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The addition of high-dose vitamin D3 to standard treatment did not delay the progression of cancer compared with the standard dose of vitamin D3.
Researchers at the European Society for Medical Oncology 2024 conference (ESMO) announced that high-dose vitamin D3 did not provide benefits for individuals with metastatic colorectal cancer. The results were found in a multicenter, double-blind, randomized phase 3 clinical trial that assessed vitamin D in combination with standard chemotherapy with bevacizumab (Avastin; Genentech) among patients who were not previously treated for metastatic colorectal cancer.1
Colorectal cancer has recently become the most common cancer globally and the second leading cause of cancer-associated death. Study authors noted that in 2020, data found a 10% incidence of colorectal cancer worldwide and about 9.4% of deaths could have been a direct cause of colorectal cancer.2 Metastatic colorectal cancer (mCRC) is an advanced stage of colorectal cancer that has already spread from the colon or rectum to other areas in the body.3 Symptoms of mCRC include changes in bowel movements, blood in the stool, fatigue, weight loss, nausea, abdominal pain, and bloating. mCRC is a fatal disease with a 14% 5-year survival rate. Colorectal cancer can typically be cured with surgery, radiation therapy, chemotherapy, and targeted therapy, but once in the metastatic stage, treatment options become less effective.3-5
Vitamin D has shown benefits through sun exposure as the body attains 80% to 90% of vitamin D via ultraviolet light exposure and 10% to 20% from nutrients consumed in food sources. Foods high in vitamin D include salmon, mackerel, eel, tuna, eggs, milk, yogurt, and mushrooms.2
Previous studies have found a connection between high levels of vitamin D and reduced risk of colorectal cancer and improved survival. However, study authors noted that most studies were conducted on mice and human studies only included a limited number of participants.2 The current SOLARIS (Alliance A021703) trial, led by Dana-Farber Cancer Institute, included more than 450 individuals.1
“One study recruiting a large cohort of patients with advanced or metastatic CRC revealed that higher plasma 25(OH)D levels are associated with improved overall and progression-free survival. However, the effects of Vitamin D supplementation on incidence and mortality of CRC remain inconclusive,” study authors said in a news release.2
The study was conducted across hundreds of cancer centers in the US and designed to test the use of high-dose vitamin D3 versus standard treatment in individuals with untreated mCRC. The investigators created this study in support of research that suggested treatment with high levels of vitamin D in the blood contributed to improved survival among individuals with mCRC.1
Approximately 450 individuals were randomly assigned to receive standard chemotherapy with bevacizumab with either high dose or standard dose of vitamin D3. The results found that after a median 20-month follow up, the addition of high-dose vitamin D3 with standard treatment did not delay the progression of cancer compared with the standard dose of vitamin D3. However, further results found that high-dose vitamin D3 did show benefits among individuals with primary tumors that occur in the descending colon, sigmoid colon, or rectum, according to study authors.1
High dose vitamin D was not reported to cause any concerning adverse effects or toxicities, but it cannot be recommended as a treatment option for individuals with untreated metastatic colon cancer, the study authors noted.1