| Autor: |
Feng Wang, Ming-Ming He, Jian Xiao, Yan-Qiao Zhang, Xiang-Lin Yuan, Wei-Jia Fang, Yan Zhang, Wei Wang, Xiao-Hua Hu, Zhi-Gang Ma, Yi-Chen Yao, Zhi-Xiang Zhuang, Fu-Xiang Zhou, Jie-Er Ying, Ying Yuan, Qing-Feng Zou, Zeng-Qing Guo, Xiang-Yuan Wu, Ying Jin, Zong-Jiong Mai, Zhi-Qiang Wang, Hong Qiu, Ying Guo, Si-Mei Shi, Shuang-Zhen Chen, Hui-Yan Luo, Dong-Sheng Zhang, Feng-Hua Wang, Yu-Hong Li, Rui-Hua Xu |
| Rok vydání: |
2022 |
| Předmět: |
|
| Zdroj: |
Clinical cancer research : an official journal of the American Association for Cancer Research. 28(19) |
| ISSN: |
1557-3265 |
| Popis: |
Purpose: 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). Patients and Methods: 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. Results: 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. Conclusions: 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. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
|
