Alternating modified CAPOX/CAPIRI plus bevacizumab in untreated unresectable metastatic colorectal cancer:a phase 2 trial  

作　　者：Sheng Li Xiaoyou Li Hanfeng Xu Jiayuan Huang Jingni Zhu Ying Peng Jun Bao Liangjun Zhu 

机构地区：[1]Department of Medical Oncology,The Affiliated Cancer Hospital of Nanjing Medical University&Jiangsu Cancer Hospital&Jiangsu Institute of Cancer Research,Nanjing,PR China [2]Department of Oncology,The Second Hospital of Nanjing,Nanjing University of Chinese Medicine,Nanjing,PR China [3]Senior Health Care Office,Jiangsu Provincial Health Commission,Nanjing,PR China

出　　处：《Signal Transduction and Targeted Therapy》2025年第1期321-327,共7页信号转导与靶向治疗(英文)

基　　金：supported by Beijing Science and Technology Innovation Medical Development Foundation(grant no.KC2021-JX-0186-106).

摘　　要：Previous studies showed encouraging efficacy of alternating FOLFOX/FOLFIRI for metastatic colorectal cancer(mCRC).This phase 2 trial(NCT04324476)aimed to evaluate efficacy and safety of alternating modified CAPOX(capecitabine and oxaliplatin)/modified CAPIRI(capecitabine and irinotecan)plus bevacizumab(anti-VEGF-A antibody)in untreated unresectable mCRC.Induction treatment included capecitabine 1000 mg/m^(2) bid D2-8 and D16-22,oxaliplatin 85 mg/m^(2) D1,irinotecan 150 mg/m^(2) D15,and bevacizumab 5 mg/kg D1 and 15 for 28-day cycles(up to six cycles).Capecitabine 1000 mg/m^(2) bid D2-15 and bevacizumab 7.5 mg/kg D1 for 21-day cycles were used as maintenance treatment.52 patients were included.Median follow-up was 25.0 months.Median progression-free survival(PFS;the primary endpoint)was 11.0 months(95%CI 9.0-12.4).Subgroup analyses showed patients with neutrophil-to-lymphocyte ratio<5 or RAS wild-type disease had longer PFS(both P<0.05).Objective response and disease control were obtained in 38(73%;95%CI 59%-84%)and 49(94%;95%CI 84%-99%),respectively.Mean depth of response,conversion and no evidence of disease rates were 46.0%±26.3%,23%and 19%,respectively.Median overall survival was 28.1 months(18.4-34.0).Grade 3-4 treatment-related adverse events(TRAE)occurred in 17(33%)patients.No treatment-related death was reported.The most common grade 3-4 TRAE were hypertension(13[25%]),neutrophil count decreased(three[6%]),and hand-foot syndrome(two[4%]).In addition,grade 3-4 TRAE of diarrhea reported in one[2%]patient and no grade 3-4 peripheral neuropathy occurred.Thus,alternating modified CAPOX/CAPIRI plus bevacizumab had promising efficacy and acceptable safety.The regimen may be a novel option for untreated unresectable mCRC.

关 键 词：BEVACIZUMAB UNTREATED COLORECTAL 

分 类 号：R73[医药卫生—肿瘤]