(186) VAGINAL CHANGES, SEXUAL FUNCTIONING AND DISTRESS OF WOMEN WITH LOCALLY ADVANCED CERVICAL CANCER TREATED IN THE EMBRACE VAGINAL MORBIDITY SUBSTUDY

Abstract Objectives The EMBRACE-vaginal morbidity substudy prospectively evaluated physician-assessed vaginal changes and patient-reported-outcomes (PRO) on vaginal and sexual functioning problems, and sexual distress in the first 2-years after radio(chemo)therapy with image-guided adaptive brachytherapy for locally advanced cervical cancer. Methods Eligible patients had FIGO 2009 stage IB1-IIIB cervical cancer with no or only limited (<5mm) vaginal involvement. Comprehensive assessment of vaginal changes was done before treatment, at 4-6 weeks and 3, 6, 12 and 24 months thereafter and graded using CTCAE. PRO were assessed at the same timepoints using validated Quality of Life and sexual questionnaires. Statistical methods included Generalized Linear Mixed Model analysis and Spearman’s rho correlation coefficients. Results 113 eligible patients were included. Over time, mostly mild (grade 1) vaginal changes were reported in 10.8-36.8% of the participants. At 24 months, 46.7% reported not being sexually active, mostly because of losing interest in sex or lacking a partner. Among the 41-53 sexually active women, 43.2-51.3% reported vaginal functioning problems starting at 4-6 weeks and more severe sexual problems and distress were reported by 5-15% of them. Physician-assessed vaginal changes and PRO sexual satisfaction differed significantly (p≤.05) between baseline and first follow-up, without further changes over time. No or only small associations between vaginal changes and vaginal functioning problems and sexual distress were found. Conclusions Relatively mild vaginal changes were reported after image-guided radio(chemo)therapy and brachytherapy according to EMBRACE-protocol. Although vaginal and sexual functioning problems and sexual distress were frequently reported, the rate of more substantial problems and distress was relatively low. These results are favorable compared to previous data, potentially due to the combination of tumors with limited vaginal involvement, EMBRACE-specific treatment optimization and rehabilitation recommendations. The lack of association between vaginal changes, vaginal functioning problems and sexual distress shows that sexual functioning is more complex than vaginal morbidity alone. Conflicts of Interest The authors declare that they have no competing interests. The EMBRACE vaginal morbidity substudy was supported by Elekta AB and Varian Medical system through unrestricted research grants and study sponsoring through the Medical University of Vienna.