Adjuvant treatment of premenopausal women with endocrine-responsive early breast cancer: Design of the TEXT and SOFT trials

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• 作者：Meredith M. Regan ; Olivia Pagani ; Gini F. Fleming ; Barbara A. Walley ; Karen N. Price ; Manuela Rabaglio ; Rudolf Maibach ; Barbara Ruepp ; Alan S. Coates ; Aron Goldhirsch ; Marco Colleoni ; Richard D. Gelber ; Prudence A. Francis ; International Breast Cancer Study Group (IBCSG) ; the SOFT ; TEXT Investigators
• 关键词：Premenopausal ; Endocrine-responsive ; Early breast cancer ; Adjuvant therapy ; Trial design
• 刊名：The Breast
• 出版年：December, 2013
• 年：2013
• 卷：22
• 期：6
• 页码：1094-1100
• 全文大小：626 K

文摘

Objectives

In 2003 the International Breast Cancer Study Group (IBCSG) initiated the TEXT and SOFT randomized phase III trials to answer two questions concerning adjuvant treatment for premenopausal women with endocrine-responsive early breast cancer: 1-What is the role of aromatase inhibitors (AI) for women treated with ovarian function suppression (OFS)? 2-What is the role of OFS for women who remain premenopausal and are treated with tamoxifen?

Methods

TEXT randomized patients to receive exemestane or tamoxifen with OFS. SOFT randomized patients to receive exemestane with OFS, tamoxifen with OFS, or tamoxifen alone. Treatment was for 5 years from randomization.

Results

TEXT and SOFT successfully met their enrollment goals in 2011. The 5738 enrolled women had lower-risk disease and lower observed disease-free survival (DFS) event rates than anticipated. Consequently, 7 and 13 additional years of follow-up for TEXT and SOFT, respectively, were required to reach the targeted DFS events (median follow-up about 10.5 and 15 years). To provide timely answers, protocol amendments in 2011 specified analyses based on chronological time and median follow-up. To assess the AI question, exemestane聽+聽OFS versus tamoxifen聽+聽OFS, a combined analysis of TEXT and SOFT became the primary analysis (n聽=聽4717). The OFS question became the primary analysis from SOFT, assessing the unique comparison of tamoxifen聽+聽OFS versus tamoxifen alone (n聽=聽2045). The first reports are anticipated in mid- and late-2014.

Conclusions

We present the original designs of TEXT and SOFT and adaptations to ensure timely answers to two questions concerning optimal adjuvant endocrine treatment for premenopausal women with endocrine-responsive breast cancer.

Trial Registration

TEXT:

SOFT: