Data from A Randomized, Open-Label, Multicenter, Phase 3 Study of High-Dose Vitamin C Plus FOLFOX ± Bevacizumab versus FOLFOX ± Bevacizumab in Unresectable Untreated Metastatic Colorectal Cancer (VITALITY Study)

• DOI: 10.1158/1078-0432.c.6532704.v1
• Publication Date: 2023-04-01T03:11:02Z
• Authors: 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
• Keywords: FOLFOX

<div>AbstractPurpose:<p>To compare the efficacy and safety of high-dose vitamin C plus FOLFOX ± bevacizumab versus as first-line treatment in patients with metastatic colorectal cancer (mCRC).</p>Patients Methods:<p>Between 2017 2019, histologically confirmed mCRC (<i>n</i> = 442) normal glucose-6-phosphate dehydrogenase status no prior for disease were randomized (1:1) into a control (FOLFOX bevacizumab) an experimental [high-dose (1.5 g/kg/d, intravenously 3 hours from D1 to D3) bevacizumab] group. Randomization was based on primary tumor location prescription.</p>Results:<p>The progression-free survival (PFS) group not superior [median PFS, 8.6 vs. 8.3 months; HR, 0.86; 95% confidence interval (CI), 0.70–1.05; <i>P</i> 0.1]. The objective response rate (ORR) overall (OS) groups similar (ORR, 44.3% 42.1%; 0.9; median OS, 20.7 19.7 0.7). Grade or higher treatment-related adverse events occurred 33.5% 30.3% groups, respectively. In prespecified subgroup analyses, RAS mutation had significantly longer PFS (median 9.2 7.8 0.67; CI, 0.50–0.91; 0.01) added chemotherapy than only.</p>Conclusions:<p>High-dose failed show compared but may be beneficial harboring mutation.</p></div>