Abstract P1-12-07: Management of genitourinary symptoms in breast cancer patients: An updated systematic review of available evidence from randomized trials
Authors: Fallah Parvaneh , Wolfe Dianna M. , Hutton Brian , Clemons Mark , Shorr Risa , Vandermeer Lisa , Rushton-Marovac Moira 
Published: March 2023

Abstract
Background: Genitourinary symptoms (GUS) such as vaginal dryness, dyspareunia, itching, urinary incontinence, urinary tract infections and discharge are common in patients with breast cancer (BC). Optimal management of GUS remains unclear. Our group previously published a systematic review (SR) on GUS management in 2014 which showed a paucity of RCT evidence addressing this knowledge gap (Mazzarello et al. 2015). We performed an updated SR to assess if more prospective trial data had been published in the past 7 years to inform management of this common complication of BC. Methods: EMBASE, Ovid Medline and the Cochrane Library were searched for RCTs evaluating treatments for GUS in BC patients from September 2014 to December 2021. A PICOS (population, intervention/comparators, outcomes and study design) framework was utilized. Population: women with breast cancer. Intervention/comparators: all forms of oral, intra-vaginal and topical hormonal and non-hormonal treatments. Outcomes of interest: improvements in vaginal symptoms (e.g., dryness, pain, dyspareunia, itching); vaginal hormone response, measured by validated scales [e.g., Vaginal Health Index (VHI) and Vaginal Maturation Index (VMI)] and quality of life [e.g., Female Sexual Function Index (FSFI)]. Study design: only RCTs were included. Two independent reviewers performed the tasks of study selection, data collection, and risk of bias assessment. Results: Of 842 unique citations identified (412 from this update, 430 from previous SR), eight studies (n = 539 patients) met inclusion criteria. Interventions included 0.005% estriol gel (EG; n=50 patients), intravaginal testosterone (IVT; n=21), intravaginal prebiotic (n=13), hyaluronic acid (HA; n=12), polyacrylic acid (PA; n=25), pH-balanced gel (two studies; n=118), Replens(n=24) and Lidocaine gel (n=22). These interventions were compared to placebo/saline/usual care (n=254). One study had three arms comparing prebiotics, HA and usual care. Study sample sizes ranged from 44 to 136 patients. Given the heterogeneity of the studies, a narrative synthesis was performed. Compared to placebo, FSFI total score was significantly improved by all interventions except IVT (which demonstrated significant improvement in only the satisfaction domain) and 4% aqueous lidocaine before vaginal penetration (which improved significantly all domains except for orgasm). FSFI changes were not reported for Replens. Significant improvements in vaginal hormone responses (VHI and VMI) were reported for 0.005% EG and pH-balanced gel; however, no significant effects were found for IVT, HA or prebiotics. Vaginal symptoms (vaginal dryness, dyspareunia and pruritis) were significantly improved by EG, IVT, and PA. Vaginal symptoms were significantly improved in the single study of pH-balanced gel that reported this outcome. Conclusion: GUS is reported in 75% of BC patients but despite its frequency, the management of GUS remains a challenging issue for patients and health care providers. Due to study heterogenicity, there remains insufficient RCT evidence to define optimal therapy. More prospective trials comparing commonly used interventions are needed. Keywords: Genitourinary symptoms, Topical moisturizers, Intra-vaginal testosterone
Citation Format: Parvaneh Fallah, Dianna M. Wolfe, Brian Hutton, Mark Clemons, Risa Shorr, Lisa Vandermeer, Moira Rushton-Marovac. Management of genitourinary symptoms in breast cancer patients: An updated systematic review of available evidence from randomized trials [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P1-12-07.