Anlotinib plus chemotherapy as afirst-line treatment for gastrointestinal cancer patients with unresectable liver metastases:a multicohort,multicenter,exploratory trial  

作　　者：Jun-Wei Wu Chen-Fei Zhou Zheng-Xiang Han Huan Zhang Jun Yan Jun Chen Chun-Bin Wang Zhi-Quan Qin Yong Mao Xin-Yu Tang Liang-Jun Zhu Xiao-Wei Wei Dong-Hai Cui Xiu-Li Yang Min Shi Li-Qin Zhao Jin-Ling Jiang Wei-You Zhu Hong-Mei Wang Chun Wang Ling-Jun Zhu Jun Zhang 

机构地区：[1]Department of Oncology,Ruijin Hospital,Shanghai Jiao Tong University School of Medicine,Shanghai,China [2]Department of Oncology,The Affiliated Hospital of Xuzhou Medical University,Xuzhou,China [3]Department of Radiology,Ruijin Hospital,Shanghai Jiao Tong University School of Medicine,Shanghai,China [4]Department of Oncology,Jiading District Central Hospital Affiliated Shanghai University of Medicine&Health Sciences,Shanghai,China [5]Department of Chemoradiotherapy,The Affiliated People’s Hospital of Ningbo University,Ningbo,China [6]Department of Oncology,The Third People’s Hospital of Yancheng,Yancheng,China [7]Department of Medical Oncology,Zhejiang Provincial People’s Hospital,Affiliated People’s Hospital,Hangzhou,China [8]Department of Oncology,Affiliated Hospital of Jiangnan University,Wuxi,China [9]Department of Oncology,Wuxi Branch of Ruijin Hospital,Shanghai Jiao Tong University School of Medicine,Wuxi,China [10]Department of Medical Oncology,Jiangsu Cancer Hospital,Nanjing,China [11]Department of Oncology,Nanjing First Hospital,Nanjing Medical University,Nanjing,China [12]Department of Internal Medicine,Anyang Tumor Hospital,Anyang,China [13]Department of Oncology,First Affiliated Hospital of Nanyang Medical College,Nanyang,China [14]Department of Oncology,The First Affiliated Hospital of Nanjing Medical University,Nanjing,China

出　　处：《Signal Transduction and Targeted Therapy》2025年第1期303-313,共11页信号转导与靶向治疗(英文)

基　　金：supported by the National Natural Science Foundation of China(82273126 and 82273407);the Collaborative Innovation Cluster Project of the Shanghai Municipal Health Commission(grant number,2020CXJQ03);the Innovative research teams of high-level local universities in Shanghai.The authors thank all patients,their families,investigators,and research staffs for participating in this trial.

摘　　要：This multicohort phase II trial(ALTER-G-001;NCT05262335)aimed to assess the efficacy offirst-line anlotinib plus chemotherapy for gastrointestinal(GI)cancer patients with unresectable liver metastases.Eligible patients with colorectal cancer(Cohort A)or noncolorectal and nonesophageal GI cancer(Cohort C)received six cycles of anlotinib plus standard chemotherapeutic regimens followed by anlotinib plus metronomic capecitabine as a maintenance therapy.Liver metastasectomy can be performed when liver metastases are converted to resectable lesions.The primary outcome was the investigator-confirmed objective response rate(ORR)in the intention-to-treat population.Among the 47 patients in Cohort A,the ORR was 40.4%(95%CI 26.4-55.7),including 1 with a complete response(CR)and 18 who achieved a partial response(PR).The median progression-free survival(PFS)was 8.7 months(95%CI 7.3-NE),and the median overall survival(OS)was not reached.In Cohort C,14 of 44 patients achieved a PR,with an ORR of 31.8%(95%CI 18.6-47.6).The PFS and OS were 5.8 months(95%CI 4.8-6.5)and 11.4 months(95%CI 5.8-19.3),respectively.The liver metastasectomy rate in patients with liver-limited disease was 22.7%(5/22)in Cohort A and 6.7%(2/30)in Cohort C.For pancreatic cancer patients,the ORR of the efficacy-evaluable population was 36.0%(9/25),and those with liver-limited metastasis had better survival.Moreover,no new safety concerns emerged.In conclusion,an anlotinib-basedfirst-line regimen demonstrated promising antitumor activity among GI cancer patients with unresectable liver metastases and led to liver metastasectomy in selected patients.

关 键 词：patients METASTASES GASTROINTESTINAL 

分 类 号：R73[医药卫生—肿瘤]