Fractional CO2 laser therapy for genitourinary syndrome of menopause (GSM) in survivors of breast cancer (BC).

Authors

null

Allison M Quick

The Ohio State University, Columbus, OH

Allison M Quick, Filadelfiya Zvinovski, Catherine Hudson, Andrew Hundley, Cynthia Evans, Anupama Suresh, Julie Stephens, Kristen Carpenter, Bhuvaneswari Ramaswamy, Raquel E. Reinbolt, Anne M. Noonan, Jeffrey Bryan VanDeusen, Robert Wesolowski, Daniel G. Stover, Nicole Olivia Williams, Sagar D. Sardesai, Karen L. Smith, Stephanie S. Faubion, Charles L. Loprinzi, Maryam B. Lustberg

Organizations

The Ohio State University, Columbus, OH, The Ohio State University Medical Center, Columbus, OH, Stefanie Spielman Comprehensive Breast Center, Columbus, OH, Center for Biostatistics in the Department of Biomedical Informatics, The Ohio State University, Columbus, OH, Ohio State University Wexner Medical Center, Dept. of Psychiatry, Columbus, OH, Ohio State University Comprehensive Cancer Center, Columbus, OH, The Ohio State University Comprehensive Cancer Center, Arthur G. James Cancer Hospital, Columbus, OH, The Ohio State Comprehensive Cancer Center, Columbus, OH, The Ohio State Univeristy Wexner Medical Center, Columbus, OH, The Ohio State University Comprehensive Cancer Center, Columbus, OH, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, Mayo Clinic, Rochester, MN

Research Funding

Other

Background: Fractional CO2 laser therapy is an emerging treatment for GSM. The objective of this study was to determine the feasibility, tolerability and preliminary efficacy of fractional CO2 laser therapy in BC survivors. Methods: This was a single arm feasibility study of BC survivors with dyspareunia and/or vaginal dryness. Participants received three treatments with office-based fractional CO2 laser on at least 30 day intervals and returned for a one-month follow-up. Feasibility was defined as treatment completion without serious adverse events (SAE) in a minimum of 80% of patients. Primary efficacy was evaluated using the mean change (∆) in the score on the Vaginal Assessment Scale (VAS). Secondary efficacy endpoints included mean ∆ in scores on the Female Sexual Function Index (FSFI) and Urogenital Distress Inventory (UDI). Descriptive statistics (means and 95% confidence intervals (CI) for continuous variables and proportions for categorical variables) were used. Results: The study is ongoing with 65 patients enrolled. To date, 37 patients have completed all study treatments and follow-up. Median age for those who have completed treatment was 57 years (range 34-72). Most were ER/PR positive (78%) and Her 2 negative (81%) with stage I (43%) or II (41%) BC. Ninety-five percent were receiving endocrine therapy, most commonly aromatase inhibitors (73%). No SAEs were reported in the 37 patients who have completed study treatments and their outcomes are as follows. Based on the VAS, 78% reported moderate-severe dyspareunia and 89% reported moderate-severe vaginal dryness at baseline. At follow up, 28% reported moderate-severe dyspareunia and 28% reported moderate-severe vaginal dryness. The VAS score improved from baseline to follow up (mean ∆ 4.1; 95% CI [3.1, 5.1]). Similarly, the FSFI score improved (mean ∆ -10.0; 95% CI [-13.2, -6.9]) and the UDI score improved (mean ∆ -5.7; 95% CI [-10.1, -1.3]). Final efficacy analysis will be reported once all patients have completed all time points. Conclusions: Fractional CO2 laser treatment is feasible and tolerable in BC survivors and may reduce symptom burden from GSM. A randomized controlled trial with sham laser is currently in development. Clinical trial information: NCT03307044

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Abstract Details

Meeting

2018 Palliative and Supportive Care in Oncology Symposium

Session Type

Poster Session

Session Title

Poster Session B: Advance Care Planning; Caregiver Support; Coordination and Continuity of Care; End-of-Life Care; Models of Care; Survivorship; and Symptom Biology, Assessment and Management

Track

Advance Care Planning,End-of-Life Care,Survivorship,Coordination and Continuity of Care,Symptom Biology, Assessment, and Management,Models of Care,Caregiver Support

Sub Track

Symptom Biology, Assessment, and Management

Clinical Trial Registration Number

NCT03307044

Citation

J Clin Oncol 36, 2018 (suppl 34; abstr 202)

DOI

10.1200/JCO.2018.36.34_suppl.202

Abstract #

202

Poster Bd #

F4

Abstract Disclosures

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