Impact of vaginal symptoms and hormonal replacement therapy on sexual outcomes in locally advanced cervical cancer patients after definitive chemoradiotherapy - results from the EMBRACE-I study.

ABSTRACT Objective To evaluate patient-reported sexual outcomes following chemoradiotherapy and image-guided adaptive brachytherapy for locally advanced cervical cancer (LACC) in the observational, prospective, multi-center XXXX-study. Methods Sexual outcomes were prospectively assessed with EORTC-QLQ-CX24 questionnaire at baseline and follow-up. Crude incidence and prevalence rates of sexual activity, vaginal functioning problems (dryness, shortening, tightening, pain during intercourse) and sexual enjoyment were evaluated. Associations between pain during intercourse and vaginal functioning problems/sexual enjoyment were calculated, pooling observations over all follow-ups (Spearman correlation coefficient). In patients who were frequently sexually active (≥50% of follow-ups), the impact of regular hormonal replacement therapy (HRT) on vaginal functioning problems was evaluated (Pearson Chi-square). Results 1045 patients were analyzed with a median follow-up of 50 months. Sexual activity was reported by 22% of patients at baseline and by 40-47% during follow-up (prevalence rates). Vaginal functioning problems in follow-up were ranging between 18-21% (dryness), 15-22% (shortening), 16-22% (tightening), 9-21% (pain during intercourse), 37-47% (compromised enjoyment). Pain during intercourse was significantly associated with vaginal tightening (r=0.544), shortening (r=0.532), dryness (r=0.408) and negatively correlated with sexual enjoyment (r=-0.407). Regular HRT was associated with significantly less vaginal dryness (p=0.015), shortening (p=0.024), pain during intercourse (p=0.003) and borderline higher sexual enjoyment (p=0.062). Conclusion Vaginal functioning problems are associated with pain and compromised sexual enjoyment. Further efforts are required for primary prevention of vaginal morbidity with dose optimization and adaptation. Secondary prevention strategies, including HRT for vaginal/sexual health after radiotherapy in LACC should be considered and sexual rehabilitation programs should be further developed.