Journal
CANCER EPIDEMIOLOGY BIOMARKERS & PREVENTION
Volume 29, Issue 6, Pages 1246-1252Publisher
AMER ASSOC CANCER RESEARCH
DOI: 10.1158/1055-9965.EPI-19-1180
Keywords
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Funding
- National Key R&D Program of China [2016YFC1302900]
- National Natural Science Foundation of China [81874101, 81772770, 81802582]
- Project of Pudong New Area Municipal Commission of Health and Family Planning [PW2016E-2]
- Project of Shanghai Municipal Education Commission-Gaofeng Clinical Medicine Grant Support [20161412]
- Key Discipline Project of Shanghai Municipal Commission of Health and Family Planning [15GWZK0701]
- Program of Shanghai Hospital Development Center [16CR2001A]
- Science and Technology Commission of Shanghai Municipality [18441904800]
- Shanghai Municipal Commission of Health and Family Planning [2017ZZ02016]
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Background: We aimed to evaluate the utility of p16/Ki-67 dual-stained cytology for triaging human papillomavirus (HPV)-positive women. Methods: HPV-positive women ages >= 21 years were recruited in a multicenter prospective observational study between May 2016 and May 2017. The clinical performance of dual-stained cytology, with or without HPV16/18 genotyping, was evaluated for all HPV-positive women to detect cervical intraepithelial neoplasia grade 2 or worse (CIN2+). Results: 846 HPV-positive women ages >= 21 years with valid cervical biopsies were enrolled for this study. For CIN2+ detection, dual-stained cytology showed statistically higher specificity (85.28%) than Pap cytology (80.00%, P < 0.001) and HPV16/18 genotyping (72.36%, P < 0.001), while the sensitivity of dualstained cytology (63.49%) remained comparable with that of Pap cytology (61.90%, P = 0.832) and HPV16/18 genotyping ( 61.90%, P = 0.897). HPV16/18 genotyping in combination with dual-stained cytology was more specific (62.50% vs. 58.06%, P < 0.001), while it showed similar sensitivity (86.51% vs. 85.71%, P = 1.000), as compared with HPV16/18 genotyping in combination with Pap cytology. Similar patterns were also observed for CIN3+. Conclusions: p16/Ki-67 dual-stained cytology, either alone or in combination with HPV16/18 genotyping, showed a good stratification with high specificity and comparable sensitivity for HPV-positive women. Impact: This is one of the few studies that has evaluated the performance of dual-stained cytology for triaging HPV-positive women in China. The higher specificity and comparable sensitivity of dual-stained cytology in comparison with Pap cytology in the detection of CIN2+ or CIN3+ is of vital importance to developing countries, where Pap cytology faces many challenges.
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