A randomized trial on the management of low-grade squamous intraepithelial lesion cytology interpretations.

Abstract

This study was undertaken to compare alternative strategies for the initial management of low-grade squamous intraepithelial lesion (LSIL) cytology. A total of 1572 women with a community-based LSIL interpretation were randomly assigned to immediate colposcopy, triage based on enrollment HPV DNA testing and liquid-based cytology at a colposcopy referral threshold of high-grade squamous intraepithelial lesion (HSIL), or conservative management based on repeat cytology at a referral threshold of HSIL. All arms included 2 years of semiannual follow-up and colposcopy at exit. Loop electrosurgical excision procedure was offered to women with histologic diagnoses of cervical intraepithelial neoplasia (CIN) grade 2 or 3 at any visit or persistent CIN grade 1 at exit. The main study end point was 2-year cumulative diagnosis of CIN grade 3. The 2-year cumulative diagnosis of CIN grade 3 was approximately 15% in all study arms. The HPV triage arm was closed early because more than 80% of women were HPV positive, precluding efficient triage. The immediate colposcopy strategy yielded 55.9% sensitivity for cumulative cases of CIN grade 3 diagnosed over 2 years. A conservative management strategy of repeat cytology at the HSIL threshold referred 18.8% of women while detecting 48.4% of cumulative CIN grade 3. At lower cytology thresholds, sensitivity would improve but would ultimately yield unacceptably high referral rates. LSIL cytology is best managed by colposcopy initially, because there was no useful triage strategy identified. Management of these patients, after colposcopy to rule out immediately overt CIN grade 2 or 3, needs to be determined.