Abstract
BACKGROUND: Genitourinary syndrome of menopause (GSM) is prevalent among breast cancer survivors (BCS), often exacerbated by oncologic treatments and compounded by contraindications to hormone-based therapies. Vaginal Erbium:YAG laser has emerged as a promising non-hormonal alternative, though long-term safety and efficacy data remain scarce. METHODS: This prospective pilot study initially enrolled twelve breast cancer survivors (BCS) presenting with moderate to severe genitourinary syndrome of menopause (GSM). The study consisted of two phases: in phase 1, patients underwent 3 monthly sessions of fractional Erbium:YAG (erbium: yttrium-aluminum garnet) laser and were evaluated before the first laser and 1 month after the third session. In Phase 2, patients were evaluated 1 year after the beginning of the treatment (first laser session). Clinical evaluations were carried out at baseline and after each study phase using the Vaginal Health Index (VHI), the Female Sexual Function Index (FSFI), and a customized Symptom Intensity Questionnaire. Vaginal biopsies and cytological samples were obtained at baseline and at the end of the first phase. H&E staining, Picrosirius Red, glycogen deposits, and epithelial thickness were evaluated in all samples. A Likert scale was administered at the end of each phase to assess patient satisfaction. Statistical analyses were performed using paired t-tests, bootstrap resampling techniques, and logistic regression models to evaluate treatment outcomes and response predictors. RESULTS: 12 patients enrolled in the study, ten completed phase one, and eight completed Phase 2. Mean VHI scores improved significantly from 10.75 ± 2.4 to 23.38 ± 3.1 (p < 0.0001). Symptom severity decreased significantly (p = 0.0078). FSFI scores showed clinical improvement (from 15.52 ± 7.20 to 25.05 ± 6.81), though not statistically significant (p = 0.0889); bootstrap and simulation analyses confirmed robustness. Histological findings indicated epithelial remodeling without adverse tissue effects. All patients gave the best satisfaction scores to the treatment (Likert = 5). No adverse events were reported. CONCLUSIONS: Vaginal Erbium:YAG laser therapy appears to be a safe and potentially effective option for GSM management in BCS. Further randomized controlled trials are needed to validate these findings.