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 

作者机构：Department of Gynecologic OncologySun Yat-sen University Cancer CentreGuangzhouGuangdongP.R.China State Key Laboratory of Oncology in South ChinaCollaborative Innovation Centre for Cancer MedicineGuangzhouGuangdongP.R.China Department of Gynecologic OncologySun Yat-sen Memorial HospitalGuangzhouGuangdongP.R.China Clinical Research Daytime Treatment CenterSun Yat-sen University Cancer CentreGuangzhouGuangdongP.R.China Department of Obstetrics and GynecologyThe First Affiliated Hospital of Sun Yat-sen UniversityGuangzhouGuangdongP.R.China Cancer Institute of PanyuPanyu Central HospitalGuangzhouGuangdongP.R.China Medical AffairsJiangsu Hengrui Pharmaceuticals Co.LtdShanghaiP.R.China Department of GynecologyClinical Oncology School of Fujian Medical UniversityFujian Cancer HospitalFuzhouFujianP.R.China 

出 版 物：《Cancer Communications》 (癌症通讯（英文）)

年 卷 期：2024年第44卷第6期

页      面：654-669页

核心收录：

学科分类：1002[医学-临床医学] 100214[医学-肿瘤学] 10[医学] 

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

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

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 *** outcomes of patients who underwent immune checkpoint inhibitor(ICI)retreatment were also ***: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 *** was continued until disease progression,unacceptable toxicity,or withdrawal of ***:Between January 21 and August 1,2019,a total of 45 patients were *** were analyzed as of July 31,2023,representing48 months since treatment initiation for all ***(20.0%)patients completed the 2-year *** median duration of response(DOR)was 16.6 months,and 45.0%of patients achieved a DOR of≥24 *** 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).Age50 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(HR1).Eight patients who initially responded in the CLAP trial but later experienced disease progression were retreated with *** them,2(25.0%)achieved a partial response,while 5(62.5%)had stable ***,four patients who received retreatment with ICIs survived for more than *** new safety signals were identified in the present ***:Long-term survival follow-up data demonstrated that camrelizumab plus apatinib has robust,sustained,and durable efficacy in patients with advanced cervical ca