Addition of High-Dose Vitamin D3 to Standard Treatment in Patients With Metastatic Colorectal Cancer: The SOLARIS Randomized Clinical Trial (Alliance A021703).
JAMASep 1, 2026
Kimmie Ng, Fang-Shu Ou, Tyler Zemla et al.
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In 30 seconds
The SOLARIS trial was a phase 3 randomized clinical trial involving 455 patients with previously untreated metastatic colorectal cancer (mCRC). It assessed the impact of high-dose vitamin D3 on progression-free survival (PFS) when added to standard chemotherapy. The median PFS was 11.8 months for high-dose vitamin D3 compared to 10.3 months for standard-dose, with no significant difference (P=0.25).
Key findings
- Median PFS was 11.8 months for high-dose vitamin D3 vs 10.3 months for standard-dose (P=0.25).
- Objective response rates were 51% for high-dose vs 44% for standard-dose (P=0.12).
- Overall survival was 25.6 months for high-dose vs 27.0 months for standard-dose (P=0.66).
- No significant differences in grade 3 or greater adverse events between groups.
Why it matters
This study highlights that high-dose vitamin D3 does not provide a significant benefit in PFS for patients with mCRC receiving standard chemotherapy, suggesting that clinicians should reconsider the routine addition of high-dose vitamin D3 in this context.