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他莫昔芬对比他莫昔芬联合氨鲁米特作为激素受体阳性绝经后乳腺癌患者辅助治疗的随机试验:奥地利乳腺癌和结直肠癌研究组试验6

Randomized trial of tamoxifen versus tamoxifen plus aminoglutethimide as adjuvant treatment in postmenopausal breast cancer patients with hormone receptor-positive disease: Austrian breast and colorectal cancer study group trial 6.

作者信息

Schmid Marianne, Jakesz Raimund, Samonigg Hellmut, Kubista Ernst, Gnant Michael, Menzel Christian, Seifert Michael, Haider Karin, Taucher Susanne, Mlineritsch Brigitte, Steindorfer Peter, Kwasny Werner, Stierer Michael, Tausch Christoph, Fridrik Michael, Wette Viktor, Steger Günther, Hausmaninger Hubert

机构信息

Medical Department, Graz University, and Second Department of Surgery, Graz Hospital, Graz, Austria.

出版信息

J Clin Oncol. 2003 Mar 15;21(6):984-90. doi: 10.1200/JCO.2003.01.138.

Abstract

PURPOSE

To determine whether the addition of aminoglutethimide to tamoxifen is able to improve the outcome in postmenopausal patients with hormone receptor-positive, early-stage breast cancer.

PATIENTS AND METHODS

A total of 2,021 postmenopausal women were randomly assigned to receive either tamoxifen for 5 years alone or tamoxifen in combination with aminoglutethimide (500 mg/d) for the first 2 years of treatment. Tamoxifen was administered at 40 mg/d for the first 2 years and at 20 mg/d for 3 years.

RESULTS

All randomized and eligible patients were included in the analysis according to the intention-to-treat principle. After a median follow-up of 5.3 years, the 5-year disease-free survival in the aminoglutethimide plus tamoxifen group was 83.6% versus 83.7% in the monotherapy group (P =.89). The corresponding data for overall survival at 5 years were 91.4% and 91.2%, respectively (P =.74). More patients failed to complete combination treatment (13.7%) because of side effects as compared to tamoxifen alone (5.2%; P =.0001).

CONCLUSION

Aminoglutethimide given for 2 years in addition to tamoxifen for 5 years does not improve the prognosis of postmenopausal patients with receptor-positive, lymph node-negative or lymph node-positive breast cancer.

摘要

目的

确定在他莫昔芬基础上加用氨鲁米特是否能够改善绝经后激素受体阳性早期乳腺癌患者的治疗结局。

患者与方法

总共2021名绝经后女性被随机分配,分别接受5年单药他莫昔芬治疗,或在治疗的前2年接受他莫昔芬联合氨鲁米特(500毫克/天)治疗。他莫昔芬在治疗的前2年以40毫克/天给药,后3年以20毫克/天给药。

结果

根据意向性分析原则,所有随机分组且符合条件的患者均纳入分析。中位随访5.3年后,氨鲁米特联合他莫昔芬组的5年无病生存率为83.6%,单药治疗组为83.7%(P = 0.89)。5年总生存率的相应数据分别为91.4%和91.2%(P = 0.74)。与单纯使用他莫昔芬(5.2%)相比,更多患者因副作用未能完成联合治疗(13.7%;P = 0.0001)。

结论

在5年他莫昔芬治疗基础上再加用2年氨鲁米特,并不能改善绝经后激素受体阳性、淋巴结阴性或淋巴结阳性乳腺癌患者的预后。

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