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High-dose vitamin D supplements have been shown to prolong progression-free survival in colorectal cancer patients treated with chemotherapy. A large scale clinical follow-up trial is being planned based on the final positive data from this study.
Results from the SUNSHINE Phase II study compared the effects of low-dose and high-dose vitamin D supplements and showed that higher doses prolonged CRC PFS from 11 to 13 months. month of follow-up. The findings were reported at a meeting of the American Society of Clinical Oncology and published in JAMA.
Available data suggest that vitamin D has antineoplastic activity, and high levels may help reduce the risk of colorectal cancer and improve the survival of patients with CRC, according to researchers at the Dana Cancer Institute. Farber. The badysis of phase III data from a trial involving chemotherapy and biological agents in more than 1,000 patients with metastatic CRC revealed that patients with higher blood levels of 25-hydroxyvitamin D had a much better overall survival and PFS.
This randomized study examined whether high doses of vitamin D could improve outcomes in patients with advanced or metastatic colorectal cancer. 139 participants all received standard chemotherapy using mFOLFOX6 plus bevacizumab, who were randomized to receive high doses of oral vitamin D3 at 4000 IU daily or 400 IU daily. The primary endpoint was measured as the time elapsed between the start of chemotherapy and vitamin D and the first onset of progression of the disease or death; secondary endpoint: objective tumor response rate defined as the proportion of subjects with partial or complete responses and overall survival; and variation in plasma levels of 25-hydroxyvitamin D were measured as another endpoint.
At the start of the trial, only 9% of subjects had sufficient vitamin D levels. During the study, those in the low-dose group showed no significant change, while those in the high-dose group achieved and rapidly maintained a sufficient level.
According to the researchers, the increase in PFS in the high-dose group did not reach statistical significance, but the risk badociated with disease progression or death was reduced by 36% . High doses of vitamin D appeared to be less effective in obese subjects, which may indicate that such subsets require even higher doses.
Several potential mechanisms of action may explain this beneficial activity, as it has been shown that vitamin D induces apoptosis and counteracts the aberrant WNT-beta-catenin signaling, which is essential for the development of colorectal cancer; and vitamin D has extensive anti-inflammatory effects, high levels of 25-hydroxyvitamin D may impact the balance between regulatory and inflammatory T cell responses.
This study had several limitations, such as its small size and inadequate power to detect the effects of high doses on overall survival. That said, it still identifies a safe, cost-effective and easily accessible agent as a potential treatment for colorectal cancer that could have a broad and widespread global impact, regardless of socio-economic or national resources.
In the same issue of JAMA, a separate article from the Jikei University School of Japan revealed no benefit of post-operative vitamin D3 supplementation on the recurrence-free survival of 417 patients with digestive tract cancer in the United States. AMATERASU test.
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