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Randomized Controlled Trial
. 2025 Jun;49(6):1396-1405.
doi: 10.1002/wjs.12587. Epub 2025 Apr 14.

Vitamin D Supplementation During Neoadjuvant Chemotherapy for Breast Cancer Improves Pathological Complete Response: A Prospective Randomized Clinical Trial

Enver Özkurt  1 , Cetin Ordu  2 , Tolga Özmen  3 , Ahmet Serkan Ilgun  4 , Gursel Soybir  5 , Filiz Celebi  6 , Ertan Koç  7 , Naziye Ak  8 , Gul Alco  9 , Sevgi Kurt  10 , Filiz Ağaçayak  11 , Ekrem Yavuz  12 , Sıtkı Tuzlalı  13 , Vahit Ozmen  14
Affiliations
Randomized Controlled Trial

Vitamin D Supplementation During Neoadjuvant Chemotherapy for Breast Cancer Improves Pathological Complete Response: A Prospective Randomized Clinical Trial

Enver Özkurt et al. World J Surg. 2025 Jun.

Abstract

Introduction: Achieving a pCR serves as a biomarker indicating enhanced overall survival for breast cancer patients undergoing NST. Vitamin D enhances the antitumor effect of chemotherapeutics as demonstrated in cancer cells and animal models. In this prospective randomized clinical study, we aim to investigate the effect of oral vitamin D supplementation during neoadjuvant systemic therapy (NST) on pathologic complete response (pCR).

Methods: Between June 2019 and June 2023, an oral form of 50,000 IU vitamin D3 (cholecalciferol) replacement was administered once a week during NST for the study group.

Results: There were 114 (50.2%) cases in the study group and 113 (49.8%) in the control group (totally 227 cases). Factors that positively influenced pCR were higher clinical T stage, higher AJCC clinical stage, Estrogen receptor negativity, progesterone receptor negativity, human epidermal growth factor receptor 2 positivity, high Ki-67 expression (≥ 20%), hormone negative molecular subtypes, and vitamin D intake in univariate analysis. In the multivariate analysis, factors significantly affecting pCR were vitamin D intake (OR: 2.33, 95% CI 1.20-4.53; p = 0.013), hormone receptor negativity (OR: 2.22, 95% CI 1.11-4.43; p = 0.024), and Ki-67 ≥ 20% (OR: 3.27, 95% CI 1.03-10.34; p = 0.044).

Conclusions: This is the first and only study to compare the effect of oral vitamin D supplementation on pCR during NST. Vitamin D supplementation during NST has a significant effect on pCR in breast cancer patients. Although this effect is not significant for axillary pCR, there is an almost significant correlation.

Trial registration: ClinicalTrials.gov (Identifier: NCT03986268).

Keywords: ERBB2 protein; breast neoplasms; dietary supplements; human; neoadjuvant systemic therapy; pathologic complete response; vitamin D.

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Conflict of interest statement

The authors declare no conflicts of interest.

Figures

FIGURE 1
FIGURE 1
5‐Year overall survival (a), disease free survival (b), and Local‐regional recurrence free survival (c) of study and control groups.
See this image and copyright information in PMC

References

    1. World Health Organization IAfRoC Global Cancer Observatory . (WHO, 2022): 2022.
    1. Özkurt E., Sakai T., Wong S. M., Tukenmez M., and Golshan M., “Survival Outcomes for Patients With Clinical Complete Response After Neoadjuvant Chemotherapy: Is Omitting Surgery an Option?,” Annals of Surgical Oncology 26, no. 10 (2019): 3260–3268, 10.1245/s10434-019-07534-1. - DOI - PubMed
    1. Cortazar P., Zhang L., Untch M., et al., “Pathological Complete Response and Long‐Term Clinical Benefit in Breast Cancer: The CTNeoBC Pooled Analysis,” Lancet 384, no. 9938 (2014): 164–172, 10.1016/s0140-6736(13)62422-8. - DOI - PubMed
    1. von Minckwitz G., Untch M., Blohmer J.‐U., et al., “Definition and Impact of Pathologic Complete Response on Prognosis After Neoadjuvant Chemotherapy in Various Intrinsic Breast Cancer Subtypes,” Journal of Clinical Oncology 30, no. 15 (2012): 1796–1804, 10.1200/jco.2011.38.8595. - DOI - PubMed
    1. Asselain B., Barlow W., Bartlett J., et al., “Long‐term Outcomes for Neoadjuvant versus Adjuvant Chemotherapy in Early Breast Cancer: Meta‐Analysis of Individual Patient Data From Ten Randomised Trials,” Lancet Oncology 19, no. 1 (2018): 27–39, 10.1016/s1470-2045(17)30777-5. - DOI - PMC - PubMed

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