title: Adjuvant topical treatment with imiquimod 5% after excisional surgery for VIN 2/3.
abstract: OBJECTIVE
  Vulvar intraepithelial neoplasia (VIN) is a premalignant lesion of the vulva. The incidence of VIN is increasing. The surgery is currently the gold standard therapy for VIN, but Imiquimod could be a completion to surgery. The aim of this study is to compare the overall complete response, the recurrence rate and the risk factors for recurrence among two groups of patients: women with high grade VIN underwent surgery and patients treated with surgery plus Imiquimod.
  
  
  METHODS
  80 patients with histologically diagnosed VIN 2/3 were enrolled in this prospective study. Our patients were divided into two groups: 40 women underwent surgery (A) and 40 patients were treated with surgery plus Imiquimod (B). All women had a 5-year follow-up. Recurrence rate and complete response were evaluated. The following patients' characteristics were analyzed: smoke, multifocal disease, multicentric disease, degree of the lesion.
  
  
  RESULTS
  In the group A recurrence rate was 44.8%, in the group B it was 48.4%. In both groups the presence of multifocal lesions (p = 0.02) and VIN 3 (p = 0.006) before treatment was associated with a higher risk of recurrence.
  
  
  CONCLUSIONS
  This study found that surgery remains the principal approach for VIN with regard to relapse and complete response since the treatment with Imiquimod associated with surgery didn't show a lower recurrence rate. Although the surgical treatments remain the best therapeutic option for VIN with regard to recurrence and overall complete response, the combined therapy seems to be an interesting modality, but further studies are needed.
authors.affiliation: Department of Gynaecological, Obstetric and Urological Sciences, Sant'Andrea Hospital, Sapienza University of Rome, Rome, Italy. giusinora@hotmail.com.
authors.forename: M
authors.initials: M
authors.lastname: Gentile
authors.forename: P
authors.initials: P
authors.lastname: Bianchi
authors.forename: F
authors.initials: F
authors.lastname: Sesti
authors.forename: F
authors.initials: F
authors.lastname: Sopracordevole
authors.forename: A
authors.initials: A
authors.lastname: Biamonti
authors.forename: P
authors.initials: P
authors.lastname: Scirpa
authors.forename: M
authors.initials: M
authors.lastname: Schimberni
authors.forename: G
authors.initials: G
authors.lastname: Cozza
authors.forename: R
authors.initials: R
authors.lastname: Marziani
authors.forename: G
authors.initials: G
authors.lastname: Di Martino
authors.forename: A
authors.initials: A
authors.lastname: Catalano
authors.forename: G N
authors.initials: GN
authors.lastname: Milazzo
authors.forename: M
authors.initials: M
authors.lastname: Zinna
authors.forename: D
authors.initials: D
authors.lastname: Caserta
authors.forename: A
authors.initials: A
authors.lastname: Frega
mesh_terms: D000287:Administration, Topical; D000634:Aminoquinolines / Q000008:administration & dosage*; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D002278:Carcinoma in Situ / Q000175:diagnosis / Q000188:drug therapy* / Q000601:surgery*; D003131:Combined Modality Therapy; D005260:Female; D006801:Humans; D000077271:Imiquimod; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000175:diagnosis / Q000188:drug therapy / Q000601:surgery; D011446:Prospective Studies; D012307:Risk Factors; D014846:Vulvar Neoplasms / Q000175:diagnosis / Q000188:drug therapy* / Q000601:surgery*
chemical_list: D000634:Aminoquinolines; D000970:Antineoplastic Agents; D000077271:Imiquimod