作者
Feng Wang,Ming-Ming He,Jing Xiao,Yan-Qiao Zhang,Xianglin Yuan,Weijia Fang,Yan Zhang,Wei Wang,Xiao-Hua Hu,Zhi-Gang Ma,Yonghong Yao,Zhixiang Zhuang,Yingying Shi,Jieer Ying,Ying Yuan,Qing-Feng Zou,Zengqing Guo,Xiang‐Yuan Wu,Ying Jin,Zong-Jiong Mai,Zhi‐Qiang Wang,Hong Qiu,Ying Guo,Si-Mei Shi,Shuang-Zhen Chen,Hongyu Luo,Dong-Sheng Zhang,Feng‐Hua Wang,Yu-Hong Li,Rui‐Hua Xu
摘要
To compare the efficacy and safety of high-dose vitamin C plus FOLFOX ± bevacizumab versus FOLFOX ± bevacizumab as first-line treatment in patients with metastatic colorectal cancer (mCRC).Between 2017 and 2019, histologically confirmed patients with mCRC (n = 442) with normal glucose-6-phosphate dehydrogenase status and no prior treatment for metastatic disease were randomized (1:1) into a control (FOLFOX ± bevacizumab) and an experimental [high-dose vitamin C (1.5 g/kg/d, intravenously for 3 hours from D1 to D3) plus FOLFOX ± bevacizumab] group. Randomization was based on the primary tumor location and bevacizumab prescription.The progression-free survival (PFS) of the experimental group was not superior to the control group [median PFS, 8.6 vs. 8.3 months; HR, 0.86; 95% confidence interval (CI), 0.70-1.05; P = 0.1]. The objective response rate (ORR) and overall survival (OS) of the experimental and control groups were similar (ORR, 44.3% vs. 42.1%; P = 0.9; median OS, 20.7 vs. 19.7 months; P = 0.7). Grade 3 or higher treatment-related adverse events occurred in 33.5% and 30.3% of patients in the experimental and control groups, respectively. In prespecified subgroup analyses, patients with RAS mutation had significantly longer PFS (median PFS, 9.2 vs. 7.8 months; HR, 0.67; 95% CI, 0.50-0.91; P = 0.01) with vitamin C added to chemotherapy than with chemotherapy only.High-dose vitamin C plus chemotherapy failed to show superior PFS compared with chemotherapy in patients with mCRC as first-line treatment but may be beneficial in patients with mCRC harboring RAS mutation.