VULVO-Vaginal Chronic Graft-Versus-Host Disease Assessment: A Single-Center Prospective Observational Study

Background: Vulvovaginal chronic graft-versus-host disease (vv-cGvHD) is an underrecognised complication after allogeneic haematopoietic stem cell transplantation (HSCT), with potential impact on sexual function, quality of life, and long-term morbidity. Few prospective data are available in the literature based on systematic gynaecological assessment. Material and methods: A prospective, observational, single-centre study was carried out to evaluate 1-year incidence and clinical features of vv-cGvHD in female patients undergoing HSCT among patients alive and relapse-free at day + 100. Standardised gynaecological examinations were performed at baseline, day + 100, 6, and 12 months. Data collection included patient-reported outcomes by use of a symptom-focused questionnaire to assess the presence and impact of vv-cGvHD. Results: Forty-one evaluable patients were included in the analysis and followed with scheduled gynaecological evaluations at defined intervals post-transplant. Vv-cGvHD was diagnosed in 12 out of 41 patients (29.3%), with six cases classified as grade 1 and six as grade 2 according to NIH criteria. The conditional cumulative incidence at 1 year was 30%. Half of the affected patients presented isolated genital involvement, without other cGvHD manifestations. Median onset was 6 months post-transplant. Chronic GvHD in other organs was the only factor associated with vv-cGvHD in univariate analysis (p = 0.02). Topical treatment with corticosteroids and hyaluronic acid was administered to 75% (n = 9) of affected patients, with no cases progressing to severe disease requiring surgical intervention. Conclusion: This study highlights a considerable incidence of vv-cGvHD among HSCT recipients, underlining the need for systematic screening and management protocols.