绝经前乳腺癌的辅助依西美坦加卵巢抑制。
Adjuvant exemestane with ovarian suppression in premenopausal breast cancer.
机构信息
The authors' affiliations are listed in the Appendix.
出版信息
N Engl J Med. 2014 Jul 10;371(2):107-18. doi: 10.1056/NEJMoa1404037. Epub 2014 Jun 1.
BACKGROUND
Adjuvant therapy with an aromatase inhibitor improves outcomes, as compared with tamoxifen, in postmenopausal women with hormone-receptor-positive breast cancer.
METHODS
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.
RESULTS
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.
CONCLUSIONS
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.).
背景
与他莫昔芬相比，芳香化酶抑制剂辅助治疗可改善激素受体阳性乳腺癌绝经后妇女的结局。
方法
在两项 3 期试验中，我们将激素受体阳性早期乳腺癌的绝经前妇女随机分配至芳香化酶抑制剂依西美坦联合卵巢抑制或他莫昔芬联合卵巢抑制，治疗时间为 5 年。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。主要分析合并了两项试验中的 4690 例患者的数据。
结果
中位随访 68 个月后，依西美坦卵巢抑制组 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、第二侵袭性癌症或死亡的风险比，0.72；95%置信区间[CI]，0.60 至 0.85；P<0.001）。依西美坦卵巢抑制组 5 年无乳腺癌生存率为 92.8%，他莫昔芬卵巢抑制组为 88.8%（复发风险比，0.66；95%CI，0.55 至 0.80；P<0.001）。两组共有 194 例死亡（占患者的 4.1%），总生存率无显著差异（依西美坦卵巢抑制组死亡风险比，1.14；95%CI，0.86 至 1.51；P=0.37）。报告了 30.6%的依西美坦卵巢抑制组患者和 29.4%的他莫昔芬卵巢抑制组患者出现 3 级或 4 级不良事件，这些不良事件的类型与绝经后妇女相似。
结论
与他莫昔芬联合卵巢抑制相比，激素受体阳性早期乳腺癌绝经前妇女的辅助治疗中使用依西美坦联合卵巢抑制可显著降低复发率。（由辉瑞等资助；TEXT 和 SOFT 临床试验.gov 编号，NCT00066703 和 NCT00066690）。
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