肌层浸润性膀胱癌新辅助化疗联合免疫治疗的安全性及有效性:101例分析  

Safety and efficacy of neoadjuvant chemotherapy combined with immunotherapy in 101 patients with muscle-invasive bladder cancer

作　　者：甘超胜 李涛[1,2] 樊俊杰[1,3] 蒋樟栋 汪国经 许珂 康启源 周杨青青 杜岳峰 范晋海[1] 李磊[1] 贺大林[1] 吴开杰[1] GAN Chaosheng;LI Tao;FAN Junjie;JIANG Zhangdong;WANG Guojing;XU Ke;KANG Qiyuan;ZHOU Yangqingqing;DU Yuefeng;FAN Jinhai;LI Lei;HE Dalin;WU Kaijie(Department of Urology,The First Affiliated Hospital of Xi'an Jiaotong University,Xi'an 710061;Department of Urology,Xi'an No.1 Hospital,Xi'an 710001;Department of Urology,Baoji Central Hospital,Baoji 721008;Department of Oncology,The First Affiliated Hospital of Xi'an Jiaotong University,Xi'an 710061,China)

机构地区：[1]西安交通大学第一附属医院泌尿外科,陕西西安710061 [2]西安市第一医院泌尿外科,陕西西安710001 [3]陕西省宝鸡市中心医院泌尿外科,陕西宝鸡721008 [4]西安交通大学第一附属医院肿瘤科,陕西西安710061

出　　处：《现代泌尿外科杂志》2024年第9期790-796,共7页Journal of Modern Urology

基　　金：白求恩·泌尿肿瘤专项研究基金项目(No.MNZL202010)。

摘　　要：目的探索肌层浸润性膀胱癌(MIBC)根治性膀胱全切联合淋巴结清扫术(RC-PLND)前行新辅助化疗(NAC)或联合免疫治疗的安全性和有效性,为临床提供参考。方法回顾性分析2019年1月—2023年12月于西安交通大学第一附属医院泌尿外科行包含NAC的新辅助治疗及RC-PLND的101例MIBC患者的临床资料。其中71例(70.3%)患者根治术前接受NAC(NAC组),30例(29.7%)患者术前接受NAC联合免疫治疗(NAC联合免疫治疗组),比较两组患者的基线资料、疗效指标和新辅助治疗期间的不良反应。应用logistic回归分析探索术后发生病理完全缓解(pCR)及病理部分缓解(pPR)的独立预测因子。结果两组患者之间基线特征相似,差异无统计学意义(P>0.05),但术前接受NAC组患者中肿瘤数量多发占比显著较NAC联合免疫治疗组高(69.0%vs.46.7%,P=0.034)。相较NAC组,NAC联合免疫治疗组可以显著提高病理降期率及pPR率(60.6%vs.83.3%,P=0.026;45.1%vs.70.0%,P=0.022)。虽然NAC联合免疫治疗可以有效地提高术后pCR率,但两组差异无统计学意义(53.3%vs.33.8%,P=0.067)。logistic回归分析结果显示临床T分期、肿瘤直径是MIBC患者行新辅助治疗后pCR和pPR的独立预测因子(P<0.05)。此外,两组患者新辅助治疗期间最常见的不良反应为贫血、白细胞计数下降及恶心、呕吐,但级别多为1~2级,对症治疗后均缓解。结论MIBC患者行RC-PLND术前NAC联合免疫治疗可以提高病理降期率、pPR及pCR,并不会增加不良反应发生率,具有良好的有效性和安全性。Objective To explore the safety and efficacy of neoadjuvant chemotherapy(NAC)combined with immunotherapy before radical cystectomy plus pelvic lymph nodes dissection(RC-PLND)for muscle-invasive bladder cancer(MIBC).Methods The clinical data of 101 patients with MIBC who underwent neoadjuvant therapy followed by RC-PLND in the Department of Urology,the First Affiliated Hospital of Xi'an Jiaotong University during Jan.2019 and Dec.2023 were retrospectively analyzed,including 71 patients(70.3%)who received NAC(NAC group)and 30(29.7%)who received NAC combined with immunotherapy(NAC combine immunotherapy group).The clinical and pathological data and adverse events during neoadjuvant therapy were compared.Logistic regression analysis was used to explore the independent predictors of pathological complete response(pCR)and pathological partial response(pPR).Results There were no significant differences in the baseline data between the two groups(P>0.05).However,the proportion of multiple tumors in patients receiving NAC before surgery was significantly higher than that in the NAC combined immunotherapy group(69.0%vs.46.7%,P=0.034).Compared with NAC group,NAC combined with immunotherapy group had significantly improved rate of pathological downstaging and pPR(60.6%vs.83.3%,P=0.026;45.1%vs.70.0%,P=0.022).Furthermore,the rate of pCR in patients undergoing NAC combined immunotherapy was higher than those undergoing NAC,but the difference was not significant(53.3%vs.33.8%,P=0.067).Logistic regression analysis revealed that clinical T-stage and tumor diameter were independent predictors of pCR and pPR(P<0.05).In addition,the most common adverse events during neoadjuvant therapy were anemia,decreased white blood cells,nausea,and vomiting,but most of them were grade 1—2 and could be relieved through symptomatic treatment.Conclusion NAC combined with immunotherapy is safe and effective,which can improve the rate of pathological downstaging,pPR and pCR,without increasing the incidence of adverse reactions.

关 键 词：膀胱癌 根治性膀胱全切术 新辅助化疗 免疫治疗 安全性 病理反应 

分 类 号：R737.14[医药卫生—肿瘤]