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Background <p>Vitamin D has been implicated in cancer biology and immunity, yet its prognostic relevance in patients receiving CDK4/6 inhibitors remains unclear.</p> Methods <p>We retrospectively analyzed 89 patients with HR+/HER2 − metastatic breast cancer (MBC) treated with ribociclib plus endocrine therapy between January 2018 and December 2023 at a single institution. Baseline serum 25-hydroxyvitamin D3 [25(OH)D3] levels obtained prior to treatment initiation were categorized as deficient (≤ 20 ng/mL) or sufficient (&gt; 20 ng/mL). The primary endpoint was progression-free survival (PFS). Survival outcomes were assessed using Kaplan–Meier estimates, log-rank tests, and Cox proportional hazards models.</p> Results <p>The median baseline vitamin D level was 19 ng/mL. The overall median PFS was 36 months. Patients with sufficient vitamin D had not reached median PFS, whereas those with deficiency had a median PFS of 14 months (95% confidence interval (CI), 12.6–15.3; <i>p</i> &lt; 0.001). At 24 months, PFS was 100% in the sufficient group versus 23.1% in the deficient group. In multivariate Cox analysis, baseline vitamin D deficiency remained associated with inferior PFS (HR 32.33, 95% CI 6.90–151.5; <i>p</i> &lt; 0.001), although the wide confidence intervals should be interpreted cautiously given the limited number of progression events in the vitamin D–sufficient subgroup. Other clinicopathological variables did not show statistically significant associations with PFS.</p> Conclusion <p>Baseline vitamin D status was associated with progression-free survival outcomes in patients with HR+/HER2 − metastatic breast cancer receiving ribociclib-based therapy. Patients with sufficient vitamin D levels demonstrated longer progression-free survival compared with those with vitamin D deficiency. However, given the retrospective design, limited sample size, residual confounding, and substantial censoring, these findings should be interpreted cautiously and considered exploratory and hypothesis-generating. Larger prospective studies are required to validate these observations and to clarify the potential clinical relevance of baseline vitamin D status in patients treated with CDK4/6 inhibitors.</p>

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Baseline vitamin D levels and progression-free survival in patients with HR+/HER2−metastatic breast cancer treated with ribociclib: a retrospective single-center analysis

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年6月24日

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  • Selahattin Çelik,
  • Bengü Dursun,
  • Serkan Gülcü,
  • Dılşa Mızrak Kaya,
  • Ömür Berna Öksüzoğlu

摘要

Background

Vitamin D has been implicated in cancer biology and immunity, yet its prognostic relevance in patients receiving CDK4/6 inhibitors remains unclear.

Methods

We retrospectively analyzed 89 patients with HR+/HER2 − metastatic breast cancer (MBC) treated with ribociclib plus endocrine therapy between January 2018 and December 2023 at a single institution. Baseline serum 25-hydroxyvitamin D3 [25(OH)D3] levels obtained prior to treatment initiation were categorized as deficient (≤ 20 ng/mL) or sufficient (> 20 ng/mL). The primary endpoint was progression-free survival (PFS). Survival outcomes were assessed using Kaplan–Meier estimates, log-rank tests, and Cox proportional hazards models.

Results

The median baseline vitamin D level was 19 ng/mL. The overall median PFS was 36 months. Patients with sufficient vitamin D had not reached median PFS, whereas those with deficiency had a median PFS of 14 months (95% confidence interval (CI), 12.6–15.3; p < 0.001). At 24 months, PFS was 100% in the sufficient group versus 23.1% in the deficient group. In multivariate Cox analysis, baseline vitamin D deficiency remained associated with inferior PFS (HR 32.33, 95% CI 6.90–151.5; p < 0.001), although the wide confidence intervals should be interpreted cautiously given the limited number of progression events in the vitamin D–sufficient subgroup. Other clinicopathological variables did not show statistically significant associations with PFS.

Conclusion

Baseline vitamin D status was associated with progression-free survival outcomes in patients with HR+/HER2 − metastatic breast cancer receiving ribociclib-based therapy. Patients with sufficient vitamin D levels demonstrated longer progression-free survival compared with those with vitamin D deficiency. However, given the retrospective design, limited sample size, residual confounding, and substantial censoring, these findings should be interpreted cautiously and considered exploratory and hypothesis-generating. Larger prospective studies are required to validate these observations and to clarify the potential clinical relevance of baseline vitamin D status in patients treated with CDK4/6 inhibitors.