Tailoring Adjuvant Endocrine Therapy for Premenopausal Breast Cancer.
Tailoring Adjuvant Endocrine Therapy for Premenopausal Breast Cancer.
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为绝经前乳腺癌调整辅助内分泌疗法。
DOI：
10.1056/nejmoa1803164
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发表时间：
2018-07-12
期刊：
影响因子：
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通讯作者：
SOFT and TEXT Investigators and the International Breast Cancer Study Group
中科院分区：
文献类型：
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作者：
Francis PA;Pagani O;Fleming GF;Walley BA;Colleoni M;Láng I;Gómez HL;Tondini C;Ciruelos E;Burstein HJ;Bonnefoi HR;Bellet M;Martino S;Geyer CE Jr;Goetz MP;Stearns V;Pinotti G;Puglisi F;Spazzapan S;Climent MA;Pavesi L;Ruhstaller T;Davidson NE;Coleman R;Debled M;Buchholz S;Ingle JN;Winer EP;Maibach R;Rabaglio-Poretti M;Ruepp B;Di Leo A;Coates AS;Gelber RD;Goldhirsch A;Regan MM;SOFT and TEXT Investigators and the International Breast Cancer Study Group
在卵巢功能抑制试验（SOFT）和他莫昔芬和依西美坦试验（TEXT）中，接受芳香化酶抑制剂依西美坦联合卵巢抑制的绝经前妇女的5年乳腺癌复发率显著低于接受他莫昔芬联合卵巢抑制的妇女。在他莫昔芬基础上加用卵巢抑制剂并没有显著降低复发率。在这里，我们报告了这两项试验的最新结果。绝经前女性在SOFT中被随机分配接受5年他莫昔芬、他莫昔芬加卵巢抑制或依西美坦加卵巢抑制，在TEXT中接受他莫昔芬加卵巢抑制或依西美坦加卵巢抑制。根据接受化疗的情况对随机化进行分层。在SOFT中，单用他莫昔芬的8年无病生存率为78.9%，他莫昔芬联合卵巢抑制的8年无病生存率为83.2%，阿司美坦联合卵巢抑制的8年无病生存率为85.9%（他莫昔芬单用vs.他莫昔芬联合卵巢抑制的P = 0.009）。单用他莫昔芬的8年总生存率为91.5%，他莫昔芬联合卵巢抑制的为93.3%，阿司美坦联合卵巢抑制的为92.1%（他莫昔芬单用与他莫昔芬联合卵巢抑制的P = 0.01）;在化疗后仍处于绝经前的妇女中，这一比率分别为85.1%、89.4%和87.2%。在接受化疗的HER 2阴性癌症患者中，阿司美坦联合卵巢抑制的8年远处复发率低于他莫昔芬联合卵巢抑制的8年远处复发率（SOFT中为7.0个百分点，TEXT中为5.0个百分点）。他莫昔芬单药组、他莫昔芬-卵巢抑制组和阿司美坦-卵巢抑制组中3级或以上不良事件的发生率分别为24.6%、31.0%和32.3%。在绝经前乳腺癌妇女中，在他莫昔芬基础上加用卵巢抑制剂比单用他莫昔芬显著提高了8年无病生存率和总生存率。使用依西美坦加卵巢抑制导致更高的无复发率。接受卵巢抑制的两组不良事件的发生率高于单用他莫昔芬组。（由辉瑞和其他公司资助; SOFT和TEXT ClinicalTrials.gov编号分别为NCT 00066690和NCT 00066703。）
In the Suppression of Ovarian Function Trial (SOFT) and the Tamoxifen and Exemestane Trial (TEXT), the 5-year rates of recurrence of breast cancer were significantly lower among premenopausal women who received the aromatase inhibitor exemestane plus ovarian suppression than among those who received tamoxifen plus ovarian suppression. The addition of ovarian suppression to tamoxifen did not result in significantly lower recurrence rates than those with tamoxifen alone. Here, we report the updated results from the two trials. Premenopausal women were randomly assigned to receive 5 years of tamoxifen, tamoxifen plus ovarian suppression, or exemestane plus ovarian suppression in SOFT and to receive tamoxifen plus ovarian suppression or exemestane plus ovarian suppression in TEXT. Randomization was stratified according to the receipt of chemotherapy. In SOFT, the 8-year disease-free survival rate was 78.9% with tamoxifen alone, 83.2% with tamoxifen plus ovarian suppression, and 85.9% with exemestane plus ovarian suppression (P = 0.009 for tamoxifen alone vs. tamoxifen plus ovarian suppression). The 8-year rate of overall survival was 91.5% with tamoxifen alone, 93.3% with tamoxifen plus ovarian suppression, and 92.1% with exemestane plus ovarian suppression (P = 0.01 for tamoxifen alone vs. tamoxifen plus ovarian suppression); among the women who remained premenopausal after chemotherapy, the rates were 85.1%, 89.4%, and 87.2%, respectively. Among the women with cancers that were negative for HER2 who received chemotherapy, the 8-year rate of distant recurrence with exemestane plus ovarian suppression was lower than the rate with tamoxifen plus ovarian suppression (by 7.0 percentage points in SOFT and by 5.0 percentage points in TEXT). Grade 3 or higher adverse events were reported in 24.6% of the tamoxifenalone group, 31.0% of the tamoxifen–ovarian suppression group, and 32.3% of the exemestane–ovarian suppression group. Among premenopausal women with breast cancer, the addition of ovarian suppression to tamoxifen resulted in significantly higher 8-year rates of both disease-free and overall survival than tamoxifen alone. The use of exemestane plus ovarian suppression resulted in even higher rates of freedom from recurrence. The frequency of adverse events was higher in the two groups that received ovarian suppression than in the tamoxifen-alone group. (Funded by Pfizer and others; SOFT and TEXT ClinicalTrials.gov numbers, NCT00066690 and NCT00066703, respectively.)