The Rational for Vitamin C in Colorectal Cancer
The use of vitamin C in cancer treatment can be traced to more than 40 years ago.
Back then two retrospective studies reported the survival prolongation of patients with advanced cancer after treatment with intravenous high-dose vitamin C.
Intravenous vitamin C alone or with chemotherapy has been shown to be safe in patients with advanced solid tumors.
Findings from a phase 1/2 trial performed on ovarian cancer demonstrated a trend toward disease progression and survival improvements when vitamin C was combined with standard chemotherapy.
The researchers of the VITALITY Study, which will be presented in this article, have completed a phase 1 dose-escalation trial of intravenous vitamin C combined with chemotherapy, in which 7 doses were studied.
Their findings showed favorable safety profiles and preliminary efficacies. These findiings provided the recommended dose for high-dose vitamin C in combination with chemotherapy.
About the VITALITY Study in Colorectal Cancer Patients
This is a randomized, open-label, multicenter, phase 3 study of high-dose Vitamin C plus FOLFOX ± Avastin versus FOLFOX ± Avastin as first-line treatment in patients with metastatic colorectal cancer.
Patients and Methods
Between 2017 and 2019, patients with colorectal cancer with normal G6PD status and no prior treatment for metastatic disease were randomized into a control (FOLFOX ± Avastin) and an experimental [high-dose vitamin C (1.5 g/kg/d, intravenously for 3 hours from D1 to D3) plus FOLFOX ± Avastin] group.
Results
The time until the disease had progressed (also called “Progression-Free Survival, PFS) of the experimental group was not superior to the control group.
The Response Rate and Survival of the experimental and control groups were similar.
Response Rate (also called ORR) is the % of patients whose tumors had shrunk or did not continue to grow, or new lesions were not seen in the scans.
Harsh treatment-related side effects 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 (9.2 vs. 7.8 months) with vitamin C added to chemotherapy than with chemotherapy only.
Conclusions
High-dose vitamin C plus chemotherapy may be beneficial in patients with metastatic colorectal cancer harboring RAS mutation.
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