Quality of life and Satisfaction With Ospemifene for Treating Vulvovaginal Atrophy in Breast Cancer Survivors: Six-Month Results From the PatiEnt SatisfactiON StudY (PEONY).

Objective: Breast cancer (BC) survivors often experience vulvovaginal atrophy (VVA) due to endocrine therapies, affecting quality of life (QoL) and well-being. We aimed to evaluate impact of ospemifene treatment in postmenopausal women with history of BC and moderate to severe VVA.

Methods: PEONY is a real-world, prospective, multicenter study. Participants completed questionnaires at baseline, after 3 and 6 months. Treatment satisfaction score was the primary outcome. As secondary outcomes, symptoms severity, day-to-day impact of vaginal aging scale, female sexual function index, female sexual distress scale-revised, and SF-12® Health survey were investigated.

Results: Sixty-four women with a mean age of 56.4 ± 7.2 years (41.9% with severe VVA) either initiated (35.9%) or continued (64.1%) ospemifene. Treatment satisfaction significantly improved over 6 months, with mean score rising from 7.1 to 7.8 (P = .047). The odds of moderate to severe symptoms, such as vaginal dryness, pain and bleeding during sexual intercourse, genital discomfort during physical activity, burning, and itching, decreased by 70% to 90% at 6 months, as well as recurrent urinary tract infections and cystitis associated with sexual intercourse (by 80% and 90%). QoL measurements showed significant improvements in physical health and daily functioning, although mental health improvements were not statistically significant. Likelihood of sexual distress decreased by 40%. Although overall sexual function remained unchanged, specific domains such as lubrication and pain showed improvement.

Conclusion: Ospemifene is effective and well-tolerated for treating moderate to severe VVA of women with history of BC. However, a comprehensive and multidisciplinary approach is needed to improve sexual function of BC survivors treated for VVA.