MedicalResearch.com Interview with:
Karin Ribi, PhD, MPH
Head of Quality of Life Office
International Breast Cancer Study Group
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Ribi: This study investigated the quality of life (QoL) outcomes for women in the Suppression of Ovarian Function (SOFT) trial. SOFT investigated the value of adding ovarian suppression (OFS) to tamoxifen and to determine the role of the aromatase inhibitor exemestane+OFS as adjuvant (post-surgery) therapies for hormone-sensitive early breast cancer. SOFT was conducted by the International Breast Cancer Study Group (IBCSG) in over 3000 premenopausal women from more than 500 centers worldwide. The primary analysis of SOFT compared tamoxifen alone with tamoxifen+OFS in over 2000 women, and showed that adding OFS to tamoxifen did not provide a significant benefit in the overall population of premenopausal women. However, for women who were at sufficient risk for recurrence to warrant adjuvant chemotherapy and who remained premenopausal, the addition of OFS improved disease outcomes.
With regard to the QoL main findings, patients on tamoxifen+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+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.
MedicalResearch.com: What should clinicians and patients take away from your report?
Dr. Ribi: Overall, ovarian suppression added to tamoxifen resulted in worse endocrine symptoms and sexual functioning during the first two years of treatment. The cumulative burden of OFS varied for individual symptoms. 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.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Dr. Ribi: Although both treatments cause treatment-induced menopausal symptoms, adding ovarian suppression can exacerbate the burden of specific symptoms (e.g. hot flushes). A detailed picture of patients’ perception of individual symptoms over time is essential for patient care. Some of the main menopausal symptoms can be lessened by a multidisciplinary approach, but there is also a need to develop more safe and effective treatments in patients with breast cancer.
MedicalResearch.com: Is there anything else you would like to add?
Dr. Ribi: In our earlier reports, we showed that the third treatment group, exemestane+OFS, was more effective than tamoxifen+OFS in preventing the return of breast cancer. In terms of QoL during these treatments, we found no differential effects on global QoL, yet distinct effects on the burden of endocrine symptoms were found for exemestane versus tamoxifen in patients who received OFS. Based on descriptive results, sexual problems, vaginal dryness, and bone and joint pains were expressed substantially more often by patients receiving exemestane+OFS compared with those receiving tamoxifen alone. Symptom-specific QoL should be balanced with disease-control benefits for individual patients as treatment decisions are made.
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- Francis PA, Regan MM, Fleming GF et al. Adjuvant ovarian suppression in premenopausal breast cancer. N Engl J Med 2015; 372: 436-446.
- Pagani O, Regan MM, Walley BA et al. Adjuvant exemestane with ovarian suppression in premenopausal breast cancer. N Engl J Med 2014; 371: 107-118.
- Bernhard J, Luo W, Ribi K et al. Patient-reported outcomes with adjuvant exemestane versus tamoxifen in premenopausal women with early breast cancer undergoing ovarian suppression (TEXT and SOFT): a combined analysis of two phase 3 randomised trials. Lancet Oncol 2015; 16: 848-858.
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, Jürg Bernhard, Prudence A. Francis, Harold J. Burstein,Eva Ciruelos, Meritxell Bellet, Lorenzo Pavesi, AnLluch, Marilena Visini, Vani Parmar,Carlo Tondini, Pierre Kerbrat, Antonia Perelló, Patrick Neven, Roberto Torres,Davide Lombardi, Fabio Puglisi, Per Karlsson, Thomas Ruhstaller, Marco Colleoni,Alan S. Coates, Aron Goldhirsch, Karen N. Price, Richard D. Gelber, Meredith M. Regan, and Gini F. Fleming
JCO JCO648675; published online on March 28, 2016;
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Dr. Karin Ribi (2016). Adding Ovarian Suppression to Tamoxifen Worsens Menopausal Symptoms in Early Breast Cancer Patients MedicalResearch.com