Title
Treatment efficacy, adherence, and quality of life among women younger than 35 years in the international breast cancer study group TEXT and SOFT adjuvant endocrine therapy trials
Date Issued
20 September 2017
Access level
open access
Resource Type
journal article
Author(s)
Saha P.
Regan M.M.
Pagani O.
Francis P.A.
Walley B.A.
Ribi K.
Bernhard J.
Luo W.
Burstein H.J.
Parmar V.
Torres R.
Stewart J.
Bellet M.
Perelló A.
Dane F.
Moreira A.
Vorobiof D.
Nottage M.
Price K.N.
Coates A.S.
Goldhirsch A.
Gelber R.D.
Colleoni M.
Fleming G.F.
Publisher(s)
American Society of Clinical Oncology
Abstract
Purpose: To describe benefits and toxicities of adjuvant endocrine therapies in women younger than 35 years with breast cancer (n = 582) enrolled in the Suppression of Ovarian Function Trial (SOFT) and Tamoxifen and Exemestane Trial (TEXT). Methods: In SOFT, women still premenopausal after surgery with or without chemotherapy were randomly assigned to tamoxifen alone, tamoxifen plus ovarian function suppression (OFS), or exemestane plus OFS. In TEXT, all received OFS with or without concomitant chemotherapy and were randomly assigned to exemestane plus OFS or tamoxifen plus OFS. We summarize treatment efficacy, quality of life, and adherence of the cohort of women younger than 35 years in SOFT and TEXT, alongside data from the cohort of older premenopausal women. Results: For 240 human epidermal growth factor receptor 2-negative patients younger than 35 years enrolled in SOFT after receiving chemotherapy, the 5-year breast cancer-free interval (BCFI) was 67.1% (95% CI, 54.6% to 76.9%) with tamoxifen alone, 75.9% with tamoxifen plus OFS (95% CI, 64.0% to 84.4%), and 83.2% with exemestane plus OFS (95% CI, 72.7% to 90.0%). For 145 human epidermal growth factor receptor 2-negative patients younger than 35 years in TEXT, 5-year BCFI was 79.2% (95% CI, 66.2% to 87.7%) with tamoxifen plus OFS and 81.6% (95% CI, 69.8% to 89.2%) with exemestane plus OFS. The most prominent quality of life symptom for patients younger than 35 years receiving OFS was vasomotor symptoms, with the greatest worsening from baseline at 6 months (on the order of 30 to 40 points), but loss of sexual interest and difficulties in becoming aroused were also clinically meaningful (≥ 8-point change). The level of symptom burden was similar in older premenopausal women. A total of 19.8% of women younger than 35 years stopped all protocol-assigned endocrine therapy early. Conclusion: In women younger than 35 years with hormone receptor-positive breast cancer, adjuvant OFS combined with tamoxifen or exemestane produces large improvements in BCFI compared with tamoxifen alone. Menopausal symptoms are significant but are not worse than those seen in older premenopausal women.
Start page
3113
End page
3122
Volume
35
Issue
27
Language
English
OCDE Knowledge area
Farmacología, Farmacia
Oncología
Scopus EID
2-s2.0-85029574133
PubMed ID
Source
Journal of Clinical Oncology
ISSN of the container
0732183X
Sponsor(s)
Grant support of cooperative groups: Australia and New Zealand Breast Cancer Trials Group supported by National Health and Medical Research Council Grants No. 351161, 510788, and 1105058; Southwest Oncology Group supported by National Institutes of Health (NIH) Grant No. CA32102; Alliance for Clinical Trials in Oncology supported by NIH Grant No. CA180821; Eastern Cooperative Oncology Group–American College of Radiology Imaging Network supported by NIH Grants No. CA21115 and CA16116; National Surgical Adjuvant Breast and Bowel Project/NRG Oncology supported by NIH Grants No. U10-CA-12027, U10-CA-69651, U10-CA-37377, and U10-CA-69974; National Cancer Institute of Canada Clinical Trials Group supported by NIH Grant No. CA077202 and Canadian Cancer Society Research Institute Grants No. 015469 and 021039; Institute of Cancer Research Clinical Trials and Statistics Unit on behalf of the National Cancer Research Institute Breast Clinical Studies Group United Kingdom supported by Cancer Research UK Grants No. CRUKE/03/022, CRUKE/03/023, and A15955; National Institute for Health Research Royal Marsden/Institute of Cancer Research Biomedical Research Centre; and National Institute for Health Research Cambridge Biomedical Research Centre.
TEXT and SOFT received financial support for trial conduct from Pfizer, the International Breast Cancer Study Group (IBCSG), and the US National Cancer Institute (NCI). Pfizer and Ipsen provided drug supply. The pharmaceutical companies have no role in the reporting or interpretation of the trials, other than a minority representation on the Steering Committee. Support for the coordinating group, IBCSG: Frontier Science and Technology Research Foundation, Swiss Group for Clinical Cancer Research, Cancer Research Switzerland/Oncosuisse, the Foundation for Clinical Cancer Research of Eastern Switzerland, and the US NCI Grant No. CA75362.
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