卡瑞利珠单抗治疗非小细胞肺癌免疫相关不良事件发生情况及其与疗效关系的初步研究  

A preliminary study on occurrence of immune-related adverse events and its relationship to camrelizumab efficacy in treatment for non-small cell lung cancer

作　　者：王少军[1] 李超 刘彩霞[1] 苏乌云[1] 黄丛秀 Wang Shaojun;Li Chao;Liu Caixia;Su Wuyun;Huang Congxiu(Department of Medical Oncology,the Affiliated Hospital of Inner Mongolia Medical University,Hohhot 010050,China;Department of Radiotherapy,the Affiliated Hospital of Inner Mongolia Medical University,Hohhot 010050,China)

机构地区：[1]内蒙古医科大学附属医院肿瘤内科,呼和浩特010050 [2]内蒙古医科大学附属医院肿瘤放疗科,呼和浩特010050

出　　处：《药物不良反应杂志》2024年第1期12-17,共6页Adverse Drug Reactions Journal

基　　金：北京医学奖励基金会项目(YXJL⁃2020⁃0785⁃0353);内蒙古医科大学青年项目(YKD2022QN023)。

摘　　要：目的探讨卡瑞利珠单抗治疗非小细胞肺癌(NSCLC)免疫相关不良事件(irAE)的发生情况及其与疗效的关系。方法收集2020年12月至2022年12月在内蒙古医科大学附属医院接受卡瑞利珠单抗治疗NSCLC患者的临床资料,对卡瑞利珠单抗的疗效及其irAE的发生情况进行回顾性分析。根据患者是否发生irAE,将患者分为irAE组和无irAE组,比较2组患者的客观反应率(ORR)、疾病控制率(DCR)和无进展生存时间(PFS)。结果共48例患者纳入分析,男性41例(85.4%),女性7例(14.6%);年龄(65.9±7.4)岁,治疗中位周期数为9(6,14)个,总体ORR为52.1%(25/48),DCR为83.3%(40/48),中位PFS为11个月。48例患者中34例(70.8%)发生59例次irAE,其中8例(16.7%)发生至少1例次≥3级的irAE。irAE发生的中位周期数为5(3,7)个。发生率>10%的irAE包括反应性毛细血管增生症(RCCEP)、甲状腺损伤、皮肤损伤、肺损伤、肝损伤和血液毒性反应,发生率依次为37.5%(18/48)、18.8%(9/48)、16.7%(8/48)、12.5%(6/48)、10.4%(5/48)和10.4%(5/48)。与无irAE组患者比较,irAE组患者的ORR和DCR更高[64.7%(22/34)比3/14,91.2%(31/34)比9/14],中位PFS更长(12.0个月比7.0个月,风险比=0.418,95%置信区间:0.193~0.905),差异均有统计学意义(均P<0.05)。结论卡瑞利珠单抗治疗NSCLC中发生的主要irAE类型为RCCEP,严重irAE较少。卡瑞利珠单抗治疗中发生irAE的患者可能有更明显的治疗反应。Objective To explore the occurrence of immune⁃related adverse events(irAEs)and the relationship to efficacy of camrelizumab in treatment for patients with non⁃small cell lung cancer(NSCLC).Methods Clinical data of patients with NSCLC who received camrelizumab in at the Affiliated Hospital of Inner Mongolia Medical University from December 2020 to December 2022 were collected,and the efficacy of camrelizumab and the occurrence of irAEs were retrospectively analyzed.Patients were divided into irAEs group and non⁃irAEs group according to whether they developed irAEs.The objective response rate(ORR),disease control rate(DCR),and progression⁃free survival(PFS)of the 2 groups were compared.Results A total of 48 patients were entered in the analysis,including 41 males(85.4%)and 7 females(14.6%),with an age of(65.9±7.4)years;the median treatment cycle was 9(6,14);the overall ORR was 52.1%(25/48),the DCR was 83.3%(40/48),and the median PFS was 11 months.Among the 48 patients,34 patients(70.8%)had 59 times of irAEs,of which 8 patients(16.7%)had at least one irAE of grade≥3.The median time of irAEs occurrence was 5(3,7)treatment cycles.The irAEs with an incidence of>10%included reactive cutaneous capillary endothelial proliferation(RCCEP),thyroid injury,skin injury,lung injury,liver injury,and blood toxicity,with the incidences of 37.5%(18/48),18.8(9/48),16.7%(8/48),12.5%(6/48),10.4%(5/48),and 10.4%(5/48),respectively.Compared with non⁃irAEs group,patients in the irAEs group had higher ORR and DCR[64.7%(22/34)vs.3/14,91.2%(31/34)vs.9/14]and longer median PFS(12.0 months vs.7.0 months,hazard ratio=0.418,95%confidence interval:0.193-0.905),and the differ⁃ences were statistically significant(all P<0.05).Conclusions The common irAEs of camrelizumab in treatment for patients with NSCLC was RCCEP,and fewer serious irAEs occurs.To a certain extent,patients who experience irAEs during camrelizumab treatment may predict a more pronounced therapeutic response.

关 键 词：癌 非小细胞肺 免疫检查点抑制剂 抗肿瘤药 药物相关副作用和不良反应 卡瑞利珠单抗 

分 类 号：R734.2[医药卫生—肿瘤] R969.3[医药卫生—临床医学]