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BOSTON – Results from a small clinical trial suggest that high dose chemotherapy supplementation of vitamin D could be beneficial for patients with metastatic colorectal cancer by delaying the progression of the disease, according to scientists at the Dana-Farber Cancer Institute.
Invited by the "very encouraging" results of the SUNSHINE clinical trial, the potential benefits of vitamin D supplementation in metastatic colorectal cancer will be evaluated as part of a larger clinical trial that should "Open in several hundred sites in the United States later in the year," said Kimmie Ng, MD, MPH, director of clinical research at the Dana-Farber Gastroenterological Cancer Center and author correspondent of the SUNSHINE study. "To our knowledge, this study is the first comprehensive randomized clinical trial on vitamin D supplementation for the treatment of advanced or metastatic colorectal cancer," said Ng.
In the high dose group, patients had a median time to 13 months before their disease worsened; in the low-dose group, the median time was 11 months. In addition, patients in the high-dose vitamin D group were 36% less likely to have disease progression or death during the 22.9-month follow-up period. The trial included too few patients to determine if those taking high-dose vitamin D showed an improvement in their overall survival.
"The results of our trial suggest improved outcomes in patients receiving vitamin D supplementation, and we look forward to launching a larger trial to confirm these exciting and challenging discoveries," said Charles Fuchs, MD, MPH, formerly from Dana-Farber. lead author of the study and now director of the Yale Cancer Center.
The first results were reported at the 2017 meeting of the American Society of Clinical Oncology. These results, together with additional data, are now published in JAMA.
The SUNSHINE study randomized 139 patients with untreated metastatic colorectal cancer. One group took tablets containing 4,000 international units (IU) of vitamin D daily with standard chemotherapy, while the other group took 400 units (about the dose found in a multivitamin) with chemotherapy.
Vitamin D, necessary for healthy bones, is produced in the body by a chemical reaction related to sun exposure and is present in certain foods. In laboratory studies, vitamin D has demonstrated anticancer properties such as triggering programmed cell death, inhibition of cancer cell growth and reduction of metastatic potential. Prospective observational studies have linked higher blood levels of vitamin D, lower risk of colorectal cancer, and improved survival of patients with the disease, but these studies have not proven that vitamin D was the cause.
In this context, the prospective randomized phase 2 study SUNSHINE recruited patients at 11 academic and community centers across the United States to test whether vitamin D supplementation could improve outcomes in patients with metastatic colorectal cancer. All patients received standard chemotherapy with a regimen called mFOLFOX6 plus bevacizumab. Patients in the high-dose vitamin D group initially took 8,000 IU daily for 14 days and then 4,000 IU per day thereafter. The low-dose or standard vitamin D group took 400 IU daily during all cycles. All patients were advised not to take any other vitamin D or calcium supplements during the test period.
The primary endpoint of the trial was progression-free survival – time to disease worsening, or death – which was longer in the high-dose group. Another calculated measure – the risk ratio of disease progression or death – revealed a lower probability of 36% in the high dose group.
The researchers also took blood samples from patients to measure changes in 25-hydroxyvitamin D levels. [25(OH)D], which is a standard test for determining a person's vitamin D status. This test showed that only 9% of patients participating in the clinical trial had sufficient vitamin D at the start of treatment. During the study, vitamin D levels in low-dose patients did not significantly change, while those in the high-dose group quickly achieved and maintained adequate vitamin D levels.
The badysis of the results showed that the benefit of the high dose of vitamin D appeared to be lower in obese patients and in those whose tumor contained a mutated KRAS gene, suggesting "that some subsets patients may need even higher doses of vitamin D anti-tumor activity, "the researchers said. However, they warned that high doses of vitamin D should only be taken in a clinical trial.
The study and its results are "extremely important," said Ng, "because they identify a cost-effective, safe, and easily accessible agent as a potential new treatment for metastatic colorectal cancer, which could potentially have a significant impact." extended. " overall impact, regardless of the socio-economic status of the patient or the resources of a country. "
The research was funded by National Cancer Institute grants P50CA127003, R01CA205406 and R01CA118553; a faculty advancement scholarship Gloria Spivak; a Cancer Institute award from friends of Dana-Farber; the Project P fund; Consano, Pharmavite LLC and Genetech.
Dr. Ng reports grants from the National Cancer Institute, grants and non-financial support from Pharmavite, Genentech grants, and Consano grants while conducting the study; Pharmavite grants and non-financial aids, Genentech Personal Expenses, Lilly Personal Expenses, Gilead Sciences Grants, Tarrex Biopharma Grants and Personal Expenses, Bayer Personal Expenses, Seattle Genetics Personal Expenses, Celgene Trovagene Grants Outside of Work submitted.
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About Dana-Farber
The Dana-Farber Cancer Institute is one of the leading cancer research and treatment centers in the world. It is the only center ranked in the top 4 of the best US hospitals in World News Report and World Report for adult and child cancer care.
Dana-Farber's mission is to reduce the burden of cancer through scientific investigations, clinical care, education, community mobilization and advocacy. We provide the latest advances in adult cancer through Dana-Farber / Brigham and Women's Cancer Care and for children via the Dana-Farber / Boston Center for Blood Cancers and Blood Disorders.
Dana-Farber is dedicated to a unique and equal balance between cancer research and care, translating discovery findings into new treatments for local and global patients.
About Yale Cancer Center
The Yale Cancer Center (YCC) is one of 49 centers in this country (NCI designated Complete Cancer) and the only one of its kind in Connecticut. Comprehensive cancer centers play a vital role in achieving NCI's goal of reducing cancer morbidity and mortality through scientific research, cancer prevention and innovative cancer treatment.
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