I just wanted to take a moment and share this article from Medscape that once again shows the benefits of Vitamin D3
SUNSHINE: Vitamin D Slows Colon Cancer Progression
June 07, 2017
CHICAGO – In recent years,
observational data have shown that higher plasma levels of vitamin D are
associated with improved survival in colorectal cancer patients.
Now, for the first time, a
randomized trial has shown that disease progression is slowed with high-dose
supplements.
The results, from a phase 2 clinical
trial known as SUNSHINE, indicate that a high dose of vitamin D supplementation
significantly improved progression-free survival (PFS) by about 2 months compared
to a low dose.
The trial was conducted in patients
with previously untreated metastatic colorectal cancer. All participants
received standard treatment with the mFOLFOX6 chemotherapy regimen (ie, folinic
acid [leucovorin], fluorouracil, and oxaliplatin) plus bevacizumab.
This is the first-ever completed
randomized trial of the use of vitamin D as a colorectal cancer therapy, said
lead author Kimmie Ng, MD, of the Dana Farber Cancer Institute in Boston,
Massachusetts, who presented the study here at the American Society of Clinical
Oncology (ASCO) 2017 Annual Meeting.
"Patients seemed to do better
on the high-dose vitamin D. I am really excited by the data," she told Medscape
Medical News.
"A phase 3 trial is
warranted," she added.
Another expert expressed similar
enthusiasm about the trial. "The findings from this study are incredibly
exciting," said Song Yao, PhD, a molecular epidemiologist at Roswell Park
Cancer Institute in Buffalo, New York, who was asked for comment.
He pointed out that at the 2015 ASCO
Gastrointestinal Cancers Symposium, the same team showed that in an
observational study, patients with higher levels of vitamin D survived longer
than those with lower levels. "This new study provides the much-needed
evidence-based randomized trial design," he commented.
Another clinician already assesses
vitamin D levels in colorectal cancer patients.
"I check vitamin D levels and
replete vitamin D when necessary for my patients, but we need more data to know
if this should be practice changing," said Allyson Ocean, MD, a
gastrointestinal oncologist at Weill Cornell Medicine and New York–Presbyterian
Hospital in New York City.
She also told Medscape Medical
News that the results are "quite intriguing" and that a phase 3
trial is needed.
Dr. Ng reported that in the
high-dose group (n = 69), the median PFS, which was the primary endpoint, was
13.1 months, compared with 11.2 months for the low-dose group (n = 70). That
translated into a 31% reduced relative risk for disease progression in the
high-dose group (unadjusted hazard ratio, 0.69; P = .04).
Patients in the high-dose group
received a loading dose of 8000 IU/day of vitamin D3 orally for 2 weeks
followed by 4000 IU/day. Those in the low-dose group received a standard
vitamin D3 dose of 400 IU/day.
Median follow-up was 16.9 months in
the high-dose group and 17.9 in the low-dose group.
Each group received similar numbers
of chemotherapy cycles, and both groups were highly compliant with vitamin D
supplementation. The primary tumor locations (right, left, and transverse) were
also similar for both groups.
The disease control rate in the
high-dose group was 96% vs 84% in the low-dose group (P = .05).
The high dose did not increase
toxicity. There was also significantly less serious (grade 3 and 4) diarrhea in
the high-dose group (12% vs 1%; P = .02).
The results were even more
impressive because there was an imbalance between the two study groups that
favored the low-dose group: 60% of the low-dose group had the best possible
performance status vs only 42% of the high-dose group.
In other words, the high-dose group
fared better despite being less physically fit than the comparator group.
Notably, more patients in the
high-dose vitamin D arm were able to undergo surgery after their chemotherapy
(11 vs 6). However, the difference was not statistically significant (P =
.19), Dr. Ng acknowledged. "It's an intriguing finding," she said.
The trial and its results have not
gone unnoticed. "There's a lot of interest from providers and
patients," said Dr. Ng.
The study was supported by funding
from the National Cancer Institute, Dana-Farber, Consano, Pharmavite, and
Genentech. Multiple study authors, including Dr. Ng, have financial ties to
industry, including Genentech. Dr. Yao has disclosed no relevant financial
relationships.
American Society of Clinical
Oncology (ASCO) 2017 Annual Meeting. Abstract 3506. Presented June 5.
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Nick Mulcahy on Twitter: @MulcahyNick
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