OBJECTIVE: To investigate the relative performances of follow-up cytology and carcinogenic human papillomavirus (HPV) DNA testing among carcinogenic HPV-negative women with atypical squamous cells of undetermined significance (ASCUS), for detection of cervical precancer. METHODS: Twelve-month follow-up management strategies to detect cervical intraepithelial neoplasia grade 3 (CIN3) or worse using cytology or HPV testing or both were compared among women with HPV-negative ASCUS in the Atypical Squamous Cells of Undetermined Significance-Low-Grade Squamous Intraepithelial Lesion (ASCUS-LSIL) Triage Study. RESULTS: Overall only 22 of 1,559 (1.4%) HPV-negative ASCUS women developed CIN grade 3 or worse during follow-up compared with 269 of 1,767 (15.2%) HPV-positive ASCUS women (P<.001). Because of the low risk of disease among HPV-negative ASCUS women, only 7 cases of CIN3 were diagnosed between 12 and 24 months of follow-up, limiting power to distinguish meaningful differences in sensitivity among 12-month testing strategies. The specificity of HPV testing (84%) was significantly higher than cytology using an ASCUS threshold (71%) (P<.001). Cotesting with cytology and HPV testing at 12 months resulted in even lower specificity (61%). Because cases were uncommon, the positive predictive value for subsequent CIN3 or worse was low for cytology (2.6%), Hybrid Capture 2 (3.8%), and cotesting with cytology and HPV testing (2.2%). The negative predictive value for all three management strategies was very high (99.70%, 99.82%, and 100.0% for HPV testing, cytology, or cotesting, respectively.) CONCLUSION: Women with HPV-negative ASCUS have very low absolute risk of subsequently detected CIN3 or worse in the subsequent 2 years, similar to women with a negative cytology in the absence of HPV testing. The results suggest that women with HPV-negative ASCUS should return to routine screening intervals which may be longer than 1 year depending on age and screening history. However, if increased surveillance is chosen, a single HPV test for carcinogenic types at 12 months has significantly higher specificity and lower referrals than cytology.
RCT Entities:
OBJECTIVE: To investigate the relative performances of follow-up cytology and carcinogenic human papillomavirus (HPV) DNA testing among carcinogenic HPV-negative women with atypical squamous cells of undetermined significance (ASCUS), for detection of cervical precancer. METHODS: Twelve-month follow-up management strategies to detect cervical intraepithelial neoplasia grade 3 (CIN3) or worse using cytology or HPV testing or both were compared among women with HPV-negative ASCUS in the Atypical Squamous Cells of Undetermined Significance-Low-Grade Squamous Intraepithelial Lesion (ASCUS-LSIL) Triage Study. RESULTS: Overall only 22 of 1,559 (1.4%) HPV-negative ASCUS women developed CIN grade 3 or worse during follow-up compared with 269 of 1,767 (15.2%) HPV-positive ASCUS women (P<.001). Because of the low risk of disease among HPV-negative ASCUS women, only 7 cases of CIN3 were diagnosed between 12 and 24 months of follow-up, limiting power to distinguish meaningful differences in sensitivity among 12-month testing strategies. The specificity of HPV testing (84%) was significantly higher than cytology using an ASCUS threshold (71%) (P<.001). Cotesting with cytology and HPV testing at 12 months resulted in even lower specificity (61%). Because cases were uncommon, the positive predictive value for subsequent CIN3 or worse was low for cytology (2.6%), Hybrid Capture 2 (3.8%), and cotesting with cytology and HPV testing (2.2%). The negative predictive value for all three management strategies was very high (99.70%, 99.82%, and 100.0% for HPV testing, cytology, or cotesting, respectively.) CONCLUSION:Women with HPV-negative ASCUS have very low absolute risk of subsequently detected CIN3 or worse in the subsequent 2 years, similar to women with a negative cytology in the absence of HPV testing. The results suggest that women with HPV-negative ASCUS should return to routine screening intervals which may be longer than 1 year depending on age and screening history. However, if increased surveillance is chosen, a single HPV test for carcinogenic types at 12 months has significantly higher specificity and lower referrals than cytology.
Authors: Debbie Saslow; Diane Solomon; Herschel W Lawson; Maureen Killackey; Shalini L Kulasingam; Joanna Cain; Francisco A R Garcia; Ann T Moriarty; Alan G Waxman; David C Wilbur; Nicolas Wentzensen; Levi S Downs; Mark Spitzer; Anna-Barbara Moscicki; Eduardo L Franco; Mark H Stoler; Mark Schiffman; Philip E Castle; Evan R Myers Journal: CA Cancer J Clin Date: 2012-03-14 Impact factor: 508.702
Authors: Debbie Saslow; Diane Solomon; Herschel W Lawson; Maureen Killackey; Shalini L Kulasingam; Joanna M Cain; Francisco A R Garcia; Ann T Moriarty; Alan G Waxman; David C Wilbur; Nicolas Wentzensen; Levi S Downs; Mark Spitzer; Anna-Barbara Moscicki; Eduardo L Franco; Mark H Stoler; Mark Schiffman; Philip E Castle; Evan R Myers; David Chelmow; Abbe Herzig; Jane J Kim; Walter Kinney; W Lawson Herschel; Jeffrey Waldman Journal: J Low Genit Tract Dis Date: 2012-07 Impact factor: 1.925
Authors: Hormuzd A Katki; Mark Schiffman; Philip E Castle; Barbara Fetterman; Nancy E Poitras; Thomas Lorey; Li C Cheung; Tina Raine-Bennett; Julia C Gage; Walter K Kinney Journal: J Low Genit Tract Dis Date: 2013-04 Impact factor: 1.925
Authors: M Kocken; J Berkhof; F J van Kemenade; J A Louwers; A Zaal; M A E Nobbenhuis; G Kenter; P J F Snijders; C J L M Meijer; T J M Helmerhorst Journal: Br J Cancer Date: 2012-02-14 Impact factor: 7.640
Authors: Philip E Castle; Barbara Fetterman; Nancy Poitras; Thomas Lorey; Ruth Shaber; Walter Kinney Journal: Obstet Gynecol Date: 2009-03 Impact factor: 7.623