新辅助化疗及联合免疫治疗在肌层浸润性膀胱癌中的疗效分析:单中心真实世界回顾性研究
Efficacy of neoadjuvant chemotherapy and combined immunotherapy in muscle-invasive bladder cancer:a single-center real-world retrospective study
周明 1杨潇 1曹强 1蔡令凯 1庄俊涛 1孙焕友 1吴启开 1于浩 1李鹏超 1吕强1
作者信息
- 1. 南京医科大学第一附属医院江苏省人民医院泌尿外科(南京,210029)
- 折叠
摘要
目的:探讨膀胱癌化疗联合免疫治疗的新辅助方案治疗肌层浸润性膀胱癌(muscle-invasive bladder cancer,MIBC)患者的疗效和安全性.方法:收集分析2018年1月-2023年3月南京医科大学第一附属医院泌尿外科收治的共56例MIBC患者的临床资料.根据新辅助治疗方案的不同将患者分为化疗组(34例)与联合组(22例),化疗组使用吉西他滨联合顺铂新辅助化疗,联合组在此化疗基础上加用免疫检查点抑制剂替雷利珠单抗200 mg或特瑞普利单抗240 mg.比较2组患者的病理降期率、病理完全缓解率及中短期不良反应发生率等相关指标.结果:联合组中12例(54.5％)患者获得了病理完全缓解(ypT0)、5例(22.7％)患者部分缓解(ypT1/Ta/Tis),病理降期率为77.3％,病理完全缓解率为54.5％;化疗组中8例(23.5％)患者获得了病理完全缓解、6例(17.6％)患者部分缓解,病理降期率为41.2％,病理完全缓解率为23.5％;2组比较差异有统计学意义(P＜0.05).联合组亚组间的病理降期率及病理完全缓解率差异无统计学意义(P＞0.05).2组患者均未发生严重过敏反应和导致患者死亡的严重不良事件,未出现4级不良事件.联合组3级不良事件发生率高于化疗组(45.6％vs 35.3％),但差异无统计学意义(P＞0.05).结论:吉西他滨、顺铂化疗联合免疫治疗的新辅助治疗方案可明显提高患者的病理降期率和病理完全缓解率,且不明显增加中短期3级不良事件发生率.
Abstract
Objective:To investigate the efficacy and safety of the neoadjuvant regimen of bladder cancer chemotherapy combined with immunotherapy in the treatment of patients with muscle-invasive bladder cancer(MI-BC).Methods:Clinical data of a total of 56 MIBC patients admitted to First Affiliated Hospital of Nanjing Medi-cal University were collected and analyzed.The patients were divided into two groups according to the different neoadjuvant treatment regimens;the chemotherapy group used gemcitabine combined with cisplatin,and the com-bination group added an immune checkpoint blocker on the basis of this chemotherapy.The pathological down-stage rate,pathological complete remission rate and short-to-medium term adverse reaction rate and other related indexes of the two groups were compared.Results:In the combination group,12 patients achieved pathological complete remission(ypT0)(54.5％),5 patients(22.7％)partial remission(ypT1),with a pathological downstag-ing rate of 77.3％and a pathological complete remission rate of 54.5％,whereas in the chemotherapy group,8 patients(23.5％)achieved complete remission,6 patients(17.6％)partial remission,with a pathological down-staging rate of 41.2％,and the pathological complete remission rate was 23.5％,with statistical differences be-tween the two groups(P＜0.05),There was no statistically significant difference in the rate of pathological down-staging or pathological complete remission between subgroups of the combined group(P＞0.05).No serious aller-gic reactions or adverse events leading to patient's death occurred in the two groups,and there were no grade 4 ad-verse events.The rate of grade 3 adverse events in the combination group was 45.6％,higher than that in the chemotherapy group(35.3％),but there was no statistically significant difference(P＞0.05).Conclusion:The neoadjuvant chemotherapy regimen of gemcitabine and cisplatin chemotherapy combined with immunotherapy can significantly increase the pathological downstage rate and pathological complete remission rate of patients,but does not significantly increase the incidence of short-to-medium term grade 3 adverse events,which can be safely applied.
关键词
膀胱癌/新辅助化疗/免疫治疗/肌层浸润性膀胱癌Key words
bladder cancer/neoadjuvant chemotherapy/immunotherapy/muscle-invasive bladder cancer引用本文复制引用
基金项目
国家自然科学基金(82072832)
国家自然科学基金(82273152)
江苏省人民医院临床能力提升工程项目(JSPH-MC-2021-15)
江苏省人民医院临床能力提升工程项目(JSPH-MA-2022-5)
出版年
2024
NETL
NSTL
万方数据