Twelve-Month Estrogen Levels in Premenopausal Women With Hormone Receptor-Positive Breast Cancer Receiving Adjuvant Triptorelin Plus Exemestane or Tamoxifen in the Suppression of Ovarian Function Trial (SOFT): The SOFT-EST Substudy
Twelve-Month Estrogen Levels in Premenopausal Women With Hormone Receptor-Positive Breast Cancer Receiving Adjuvant Triptorelin Plus Exemestane or Tamoxifen in the Suppression of Ovarian Function Trial (SOFT): The SOFT-EST Substudy
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DOI：
10.1200/jco.2015.61.2259
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发表时间：
2016-05-10
影响因子：
45.3
通讯作者：
Regan, Meredith M.
中科院分区：
文献类型：
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作者：
Bellet, Meritxell;Gray, Kathryn P.;Regan, Meredith M.
目的描述雌二醇（E2）、雌酮（E1）、硫酸雌酮（E1 S）患者和方法卵巢功能抑制试验中选择曲普瑞林作为卵巢抑制方法的绝经前早期乳腺癌患者，随机分配到曲普瑞林组，加曲普瑞林或他莫昔芬加曲普瑞林，直至达到120名患者的目标人群。采血时间点为0、3、6、12、18、24、36和48个月。血清雌激素测定具有高度敏感性和特异性的测定。这项预先计划的12个月分析评估了所有患者的E2、E1、E1 S、促卵泡激素和促黄体激素水平，以及在阿司美坦加曲普瑞林治疗期间任何时间点E2水平大于2.72 pg/mL的患者比例。（西美坦，n = 86;他莫昔芬，n = 30;中位年龄，44岁;中位E2，51 pg/mL; 55%既往化疗）开始曲普瑞林，并抽取一个或多个样本。使用阿司美坦加曲普瑞林时，E2、E1和E1 S水平较基线的中位数降低始终>= 95%，导致在所有时间点的水平均显著低于他莫昔芬加曲普瑞林。在接受阿司美坦加曲普瑞林治疗的患者中，分别有25%、24%和17%的患者在3、6和12个月时E2水平大于2.72 pg/mL。与治疗期间E2水平大于2.72 pg/mL相关的基线因素为既往未接受过化疗（P = .06），体重指数较高（P = .05），促卵泡激素和促黄体生成素水平较低结论：在第一年，大多数接受依西美坦加曲普瑞林治疗的患者的E2水平低于2.72 pg/mL的定义阈值，与绝经后患者服用芳香酶抑制剂的水平一致，但在每个时间点，至少17%的患者的水平高于阈值。(C)2016年美国临床肿瘤学会
PurposeTo describe estradiol (E2), estrone (E1), and estrone sulfate (E1S) levels during the first year of monthly triptorelin plus exemestane or tamoxifen and to assess possible suboptimal suppression while receiving exemestane plus triptorelin.Patients and MethodsPremenopausal patients with early breast cancer on the Suppression of Ovarian Function Trial who selected triptorelin as the ovarian suppression method and were randomly assigned to exemestane plus triptorelin or tamoxifen plus triptorelin were enrolled until the target population of 120 patients was reached. Blood sampling time points were 0, 3, 6, 12, 18, 24, 36, and 48 months. Serum estrogens were measured with a highly sensitive and specific assay. This preplanned 12-month analysis evaluated E2, E1, E1S, follicle-stimulating hormone, and luteinizing hormone levels in all patients and the proportion of patients with E2 levels greater than 2.72 pg/mL at any time point during treatment with exemestane plus triptorelin.ResultsOne hundred sixteen patients (exemestane, n = 86; tamoxifen, n = 30; median age, 44 years; median E2, 51 pg/mL; 55% prior chemotherapy) started triptorelin and had one or more samples drawn. With exemestane plus triptorelin, median reductions from baseline E2, E1, and E1S levels were consistently >= 95%, resulting in significantly lower levels than with tamoxifen plus triptorelin at all time points. Among patients on exemestane plus triptorelin, 25%, 24%, and 17% had an E2 level greater than 2.72 pg/mL at 3, 6, and 12 months, respectively. Baseline factors related to ontreatment E2 level greater than 2.72 pg/mL were no prior chemotherapy (P = .06), higher body mass index (P = .05), and lower follicle-stimulating hormone and luteinizing hormone (each P< .01).ConclusionDuring the first year, most patients on exemestane plus triptorelin had E2 levels below the defined threshold of 2.72 pg/mL, consistent with levels reported in postmenopausal patients on aromatase inhibitors, but at each time point, at least 17% of patients had levels greater than the threshold. (C) 2016 by American Society of Clinical Oncology