AIMS
Vaginal atrophy (VA) in post-menopausal women with breast cancer (BC) is common and often exacerbated by endocrine therapies. Fractional CO2 intra-vaginal laser is a non-hormonal therapy designed to treat VA by improving microcirculation and collagen formation. We evaluated the feasibility of CO2 laser in women with BC on aromatase inhibitors (AI).
METHODS
In this single-arm pilot study, post-menopausal BC patients receiving adjuvant AI with symptomatic VA had 3 laser treatments scheduled 4 weeks apart. Clinician assessment, vaginal cytology, biopsy and questionnaires were undertaken at baseline and 12-weeks post treatment. The primary endpoint was improvement in the Urogenital Atrophy Questionnaire (UAQ) and Vaginal Health Index Scores (VHIS). Secondary end points were improvement in epithelial cytology and vaginal atrophy by central review and the Female Sexual Function Index (FSFI).
RESULTS
Between May 2017 and July 2020, 33 patients were enrolled. Slow recruitment and COVID-19 restrictions lead to premature study closure. Participants: median age 52 years (range 32-76), bilateral oophorectomy (n=15, 45%), prior chemotherapy (n=24, 73%) and bilateral mastectomy (n=9, 27%). 27 patients completed all 3 pre-planned treatments and post-treatment assessment (T1 n=30; T2 n=30; T3 n=28; post-Rx n=27) and were eligible for final analysis. Patient-reported vaginal dryness (100 vs 48%), irritation/itch (56 vs 19%), pain (63 vs 11%) and dyspareunia (89 vs 78%) all reduced in frequency at 12-weeks post treatment. VHIS score improved by a median of 5-points, predominantly due to increase in epithelial integrity score. Reported vaginal dryness for most/all the time on UAQ reduced from n=21/27 (78% to n=8/27 (30%). No clinically meaningful improvement in sexual function domains were detected on UAQ and FSFI questionnaires. Cytology and histological findings will be presented.
CONCLUSIONS
Pilot work suggests CO2 laser may be a feasible non-hormonal option for management of vaginal dryness and clinician-assessed VA, with little impact on sexual dysfunction.