疗后过程。比较 RNU 组和 BCG 组的疗效和安全性。采用逆概率治疗加权（IPTW）调整的多变量 Cox 回归分析，确定 BCG 治疗对预后的影响。RNU 组和 BCG 组分别包括 20 例和 38 例患者。两组患者的背景，包括年龄、性别和表现状态，无显著差异。选择 BCG 治疗的原因是上尿路 CIS 双侧（50%）、孤立肾（26%）、不愿接受 RNU（13%）和手术不合格（11%）。38 例患者中，30 例（79%）在 6 周的 BCG 治疗后细胞学转为阴性，其中 17 例（57%）持续阴性。92%的患者出现 BCG 相关不良反应（AE）。最常见的 AE 是膀胱炎（76%），其次是发热（50%）。RNU 组和 BCG 组在无进展生存期、癌症特异性生存期和总生存期方面无显著差异。IPTW 调整的多变量分析显示，BCG 治疗并未恶化这些患者的预后。本研究的局限性在于其回顾性设计和样本量小。总之，在上尿路 CIS 患者不适合 RNU 治疗的情况下，BCG 治疗可能是一种有用的替代方法，需要仔细观察 AE。
