Adjuvant exemestane with ovarian suppression in premenopausal breast cancer.
Adjuvant exemestane with ovarian suppression in premenopausal breast cancer.
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DOI：
10.1056/nejmoa1404037
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发表时间：
2014-07-10
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影响因子：
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通讯作者：
International Breast Cancer Study Group
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作者：
Pagani O;Regan MM;Walley BA;Fleming GF;Colleoni M;Láng I;Gomez HL;Tondini C;Burstein HJ;Perez EA;Ciruelos E;Stearns V;Bonnefoi HR;Martino S;Geyer CE Jr;Pinotti G;Puglisi F;Crivellari D;Ruhstaller T;Winer EP;Rabaglio-Poretti M;Maibach R;Ruepp B;Giobbie-Hurder A;Price KN;Bernhard J;Luo W;Ribi K;Viale G;Coates AS;Gelber RD;Goldhirsch A;Francis PA;TEXT and SOFT Investigators;International Breast Cancer Study Group
芳香化酶抑制剂辅助治疗与他莫昔芬相比改善绝经后乳腺癌患者的预后。在两项3期临床试验中，我们将绝经前乳腺癌患者随机分为芳香化酶抑制剂阿替美坦联合卵巢抑制组或他莫昔芬联合卵巢抑制组，为期5年。通过使用促性腺激素释放激素激动剂曲普瑞林、卵巢切除术或卵巢照射来抑制卵巢雌激素的产生。主要分析结合了两项试验中4690例患者的数据。中位随访时间为68个月后，维甲酸-卵巢抑制组的5年无病生存率为91.1%，他莫昔芬-卵巢抑制组为87.3%（疾病复发、第二次浸润性癌或死亡的风险比为0.72; 95%可信区间为0.60 ~ 0.85; P<0.001）。维甲酸-卵巢抑制组5年无乳腺癌发生率为92.8%，而他莫昔芬-卵巢抑制组为88.8%（复发风险比为0.66; 95%CI为0.55 ~ 0.80; P<0.001）。死亡194例（占患者的4.1%），两组的总生存率无显著差异（阿司美坦-卵巢抑制组死亡风险比为1.14; 95%CI为0.86 - 1.51; P = 0.37）。选择的3级或4级不良事件在依西美坦-卵巢抑制组中有30.6%的患者报告，在他莫昔芬-卵巢抑制组中有29.4%的患者报告，其特征与绝经后妇女相似。在绝经前妇女中，与他莫昔芬联合卵巢抑制相比，阿司美坦联合卵巢抑制的辅助治疗显著降低了复发率。（由辉瑞和其他公司资助; TEXT和SOFT ClinicalTrials.gov编号分别为NCT 00066703和NCT 00066690。）
Adjuvant therapy with an aromatase inhibitor improves outcomes, as compared with tamoxifen, in postmenopausal women with hormone-receptor–positive breast cancer. In two phase 3 trials, we randomly assigned premenopausal women with hormone-receptor–positive early breast cancer to the aromatase inhibitor exemestane plus ovarian suppression or tamoxifen plus ovarian suppression for a period of 5 years. Suppression of ovarian estrogen production was achieved with the use of the gonadotropin-releasing-hormone agonist triptorelin, oophorectomy, or ovarian irradiation. The primary analysis combined data from 4690 patients in the two trials. After a median follow-up of 68 months, disease-free survival at 5 years was 91.1% in the exemestane–ovarian suppression group and 87.3% in the tamoxifen–ovarian suppression group (hazard ratio for disease recurrence, second invasive cancer, or death, 0.72; 95% confidence interval [CI], 0.60 to 0.85; P<0.001). The rate of freedom from breast cancer at 5 years was 92.8% in the exemestane–ovarian suppression group, as compared with 88.8% in the tamoxifen–ovarian suppression group (hazard ratio for recurrence, 0.66; 95% CI, 0.55 to 0.80; P<0.001). With 194 deaths (4.1% of the patients), overall survival did not differ significantly between the two groups (hazard ratio for death in the exemestane–ovarian suppression group, 1.14; 95% CI, 0.86 to 1.51; P = 0.37). Selected adverse events of grade 3 or 4 were reported for 30.6% of the patients in the exemestane–ovarian suppression group and 29.4% of those in the tamoxifen–ovarian suppression group, with profiles similar to those for postmenopausal women. In premenopausal women with hormone-receptor–positive early breast cancer, adjuvant treatment with exemestane plus ovarian suppression, as compared with tamoxifen plus ovarian suppression, significantly reduced recurrence. (Funded by Pfizer and others; TEXT and SOFT ClinicalTrials.gov numbers, NCT00066703 and NCT00066690, respectively.)