Vitamin D supplementation and survival of patients with non-small-cell lung cancer: A randomized, double-blind, placebo-controlled trial

Purpose: Higher serum 25-hydroxyvitamin D (25(OH)D) levels are reportedly associated with better survival in early-stage non-small-cell lung cancer (NSCLC). Therefore, whether vitamin D supplementation can improve the prognosis of NSCLC patients was examined (UMIN000001869). Experimental Design: A randomized, double-blind trial comparing vitamin D supplements (1,200 IU/day) with placebo for 1 year after operation was conducted. The primary and secondary outcomes were relapse-free survival (RFS) and overall survival (OS), respectively. Pre-specified subgroup analyses were performed with stratification by stage (early vs. advanced), pathology (adenocarcinoma vs. others), and 25(OH)D levels (low, <20 ng/ml vs. high, ≥20 ng/ml). Polymorphisms of vitamin D receptor (VDR) and vitamin D binding protein (DBP) and survival were also examined. Results: NSCLC patients (n=155) were randomly assigned to receive vitamin D (n=77) or placebo (n=78) and followed for a median of 3.3 years. Relapse and death occurred in 40 (28%) and 24 (17%) patients, respectively. In the total study population, no significant difference in either RFS or OS was seen with vitamin D compared to the placebo group. However, by restricting the analysis to the subgroup with early-stage adenocarcinoma with low 25(OH)D, the vitamin D group showed significantly better 5-year RFS (86% vs. 58%, P=0.04) and OS (92% vs. 56%, P=0.02) than the placebo group. Among the examined polymorphisms, DBP1 (rs7041) TT and CDX2 (rs11568820) AA/AG genotypes were markers of better prognosis, even with multivariate adjustment. Conclusions: In NSCLC patients, vitamin D supplementation may improve survival of early-stage lung adenocarcinoma patients with lower 25(OH)D levels.

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