title: Topical imiquimod treatment for human papillomavirus infection in patients with and without cervical/vaginal intraepithelial neoplasia.
abstract: OBJECTIVE
  To evaluate the efficacy and toxicity of topical imiquimod for the treatment of persistent human papillomavirus (HPV) infection in patients with or without cervical/vaginal intraepithelial neoplasia (CIN/VAIN).
  
  
  METHODS
  Patients with persistent HPV infection (≥ 1 year) after a history of treatment for cervical or vaginal neoplasm but normal histology and cytology, abnormal Papanicolaou (Pap) smears without abnormal histology, and untreated histology-documented CIN/VAIN Grade 1/2/3 with HPV-positive testing were recruited. Patients were instructed to apply 250 mg of 5% imiquimod cream intravaginally on consecutive days or at least twice weekly on an outpatient basis for a minimum of 12 doses. A group of age- and previous diagnosis-matched, imiquimod-untreated historical controls (n = 20) were selected. The main outcome measures included HPV DNA detection, cytology, and colposcopy/histology at 6 months after treatment.
  
  
  RESULTS
  A total of 72 patients were eligible for analysis. At a median follow-up of 33.6 months, 37 patients (51.4%) had cytological/histological regression and tested HPV-negative. Six patients (8.3%) had progressive cytology/histology with persistent HPV infections. Of the 72 treated patients, 26 patients who had a normal Pap test but were persistently HPV-positive for at least 1 year had a complete regression rate of 65.4%, which was significantly different from the rate (30%) observed in the untreated historical control (p = 0.036). Six patients with histologically proven CIN2/3 or VAIN2/3 had a complete regression rate of 66.6% (4/6).
  
  
  CONCLUSIONS
  The tolerability of intravaginal self-administered imiquimod is confirmed. Its efficacy in the treatment of women with persistent HPV infection and normal cytology warrants further randomized, controlled trials to determine appropriate dosages and scheduling.
authors.affiliation: Department of Obstetrics and Gynecology, Chang Gung Memorial Hospital and Chang Gung University, Taoyuan, Taiwan.
authors.forename: Cheng-Tao
authors.initials: CT
authors.lastname: Lin
authors.forename: Jian-Tai
authors.initials: JT
authors.lastname: Qiu
authors.forename: Chin-Jung
authors.initials: CJ
authors.lastname: Wang
authors.forename: Shuenn-Dyh
authors.initials: SD
authors.lastname: Chang
authors.forename: Yun-Hsin
authors.initials: YH
authors.lastname: Tang
authors.forename: Pei-Ju
authors.initials: PJ
authors.lastname: Wu
authors.forename: Shih-Ming
authors.initials: SM
authors.lastname: Jung
authors.forename: Chu-Chun
authors.initials: CC
authors.lastname: Huang
authors.forename: Hung-Hsueh
authors.initials: HH
authors.lastname: Chou
authors.forename: Mei-Shan
authors.initials: MS
authors.lastname: Jao
authors.forename: Chyong-Huey
authors.initials: CH
authors.lastname: Lai
mesh_terms: D000276:Adjuvants, Immunologic / Q000009:adverse effects / Q000627:therapeutic use*; D000287:Administration, Topical; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000634:Aminoquinolines / Q000009:adverse effects / Q000627:therapeutic use*; D002278:Carcinoma in Situ / Q000188:drug therapy* / Q000473:pathology / Q000821:virology; D004279:DNA, Viral / Q000097:blood; D005260:Female; D006801:Humans; D000077271:Imiquimod; D008875:Middle Aged; D027383:Papillomaviridae; D030361:Papillomavirus Infections / Q000097:blood / Q000188:drug therapy* / Q000473:pathology; D012189:Retrospective Studies; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000821:virology; D014625:Vaginal Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000821:virology
chemical_list: D000276:Adjuvants, Immunologic; D000634:Aminoquinolines; D004279:DNA, Viral; D000077271:Imiquimod