免疫检查点抑制剂治疗43例复发性、持续性、转移性宫颈鳞状细胞癌的疗效及安全性

Efficacy and Safety of Immune Checkpoint Inhibitors in Treatment of 43 Cases with Recurrent,Persistent and Metastatic Cervical Squamous Cell Carcinoma

[目的]评估免疫检查点抑制剂在复发性、持续性、转移性宫颈鳞状细胞癌治疗中的疗效及安全性。[方法]回顾性分析2020年1月至2023年8月期间在中国医学科学院肿瘤医院、北京市朝阳区桓兴肿瘤医院及天津石氏医院43例复发性、持续性、转移性宫颈鳞状细胞癌患者应用免疫检查点抑制剂治疗的临床资料,根据CTCAE 5.0标准评估不良反应,以及根据RECIST 1.1标准评估治疗疗效。[结果]43例患者中位年龄58岁(26~73岁),中位治疗4个周期(1~21个周期),随访1~52个月。客观缓解率为39.5%,疾病控制率为79.1%,中位无进展生存时间为13个月,中位生存时间为32个月。常见不良反应包括白细胞减少(48.8%)、胃肠道反应(32.6%)、血小板减少(18.6%)、瘙痒皮疹(16.3%)、肝功能不全(14.0%)。≥3级不良反应发生率为62.8%,包括白细胞减少、血小板减少、胃肠道反应、瘙痒皮疹、甲状腺功能减退、甲状腺功能亢进、心肌炎、肺炎等。1例因不良反应终止治疗,1例并发阴道尿道瘘,1例因感染并发症死亡。[结论]免疫检查点抑制剂在复发性、持续性、转移性宫颈鳞状细胞癌治疗中展现出了一定的疗效。然而也需要高度关注其可能带来的严重不良反应。

[Objective]To investigate the efficacy and safety of immune checkpoint inhibitors(ICIs)in treat-ment of recurrent,persistent and metastatic cervical squamous cell carcinoma.[Methods]Clinical data of 43 patients with recurrent,persistent and metastatic cervical squamous cell carcinoma treated by ICIs in Cancer Hospital of Chinese Academy of Medical Sciences,Cancer Hospital of Huanxing Chaoyang District,Tianjin Shixuenin General Hospital from January 2020 to August 2023 were retrospectively analyzed.The therapeutic efficacy was assessed according to RECIST 1.1 criteria and the side effects were assessed according to CTCAE 5.0 criteria.[Results]The median age of patients was 58(26~73)years old,the median treatment cycle was 4(1~21)and the median follow-up time was 12 months(1~52).The objective response rate was 39.5%and the disease control rate was 79.1%.The median progression-free survival was 13 months and the median overall survival was 32 months.Common adverse reactions inclueded leukopenia(48.8%),gastrointestinal reaction(32.6%),thrombocytopenia(18.6%),itching rash(16.3%),liver dysfunction(14.0%).The incidence of grade≥3 adverse reactions was 62.8%,including leukopenia,thrombocytopenia,gastrointestinal reactions,itching rash,hypothyroidism,hyperthyroidism,myocarditis,pneumonia,etc.One case terminated treatment due to adverse reactions,1 case was complicated with vaginal urethral fistula,and 1 case died of infection compli-cations.[Conclusion]ICIs have shown exciting efficacy in the treatment of recurrent,persistent,and metastatic cervical squamous cell carcinoma.However,we also need to pay close attention to its possible se-rious adverse reactions.