title: Postcolposcopy management of women with histologically proven CIN 1: results from TOMBOLA.
abstract: OBJECTIVE
  This study aimed to determine during 36 months of follow-up the (1) clinical outcomes and (2) influence of high-risk human papillomavirus (HPV) status on the risk of progression to cervical intraepithelial neoplasia 2+ (CIN 2+), among women with histologically proven CIN 1.
  
  
  METHODS
  This is an ad hoc analysis of women with CIN 1 within TOMBOLA, a randomized trial of the management of women with low-grade cervical cytology. Women from the colposcopy arm with CIN 1 confirmed on punch biopsies and managed conservatively by cytology every 6 months in primary care were included. Sociodemographic data and a sample for HPV testing were collected at recruitment. Data on the sample women were extracted to calculate the cumulative incidence of CIN 2+ and the performance characteristics of the baseline HPV test. Detection of CIN 2 or worse (CIN 2+) during follow-up or at exit colposcopy was analyzed.
  
  
  RESULTS
  A total of 171 women were included. Their median age was 29 years. Fifty-two percent were high-risk HPV positive, 17% were HPV-16 positive, and 11% were HPV-18 positive. Overall, 21 women (12%) developed CIN 2+, with a median time to detection of 25 months. Factors associated with progression to CIN 2+ were presence of HPV-18 (relative risk = 3.04; 95% CI = 1.09-8.44) and HPV-16 and/or HPV-18 at recruitment (relative risk = 3.98; 95% CI = 1.60-9.90). The sensitivity and specificity of a combined HPV-16/HPV-18 test for the detection of CIN 2+ during 3 years were 58% and 78%, respectively.
  
  
  CONCLUSIONS
  Our results suggest that women with confirmed CIN 1 have low rates of progression to high-grade CIN within 3 years. Because the median time to progression was 25 months, conservative management could recommend the next repeat cytology at 2 years.
authors.affiliation: 1Gynaecological Oncology, University Hospital of Llandough, Wales; and 2University of Aberdeen, Aberdeen, United Kingdom; 3National Cancer Registry Ireland, Cork, Ireland; 4Aberdeen Royal Infirmary, Aberdeen, United Kingdom; 5Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Canada; and 6Warwick Medical School, Coventry, United Kingdom.
authors.forename: Mahalakshmi
authors.initials: M
authors.lastname: Gurumurthy
authors.forename: Seonaidh C
authors.initials: SC
authors.lastname: Cotton
authors.forename: Linda
authors.initials: L
authors.lastname: Sharp
authors.forename: Louise
authors.initials: L
authors.lastname: Smart
authors.forename: Julian
authors.initials: J
authors.lastname: Little
authors.forename: Norman
authors.initials: N
authors.lastname: Waugh
authors.forename: Margaret E
authors.initials: ME
authors.lastname: Cruickshank
mesh_terms: D000328:Adult; D001706:Biopsy; D003127:Colposcopy / Q000379:methods*; D018450:Disease Progression; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008875:Middle Aged; D027383:Papillomaviridae / Q000302:isolation & purification; D030361:Papillomavirus Infections / Q000175:diagnosis / Q000821:virology; D011446:Prospective Studies; D016896:Treatment Outcome; D055815:Young Adult; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis* / Q000628:therapy*