Recurrence of High-Grade Vulvar Intraepithelial Neoplasia After Treatment With Excision Compared With Imiquimod
OBJECTIVE:
To evaluate long-term recurrence rates and time to first recurrence for human papillomavirus (HPV)–associated high-grade vulvar intraepithelial neoplasia (VIN) by initial treatment.
METHODS:
This was a retrospective cohort study of patients treated with excision, imiquimod, or laser for HPV-associated VIN grade 2–3 at a high-risk colposcopy center. We collected demographic, clinical, and longitudinal pathology data. Given the small number (n=15), the cohort of patients treated with laser were excluded from analyses. We performed χ 2 and Wilcoxon rank-sum tests to compare the rates of recurrence and median time to first recurrence by treatment modality. Univariate and multivariate analyses were conducted to compare predictors of recurrence and time to recurrence. Multivariate models were adjusted for side effects or barriers to imiquimod use, lesion focality, and initial histology based on significant findings in the univariate models.
RESULTS:
Three hundred fifteen patients met the criteria for inclusion, 231 treated with excision and 84 with imiquimod. Median follow-up time from initial diagnosis was 36 months. Recurrence rates and median time to recurrence with imiquimod (40.5% and 7.4 months) and excision (34.6% and 11.3 months, P =.34, P =.38) did not differ significantly. In univariate analysis, positive margins (odds ratio [OR] 4.68, 95% CI, 2.53–8.62), multifocal disease (OR 2.27, 95% CI, 1.19–4.33), and presence of carcinoma in situ on initial diagnosis (OR 6.21, 95% CI, 1.45–26.6) were predictors of recurrence after excision. Only the presence of side effects or barriers to imiquimod use (OR 2.46, 95% CI, 1.01–6.02) was significant in the univariate model for recurrence after imiquimod. No significant difference remained for the odds of recurrence after treatment with imiquimod compared with excision in the multivariate model (OR 1.28, 95% CI, 0.77–2.14); there was similarly no significant difference in the multivariate model of time to recurrence (hazard ratio 1.41, 95% CI, 0.86–2.30).
CONCLUSION:
In appropriately selected patients, imiquimod appears to have outcomes similar to those of excision for the prevention of recurrent HPV-associated VIN.