title: Imiquimod 5% cream versus cold knife excision for treatment of VIN 2/3: a five-year follow-up.
abstract: BACKGROUND
  Vulvar intraepithelial neoplasia (VIN) is a premalingnant condition. For long time, surgery was considered the first-line therapy in the treatment of high grade VIN. Imiquimod was recently introduced as an alternative to surgery.
  
  
  OBJECTIVE
  To compare the overall complete response, the recurrence rate and the risk factors for relapse among patients with VIN 2/3 treated with Imiquimod or surgical excision.
  
  
  METHODS
  Eighty women who had histological diagnosis of VIN 2 and VIN 3 were enrolled in this prospective study. Patients immunocompromised, with recurrent VIN, with well differentiated type VIN or VIN 1 and women treated more than once were excluded from the study. Patients were divided into two groups: group A was treated with Imiquimod, group B underwent surgical excision. Patients' characteristics analyzed were: age, smoking, degree of the primary lesion, state of margins, multifocal disease. We have evaluated the recurrence rate, the relapse rate, and the overall complete response, considering as recurrence the onset of a lesion after an initial complete response to Imiquimod and/or after the surgical treatment and as relapse all patients who had a recurrence plus those with medical treatment failure.
  
  
  RESULTS
  Multifocal lesions (p = 0.03) and VIN 3 (p = 0.002) were associated with a higher risk of relapse. The recurrence rate was higher in the group B (p = 0.009), but the relapse rate was higher in the group A (p = 0.04). The overall complete response was better in the group B (p = 0.04).
  
  
  CONCLUSIONS
  Although the advent of new medical options can decrease the morbidity associated with invasive surgical procedures, surgical treatments remain the best treatment modality for VIN with regard to relapse and overall complete response.
authors: Department of Gynecological, Obstetric and Urological Sciences, Sant'Andrea Hospital, Sapienza University of Rome, Rome, Italy.
authors: A
authors: A
authors: Frega
authors: F
authors: F
authors: Sesti
authors: F
authors: F
authors: Sopracordevole
authors: A
authors: A
authors: Biamonti
authors: P
authors: P
authors: Scirpa
authors: G N
authors: GN
authors: Milazzo
authors: A
authors: A
authors: Catalano
authors: C
authors: C
authors: Assorgi
authors: D
authors: D
authors: Lombardi
authors: M
authors: M
authors: Gentile
authors: P
authors: P
authors: Maniglio
authors: E
authors: E
authors: Ricciardi
authors: G
authors: G
authors: Cozza
authors: R
authors: R
authors: Marziani
authors: M
authors: M
authors: Moscarini
mesh_terms: D000328:Adult; D000634:Aminoquinolines / Q000008:administration & dosage*; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D002278:Carcinoma in Situ / Q000473:pathology / Q000628:therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D000077271:Imiquimod; D009364:Neoplasm Recurrence, Local; D009824:Ointments; D014846:Vulvar Neoplasms / Q000473:pathology / Q000628:therapy*
chemical_list: D000634:Aminoquinolines; D000970:Antineoplastic Agents; D009824:Ointments; D000077271:Imiquimod