Efficacy and safety of chemotherapy combined with bevacizumab in Chinese patients with metastatic colorectal cancer: A prospective, multicenter, observational, non-interventional phase IV trial

作者：Feng‐Hua Wang, Guanghai Dai, Yanhong Deng, Yong Tang, Wei Wang, Zuoxing Niu, Feng Bi, Liangjun Zhu, Zengqing Guo, Jin Yan, Bing Hu, Min Tao, Shujun Yang, Suzhan Zhang, Lu Wen, Rui‐Hua Xu · 发表于：Chinese Journal of Cancer Research · 年份：2021 · DOI：10.21147/j.issn.1000-9604.2021.04.06 · 被引用次数：11 · 研究领域：Colorectal Cancer Treatments and Studies、Colorectal Cancer Surgical Treatments、Cancer Treatment and Pharmacology

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 beva...