Clinical validation of p16/Ki-67 dual-stained cytology triage of HPV-positive women: Results from the IMPACT trial.
Int J Cancer
; 150(3): 461-471, 2022 02 01.
Article
in En
| MEDLINE
| ID: mdl-34536311
ABSTRACT
Triage strategies are needed for primary human papillomavirus (HPV)-based cervical cancer screening to identify women requiring colposcopy/biopsy. We assessed the performance of p16/Ki-67 dual-stained (DS) immunocytochemistry to triage HPV-positive women and compared it to cytology, with or without HPV16/18 genotyping. A prospective observational screening study enrolled 35 263 women aged 25 to 65 years at 32 U.S. sites. Cervical samples had HPV and cytology testing, with colposcopy/biopsy for women with positive tests. Women without cervical intraepithelial neoplasia Grade 2 or worse (≥CIN2) at baseline (n = 3876) were retested after 1 year. In all, 4927 HPV-positive women with valid DS results were included in this analysis. DS sensitivity for ≥CIN2 and ≥CIN3 at baseline was 91.2% (95% confidence interval [CI] 86.8%-94.2%) and 91.9% (95% CI 86.1%-95.4%), respectively, in HPV16/18-positive women and 83.0% (95% CI 78.4%-86.8%) and 86.0% (95% CI 77.5%-91.6%) in women with 12 "other" genotypes. Using DS alone to triage HPV-positive women showed significantly higher sensitivity and specificity than HPV16/18 genotyping with cytology triage of 12 "other" genotypes, and substantially higher sensitivity but lower specificity than using cytology alone. The risk of ≥CIN2 was significantly lower in HPV-positive, DS-negative women (3.6%; 95% CI 2.9%-4.4%), compared to triage-negative women using HPV16/18 genotyping with cytology for 12 "other" genotypes (7.4%; 95% CI 6.4%-8.5%; P < .0001) or cytology alone (7.5%; 95% CI 6.7%-8.4%; P < .0001). DS showed better risk stratification than cytology-based strategies and provided high reassurance against pre-cancers both at baseline and at 1-year follow-up, irrespective of the HPV genotype. DS allows for the safe triage of primary screening HPV-positive women.
Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Uterine Cervical Neoplasms
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Ki-67 Antigen
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Cyclin-Dependent Kinase Inhibitor p16
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Human papillomavirus 16
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Human papillomavirus 18
Type of study:
Observational_studies
Limits:
Adult
/
Aged
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Female
/
Humans
/
Middle aged
Language:
En
Journal:
Int J Cancer
Year:
2022
Document type:
Article
Affiliation country: