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SOLARIS (Alliance A021703), a multicenter, double-blind, randomized Phase III clinical trial led by Dana-Farber Cancer Institute researchers and conducted across several hundred cancer centers in the U.S. tested the addition of high-dose vitamin D3 to standard treatment for patients with untreated metastatic colorectal cancer.
More than 450 patients received standard chemotherapy plus bevacizumab and were randomized to high-dose or standard dose vitamin D3. The results were presented at the European Society for Medical Oncology 2024 congress. The team observed no additional concerning side-effects or toxicities with the addition of high-dose vitamin D3.
However, the addition of high-dose vitamin D3 to standard treatment did not delay the progression of cancer more so than standard-dose vitamin D3, according to the team's analysis after a median 20-month follow up. A potential benefit for high-dose vitamin D3 was observed for patients with left-sided disease (i.e.
, primary tumors that arise in the descending colon, sigmoid colon, or rectum) and requires further investigation. The SOLARIS trial was inspired by previous research suggesting that higher levels of vitamin D in the blood are associated with improved survival for metastatic colorectal cancer and that the addition of high-dose vitamin D3 to standard therapy could potentially improve progression free survival. The SOLARIS results suggest, however, that high-dose vitamin D3 cannot be recommended as a treatment for patients with untreated metastatic colon cancer.
More information: European Society for Medical Oncology 2024 Abstract LBA26.
