Recurrence and risk of progression to lower genital tract malignancy in women with high grade VAIN

Abstract Objective High-grade vaginal intraepithelial neoplasia (VAIN) II–III has a variable clinical course. Due to the rarity of VAIN, existing data on the efficacy of treatment, risk of recurrence and progression to carcinoma is limited. Our objective was to evaluate predictors of recurrent disease and describe the risk of progression to carcinoma. Methods Under an IRB-approved protocol 42 patients with biopsy-proven VAIN II–III from 1995 to 2015 were retrospectively identified. Demographics, treatment, and clinical course were abstracted from medical records. Patients were followed with semi-annual colposcopy and biopsies at physician discretion. Standard statistical analyses were applied. Results Median patient age was 58 years old (range 20–81). Median follow-up time was 45 months (range 9–195). Management included excision (31%), laser ablation (33%), topical agents (19%), and observation (10%), with the following rates of recurrence: 38%, 43%, 75%, and 50% (p = 0.26). 20 patients (48%) had recurrent or persistent disease during treatment follow-up. No specific primary treatment was significantly more effective in preventing recurrence. Recurrence of VAIN II–III occurred at a median of 17.4 months (7–78 months) from time of initial diagnosis. Five (12%) patients developed invasive cancer of the lower genital tract. Median time to cancer diagnosis was 64 months (30 to 101 months). Conclusions Patients with VAIN II–III are at high risk of recurrence and progression, suggesting the need for ongoing evaluation with cytology and comprehensive colposcopy by a skilled specialist. There were no clear risk factors or histopathologic criteria which predicted recurrence or progression to cancer.