卡介苗膀胱灌注预防中、高危非肌层浸润性膀胱癌复发的疗效及安全性  

Efficacy and safety of intravesical instillation of BCG to prevent recurrence of moderate and high-risk non-muscle invasive bladder cancer

作　　者：赵攀 李明东 王昭翔 何盛银 刘孝德[3] 刘嘉铭[1] 林天海[1] 张朋[1] ZHAO Pan;LI Ming-dong;WANG Zhao-xiang;HE Shen-ying;LIU Xiao-de;LIU Jia-ming;LIN Tian-hai;ZHANG Peng(Department of Urology,West China Hospital,Sichuan University,Chengdu 610041;Department of Urology,West China Fourth Hospital,Sichuan University,Chengdu 610041;Department of Urology,Qinghai Provincial Hospital of Chinese Medicine,Xining 810000,China)

机构地区：[1]四川大学华西医院泌尿外科,四川成都610041 [2]四川大学华西第四医院泌尿外科,四川成都610041 [3]青海省中医院泌尿外科,青海西宁810000

出　　处：《现代泌尿外科杂志》2020年第8期702-707,共6页Journal of Modern Urology

基　　金：四川大学华西医院学科卓越发展1·3·5工程(No.ZY2016104)。

摘　　要：目的评价卡介苗对预防中、高危非肌层浸润性膀胱癌患者复发的疗效及安全性。方法回顾性分析2014年6月至2019年10月华西医院收治的215例非肌层浸润性膀胱癌患者的临床资料。其中男性166例,女性49例;平均年龄(64.75±11.45)岁。所有患者均接受标准的经尿道膀胱肿瘤电切术(TURBT),部分患者经历二次电切,所有患者术后均接受卡介苗(BCG)膀胱内灌注治疗。观察并记录灌注前、中、后相关临床指标,采用1年无复发生存率、累计复发率、累计进展率评估BCG灌注治疗的疗效,单因素和Cox回归分析预测膀胱癌患者BCG灌注治疗失败的危险因素。采用CTCAE 5.0将不良反应分为5级,评估BCG灌注的安全性。结果本研究中位随访时间22(1~79)个月,1年无复发生存率89.3%,累计复发率17.7%,平均无复发生存时间(19.45±13.78)个月。单因素分析(P<0.0001)及Cox回归分析(P=0.003)结果均显示膀胱癌复发病史是BCG灌注治疗失败的独立预测因素。170例发生不良反应,其中1、2、3级不良反应分别占62.9%(107/170)、27.1%(46/170)、10.0%(17/170),无4级和5级不良反应发生。16例(7.2%)患者因无法耐受不良反应而停药。结论中高危非肌层浸润性膀胱癌TURBT术后行BCG膀胱内灌注疗效显著,不良反应发生率高,但患者可耐受。膀胱癌复发病史是中高危NMIBC患者BCG灌注治疗失败的独立预测因素。Objective To evaluate the efficacy and safety of intravesical instillation of Bacillus Calmette-Guerin(BCG)to prevent recurrence of moderate and high-risk non-muscle invasive bladder cancer(NMIBC).Methods The clinical data of 215 NMIBC patients treated in West China Hospital during Jun.2014 and Oct.2019 were retrospectively analyzed.The patients included 166 males and 49 females,average age(64.75±11.45)years.All patients underwent standard transurethral resection of bladder tumor(TURBT),some received a second operation,and all received BCG intravesical instillation to prevent recurrence.Relevant clinical parameters before,during and after instillation were collected and analyzed.The efficacy of BCG instillation was evaluated by one-year recurrence-free survival rate,cumulative recurrence rate and cumulative progress rate.The risk factors of BCG instillation failure were predicted with univariate and Cox regression analyses.The adverse reactions were classified into 5 grades according to CTCAE 5.0 to evaluate the safety of BCG instillation.Results During the median follow-up of 22(1-79)months,the 1-year recurrence-free survival rate was 89.3%,cumulative recurrence rate was 17.7%,and average recurrence-free survival was(19.45±13.78)months.Both univariate analysis(P<0.0001)and Cox regression analysis(P=0.003)showed that recurrence history was an independent predictor of BCG instillation failure.Adverse reactions occurred in 170 cases,and grade 1,2 and 3 adverse reactions accounted for 62.9%(107/170),27.1%(46/170)and 10.0%(17/170),respectively,and 16(7.2%)patients discontinued due to intolerable adverse reactions.Conclusion BCG intravesical instillation is effective to prevent recurrence in patients with moderate and high-risk NMIBC after TURBT.The incidence of adverse reactions is high,but most were tolerable.The history of bladder cancer recurrence is an independent predictor of BCG instillation therapy failure.

关 键 词：非肌层浸润性膀胱癌 卡介苗 复发 不良反应 预测因子 

分 类 号：R737.14[医药卫生—肿瘤]