基于卡瑞利珠单抗的方案治疗局部晚期及转移性食管癌的真实世界研究  

Real-World Study of Camrelizumab-based Regimen for Locally Advanced and Metastatic Esophageal Cancer

作　　者：宋芬芬 李胜棉[1] SONG Fenfen;LI Shengmian(Department of Gastroenterology,The Fourth Hospital of Hebei Medical University,Shijiazhuang 050011,China)

机构地区：[1]河北医科大学第四医院消化内科,河北省石家庄市050011

出　　处：《中国全科医学》2025年第7期844-852,共9页Chinese General Practice

基　　金：中关村精准医学基金(3202425202203012)。

摘　　要：背景 卡瑞利珠单抗是我国自主研发的一种人源化程序性细胞死亡蛋白受体1(PD-1)抑制剂,目前已在食管癌治疗中获批适应证,但其在临床实践中的有效性及安全性数据仍缺乏。目的 评估基于卡瑞利珠单抗的方案在真实世界中治疗局部晚期及转移性食管癌的有效性和安全性;探索在不同的治疗背景 下,反应性毛细血管增生症(RCCEP)能否预测卡瑞利珠单抗的疗效。方法 回顾性收集2019-11-01—2022-05-31于河北医科大学第四医院接受卡瑞利珠单抗治疗的局部晚期及转移性食管癌患者临床资料。评估无进展生存期(PFS)、总生存期(OS)、客观缓解率(ORR)、疾病控制率(DCR)和不良反应发生情况。比较RCCEP组患者和无RCCEP组患者的生存情况。结果在纳入研究的70例局部晚期及转移性食管癌患者中,疗效评价为完全缓解(CR)11例(15.7%)、部分缓解(PR)35例(50.0%)、疾病稳定(SD)17例(24.3%)、疾病进展(PD)7例(10%),ORR 65.7%(46/70),DCR 90.0%(63/70)。其中,接受一线至三线治疗的47例患者的中位PFS为8.1个月(95%CI=6.46~9.74个月),1年PFS率为34.0%;中位OS未达到,1年OS率为76.3%。接受新辅助治疗的23例患者都达到R0切除,6例患者达到病理完全缓解(pCR)(26.1%)。RCCEP(65.7%)、恶心/呕吐(42.8%)、贫血(37.1%)、乏力(37.1%)和脱发(34.2%)是常见的不良反应类型。≥3级的不良反应发生率为21.4%(15/70),主要为白细胞计数减低(5.7%)、中性粒细胞计数减低(5.7%)以及血小板计数减低(4.3%)。4例患者发生了≥3级的免疫相关不良反应,包括3级心肌炎1例,3级肺炎1例,3级皮疹1例以及4级肾炎1例。所有患者经对症和/或糖皮质激素治疗后均得到缓解,未发生治疗相关的死亡。RCCEP与卡瑞利珠单抗的疗效相关,RCCEP组患者的ORR(76.1%比45.8%,P=0.010)和DCR(97.8%比75.0%,P=0.009)高于无RCCEP组患者,RCCEP组患者较无RCCEP组患者的中位PFS(18个月比7.4个月,P=0.015)及OS(未达到比15Background Camrelizumab is a PD-1 inhibitor independently developed in China,which has been approved for use in the treatment of esophageal cancer.However,its efficacy and safety data in clinical practice are still lacking.Objective This study is aimed at assessing the Camrelizumab-based regimens'safety and efficacy for locally advanced and metastatic esophageal cancer in the real world,and explore whether the reactive cutaneous capillary endothelial proliferation(RCCEP)could predict the efficacy of carrelizumab under different treatment modalities.Methods Cases of locally advanced and metastatic esophageal cancer treated with camrelizumab-based regimens in the Fourth Hospital of Hebei Medical University between 1 November 2019 and 31 May 2022 were retrospectively examined.Progression free survival(PFS),overall survival(OS),disease control rate(DCR),objective remission rate(ORR)and adverse events were evaluated.Using the Kaplan-Meier approach to compute the median and estimated 95%CI for PFS and OS.Comparing the survival function of patients in the RCCEP group and without RCCEP group.Results A total of 70 patients were included in the study.In all patients,the efficacy was evaluated as CR 11(15.7%),PR 35(50.0%),SD 17(24.3%),PD 7(10%),ORR 65.7%(46/70)and DCR 90.0%(63/70).In the 47 patients who receiving first-line to third-line treatment,the median PFS was 8.1 months(95%CI=6.46 to 9.74 months)and the 1-year PFS rate was 34.0%.The median OS was not reached,the 1-year OS rate of 76.3%.In the 23 patients who receiving neoadjuvant therapy,all patients achieved R0 resection,and 6 patients(26.1%)achieved pCR.In terms of safety,the most observed TRAEs included RCCEP(65.7%),nausea/vomiting(42.8%),anemia(37.1%),fatigue(37.1%)and alopecia(34.2%).The incidence of adverse reactions≥grade 3 was 21.4%(15/70),mainly including leukopenia(5.7%),neutropenia(5.7%)and thrombocytopenia(4.3%).Four patients developed immune related adverse reactions≥grade 3,including one case of grade 3 myocarditis,one case of grade 3 pneumonia,one

关 键 词：卡瑞利珠单抗 食管癌 反应性毛细血管增生症 有效性 安全性 免疫治疗 

分 类 号：R735[医药卫生—肿瘤]