title: Randomised trial on treatment of vaginal intraepithelial neoplasia-Imiquimod, laser vaporisation and expectant management.
abstract: 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.
authors.affiliation: Obstetrics and Gynecology, University of Helsinki and Helsinki University Hospital. karoliina.tainio@hus.fi.
authors.forename: Karoliina
authors.initials: K
authors.lastname: Tainio
authors.affiliation: Obstetrics and Gynecology, University of Helsinki and Helsinki University Hospital.
authors.forename: Maija
authors.initials: M
authors.lastname: Jakobsson
authors.affiliation: Obstetrics and Gynecology, University of Helsinki and Helsinki University Hospital.|Obstetrics and Gynecology, Turku University Hospital.
authors.forename: Karolina
authors.initials: K
authors.lastname: Louvanto
authors.affiliation: Obstetrics and Gynecology, University of Helsinki and Helsinki University Hospital.|Imperial College London, Institute of Reproductive and Developmental Biology, Department of Surgery & Cancer.
authors.forename: Ilkka
authors.initials: I
authors.lastname: Kalliala
authors.affiliation: Obstetrics and Gynecology, University of Helsinki and Helsinki University Hospital.
authors.forename: Jorma
authors.initials: J
authors.lastname: Paavonen
authors.affiliation: Obstetrics and Gynecology, University of Helsinki and Helsinki University Hospital.
authors.forename: Pekka
authors.initials: P
authors.lastname: Nieminen
authors.affiliation: Obstetrics and Gynecology, University of Helsinki and Helsinki University Hospital.
authors.forename: Annika
authors.initials: A
authors.lastname: Riska
mesh_terms: D000282:Administration, Intravaginal; D000328:Adult; D000368:Aged; D000634:Aminoquinolines / Q000008:administration & dosage*; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D002278:Carcinoma in Situ / Q000628:therapy* / Q000821:virology; D005260:Female; D006801:Humans; D000077271:Imiquimod; D053685:Laser Therapy / Q000379:methods*; D008875:Middle Aged; D030361:Papillomavirus Infections / Q000473:pathology / Q000821:virology; D010865:Pilot Projects; D011446:Prospective Studies; D014625:Vaginal Neoplasms / Q000628:therapy* / Q000821:virology; D057832:Watchful Waiting
chemical_list: D000634:Aminoquinolines; D000970:Antineoplastic Agents; D000077271:Imiquimod
keywords: HPV; human papillomavirus; imiquimod; vaginal high-grade squamous intraepithelial lesion; vaginal intraepithelial neoplasia