Vitamin D Supplementation Improves Pathological Complete Response in Breast Cancer Patients Undergoing Neoadjuvant Chemotherapy: A Randomized Clinical Trial.
Michelle Sako Omodei, Jackeline Chimicoviaki, Daniel Araujo Brito Buttros, Benedito Souza Almeida-Filho, Carla Priscila Carvalho-Pessoa, Eduardo Carvalho-Pessoa, Heloisa De Luca Vespoli, Eliana Aguiar Petri Nahas
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Abstract
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 (n = 40) or placebo (n = 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, p = 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, p = 0.03). The pCR rate was higher in women supplemented with VD when compared than the placebo (43% vs. 24%, p = 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, p = 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.
本研究旨在评估补充维生素D (VD)对乳腺癌(BC)新辅助化疗(NCT)患者病理完全缓解(pCR)率的影响。一项随机临床试验对80名年龄≥45岁的BC患者进行了NCT治疗。女性被随机分为两组:VD组,每天补充2000国际单位的胆钙化醇(n = 40)或安慰剂(n = 40),持续6个月。主要结局指标为pCR率。在BC诊断和NCT结束后测定血清25-羟基维生素D [25(OH)D]水平。在80名随机分配的女性中,75名完成了NCT并接受了手术。基线25(OH)D值显示两组维生素D缺乏症(VD: 19.6±5.8 ng/mL,安慰剂:21±7.9 ng/mL, p = 0.33)。6个月后,与安慰剂组相比,VD组25(OH)D水平升高(28±8.7 vs. 20.2±6.1 ng/mL, p = 0.03)。与安慰剂组相比,补充VD组的pCR率更高(43% vs. 24%, p = 0.04)。经校正的logistic回归显示,25(OH)D水平≥20ng/mL的女性更有可能实现pCR (OR3.65, 95%CI 1.09-12.8, p = 0.04)。接受NCT治疗的BC患者在补充2000 iu VD后比安慰剂组更有可能达到病理完全缓解。试验注册:Ensaiosclinicos.gov.br,标识符RBR-10k4gqdg。
期刊介绍:
This timely publication reports and reviews current findings on the effects of nutrition on the etiology, therapy, and prevention of cancer. Etiological issues include clinical and experimental research in nutrition, carcinogenesis, epidemiology, biochemistry, and molecular biology. Coverage of therapy focuses on research in clinical nutrition and oncology, dietetics, and bioengineering. Prevention approaches include public health recommendations, preventative medicine, behavior modification, education, functional foods, and agricultural and food production policies.