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Objectives: Radiochemotherapy for cervical cancer has a substantial risk to cause long-term vaginal stenosis (shortening/narrowing), due to irreversible fibrotic changes and can cause dyspareunia in many cancer survivors. Clinical recommendations for aftercare include vaginal dilation with cylinders; sexually active patients with partners are encouraged to engage in intercourse involving penetration. However, the evidence for prevention is limited. Aim of this report is to evaluate the association between regular vaginal dilation, sexual activity and vaginal stenosis in locally advanced cervical cancer patients after definitive radiochemotherapy and image-guided adaptive brachytherapy from the prospective, international, longitudinal EMBRACE I study (www.embracestudy.dk). Methods: Physician-assessed vaginal stenosis (CTCAE v.3), vaginal dilation and patient-reported sexual activity (EORTC QLQ CX24) were assessed at baseline, every 3 months in the 1st year, every 6 months in the 2nd and 3rd year and yearly thereafter. For this longitudinal analysis, a subgroup of patients was selected with at least 3 follow-ups with information on vaginal dilation and sexual activity. Regular dilation was defined if reported in ≥50%, irregular/no dilation if reported in <50% of follow-ups. The same method was applied to sexual activity. Actuarial estimates of vaginal stenosis G≥2 were calculated with Kaplan-Meier method; group comparisons evaluated with the log-rank test. Results: The EMBRACE I study recruited 1416 patients overall (2008-2015); the subgroup of patients for this longitudinal evaluation included 821 patients, with a median follow-up of 61 months. Of those, 296 (36%) reported regular dilation; this was associated with a significantly lower risk of vaginal stenosis G≥2 at 5 years, p=0.023 (figure A). 381 patients (46%) reported regular sexual activity; this was associated with a significantly lower risk of vaginal stenosis G≥2 at 5 years, p≤0.001 (figure B). Conclusions: These long-term data support clinical recommendations for regular dilation and/or sexual activity after radiotherapy. Conflicts of Interest: The authors have no conflict of interest to declare. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]