摘要
目的:探讨真实世界中肌层浸润性膀胱癌(muscle invasive bladder cancer,MIBC)新辅助化免治疗后发生的不良事件(adverse events,AE),评估治疗的安全性.方法:回顾性分析2021年1月-2023年12月在解放军总医院接受过4周期吉西他滨联合顺铂(GC)化疗并联合替雷利珠单抗治疗的MIBC患者,收集各类AE、早期术后并发症(Clavien-Dindo分级)发生情况.结果:36例患者中有32例患者(88.89％)出现至少1项化免药物治疗相关AE,最常见的AE为恶心(19例,52.78％)、中性粒细胞计数减少(16例,44.44％)、食欲减退(16例,44.44％)、疲劳(14 例,38.89％)、呕吐(12 例,33.33％)、瘙痒(10 例,27.78％),5 例患者(13.89％)发生 3 级化免治疗相关的AE.22例接受根治性膀胱切除术的患者术后并发症包括:炎性肠梗阻5例(22.73％)、盆腔积液1例(4.55％),腹腔感染1例(4.55％),直肠阴道瘘1例(4.55％).结论:对于MIBC患者,新辅助化免治疗方案AE发生率较高,但严重AE发生率较低,总体有较高的安全性.
Abstract
Objective:To investigate the adverse events(AEs)occurring after neoadjuvant chemotherapy and immunotherapy in patients with muscle-invasive bladder cancer(MIBC)in the real world and evaluate the safety of the treatment.Methods:A retrospective analysis was conducted on patients with MIBC who received 4 cycles of gemcitabine plus cisplatin(GC)chemotherapy and tislelizumab at PLA General Hospital from January 2021 to De-cember 2023.Various AEs and postoperative complications(Clavien-Dindo grading)were collected.Results:Among the 36 patients,32 patients(88.89％)experienced at least one drug-related adverse event,and nausea(n=19,52.78％),neutropenia(n=16,44.44％),anorexia(n=16,44.44％),fatigue(n=14,38.89％),vomiting(n=12,33.33％),and pruritus(n=10,27.78％)were common.Five patients(13.89％)experienced Grade 3 adverse events related to neoadjuvant therapy.Postoperative complications included inflammatory bowel obstruction(n=5,22.73％),pelvic effusion(n=1,4.55％),abdominal infection(n=1,4.55％),and recto-vaginal fistula(n=1,4.55％)in 22 patients who undergoing radical cystectomy.Conclusion:For MIBC patients,the incidence of AEs associated with neoadjuvant chemotherapy and immunotherapy is relatively high,but the rate of severe AEs is low,indicating an overall high level of safety.
基金项目
国家重点研发计划(2022YFC3602900)
解放军总医院青年自主创新科学基金扶持项目(22QNFC047)
NETL
NSTL
万方数据