OBJECTIVE: This study was undertaken to compare alternative strategies for the initial management of a cytologic diagnosis of atypical squamous cells of undetermined significance (ASCUS). STUDY DESIGN: A total of 3488 women with a community-based ASCUS interpretation were randomly assigned to immediate colposcopy, triage that was 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 study end point was 2-year cumulative diagnosis of CIN grade 3. RESULTS: The 2-year cumulative diagnosis of CIN grade 3 was 8% to 9% in all study arms. The immediate colposcopy strategy yielded 53.6% sensitivity for cumulative cases of CIN grade 3 diagnosed over 2 years. The human papillomavirus (HPV) triage strategy referred 55.6% of women and detected 72.3% of cumulative cases of CIN grade 3. A conservative management strategy of repeat cytology at the HSIL threshold referred 12.3% of women while detecting 54.6% of cumulative CIN grade 3. To compare triage tests, we re-estimated the performance of HPV and cytology in successfully referring women with underlying CIN grade 3 (ie, ignoring the insensitivity we discovered in colposcopically directed biopsies). A single enrollment HPV test identified 92.4% of the women diagnosed with CIN grade 3. Serial cytology, even at an ASCUS threshold, would have required two visits to achieve similar sensitivity (95.4%) and would have referred 67.1% to colposcopy. CONCLUSION: HPV triage is at least as sensitive as immediate colposcopy for detecting CIN grade 3 and refers about half as many women to colposcopy. Follow-up that used repeat cytology is sensitive at an ASCUS referral threshold but requires two follow-up visits and ultimately more colposcopic examinations than HPV triage.
RCT Entities:
OBJECTIVE: This study was undertaken to compare alternative strategies for the initial management of a cytologic diagnosis of atypical squamous cells of undetermined significance (ASCUS). STUDY DESIGN: A total of 3488 women with a community-based ASCUS interpretation were randomly assigned to immediate colposcopy, triage that was 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 study end point was 2-year cumulative diagnosis of CIN grade 3. RESULTS: The 2-year cumulative diagnosis of CIN grade 3 was 8% to 9% in all study arms. The immediate colposcopy strategy yielded 53.6% sensitivity for cumulative cases of CIN grade 3 diagnosed over 2 years. The human papillomavirus (HPV) triage strategy referred 55.6% of women and detected 72.3% of cumulative cases of CIN grade 3. A conservative management strategy of repeat cytology at the HSIL threshold referred 12.3% of women while detecting 54.6% of cumulative CIN grade 3. To compare triage tests, we re-estimated the performance of HPV and cytology in successfully referring women with underlying CIN grade 3 (ie, ignoring the insensitivity we discovered in colposcopically directed biopsies). A single enrollment HPV test identified 92.4% of the women diagnosed with CIN grade 3. Serial cytology, even at an ASCUS threshold, would have required two visits to achieve similar sensitivity (95.4%) and would have referred 67.1% to colposcopy. CONCLUSION:HPV triage is at least as sensitive as immediate colposcopy for detecting CIN grade 3 and refers about half as many women to colposcopy. Follow-up that used repeat cytology is sensitive at an ASCUS referral threshold but requires two follow-up visits and ultimately more colposcopic examinations than HPV triage.
Authors: Philip E Castle; Erin C Gutierrez; Sharon V Leitch; Courtney E Maus; Ray A McMillian; William A Nussbaumer; Laurence M Vaughan; Cosette M Wheeler; Patti E Gravitt; Mark Schiffman Journal: J Clin Microbiol Date: 2011-06-01 Impact factor: 5.948
Authors: Simon Grandjean Lapierre; Philippe Sauthier; Marie-Hélène Mayrand; Simon Dufresne; Patrick Petignat; Diane Provencher; Pierre Drouin; Philippe Gauthier; Marie-Josée Dupuis; Bertrand Michon; Stéphan Ouellet; Rachid Hadjeres; Alex Ferenczy; Eduardo L Franco; François Coutlée Journal: J Clin Microbiol Date: 2012-02-01 Impact factor: 5.948
Authors: Long Fu Xi; Laura A Koutsky; Philip E Castle; Cosette M Wheeler; Denise A Galloway; Constance Mao; Jesse Ho; Nancy B Kiviat Journal: J Natl Cancer Inst Date: 2009-01-27 Impact factor: 13.506
Authors: Philip E Castle; Mark Schiffman; Cosette M Wheeler; Nicolas Wentzensen; Patti E Gravitt Journal: Am J Epidemiol Date: 2009-12-10 Impact factor: 4.897
Authors: Philip E Castle; Patti E Gravitt; Diane Solomon; Cosette M Wheeler; Mark Schiffman Journal: J Clin Microbiol Date: 2007-11-07 Impact factor: 5.948
Authors: Qinghua Feng; Stephen Cherne; Rachel L Winer; Akhila Balasubramanian; Shu-Kuang Lee; Stephen E Hawes; Nancy B Kiviat; Laura A Koutsky Journal: J Clin Microbiol Date: 2009-01-14 Impact factor: 5.948