Adverse events of neoadjuvant chemotherapy and immunotherapy for muscle-invasive bladder cancer in the real world and literature review
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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 December 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 rectovaginal 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.
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Key words:
- bladder cancer /
- neoadjuvant chemotherapy /
- immunotherapy /
- adverse events
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表 1 患者基线资料及围术期AE
例(%)，M(Q1，Q3) 特征 联合组(36例) RC组(22例) 年龄/岁 62(34，82) 61.5(46，82) 性别 男 33(91.67) 20(90.91) 女 3(8.33) 2(9.09) 既往卡介苗治疗人数 6(16.67) 3(13.64) 术前病理T分期 T2 21(58.33) 14(63.64) T3 14(38.89) 7(31.82) T4 1(2.78) 1(4.54) AE 至少1项AE 32(88.89) 19(86.36) 至少1项3级AE 5(13.89) 3(13.64) Clavien-Dindo分级评估术后并发症 Clavien-Dindo 0级 0(0) 15(68.18) Clavien-Dindo 1~2级 0(0) 7(31.82) 
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表 2 匹配后联合组和RC组患者临床特征比较
例(%)，M(Q1，Q3) 临床特征 联合组(22例) RC组(22例) P值 性别 1.000 男 20(90.91) 20(90.91) 女 2(9.09) 2(9.09) 年龄/岁 61.5(46，82) 61.5(52，77) 0.510 T分期 0.786 T2 14(63.64) 12(54.55) T3 7(31.82) 10(45.45) T4 1(4.54) 0(0) N分期 0.186 N0 22(100) 20(90.91) N+ 0(0) 2(9.09)
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