Efficacy and safety of chemotherapy combined with bevacizumab in Chinese patients with metastatic colorectal cancer: A prospective, multicenter, observational, non-interventional phase IV trial
机构：[1]Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou 510060, China[2]Department of Medical Oncology, ChinesePLA General Hospital, Beijing 100853, China[3]Department of Medical Oncology, the Sixth Affiliated Hospital, Sun Yat-sen University,Guangzhou 510655, China[4]Department of Medical Oncology, Xinjiang Medical University Cancer Hospital, Urumqi 830000, China[5]Departmentof Medical Oncology, Foshan First People’s Hospital, Foshan 528010, China[6]Department of Medical Oncology, Shandong Cancer Hospital, Jinan250117, China[7]Department of Medical Oncology, West China Hospital of Sichuan University, Chengdu 610041, China四川大学华西医院[8]Department of MedicalOncology, Jiangsu Cancer Hospital, Nanjing 210009, China[9]Department of Medical Oncology, Fujian Cancer Hospital, Fuzhou 350014, China[10]Department of Surgical Oncology, Sichuan Cancer Hospital, Chengdu 610041, China四川省肿瘤医院[11]Department of Medical Oncology, Anhui ProvincialHospital, Hefei 230001, China[12]Department of Medical Oncology, the First Affiliated Hospital of Soochow University, Suzhou 215006, China[13]Department of Medical Oncology, Henan Cancer Hospital, Zhengzhou 450003, China河南省肿瘤医院[14]Department of Medical Oncology, the Second AffiliatedHospital of Zhejiang University School of Medicine, Hangzhou 310009, China[15]Department of Medical Oncology, Shanxi Provincial CancerHospital, Taiyuan 030009, China
Objective: Bevacizumab has an important and evolving role in improving outcomes in patients with metastatic colorectal cancer (mCRC) worldwide and was approved in China in 2010. However, there are limited real-world data on the efficacy and safety of chemotherapy regimens combined with bevacizumab in Chinese patients with mCRC. This observational, phase IV trial study aimed to obtain more experience on the efficacy and safety of bevacizumab combined with chemotherapy in Chinese mCRC patients. Methods: Between September 2013 and November 2016, patients with histologically confirmed mCRC were enrolled in a prospective, multicenter, observational, non-interventional phase IV trial at 26 centers across China. Eligible patients received different chemotherapeutic regimens combined with bevacizumab. The efficacy and safety data in the intention-to-treat study population were analyzed. Results: A total of 611 patients were included in the efficacy analysis. The median overall survival and median progression-free survival was 18.00 and 10.05 months, respectively. The objective response rate was 21.00% and disease control rate was 89.40%. In subgroup analyses, the survival differences were observed according to metastatic status, duration of treatment and elevation in blood pressure. A total of 613 patients were evaluable for safety assessments. And 569 (92.82%) patients reported at least one adverse event (AE), and 151 (24.63%) experienced grade 3 or higher AEs. The incidence of bevacizumab-associated AEs of special interest was reported in 31 (5.06%) patients with hypertension (n=12), abscesses and fistulae (n=7), bleeding (n=6), proteinuria (n=3), gastrointestinal perforation (n=2) and venous thrombotic events (n=1). Conclusions: This observational phase IV trial broadens our experience and knowledge of bevacizumab in the Chinese population and provides a good indication of its overall efficacy and safety. Bevacizumab in combination with chemotherapy offers clinical benefits to Chinese patients with mCRC and has an acceptable and manageable safety profile.
第一作者机构：[1]Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou 510060, China
共同第一作者：
通讯作者：
通讯机构：[1]Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou 510060, China[*1]Department of Medical Oncology, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine. No. 651 Dongfeng East Road, Guangzhou 510060, China
推荐引用方式(GB/T 7714)：
Wang Fenghua,Dai Guanghai,Deng Yanhong,et al.Efficacy and safety of chemotherapy combined with bevacizumab in Chinese patients with metastatic colorectal cancer: A prospective, multicenter, observational, non-interventional phase IV trial[J].CHINESE JOURNAL OF CANCER RESEARCH.2021,33(4):490-499.doi:10.21147/j.issn.1000-9604.2021.04.06.
APA：
Wang, Fenghua,Dai, Guanghai,Deng, Yanhong,Tang, Yong,Wang, Wei...&Xu, Ruihua.(2021).Efficacy and safety of chemotherapy combined with bevacizumab in Chinese patients with metastatic colorectal cancer: A prospective, multicenter, observational, non-interventional phase IV trial.CHINESE JOURNAL OF CANCER RESEARCH,33,(4)
MLA：
Wang, Fenghua,et al."Efficacy and safety of chemotherapy combined with bevacizumab in Chinese patients with metastatic colorectal cancer: A prospective, multicenter, observational, non-interventional phase IV trial".CHINESE JOURNAL OF CANCER RESEARCH 33..4(2021):490-499
