Carbon dioxide laser treatment for vulvovaginal atrophy in women treated for breast cancer: Preliminary results of the feasibility EPIONE trial

Abstract

Quality of life preservation after anti-cancer therapy is a major challenge for breast cancer survivors. Approximately 42-70% of patients who receive systemic therapy for breast cancer, including endocrine therapy, will develop vulvovaginal atrophy (VVA). For these patients, the commonly proposed gel-based treatments for topical applications are restrictive. Recently, innovative, non-hormonal therapeutic approaches, such as laser therapy, have emerged. The purpose of this feasibility study is to investigate the safety and efficacy of CO2 laser therapy in women with a history of breast cancer. This prospective monocentric study included 20 patients with vulvovaginal atrophy who were treated at Henri Mondor University Hospital between 2017 and 2018. We included patients with a vaginal health index (VHI) score<15 and a contraindication for hormone administration due to a history of breast cancer. Two carbon dioxide laser sessions were used. The treatment was delivered using the following settings: vaginal tightening, FinePulse (pulse width 0.9ms), and energy density of 11.5J/cm2 that allows coverage of 70% of the targeted vaginal area to be treated. All patients had their follow-up visit at one (M1), three (M3), and six (M6) months after the first treatment to evaluate efficacy of the treatment on vulvovaginal atrophy. Vaginal health index score and female sexual distress (FSD) score were used to assess treatment efficacy and its impact on sexual quality of life. A score≥11 was associated with sexual dysfunction. The vaginal health index and female sexual distress scores were evaluated at baseline, M1, M3, and M6 of follow-up. The mean age of the patients was 56.1±8.8 years (range, 27-69 years). Seventeen of the 20 patients had experienced menopause (mean menopausal age, 51.25±1.5 years). At inclusion, the mean vaginal health index and the female sexual distress scores were 10.58±1.71 and 21.36±15.10, respectively. Fourteen out of 20 patients (70%) had FSD scores≥11 at the baseline. At M1, the mean vaginal health index score increased significantly to 13.42±2.3 (P=0.03), which represented an improvement of 21% from the baseline. A persistent and significant improvement in the vaginal health index score was observed at M6, with the score increasing to 16.75±4.23 post-treatment (P<0.0001), representing a 34% improvement from the mean baseline score. The mean female sexual distress at M1 was 19.83±13.57, representing a 7% decrease compared to the baseline scores (P<0.01). At M3, the female sexual distress significantly decreased to 13.88±15.58, representing an improvement of 35% (P=0.006). It increased to 10.35±14.7 at M6, representing an improvement of 52% (P=0.001). At M3, 35% of the patients had a female sexual distress score>11, and at M6, only 15% had a female sexual distress score>11. No side effects were reported during follow-up. This pilot feasibility study showed that carbon dioxide laser treatment appears to be an effective and safe method to improve the trophicity and decrease vaginal mucosal dryness in women with vulvovaginal atrophy that developed after systemic breast cancer therapy.