Journal article

Adjuvant Tamoxifen Plus Ovarian Function Suppression Versus Tamoxifen Alone in Premenopausal Women With Early Breast Cancer: Patient-Reported Outcomes in the Suppression of Ovarian Function Trial

Karin Ribi, Weixiu Luo, Jurg Bernhard, Prudence A Francis, Harold J Burstein, Eva Ciruelos, Meritxell Bellet, Lorenzo Pavesi, Ana Lluch, Marilena Visini, Vani Parmar, Carlo Tondini, Pierre Kerbrat, Antonia Perello, Patrick Neven, Roberto Torres, Davide Lombardi, Fabio Puglisi, Per Karlsson, Thomas Ruhstaller Show all

JOURNAL OF CLINICAL ONCOLOGY | AMER SOC CLINICAL ONCOLOGY | Published : 2016

Abstract

PURPOSE: The Suppression of Ovarian Function trial showed improved disease control for tamoxifen plus ovarian function suppression (OFS) compared with tamoxifen alone for the cohort of premenopausal patients who received prior chemotherapy. We present the patient-reported outcomes. PATIENTS AND METHODS: The quality-of-life (QoL) analysis includes 1,722 of 2,045 premenopausal patients with hormone receptor-positive breast cancer randomly assigned to receive adjuvant treatment with 5 years of tamoxifen plus OFS or tamoxifen alone. Chemotherapy use before enrollment was optional. Patients completed a QoL form consisting of global and symptom indicators at baseline, every 6 months for 24 months,..

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Grants

Awarded by NCI


Awarded by Australia and New Zealand Breast Cancer Trials Group (National Health and Medical Research Council)


Awarded by Southwest Oncology Group (NIH)


Awarded by Alliance (NIH)


Awarded by Eastern Cooperative Oncology Group-American College of Radiology Imaging Network (NIH)


Awarded by National Surgical Adjuvant Breast and Bowel Project/NRG Oncology (NIH)


Awarded by National Cancer Institute of Canada (NIH)


Awarded by National Cancer Institute of Canada (Canadian Cancer Society Research Institute)


Awarded by NATIONAL CANCER INSTITUTE


Funding Acknowledgements

Written on behalf of the Suppression of Ovarian Function Trial (SOFT) investigators and the International Breast Cancer Study Group (IBCSG); investigators and affiliations are listed in the Appendix (online only). SOFT received financial support for trial conduct from Pfizer, the IBCSG, and the US National Cancer Institute (NCI). Pfizer and Ipsen provided drug supply. The coordinating group of IBCSG was supported by Frontier Science and Technology Research Foundation, the Swiss Group for Clinical Cancer Research, NCI (Grant No. CA75362 to M.M.R.), Cancer Research Switzerland/Oncosuisse, and the Foundation for Clinical Cancer Research of Eastern Switzerland. Grant support for cooperative groups was as follows: Australia and New Zealand Breast Cancer Trials Group (National Health and Medical Research Council Grants No. 351161, 510788, and 1105058); Southwest Oncology Group (NIH Grant No. CA32102); Alliance (NIH Grant No. U10-CA180821); Eastern Cooperative Oncology Group-American College of Radiology Imaging Network (NIH Grants No. CA21115 and CA16116); National Surgical Adjuvant Breast and Bowel Project/NRG Oncology (NIH Grants No. U10-CA-12027, U10-CA-69651, U10-CA-37377, and U10-CA-69974); and National Cancer Institute of Canada (NIH Grant No. CA077202 and Canadian Cancer Society Research Institute Grants No. 015469 and 021039).