In a study reported in JAMA Oncology, Clarke et al found that triage with p16/Ki-67 dual-stain testing (DS) was associated with better risk stratification for cervical precancer than Papanicolaou cytology testing over 5 years among human papilloma virus (HPV)–positive women.
The study involved data from 1,549 HPV-positive women aged ≥ 30 years undergoing routine cervical cancer screening in 2012 with HPV and cytology cotesting in the Kaiser Permanente Northern California health-care system. Follow-up was performed through 2017. Five-year cumulative risk of cervical intraepithelial neoplasia of grade 2 or worse (≥ CIN2) or grade 3 or worse (≥ CIN3) was assessed according to baseline DS and cytology was estimated at yearly intervals. Risks were also analyzed in the context of internal clinical management thresholds for colposcopy referral and a 1-year return interval. Patients had a mean age of 42 years at enrollment.
Median follow-up was 3.7 years. Positive baseline DS results were associated with significantly higher cumulative 5-year risk of ≥ CIN2 vs abnormal cytology (31.0% vs 25.0%, P = .03). Women with negative baseline DS results had significantly lower cumulative 5-year risk of ≥ CIN2 vs women with normal cytology (8.5% vs 12.3%, P = .04). Similar findings were made for cumulative risk of ≥ CIN3 according to baseline results.
Cumulative risks of ≥ CIN2 and ≥ CIN3 in DS-positive women and in women with atypical squamous cells of undetermined significance on cytology at baseline exceeded the internal risk thresholds for colposcopy referral for all 5 years. In women who were DS-negative at baseline, cumulative risks of ≥ CIN2 and ≥ CIN3 remained below the colposcopy referral threshold for up to 5 years and crossed the 1-year return referral threshold at year 3. Cumulative risks of ≥ CIN2 and ≥ CIN3 in women who were negative for intraepithelial lesion or malignancy on cytology crossed the threshold for immediate colposcopy referral after year 4 and the 1-year return risk threshold at year 1.
The investigators concluded, “Triage with p16/Ki-67 DS provides better long-term risk stratification than cytology over 5 years. The low risk of cervical precancer in p16/Ki-67 DS–negative women permits safe extension of follow-up intervals for 3 years.”
The study was supported by the Intramural Research Program of the National Institutes of Health and the National Cancer Institute.
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