Clinical Evaluation of DNA Ploidy for the Triage of HPV-Positive Chinese Women During Cervical Cancer Screening
- 1 March 2021
- journal article
- research article
- Published by American Association for Cancer Research (AACR) in Cancer Prevention Research
- Vol. 14 (3), 355-362
- https://doi.org/10.1158/1940-6207.capr-20-0229
Abstract
Quantification of DNA aneuploidy has great potential as a prognostic marker of cervical precancerous lesions. We aim to evaluate the performance of DNA ploidy analysis for the triage of HPV-positive women. 523 HPV-positive women aged 25-64 undergoing HPV and pap cytology testing with valid cervical biopsies in Renji Hospital were enrolled in a prospective observational study from June 2018 to June 2019. The clinical performance of DNA ploidy, with or without HPV16/18 genotyping, were evaluated for all HPV-positive women to detect histologic high grade squamous intraepithelial lesion or worse (HSIL+). For HSIL+ detection, DNA ploidy had statistically higher specificity (83.89%) than Pap cytology (75.50%, P=0.002) and HPV16/18 genotyping (77.92%, P=0.023). While the sensitivity of DNA ploidy (58.57%) remained similar with pap cytology (65.71%, P=0.461) and HPV16/18 genotyping (55.71%, P=0.734). A comparable sensitivity (84.29% vs 84.29%, P=1.000) and a higher specificity (66.00% vs 58.94%, P<0.001) compared to combination with Pap cytology. DNA ploidy triage strategy required fewer colposcopies per detection of HSIL+ compared with pap cytologic testing, with a 13.1% (34 of 258) reduction of colposcopies compared with routine triage strategy of HPV screening with Pap cytologic testing. HPV16/18-negative women with negative DNA ploidy results had the lowest risk of HSIL+ among HPV positive women (3.55%). Automated DNA ploidy analysis, alone or in combination with HPV16/18 genotyping, shows the potential as a triage strategy of cervical cancer screening for HPV-positive women.Keywords
Funding Information
- National Key R&D Program of China (2016YFC1302900)
- National Natural Science Foundation of China (81874101)
- Project of Shanghai Municipal Education Commission—Gaofeng Clinical Medicine Grant Support (20161412)
- Science and Technology Commission of Shanghai Municipality (18411963100, 18441904800)
- Key Discipline Project of Shanghai Municipal Commission of Health and Family Planning (15GWZK0701)
- Program of Shanghai Hospital Development Center (16CR2001A)
- Shanghai Municipal Commission of Health and Family Planning (2017ZZ02016)
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