Predictive Effect of IGFBP-3 on Low-Dose Tamoxifen Efficacy in Noninvasive Breast Cancer in the Phase III Tam-01 Trial.

However, predictive biomarkers of babytam efficacy are lacking.

然而，目前尚缺乏预测babytam疗效的生物标志物。

We studied whether baseline levels of insulin-like growth factor-1 (IGF-I), IGF-binding protein-3 (IGFBP-3), estradiol, and sex hormone-binding globulin (SHBG) and their ratios predict babytam efficacy on breast cancer events in a preplanned secondary analysis.

我们研究了基线水平的胰岛素样生长因子-1（IGF-I）、IGF结合蛋白-3（IGFBP-3）、雌二醇和性激素结合球蛋白（SHBG）及其比率是否能预测babytam对乳腺癌事件的有效性，这是在一个预先计划的次要分析中进行的。

patients_and_methods

Within a 1:1 placebo-controlled, multicenter randomized trial of babytam or placebo administered for 3 years after surgery in women with hormone-sensitive or unknown breast intraepithelial neoplasia, including atypical ductal hyperplasia and lobular or ductal carcinoma in situ, 406 of 500 participants consented to blood sampling at baseline and at 1 and 3 years.

在一个1:1的安慰剂对照、多中心随机试验中，对接受手术后3年的乳腺激素敏感或未知乳腺上皮内瘤变的女性，包括非典型导管增生和小叶或导管原位癌，给予babytam或安慰剂治疗，500名参与者中有406名同意在基线以及1年和3年时进行血液采样。

Serum IGF-I, IGFBP-3, estradiol, and SHBG levels and their ratios were measured using chemiluminescent immunoassays.

血清IGF-I、IGFBP-3、雌二醇和SHBG水平及其比率通过化学发光免疫测定法进行测量。

Biomarker changes were estimated using mixed-effects models, and incidencerate ratios were calculated after 10 years of follow-up with Poisson regression.

使用混合效应模型估计生物标志物的变化，并在10年的随访后使用泊松回归计算发生率比。

Subgroup analyses were performed using an interaction test and subpopulation treatment effect pattern plot.

使用交互作用检验和亚组治疗效果模式图进行了亚组分析。

Results

Baseline levels of IGFBP-3 in the three top quartiles (≥3.44 µg/mL), but not in the lower quartile, predicted greater babytam efficacy compared with placebo (Pinteraction = 0.006).

基线时IGFBP-3水平在最高的三个四分位数（≥3.44 µg/mL）中，而不是在最低的四分位数中，预测了与安慰剂相比，babytam的疗效更好（Pinteraction = 0.006）。

Baseline IGF-I, estradiol, or SHBG levels were not predictive of babytam efficacy, whereas the IGF-I/IGFBP-3 ratio was borderline significant (Pinteraction = 0.067).

基线IGF-I、雌二醇或SHBG水平并不能预测宝贝坦的疗效，而IGF-I/IGFBP-3比率的预测作用接近显著（Pinteraction = 0.067）。

Conclusions

High baseline levels of IGFBP-3 (≥3.44 µg/mL) predicted babytam efficacy and may help differentiate which women benefit most from this treatment.

高基线IGFBP-3水平（≥3.44 µg/mL）预测了宝贝坦的疗效，并可能帮助区分哪些女性最能从这种治疗中受益。