Patient-reported Outcomes Show Tamoxifen Plus OFS Worse
Women who received tamoxifen plus ovarian function suppression (OFS) reported worse endocrine symptoms and sexual functioning.
Women who received tamoxifen plus ovarian function suppression (OFS) reported worse endocrine symptoms and sexual functioning during the first 2 years of treatment compared with those who received tamoxifen alone, according to the patient-reported outcomes of the Suppression of Ovarian Function trial published online ahead of print in the Journal of Clinical Oncology.1
For this quality-of-life (QoL) analysis, 1722 of 2045 premenopausal women with hormone receptor-positive breast cancer were randomized to receive adjuvant treatment with 5 years of tamoxifen plus OFS or tamoxifen alone; prior chemotherapy use was optional.
The participants completed a QoL form at baseline, every 6 months for 2 years, and annually for 4 years. The form measured global and symptom indicators. Differences in the change of QoL from baseline between the 2 treatments were tested at 6, 24, and 60 months. Mixed models were used for repeated measures with and without chemotherapy and overall.
Women who received tamoxifen plus OFS were more affected 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 than the women who received tamoxifen alone.
Among those who did not receive prior chemotherapy, Vaginal discharge was reported by more women receiving tamoxifen alone than those receiving tamoxifen plus OFS over the 5 years. Among those who received prior chemotherapy, symptom-specific treatment differences were less pronounced at 6 months.
Over the whole treatment period, changes in global QoL indicators from baseline were small and similar between the 2 treatment groups.
In the Suppression of Ovarian Function trial, disease control was improved with tamoxifen plus OFS compared with tamoxifen alone in women who received prior chemotherapy. However, patient-reported outcomes showed short-term differences in symptom-specific quality of life (QoL), treatment burden, and coping effort were less pronounced for patients who received prior chemotherapy.
1. Ribi K, Luo W, Bernhard J, et al. 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 [published online ahead of print March 28, 2016]. J Clin Oncol. doi:10.1200/JCO.2015.64.8675.