Medical interventions for high grade vulval intraepithelial neoplasia

Abstract

Background Vulval intraepithelial neoplasia (VIN) is a pre-malignant condition of the vulval skin; its incidence is increasing in women under 50 years. VIN is graded histologically as low grade or high grade. High grade VIN is associated with infection with human papilloma virus (HPV) infection and may progress to invasive disease. There is no consensus on the optimal management of high grade VIN. The high morbidity and high relapse rate associated with surgical interventions call for a formal appraisal of the evidence available for less invasive but effective interventions for high grade VIN. Objectives To evaluate the effectiveness and safety of medical interventions for high grade VIN. Search methods We searched the Cochrane Gynaecological Cancer Group Trials Register, Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2010, Issue 3), MEDLINE and EMBASE (up to September 2010). We also searched registers of clinical trials, abstracts of scientific meetings, reference lists of included studies and contacted experts in the field. Selection criteria Randomised controlled trials (RCTs) that assessed medical interventions, in adult women diagnosed with high grade VIN. Data collection and analysis Two review authors independently abstracted data and assessed risk of bias. Where possible the data were synthesised in a meta-analysis. Main results Four trials met our inclusion criteria: three assessed the effectiveness of topical imiquimod versus placebo in women with high grade VIN; one examined low versus high dose indole-3-carbinol in similar women. Meta-analysis of three trials found that the proportion of women who responded to treatment at 5 to 6 months was much higher in the group who received topical imiquimod than in the group who received placebo (relative risk (RR) = 11.95, 95% confidence interval (CI) 3.21 to 44.51). A single trial showed similar results at 12 months in (RR = 9.10, 95% CI 2.38 to 34.77). Only one trial reported adverse events, which were more common in the imiquimod group. One trial found no significant differences in quality of life (QoL) or body image between the imiquimod and placebo groups. Authors’ conclusions Imiquimod appears to be effective, but its safety needs further examination. Its use is associated with side effects which are tolerable, but more extensive data on adverse effects are required. Long term follow-up should be mandatory in view of the known progression of high grade VIN to invasive disease. Alternative medical interventions, such as cidofovir, should be explored.

Vulvar intraepithelial neoplasia (VIN2/3): Comparing clinical outcomes and evaluating risk factors for recurrence

“…However, a smaller retrospective review of 93 patients by Hillemans et al (11) showed no significant difference in recurrence between wide local excision (41.7%) and laser ablation (40.4%), but no recurrences were found among 7 patients treated with vulvectomy. Finally, imiquimod has been shown to be effective vs. placebo, but there is a lack of research comparing this treatment to other common interventions for VIN 2/3 (12). Our data suggest imiquimod may be superior to laser ablation in preventing recurrence, but prospective evaluation is needed.…”

Medical interventions for high-grade vulval intraepithelial neoplasia

“…VIN and vulval cancer are being increasingly diagnosed in younger women for whom surgical options are unlikely to be readily accepted. The previous version of this review called for more high-quality trials on medical treatment options for VIN (Pepas 2011). We continue to update this review on the medical alternatives to surgery, to inform women's choices, to support clinical guidelines, and to stimulate VIN research.…”

Management of Vaginal Discharge in Primary Care

“…37,38 Most studies and research relate to full thickness VIN. Multifocal lesions can be treated in the same manner as single lesions, but may have a higher recurrence rate.…”