KEY TAKEAWAYS
- The VITALITY study is a randomized, open-label, multicenter, phase 3 study that compared high-dose vitamin C plus FOLFOX ± bevacizumab versus FOLFOX ± bevacizumab as first-line treatment in patients with mCRC.
- The study compared the efficacy and safety of high-dose vitamin C plus FOLFOX ± bevacizumab versus FOLFOX ± bevacizumab as first-line treatment.
- Patients with mCRC (n = 442) with normal glucose-6-phosphate dehydrogenase status were randomized (1:1) into a control (FOLFOX ± bevacizumab) and an experimental group.
- The experimental and control groups’ objective response rate (ORR) and overall survival (OS) were similar. Grade 3 or higher treatment-related adverse events occurred in a similar proportion of patients in both groups.
This study aimed to compare the safety and efficacy of FOLFOX ± bevacizumab with or without high-dose vitamin C as first-line treatment for metastatic colorectal cancer patients. Four hundred forty-two treatment-naive metastatic colorectal cancer patients with normal glucose-6-phosphate dehydrogenase status were randomized into two groups, with one group receiving standard treatment and the other receiving the experimental treatment consisting of high-dose vitamin C (administered intravenously for 3 hours on D1 to D3) in addition to FOLFOX ± bevacizumab. Randomization was based on the location of the primary tumor and the prescription of bevacizumab.
The experimental group did not exhibit superior progression-free survival (PFS) compared to the control group (median PFS, 8.6 vs. 8.3 months; HR, 0.86; 95% CI, 0.70-1.05; P = 0.1). The objective response rate (ORR) and overall survival (OS) between the two groups were comparable (ORR, 44.3% vs. 42.1%; P = 0.9; median OS, 20.7 vs. 19.7 months; P = 0.7). Treatment-related grade three or higher adverse events were observed in 33.5% and 30.3% of patients in the experimental and control groups, respectively. Notably, in subgroup analyses, patients with RAS mutation exhibited significantly longer PFS with the addition of vitamin C to chemotherapy (median PFS, 9.2 vs. 7.8 months; HR, 0.67; 95% CI, 0.50-0.91; P = 0.01) than with chemotherapy alone.
While high-dose vitamin C combined with chemotherapy did not exhibit improved PFS over chemotherapy alone as a first-line treatment for mCRC patients, it may benefit those with RAS mutation.
Source: https://pubmed.ncbi.nlm.nih.gov/35929990/
Clinical Trial: https://clinicaltrials.gov/ct2/show/NCT02969681
Wang F, He MM, Xiao J, Zhang YQ, Yuan XL, Fang WJ, Zhang Y, Wang W, Hu XH, Ma ZG, Yao YC, Zhuang ZX, Zhou FX, Ying JE, Yuan Y, Zou QF, Guo ZQ, Wu XY, Jin Y, Mai ZJ, Wang ZQ, Qiu H, Guo Y, Shi SM, Chen SZ, Luo HY, Zhang DS, Wang FH, Li YH, Xu RH. 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). Clin Cancer Res. 2022 Oct 3;28(19):4232-4239. doi 10.1158/1078-0432.CCR-22-0655. PMID: 35929990; PMCID: PMC9527503.
