title: Cumulative 5-year diagnoses of CIN2, CIN3 or cervical cancer after concurrent high-risk HPV and cytology testing in a primary screening setting.
abstract: The aim of our study was to assess the cumulative 5-year diagnoses of CIN2, CIN3 or invasive cervical cancer (CIN2+) after concurrent screening by high-risk HPV test and Pap smear in a primary screening setting. Four thousand thirty-four women from Eastern Thuringia/Germany were recruited from 1996 to 1998 for baseline screening that included routine cytology, high-risk HPV testing by consensus primer PCR GP5+/6+ and routine colposcopy. After a median of 59 months 3,153 women participated in final screening using identical methods. Women with abnormal cytology or colposcopy or a positive high-risk HPV test at any time during the study period were recalled for expert colposcopy and histologic verification. CIN2+ was detected in 160 women resulting in a cumulative 5-year proportion of 4.4% (95% CI: 3.7-5.0%). Of 3,702 women who were high-risk HPV negative at baseline, 34 (1.1-95% CI: 0.7-1.4%) had either prevalent CIN2+ or developed CIN2+ within the observation period. HPV/cytology double negatives at baseline were at lowest risk for CIN2+ (1.0-95% CI: 0.7-1.4%) compared to screening positives (16.8-100% depending on combined test results). The 5-year negative predictive value in HPV-/Cyto- women was 99.0% (95% CI: 98.6-99.3%). This suggests that a prolongation of the screening intervals in this group is feasible. However, it should be noted that 1 woman developed a microinvasive carcinoma within the observation period. Moreover, 2 women with prevalent cancer were missed by both tests. The prognostic relevance of concurrent high-risk HPV/cytology screening needs to be verified further by randomized trials.
authors.affiliation: Institute of Medical Statistics, Information Sciences and Documentation, Friedrich-Schiller-University, Jena, Germany.
authors.forename: Heike
authors.initials: H
authors.lastname: Hoyer
authors.forename: Cornelia
authors.initials: C
authors.lastname: Scheungraber
authors.forename: Rosemarie
authors.initials: R
authors.lastname: Kuehne-Heid
authors.forename: Karin
authors.initials: K
authors.lastname: Teller
authors.forename: Christiane
authors.initials: C
authors.lastname: Greinke
authors.forename: Sabine
authors.initials: S
authors.lastname: Leistritz
authors.forename: Beate
authors.initials: B
authors.lastname: Ludwig
authors.forename: Matthias
authors.initials: M
authors.lastname: Dürst
authors.forename: Achim
authors.initials: A
authors.lastname: Schneider
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D015331:Cohort Studies; D005260:Female; D006801:Humans; D008875:Middle Aged; D065006:Papanicolaou Test; D027383:Papillomaviridae / Q000302:isolation & purification*; D030361:Papillomavirus Infections / Q000150:complications*; D012680:Sensitivity and Specificity; D014412:Tumor Virus Infections / Q000150:complications*; D002583:Uterine Cervical Neoplasms / Q000453:epidemiology*; D014626:Vaginal Smears; D002578:Uterine Cervical Dysplasia / Q000453:epidemiology*