Safety and Efficacy of Ospemifene in Women with A History of Breast Cancer-Journal of Gynecology and Women’s Health-Juniper Publishers

JUNIPER PUBLISHERS-Journal of Gynecology and Women’s Health

Safety and Efficacy of Ospemifene in Women with A History of Breast Cancer

Authored by Nico Bruyniks*

This post-hoc analysis compares the efficacy and safety data from women with or without a history of breast cancer who had been enrolled in the ospemifene clinical trial program. Efficacy was assessed by the co-primary endpoints of most bothersome symptom (MBS; pooled data from two studies) and mean baseline to Week 12 change in vaginal pH and maturation index (pooled data from three studies). Safety was assessed using pooled data from all three studies. Comparisons were made between ospemifene-treated women with a history of breast cancer (≥10 years prior to enrolment; n=11) versus those without (n=1091). There were no differences in ospemifene-related improvements in symptoms of vulvar and vaginal atrophy (percentage whose MBS severity improved by ≥1 point on the 4-point severity scale) and in physiological parameters (vaginal pH, parabasal cells, and superficial cells) in women with versus without a history of breast cancer. Treatment-emergent adverse events and adverse drug reactions were comparable in the women using ospemifene who had a previous history of breast cancer (64% and 36%, respectively) compared with those that who did not (69% and 47%, respectively). In this small post-hoc analysis, previous history of breast cancer did not appear to affect the efficacy or safety of ospemifene. Trial registration numbers NCT01585558, NCT01586364, NCT00729469 and NCT00566982.

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