Long-term survival outcomes and immune checkpoint inhibitor retreatment in patients with advanced cervical cancer treated with camrelizumab plus apatinib in the phase II CLAP study  

作　　者：Chunyan Lan Huaiwu Lu Lin Zhou Kunlun Liao Junxiu Liu Zhiwen Xie Haixi Liang Guorong Zou Ting Yang Qin Xu Xin Huang 

机构地区：[1]Department of Gynecologic Oncology,Sun Yat-sen University Cancer Centre,Guangzhou,Guangdong,P.R.China [2]State Key Laboratory of Oncology in South China,Collaborative Innovation Centre for Cancer Medicine,Guangzhou,Guangdong,P.R.China [3]Department of Gynecologic Oncology,Sun Yat-sen Memorial Hospital,Guangzhou,Guangdong,P.R.China [4]Clinical Research Daytime Treatment Center,Sun Yat-sen University Cancer Centre,Guangzhou,Guangdong,P.R.China [5]Department of Obstetrics and Gynecology,The First Affiliated Hospital of Sun Yat-sen University,Guangzhou,Guangdong,P.R.China [6]Cancer Institute of Panyu,Panyu Central Hospital,Guangzhou,Guangdong,P.R.China [7]Medical Affairs,Jiangsu Hengrui Pharmaceuticals Co.,Ltd,Shanghai,P.R.China [8]Department of Gynecology,Clinical Oncology School of Fujian Medical University,Fujian Cancer Hospital,Fuzhou,Fujian,P.R.China

出　　处：《Cancer Communications》2024年第6期654-669,共16页癌症通讯（英文）

基　　金：Research Fund Provincial Enterprise Joint Fund,Grant/Award Number:2021A1515220166;Chinese National Natural Science Foundation project,Grant/Award Number:82273242。

摘　　要：Background:Camrelizumab plus apatinib have demonstrated robust antitumor activity and safety in patients with advanced cervical cancer(CLAP study;NCT03816553).We herein present the updated long-term results of the CLAP study and explore potential biomarkers for survival.The outcomes of patients who underwent immune checkpoint inhibitor(ICI)retreatment were also reported.Methods:In this phase II trial,eligible patients received camrelizumab 200 mg intravenously every two weeks and apatinib 250 mg orally once daily in 4-week cycles for up to two years.Treatment was continued until disease progression,unacceptable toxicity,or withdrawal of consent.Results:Between January 21 and August 1,2019,a total of 45 patients were enrolled.Data were analyzed as of July 31,2023,representing>48 months since treatment initiation for all patients.Nine(20.0%)patients completed the 2-year study.The median duration of response(DOR)was 16.6 months,and 45.0%of patients achieved a DOR of≥24 months.The 12-month progression-free survival(PFS)rate was 40.7%(95%confidence interval[CI],25.2-55.6),with an 18-month PFS rate of 37.8%(95%CI,22.7-52.8).The median overall survival(OS)was 20.3 months(95%CI,9.3-36.9),and the 24-month OS rate was 47.8%(95%CI,31.7-62.3).Age>50 years,programmed death-ligand 1(PD-L1)combined positive score(CPS)≥1(versus[vs.]<1),CPS≥10(vs.<1),high tumor mutational burden,and PIK3CA mutations were associated with improved PFS(hazard ratio[HR]<1)and longer OS(HR<1).Eight patients who initially responded in the CLAP trial but later experienced disease progression were retreated with ICIs.Among them,2(25.0%)achieved a partial response,while 5(62.5%)had stable disease.Notably,four patients who received retreatment with ICIs survived for more than 45months.No new safety signals were identified in the present study.Conclusion:Long-term survival follow-up data demonstrated that camrelizumab plus apatinib has robust,sustained,and durable efficacy in patients with advanced cervical cancer who progress after first-line platinu

关 键 词：Cemrelizumab apatinib programmed cell death-1(PD-1) programmed death-ligand 1(PD-L1) tumor mutational burden(TMB) PIK3CA advanced cervical cancer 

分 类 号：R737.33[医药卫生—肿瘤] R730.5[医药卫生—临床医学]