维生素D浓度低与乳腺癌患者的预后差相关。我们检测了血液中维生素D的浓度与所有MA.21患者和乳腺癌亚组患者的无复发生存期之间的关系。
研究方法
我们收集935/2104位(44.4%)患者化疗前的空腹血糖。血清在零下80℃的温度中冰冻，用干冰冷冻装船运往多伦多西奈山医院，应用放射免疫检验技术对维生素D的浓度(nmol/L)进行了检测。应用λ=0.5 Box-Cox转换分析以减少其不对称性。再将数据转换回来进行报道。把维生素D作为连续转换因素、通过四分位数和医学研究所分类进行评估，应用Cox模型进行单变量和多变量分析，根据治疗、分层因素和已经评估过维生素D水平患者的不平衡进行校正，
研究结果
患者的年龄的中位数为47.8岁，大多数患者为白人(91.6%)，处于绝经前期(69.4%)，体能评分0-1分(99.9%)。绝大多数患者为III期(52%)、HER2阴性(66.6%)、HER2缺失(22.9%)、雌激素受体阳性(61.9%)、T1-2 (89.4%)、N+ (72.7%)的乳腺癌患者。52.1%的患者行乳腺切除术，74.3%的患者接受了辅助放疗。与所有MA.21人群相比，维生素D浓度低的患者多为白人、体能评分为1或2，进行过乳腺切除术，肿瘤多为雌激素受体阳性、HER2阴性的。平均维生素D浓度为69.7 nmol/L[95% CI (68.1-71.3)].绝大多数(752/935 = 80.5%)浓度> 50nmol/L (20ng/ml)，医学研究所认为是充足的。校正后的分析显示，维生素D与无复发生存期(HR 0.98, 95% CI (0.93-1.03); p=0.36)和分类变量(四分位数, p=0.20-0.43; 医学研究所分类, p=0.33-0.78)无关。各肿瘤亚型的平均维生素D浓度或维生素D与无复发生存期之间的相关性没有明显差异。
结论
没有证据证明，维生素D与MA.21人群的无复发生存期之间存在相关性，绝大多数患者在入组时维生素D浓度充足。临床试验信息：NCT00014222.
医脉通整理报道，转载请注明出处。
会议专题》》》2014年ASCO年会专题报道
阅读英文摘要
Prognostic associations of 25OH vitamin D in NCIC CTG MA.21, a phase III adjuvant RCT of three chemotherapy regimens (EC/T, CEF, AC/T) in high-risk breast cancer (BC).（Abstract No:504）
Authors: Ana Elisa Lohmann, Judy-Anne W. Chapman, et al.
Session Type: Oral Abstract Session
Background: Low vitamin D (VitD) has been associated with poor outcomes in BC. We examined in MA.21 the association of VitD blood levels with relapse-free-survival (RFS) in all patients, and in BC subtypes.
Methods: Fasting blood was collected pre-chemotherapy in 935/2,104 ((44.4%) of subjects (blood collection was initiated part-way through the trial); serum was frozen at -80C and shipped on dry ice to Mount Sinai Hospital (Toronto); it was analyzed for Vit D (radioimmunoassay, Diasorin) 25(OH)D (nmol/L). VitD underwent a λ=0.5 Box-Cox transformation for analysis to reduce asymmetry; data were back-transformed for reporting. VitD was assessed as a transformed continuous factor, and by quartiles and IOM categories (<40, [40-50), [50-125), >125 nmol/L). Univariate and multivariate (mv) assessments were with Cox models, adjusted for treatment, stratification factors, and imbalances in who had VitD assessed.
Results: Median age was 47.8 years; most patients were white (91.6%), premenopausal (69.4%) with good performance status (PS) 0-1 (99.9%). The majority presented with grade III (52%), HER2 neg (66.6%), HER2 missing (22.9%), ER pos (61.9%), T1-2 (89.4%), N+ (72.7%) BC. 52.1% underwent mastectomy and 74.3% received adjuvant radiotherapy. Compared to the full MA.21 population, those with VitD levels were marginally (but significantly) more likely to be white, PS 1 or 2, to have undergone mastectomy and to have ER+, HER2 neg tumors. Mean Vit D was 69.7 nmol/L [95% CI (68.1-71.3)] nmol/L. The majority (752/935 = 80.5%) had levels > 50nmol/L (20ng/ml), considered adequate by the Institute of Medicine (IOM). In adjusted mv analyses, (continuous) VitD was not associated with RFS (HR 0.98, 95% CI (0.93-1.03); p=0.36) or categorical variable (between quartiles, p=0.20-0.43; between IOM categories, p=0.33-0.78). There were no significant differences in mean VitD levels or association of VitD with RFS in tumor subtypes (ER+, HER2- / any ER, HER2+ / ER-, HER2-; p=0.14-0.50).
Conclusions: There is no evidence that VitD was associated with RFS in MA.21; the majority of subjects had adequate VitD levels at study entry. Clinical trial information: NCT00014222.
