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Observational Study
. 2024 May:183:107950.
doi: 10.1016/j.maturitas.2024.107950. Epub 2024 Mar 5.

Vulvovaginal atrophy in women with and without a history of breast cancer: Baseline data from the PatiEnt satisfactiON studY (PEONY) in Italy

Maria Cristina Meriggiola  1 , Paola Villa  2 , Silvia Maffei  3 , Angelamaria Becorpi  4 , Tiziana Di Paolantonio  5 , Antonio Nicolucci  6 , Stefano Salvatore  7 , Rossella E Nappi  8 ; PEONY Study Group
Affiliations
Free article
Observational Study

Vulvovaginal atrophy in women with and without a history of breast cancer: Baseline data from the PatiEnt satisfactiON studY (PEONY) in Italy

Maria Cristina Meriggiola et al. Maturitas. 2024 May.
Free article

Abstract

Objectives: To assess clinical characteristics of postmenopausal women with moderate/severe vulvovaginal atrophy, as well as its impact on sexual function, well-being, and quality of life, and to provide an overview of most used treatments.

Study design: Ongoing longitudinal, observational study conducted in 17 Italian gynecology centers, involving women already treated or initiating a local vaginal estrogen therapy or ospemifene. We report baseline data for women with and without a history of breast cancer. Participants filled in self-reported questionnaires at study entry.

Main outcome measures: Severity of vulvovaginal atrophy; ongoing treatments; patient-reported outcomes, including severity of symptoms, Day-to-Day Impact of Vaginal Aging (DIVA), Female Sexual Function Index (FSFI), Female Sexual Distress Scale-Revised (FSDS-R), and SF-12® Health Survey.

Results: Overall, 334 women (20.4 % with a history of breast cancer) started or continued local therapy (61.1 %) or ospemifene (38.8 %) at study entry. Vulvovaginal atrophy was severe in 28.6 %, and was responsible for severe symptoms, particularly vulvar dryness with burning or irritation and pain during sexual intercourse. Both sexual dysfunction (FSFI≤26) (81.5 %) and sexual distress (FSDS-R ≥ 11) (74.4 %) were common. A reduction in the SF-12 mental component score was documented. Women with breast cancer more often had severe vulvovaginal atrophy (41.2 %), had more severe symptoms, and the impact of vaginal symptoms on emotional well-being, sexual functioning and self-concept/body image was greater. The majority of them (83.8 %) received ospemifene as a treatment.

Conclusions: Moderate/severe vulvovaginal atrophy is a common, often neglected condition with an impact on QoL and sexuality, particularly in women with a history of breast cancer. It is important to alleviate the burden associated with the disease.

Keywords: Breast cancer; Local estrogens; Nonhormonal local treatments; Ospemifene; Vulvovaginal atrophy.

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Conflict of interest statement

Declaration of competing interest REN had past financial relationships (lecturer, member of advisory boards and/or consultant) with Boehringer Ingelheim, Ely Lilly, Endoceutics, Palatin Technologies, Pfizer Inc., Procter & Gamble Co, TEVA Women's Health Inc. and Zambon SpA. At present, she has on-going relationship with Abbott, Astellas, Bayer HealthCare AG, Besins Healthcare, Exeltis, Fidia, Gedeon Richter, HRA Pharma, Merck Sharpe & Dohme, Novo Nordisk, Organon & Co, Shionogi Limited, Theramex, and Viatris. TDP is an employee of SHIONOGI S.r.l. AN has financial relationships (support to research, lecturer, consultant) with AlfaSigma, Astra Zeneca, Eli Lilly, Novo Nordisk, Sanofi, Shionogi, Theras, SOBI. PV has financial relationship (presentations, speakers bureaus, manuscript writing or educational events) with PharmExtracta, Bromatech. Shionogi, Amgen. MCM had financial relationship (lecturer, consultant) with Bayer HealthCare AG, Exeltis, Gedeon Richter, Organon & Co, Sandoz, Shionogi Limited and Theramex. The other authors declare that they have no competing interest.

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