Title
Absolute benefit of adjuvant endocrine therapies for premenopausal women with hormone receptor-positive, Human epidermal growth factor receptor 2-Negative early breast cancer: TEXT and SOFT Trials
Date Issued
01 July 2016
Access level
open access
Resource Type
journal article
Author(s)
Regan M.M.
Francis P.A.
Pagani O.
Fleming G.F.
Walley B.A.
Viale G.
Colleoni M.
Láng I.
Tondini C.
Pinotti G.
Price K.N.
Coates A.S.
Goldhirsch A.
Gelber R.D.
Publisher(s)
American Society of Clinical Oncology
Abstract
Purpose Risk of recurrence is the primary consideration in breast cancer adjuvant therapy recommendations. The TEXT (Tamoxifen and Exemestane Trial) and SOFT (Suppression of Ovarian Function Trial) trials investigated adjuvant endocrine therapies for premenopausal women with hormone receptor-positive breast cancer, testing exemestane plus ovarian function suppression (OFS), tamoxifen plus OFS, and tamoxifen alone. We examined absolute treatment effect across a continuum of recurrence risk to individualize endocrine therapy decision making for premenopausal women with human epidermal growth factor receptor 2 (HER2) -negative disease. Patients and Methods The TEXT and SOFT hormone receptor-positive, HER2-negative analysis population included 4,891 women. The endpoint wasbreast cancer-free interval (BCFI), defined as time from random assignment to first occurrence of invasive locoregional, distant, or contralateral breast cancer. A continuous, composite measure of recurrence risk for each patient was determined from a Cox model incorporating age, nodal status, tumor size and grade, and estrogen receptor, progesterone receptor, and Ki-67 expression levels. Subpopulation treatment effect pattern plot methodology revealed differential treatment effects on 5-year BCFI according to composite risk. Results SOFT patients who remained premenopausal after chemotherapy experienced absolute improvement of 5% or more in 5-year BCFI with exemestane plus OFS versus tamoxifen plus OFS or tamoxifen alone, reaching 10% to 15% at intermediate to high composite risk; the benefit of tamoxifen plus OFS versus tamoxifen alone was apparent at the highest composite risk. The SOFT no-chemotherapy cohort-for whom composite risk was lowest on average-did well with all endocrine therapies. For TEXT patients, the benefit of exemestane plus OFS versus tamoxifen plus OFS in 5-year BCFI ranged from 5% to 15%; patients not receiving chemotherapy and with lowest composite risk did well with both treatments. Conclusion Premenopausal women with hormone receptor-positive, HER2-negative disease and high recurrence risk, as defined by clinicopathologic characteristics, may experience improvement of 10% to 15% in 5-year BCFI with exemestane plus OFS versus tamoxifen alone. An improvement of at least 5% may be achieved for women at intermediate risk, and improvement is minimal for those at lowest risk.
Start page
2221
End page
2230
Volume
34
Issue
19
Language
English
OCDE Knowledge area
Oncología
Patología
Scopus EID
2-s2.0-84976311631
PubMed ID
Source
Journal of Clinical Oncology
ISSN of the container
0732183X
Sponsor(s)
Supported by the International Breast Cancer Study Group (IBCSG), the National Cancer Institute, and Pfizer, which along with Ipsen also provided trial drugs (SOFT and TEXT trials); by the Frontier Science and Technology Research Foundation, the Swiss Group for Clinical Cancer Research, Cancer Research Switzerland/Oncosuisse, the Foundation for Clinical Cancer Research of Eastern Switzerland, Grant No. CA75362 from the National Cancer Institute, Promise Grant No. KG080081 from Susan G. Komen for the Cure, and the Breast Cancer Research Foundation (IBCSG); by Grants No. 351161 and 510788 from the National Health and Medical Research Council to the Australia and New Zealand Breast Cancer Trials Group; by Grant No. CA32102 from the National Institutes of Health (NIH) to SWOG; by Grant No. CA180821 from the NIH to the Alliance for Clinical Trials in Oncology; by Grants No. CA21115 and CA16116 from the NIH to the Eastern Cooperative Oncology Group-American College of Radiology Imaging Network; by Grants No. U10-CA-12027, U10-CA-69651, U10-CA-37377, and U10-CA-69974 from the NIH to the National Surgical Adjuvant Breast and Bowel Project/NRG Oncology; by Grant No. CA077202 from the NIH and Grants No. 015469 and 021039 from the Canadian Cancer Society Research Institute to the National Cancer Institute of Canada Clinical Trials Group; and by Cancer Research UK (CRUK), Grants No. 03/022, 03/023, and A15955 from CRUK, the National Institute for Health Research Royal Marsden/Institute of Cancer Research (ICR) Biomedical Research Centre, and the NIHR Cambridge Biomedical Research Centre to the ICR-Clinical Trials and Statistics Unit (CTSU) on behalf of the National Cancer Research Institute (NCRI) Breast Clinical Studies Group (BCSG) United Kingdom (NCRI-BCSG-ICR-CTSU partnership).
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