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

Publication

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

Journal Paper/Review - Mar 28, 2016

Ribi Karin, Torres Roberto, Lombardi Davide, Puglisi Fabio, Karlsson Per, Ruhstaller Thomas, Colleoni Marco, Coates Alan S, Goldhirsch Aron, Price Karen N, Gelber Richard D, Regan Meredith M, Neven Patrick, Perelló Antonia, Kerbrat Pierre, Luo Weixiu, Bernhard Jürg, Francis Prudence A, Burstein Harold J, Ciruelos Eva, Bellet Meritxell, Pavesi Lorenzo, Lluch Ana, Visini Marilena, Parmar Vani, Tondini Carlo, Fleming Gini F

Citation

Ribi K, Torres R, Lombardi D, Puglisi F, Karlsson P, Ruhstaller T, Colleoni M, Coates A, Goldhirsch A, Price K, Gelber R, Regan M, Neven P, Perelló A, Kerbrat P, Luo W, Bernhard J, Francis P, Burstein H, Ciruelos E, Bellet M, Pavesi L, Lluch A, Visini M, Parmar V, Tondini C, Fleming G. 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. J Clin Oncol 2016; 34:1601-10.

Type

Journal Paper/Review (English)

Journal

J Clin Oncol 2016; 34

Publication Date

Mar 28, 2016

Issn Electronic

1527-7755

Pages

1601-10

Brief description/objective

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.