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J Clin Oncol. 2016 May 10;34(14):1601-10. doi: 10.1200/JCO.2015.64.8675. Epub 2016 Mar 28.

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.

Author information

1
Karin Ribi, Aron Goldhirsch, and Jürg Bernhard, International Breast Cancer Study Group Coordinating Center; Jürg Bernhard, Bern University Hospital, Inselspital, Bern; Thomas Ruhstaller, Breast Center St Gallen, Swiss Group for Clinical Cancer Research, and International Breast Cancer Study Group, St Gallen, Switzerland; Weixiu Luo, Karen N. Price, Richard D. Gelber, and Meredith M. Regan, International Breast Cancer Study Group Statistical Center; Weixiu Luo, Harold J. Burstein, Richard D. Gelber, and Meredith M. Regan, Dana-Farber Cancer Institute; Harold J. Burstein, Alliance for Clinical Trials in Oncology; Karen N. Price and Richard D. Gelber, Frontier Science and Technology Research Foundation; Richard D. Gelber and Meredith M. Regan, Harvard Medical School, Boston, MA; Gini F. Fleming, The University of Chicago Medical Center and Alliance for Clinical Trials in Oncology, Chicago, IL; Prudence A. Francis, International Breast Cancer Study Group, Peter MacCallum Cancer Center, St Vincent's Hospital, University of Melbourne, Melbourne, Victoria; Australia and New Zealand Breast Cancer Trials Group, University of Newcastle, Newcastle; Alan S. Coates, International Breast Cancer Study Group and University of Sydney, Sydney, New South Wales, Australia; Eva Ciruelos, University Hospital 12 de Octubre and SOLTI Group, Madrid; Meritxell Bellet, Vall d'Hebron Institute of Oncology, Vall d'Hebron University Hospital, and SOLTI Group, Universitat Autònoma de Barcelona, Barcelona; Ana Lluch, Hospital Clinico Universitario de Valencia, Incliva Biomedical Research Institute, University of Valencia and SOLTI Group, Valencia; Antonia Perelló, Hospital Universitari Son Espases and SOLTI Group, Palma de Mallorca, Spain; Lorenzo Pavesi, Salvatore Maugeri Foundation and International Breast Cancer Study Group, Pavia; Marilena Visini, Ospedale Civile di Lecco and International Breast Cancer Study Group, Lecco; Carlo Tondini, Ospedale Papa Giovanni XXIII and International Brea

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, and annually during years 3 to 6. Differences in the change of QoL from baseline between the two treatments were tested at 6, 24, and 60 months with mixed models for repeated measures with and without chemotherapy and overall.

RESULTS:

Patients on tamoxifen plus OFS were more affected than patients on tamoxifen alone by hot flushes at 6 and 24 months, by loss of sexual interest and sleep disturbance at 6 months, and by vaginal dryness up to 60 months. Without prior chemotherapy, patients on tamoxifen alone reported more vaginal discharge over the 5 years than patients on tamoxifen plus OFS. Symptom-specific treatment differences at 6 months were less pronounced in patients with prior chemotherapy. Changes in global QoL indicators from baseline were small and similar between treatments over the whole treatment period.

CONCLUSION:

Overall, OFS added to tamoxifen resulted in worse endocrine symptoms and sexual functioning during the first 2 years of treatment, with variable magnitudes of treatment differences. Short-term differences in symptom-specific QoL, treatment burden, and coping effort between treatment groups were less pronounced for patients with prior chemotherapy, the cohort that benefited most from OFS in terms of disease control.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00066690.

PMID:
27022111
PMCID:
PMC4872319
DOI:
10.1200/JCO.2015.64.8675
[Indexed for MEDLINE]
Free PMC Article

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