title: Expectant management versus immediate treatment for low-grade cervical intraepithelial neoplasia : a randomized trial in Canada and Brazil.
abstract: BACKGROUND
  The optimal management strategy for women with low-grade biopsy-proven cervical intraepithelial neoplasia (CIN) is not clear. Our objective was to compare the effectiveness of regular colposcopic follow-up and treatment of progressive disease only versus immediate treatment.
  
  
  METHODS
  Data were accrued between November 2000 and March 2006 for a noninferiority randomized clinical trial of 415 women with biopsy-proven grade 1 CIN from 8 Canadian and 2 Brazilian colposcopy clinics. Subjects were randomly assigned to either undergo immediate treatment with a loop electrical excision procedure (LEEP) or receive regular colposcopic follow-up for 18 months. The primary outcome was progression of disease to CIN 2 to 3 was based on histology obtained during 18 months of follow-up. Treatments were compared using differences of proportion with a 9% noninferiority margin. Analysis was conducted on the basis of intention-to-treat.
  
  
  RESULTS
  An initial LEEP was performed on 179 women. Disease progression was found in 32. Easily controlled vaginal bleeding occurred in 16 (8.9%). During follow-up, disease progression was identified in 3 (1.7%) women in the immediate treatment arm and 9 (4.4%) in the colposcopic follow-up arm-a tolerable difference of 2.7% with 1-sided 95% confidence interval (CI) upper limit of 6.0%. Compliance with all 3 follow-up visits was 61% overall, but significantly worse in women ≤30 years of age (P < .05).
  
  
  CONCLUSIONS
  The risk of progression to CIN grade 2 or 3 or cancer over 18 months was similar in the 2 treatment groups. In Canada and Brazil, follow-up for 18 months is a reasonable management strategy for women with persistent low-grade cytology who are found to have grade 1 CIN on referral for colposcopy and cervical biopsy.
authors.affiliation: Ontario Clinical Oncology Group, Department of Oncology, McMaster University, Hamilton, Ontario, Canada. laurie.elit@jcc.hhsc.ca
authors.forename: Laurie
authors.initials: L
authors.lastname: Elit
authors.forename: Mark N
authors.initials: MN
authors.lastname: Levine
authors.forename: Jim A
authors.initials: JA
authors.lastname: Julian
authors.forename: John W
authors.initials: JW
authors.lastname: Sellors
authors.forename: Alice
authors.initials: A
authors.lastname: Lytwyn
authors.forename: Sylvia
authors.initials: S
authors.lastname: Chong
authors.forename: James B
authors.initials: JB
authors.lastname: Mahony
authors.forename: Chushu
authors.initials: C
authors.lastname: Gu
authors.forename: Terri
authors.initials: T
authors.lastname: Finch
authors.forename: Luiz C
authors.initials: LC
authors.lastname: Zeferino
mesh_terms: D000293:Adolescent; D000328:Adult; D001938:Brazil; D002170:Canada; D003127:Colposcopy; D018450:Disease Progression; D004598:Electrosurgery / Q000379:methods*; D005260:Female; D006801:Humans; D008875:Middle Aged; D057832:Watchful Waiting / Q000379:methods*; D002578:Uterine Cervical Dysplasia / Q000473:pathology / Q000601:surgery / Q000628:therapy*