维生素D补充剂可改善接受新辅助化疗的乳腺癌患者的病理完全缓解率：一项随机临床试验

Vitamin D Supplementation Improves Pathological Complete Response in Breast Cancer Patients Undergoing Neoadjuvant Chemotherapy: A Randomized Clinical Trial.

作者信息

Omodei Michelle Sako, Chimicoviaki Jackeline, Buttros Daniel Araujo Brito, Almeida-Filho Benedito Souza, Carvalho-Pessoa Carla Priscila, Carvalho-Pessoa Eduardo, Vespoli Heloisa De Luca, Nahas Eliana Aguiar Petri

机构信息

Graduate Program in Tocogynecology, Botucatu Medical School, Sao Paulo State University - UNESP, Botucatu, Sao Paulo, Brazil.

Department of Gynecology and Obstetrics, Botucatu Medical School, Sao Paulo State University - UNESP, Botucatu, Sao Paulo, Brazil.

出版信息

Nutr Cancer. 2025;77(6):648-657. doi: 10.1080/01635581.2025.2480854. Epub 2025 Mar 17.

DOI:10.1080/01635581.2025.2480854

PMID:40098326

Abstract

UNLABELLED

This study aimed to evaluate the effect of vitamin D (VD) supplementation on the pathological complete response (pCR) rate in women with breast cancer (BC) undergoing neoadjuvant chemotherapy (NCT). A randomized clinical trial was conducted with 80 women aged ≥45years with BC who were eligible for NCT. Women were randomized into two groups: VD group, daily supplementation with 2,000IU of cholecalciferol ( = 40) or placebo ( = 40), for 6 months. The primary outcome measure was the pCR rate. Serum 25-hydroxyvitamin-D [25(OH)D] levels were measured after BC diagnosis and the end of NCT. Of the 80 randomized women, 75 completed the NCT and underwent surgery. Baseline 25(OH)D values indicated hypovitaminosis D in both groups (VD: 19.6 ± 5.8 ng/mL and placebo: 21 ± 7.9 ng/mL, = 0.33). After 6 months, 25(OH)D levels increased in the VD group compared to the placebo group (28 ± 8.7 vs. 20.2 ± 6.1 ng/mL, = 0.03). The pCR rate was higher in women supplemented with VD when compared than the placebo (43% vs. 24%, = 0.04). Adjusted logistic regression showed that women with 25(OH)D levels ≥20ng/mL were more likely to achieve pCR (OR3.65, 95%CI 1.09-12.8, = 0.04). Women with BC undergoing NCT who received supplementation with 2,000IU of VD were more likely to achieve a pathological complete response than women in the placebo group.

TRIAL REGISTRATION

Ensaiosclinicos.gov.br, identifier RBR-10k4gqdg.

摘要

未标注

本研究旨在评估补充维生素D（VD）对接受新辅助化疗（NCT）的乳腺癌（BC）女性患者病理完全缓解（pCR）率的影响。对80名年龄≥45岁、符合NCT条件的BC女性患者进行了一项随机临床试验。将女性患者随机分为两组：VD组，每天补充2000IU胆钙化醇（n = 40）或安慰剂组（n = 40），持续6个月。主要结局指标为pCR率。在BC诊断后及NCT结束时测量血清25-羟基维生素D[25(OH)D]水平。80名随机分组的女性中，75名完成了NCT并接受了手术。基线25(OH)D值表明两组均存在维生素D缺乏（VD组：19.6±5.8 ng/mL，安慰剂组：21±7.9 ng/mL，P = 0.33）。6个月后，与安慰剂组相比，VD组的25(OH)D水平升高（28±8.7 vs. 20.2±6.1 ng/mL，P = 0.03）。补充VD的女性患者的pCR率高于安慰剂组（43% vs. 24%，P = 0.04）。校正逻辑回归显示，25(OH)D水平≥20 ng/mL的女性更有可能实现pCR（OR 3.65，95%CI 1.09 - 12.8，P = 0.04）。接受2000IU VD补充的接受NCT的BC女性比安慰剂组女性更有可能实现病理完全缓解。