05 Jun Premenopausal Breast Cancer: Ovarian Suppression with Exemestane
MedicalResearch: What are the main findings of the study?
Dr. Pagani: The studies show that also in premenopausal women (as already proven in postmenopausal women), aromatase inhibitors (AIs) (in this case Exemestane) given as adjuvant treatment are more effective than Tamoxifen in women with hormone receptor positive early breast cancer who are given concomitantly ovarian suppression to lower estrogen production. The 28% improvement in disease free survival is comparable to that seen in postmenopausal women. In particular, outcomes in women who did not receive chemotherapy (43% of the entire population, 29% of whom with node positive disease) were strikingly good (<97% were breast cancer free at 5 years).
MedicalResearch: Were any of the findings unexpected?
Dr. Pagani: The background idea was that aromatase inhibitors should be more effective than tamoxifen in this patients’ population as they are in menopausal women but on the other hand the different hormonal milieu could modify their effect. So we confirmed our hypothesis.
MedicalResearch: What should clinicians and patients take away from your report?
Dr. Pagani: This is a new effective treatment strategy and clinicians who routinely use ovarian suppression in their premenopausal patients should discuss with them Exemestane instead of tamoxifen. Compliance, a major concern for many clinicians, was very good (only 16% stopped all treatment during the 5 years’ therapy) which means that’s feasible in routine clinical practice to give ovarian suppression and aromatase inhibitors in premenopausal women.
MedicalResearch: What recommendations do you have for future research as a result of this study?
Dr. Pagani: We will investigate in depth all the other relevant aspects in this huge patients population (4690 women in the present analysis) to see if for example BMI or gene profiling can help in better tailoring the different treatment options in the individual woman.
In addition several issues remain open in this patients’ population: for instance IBCSG is launching the POSITIVE study to better investigate pregnancy after breast cancer, so stay tuned.
Adjuvant Exemestane with Ovarian Suppression in Premenopausal Breast Cancer
Olivia Pagani, M.D., Meredith M. Regan, Sc.D., Barbara A. Walley, M.D., Gini F. Fleming, M.D., Marco Colleoni, M.D., István Láng, M.D., Henry L. Gomez, M.D., Carlo Tondini, M.D., Harold J. Burstein, M.D., Edith A. Perez, M.D., Eva Ciruelos, M.D., Vered Stearns, M.D., Hervé R. Bonnefoi, M.D., Silvana Martino, D.O., Charles E. Geyer, Jr., M.D., Graziella Pinotti, M.D., Fabio Puglisi, M.D., Diana Crivellari, M.D., Thomas Ruhstaller, M.D., Eric P. Winer, M.D., Manuela Rabaglio-Poretti, M.D., Rudolf Maibach, Ph.D., Barbara Ruepp, Pharm.D., Anita Giobbie-Hurder, M.S., Karen N. Price, B.S., Jürg Bernhard, Ph.D., Weixiu Luo, M.S., Karin Ribi, Ph.D., Giuseppe Viale, M.D., Alan S. Coates, M.D., Richard D. Gelber, Ph.D., Aron Goldhirsch, M.D., and Prudence A. Francis, M.D. for the TEXT and SOFT Investigators and the International Breast Cancer Study Group
June 1, 2014DOI: 10.1056/NEJMoa1404037