中、高危非肌层浸润性膀胱癌卡介苗膀胱灌注的疗效与不良反应分析

Efficacy and adverse reactions of Bacillus Calmette-Guérin intravesical instillation in moderate-to-high risk non-muscle-invasive bladder cancer

目的探究非肌层浸润性膀胱癌(NMIBC)患者卡介苗(BCG)膀胱灌注治疗的疗效、预后因素及不良反应。方法回顾性分析2014年4月至2021年4月我院泌尿外科收治的147例经尿道膀胱肿瘤切除(TURBT)术后接受BCG膀胱灌注的中、高危NMIBC患者的临床资料。采用累积复发率、累积进展率、1年无复发生存率、平均无复发生存时间及平均无进展生存时间评估BCG膀胱灌注治疗的疗效。采用单因素和多因素Cox回归分析探究BCG膀胱灌注治疗后肿瘤复发的危险因素。采用不良反应事件评价标准(CTCAE)5.0版评估不良反应发生情况。结果147例患者中男128例(87.1%)、女19例(12.9%),中位随访时间为25(4~85)个月,年龄为39~98(66.5±10.6)岁。1年无复发生存率为81.9%(104/127),累积复发率为21.8%(32/147),平均无复发生存时间为49.49个月;累积进展率为9.5%(14/147),平均无进展生存时间为56.81个月。单因素分析显示,膀胱癌复发史和病理分期与BCG膀胱灌注治疗后肿瘤复发相关(P=0.004、0.069)。多因素Cox回归分析显示,膀胱癌复发史(HR=2.081,95%CI 1.048~4.130,P=0.036)是BCG膀胱灌注治疗后肿瘤复发的独立预测因素。86.6%(110/127)的患者在BCG膀胱灌注治疗过程中出现不良反应,1级不良反应38例(29.9%),2级不良反应69例(54.3%),3级不良反应3例(2.4%),无4、5级不良反应患者。9.5%(14/147)的患者因不耐受不良反应而中断治疗。结论中、高危NMIBC患者TURBT术后BCG膀胱灌注治疗效果显著,膀胱癌复发史是患者BCG膀胱灌注治疗后肿瘤复发的独立预测因素。患者在BCG膀胱灌注治疗过程中会发生一定不良反应,但大部分可耐受。

Objective To investigate the efficacy,prognostic factors and adverse reactions of intravesical instillation with Bacillus Calmette-Guérin(BCG)in patients with non-muscle-invasive bladder cancer(NMIBC).Methods The clinical data of 147 patients with moderate-to-high risk NMIBC who received BCG intravesical instillation after transurethral resection of bladder tumor(TURBT)in the Department of Urology of our hospital from Apr.2014 to Apr.2021 were retrospectively analyzed.Cumulative recurrence rate,cumulative progression rate,1-year relapsefree survival rate,mean relapse-free time and mean progression-free survival time were used to evaluate the efficacy of BCG intravesical instillation,univariate and multivariate Cox regression analyses were used to explore the relapserelated risk factors,and Common Terminology Criteria for Adverse Events(CTCAE)Vesion 5.0 was used to evaluate adverse reactions.Results There were a total of 147 patients including 128 males(87.1%)and 19 females(12.9%),with a median follow-up time of 25(4-85)months and an age of 39-98(66.5±10.6)years.The 1-year relapsefree survival rate was 81.9%(104/127),the cumulative recurrence rate was 21.8%(32/147),and the mean relapsefree survival time was 49.49 months;the cumulative progression rate was 9.5%(14/147),and the mean progressionfree survival time was 56.81 months.Univariate analysis showed that relapse history(P=0.004)and pathological stage(P=0.069)of bladder cancer were correlated with tumor relapse.Multivariate Cox regression analysis showed that the relapse history of bladder cancer(hazard ratio[HR]=2.081,95%confidence interval[CI]1.048-4.130,P=0.036)was an independent predictor of cancer relapse after BCG intravesical instillation.Adverse reactions occurred in 86.6%(110/127)patients during BCG intravesical instillation,including grade 1 adverse reactions in 38 cases(29.9%),grade 2 adverse reactions in 69 cases(54.3%),and grade 3 adverse reactions in 3 cases(2.4%),and there were no grade 4 or 5 adverse reactions.There were 9.5%(14/147)patients who discontinued treatment due to intolerance of adverse reactions.Conclusion Intravesical instillation with BCG after TURBT is effective in patients with moderate-to-high risk of NMIBC,and relapse history of bladder cancer is an independent predictor for tumor relapse.Some adverse reactions may occur in patients during BCG intravesical instillation,but most of them can be tolerated.