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

Fenghua 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; Ruihua Xu

doi:10.21147/j.issn.1000-9604.2021.04.06

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

Chin J Cancer Res. 2021 Aug 31;33(4):490-499. doi: 10.21147/j.issn.1000-9604.2021.04.06.

Authors

Fenghua Wang¹, Guanghai Dai², Yanhong Deng³, Yong Tang⁴, Wei Wang⁵, Zuoxing Niu⁶, Feng Bi⁷, Liangjun Zhu⁸, Zengqing Guo⁹, Jin Yan¹⁰, Bing Hu¹¹, Min Tao¹², Shujun Yang¹³, Suzhan Zhang¹⁴, Lu Wen¹⁵, Ruihua Xu¹

Affiliations

¹ Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou 510060, China.
² Department of Medical Oncology, Chinese PLA 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 Department of Medical Oncology, Foshan First People's Hospital, Foshan 528010, China.
⁶ Department of Medical Oncology, Shandong Cancer Hospital, Jinan 250117, China.
⁷ Department of Medical Oncology, West China Hospital of Sichuan University, Chengdu 610041, China.
⁸ Department of Medical Oncology, 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.
¹¹ Department of Medical Oncology, Anhui Provincial Hospital, 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.
¹⁴ Department of Medical Oncology, the Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou 310009, China.
¹⁵ Department of Medical Oncology, Shanxi Provincial Cancer Hospital, Taiyuan 030009, China.

PMID: 34584374
PMCID: PMC8435824
DOI: 10.21147/j.issn.1000-9604.2021.04.06

Abstract

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.

Keywords: Metastatic colorectal cancer; bevacizumab; chemotherapy; efficacy; safety.