Randomised trial on treatment of vaginal intraepithelial neoplasia-Imiquimod, laser vaporisation and expectant management.
Vaginal intraepithelial neoplasia (VAIN) is associated with human papillomavirus (HPV) infection. The most common treatment modality is laser vaporisation, but recurrences are common. Imiquimod is an immune response modulator which is used for the treatment of external condylomas and other HPV-related genital neoplasias. The aim of the study was to evaluate the efficacy and tolerability of vaginally administered imiquimod in comparison with laser vaporisation and expectant management of high-grade VAIN. This proof of principle pilot study was a prospective 16-week randomised trial. We enrolled 30 patients with histologically confirmed VAIN 2 or 3 into three study arms: vaginally administered imiquimod, laser vaporisation and expectant management. Follow-up colposcopy visits included high-risk human papillomavirus (hrHPV) testing, cytology and punch biopsies. At baseline 77% (n = 20/26) of the patients were hrHPV positive. HPV clearance was significantly higher in the imiquimod arm (63%, n = 5/8) than in the laser arm (11%, n = 1/9) (p = 0.05) or in the expectant management arm (17%, n = 1/6) (p = 0.138). At baseline 25 patients (83%) had VAIN 2 and five (17%) had VAIN 3. None of the lesions progressed during the follow-up. Histological regression (≤VAIN 1) was observed in 80% (n = 8/10) of patients in the imiquimod arm, 100% (n = 10/10) of the laser arm (p = 0.474) and 67% (n = 6/9) of the expectant management arm (p = 0.628). Vaginal imiquimod appears to be as effective as laser treatment in high-grade VAIN.
['Tainio|Karoliina|K|', 'Jakobsson|Maija|M|', 'Louvanto|Karolina|K|', 'Kalliala|Ilkka|I|', 'Paavonen|Jorma|J|', 'Nieminen|Pekka|P|', 'Riska|Annika|A|']
D000282:Administration, Intravaginal D000328:Adult D000368:Aged D000634:Aminoquinolines D000970:Antineoplastic Agents D002278:Carcinoma in Situ D005260:Female D006801:Humans D000077271:Imiquimod D053685:Laser Therapy D008875:Middle Aged D030361:Papillomavirus Infections D010865:Pilot Projects D011446:Prospective Studies D014625:Vaginal Neoplasms D057832:Watchful Waiting
vaginal intraepithelial neoplasia human papillomavirus HPV imiquimod vaginal high-grade squamous intraepithelial lesion