title: Treatment of undifferentiated vulvar intraepithelial neoplasia with 5% imiquimod cream: a prospective study of 12 cases.
abstract: OBJECTIVE
  To assess the efficacy of 5% imiquimod cream on undifferentiated vulvar intraepithelial neoplasia (VIN), a disease caused by high-risk human papillomavirus.
  
  
  METHODS
  Prospective, uncontrolled study.
  
  
  METHODS
  University hospital vulvar clinic. Patients Twelve consecutive patients treated with 5% imiquimod cream for undifferentiated VIN between March 1, 1999, and May 31, 2001.
  
  
  METHODS
  Self-application of 5% imiquimod cream, initially 3 times a week, then adjusted according to tolerance, for up to 7 months according to clinical response.
  
  
  METHODS
  Therapeutic response, clinically assessed by successive photographs and histologically confirmed for complete responders, was scored as complete, partial (> or =50% decrease in lesion size), or failure. Tolerance was evaluated at each visit.
  
  
  RESULTS
  A total of 3, 4, and 5 patients achieved complete response, partial response (> or =75% reduction in lesion size for all such cases), and failure, respectively. Mean duration of treatment was 3.6 months (37.3 applications), 5.0 months (50.7 applications), and 3.4 months (25.2 applications) for complete responders, partial responders, and failures, respectively. Follow-up after treatment was 5 to 18, 14 to 32, and 2 to 28 months, respectively, with 1 partial responder lost to long-term follow-up. No patient developed invasive carcinoma. All but 2 patients experienced vulvar discomfort, resulting in treatment withdrawal for 3. Two patients had flulike symptoms.
  
  
  CONCLUSIONS
  Imiquimod cream could be a therapeutic option for undifferentiated VIN. Although poorly tolerated, this self-applied treatment could spare patients, either totally or partially, the classic painful and sometimes mutilating treatments of VIN. Controlled, randomized studies are needed to evaluate its efficacy and tolerance.
authors.affiliation: Service de Dermatologie Générale et Oncologique and Service d'Anatomopathologie, Hôpital Ambroise-Paré, Assistance Publique des Hôpitaux de Paris, Université Versailles Saint-Quentin en Yvelines, 92104 Boulogne, France.
authors.forename: Jeanne
authors.initials: J
authors.lastname: Wendling
authors.forename: Philippe
authors.initials: P
authors.lastname: Saiag
authors.forename: Sophie
authors.initials: S
authors.lastname: Berville-Levy
authors.forename: Isabelle
authors.initials: I
authors.lastname: Bourgault-Villada
authors.forename: Thierry
authors.initials: T
authors.lastname: Clerici
authors.forename: Micheline
authors.initials: M
authors.lastname: Moyal-Barracco
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D000634:Aminoquinolines / Q000008:administration & dosage / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D000077271:Imiquimod; D008875:Middle Aged; D027383:Papillomaviridae; D011230:Precancerous Conditions / Q000188:drug therapy / Q000473:pathology / Q000821:virology; D011446:Prospective Studies; D016896:Treatment Outcome; D014846:Vulvar Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000821:virology
chemical_list: D000634:Aminoquinolines; D000970:Antineoplastic Agents; D000077271:Imiquimod