Department of Urology, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Department of Diagnostic Pathology, Kyoto University Hospital, Kyoto, Japan.
Clin Genitourin Cancer. 2019 Oct;17(5):e1003-e1010. doi: 10.1016/j.clgc.2019.05.028. Epub 2019 May 30.
Non-muscle-invasive bladder cancer (NMIBC) can be treated using transurethral resection (TUR), but high incidence of intravesical recurrence remains a clinical challenge. Single immediate postoperative instillation of chemotherapy (IPIOC) is controversial for NMIBC patients with intermediate recurrence risk. The aim of the present study was to report the efficacy and toxicity of IPIOC, particularly in intermediate-risk NMIBC patients, in the real-world setting.
We retrospectively analyzed 363 consecutive patients with primary NMIBC who underwent radical TUR at Kyoto University Hospital between 2007 and 2016.
In low-risk patients, recurrence-free survival (RFS) was significantly better for IPIOC than non-IPIOC (2-year RFS: 89.3% vs. 59.4%; P = .001). In intermediate-risk patients, IPIOC was associated with significantly longer RFS compared with non-IPIOC (2-year RFS: 85.5% vs. 58.2%; P = .011). IPIOC and bacillus Calmette-Guérin (BCG) were independent predictors for post-TUR recurrence (non-IPIOC vs. IPIOC: hazard ratio [HR], 2.33; 95% confidence interval [CI], 1.14-4.88; P = .02; non-BCG vs. BCG: HR, 2.22; P = .045, 95% CI, 1.02-5.30). In the high-risk group, only BCG was an independent prognostic factor of recurrence in a multivariate Cox proportional hazards model (HR, 2.55; P = .006, 95% CI, 1.32-4.87). There were no significant differences between the BCG-only group and the IPIOC with BCG group in Grade 3 or more local (16 patients [21%] vs. 21 patients [24%]; P = .61) or systemic (3 patients [4%] vs. 6 patients [7%]; P = .40) toxicity rates.
Our study showed the efficacy of IPIOC for the prevention of intravesical recurrence in primary intermediate-risk NMIBC patients regardless of BCG therapy.
非肌层浸润性膀胱癌（NMIBC）可以通过经尿道膀胱肿瘤切除术（TUR）进行治疗，但膀胱内复发的高发生率仍然是一个临床挑战。对于有中等复发风险的 NMIBC 患者，单次即刻术后膀胱内化疗（IPIOC）的应用存在争议。本研究旨在报告 IPIOC 的疗效和毒性，特别是在中危 NMIBC 患者中的疗效和毒性。
我们回顾性分析了 2007 年至 2016 年在京都大学医院接受根治性 TUR 的 363 例初发 NMIBC 连续患者的资料。
在低危患者中，与非 IPIOC 相比，IPIOC 显著改善了无复发生存率（RFS）（2 年 RFS：89.3%比 59.4%；P=0.001）。在中危患者中，与非 IPIOC 相比，IPIOC 显著延长了 RFS（2 年 RFS：85.5%比 58.2%；P=0.011）。IPIOC 和卡介苗（BCG）是 TUR 后复发的独立预测因素（非 IPIOC 比 IPIOC：风险比 [HR]，2.33；95%置信区间 [CI]，1.14-4.88；P=0.02；非 BCG 比 BCG：HR，2.22；P=0.045，95%CI，1.02-5.30）。在高危组中，只有 BCG 是多变量 Cox 比例风险模型中复发的独立预后因素（HR，2.55；P=0.006，95%CI，1.32-4.87）。BCG 组和 IPIOC 加 BCG 组之间，3 级或更高级别的局部（16 例[21%]比 21 例[24%]；P=0.61）或全身（3 例[4%]比 6 例[7%]；P=0.40）毒性发生率无显著差异。
本研究表明，IPIOC 对预防原发性中危 NMIBC 患者的膀胱内复发有效，无论是否使用 BCG 治疗。
