Triage Strategies for Non-16/Non-18 HPV-Positive Women in Primary HPV-Based Cervical Cancer Screening: p16/Ki67 Dual Stain vs. Cytology
Background: In the context of primary HPV cervical cancer screening, the identification of minor screening abnormalities necessitates triage tests to optimize management and mitigate overtreatment. Currently, reflex cytology and reflex p16/Ki67 dual-stain (DS) are under scrutiny for their applicabil...
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| Format: | Article |
| Language: | English |
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MDPI AG
2023-10-01
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| Series: | Cancers |
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| Online Access: | https://www.mdpi.com/2072-6694/15/20/5095 |
| _version_ | 1797574356077903872 |
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| author | Karolina Mazurec Martyna Trzeszcz Maciej Mazurec Joanna Streb Agnieszka Halon Robert Jach |
| author_facet | Karolina Mazurec Martyna Trzeszcz Maciej Mazurec Joanna Streb Agnieszka Halon Robert Jach |
| author_sort | Karolina Mazurec |
| collection | DOAJ |
| description | Background: In the context of primary HPV cervical cancer screening, the identification of minor screening abnormalities necessitates triage tests to optimize management and mitigate overtreatment. Currently, reflex cytology and reflex p16/Ki67 dual-stain (DS) are under scrutiny for their applicability in primary HPV-based screening. However, there remains a dearth of comprehensive data for comparing their performance. Methods: Among 30,066 results from liquid-based cervical cancer screening tests, a cohort of 332 cases was meticulously selected based on available high-risk human papillomavirus (HPV) test results, limited genotyping for HPV 16 and 18, liquid-based cytology, DS, and histology outcomes from standardized colposcopy with biopsy. For cases positive for 12 other high-risk HPV genotypes, three retrospective triage approaches were analyzed. We computed the positive predictive value (PPV) for the detection of high-grade squamous intraepithelial lesions or worse (HSIL+). Results: Both triage models employing DS (reflex cytology followed by DS and reflex DS alone in all cases) exhibited significantly higher PPV for HSIL+ compared to the strategy with reflex cytology alone (35.9%/33.3% vs. 18.8%; <i>p</i> < 0.0001). Additionally, these DS-based models showed higher negative predictive values (NPV) (100%/96.2% vs. 69.2%; <i>p</i> = 0.0024/0.0079). In the DS-inclusive models, fewer colposcopies were necessitated (103/102 vs. 154), and fewer cases of HSIL+ were overlooked (0/3 vs. 8). Conclusions: Our findings suggest that p16/Ki67 dual-stain, either as a standalone or combined triage test, holds promise for the effective detection of HSIL+ in patients with minor screening abnormalities in primary HPV-based cervical cancer screening. |
| first_indexed | 2024-03-10T21:21:48Z |
| format | Article |
| id | doaj.art-a5482d4cfa1e435faacb30fddad99874 |
| institution | Directory Open Access Journal |
| issn | 2072-6694 |
| language | English |
| last_indexed | 2024-03-10T21:21:48Z |
| publishDate | 2023-10-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Cancers |
| spelling | doaj.art-a5482d4cfa1e435faacb30fddad998742023-11-19T16:00:31ZengMDPI AGCancers2072-66942023-10-011520509510.3390/cancers15205095Triage Strategies for Non-16/Non-18 HPV-Positive Women in Primary HPV-Based Cervical Cancer Screening: p16/Ki67 Dual Stain vs. CytologyKarolina Mazurec0Martyna Trzeszcz1Maciej Mazurec2Joanna Streb3Agnieszka Halon4Robert Jach5Corfamed Woman’s Health Center, Kluczborska 37, 50-322 Wroclaw, PolandCorfamed Woman’s Health Center, Kluczborska 37, 50-322 Wroclaw, PolandCorfamed Woman’s Health Center, Kluczborska 37, 50-322 Wroclaw, PolandDepartment of Oncology, Jagiellonian University Medical College, Kopernika 50, 31-501 Krakow, PolandDepartment of Clinical and Experimental Pathology, Division of Clinical Pathology, Wroclaw Medical University, Borowska 213, 50-556 Wroclaw, PolandDivision of Gynecologic Endocrinology, Jagiellonian University Medical College, Kopernika 23, 31-501 Krakow, PolandBackground: In the context of primary HPV cervical cancer screening, the identification of minor screening abnormalities necessitates triage tests to optimize management and mitigate overtreatment. Currently, reflex cytology and reflex p16/Ki67 dual-stain (DS) are under scrutiny for their applicability in primary HPV-based screening. However, there remains a dearth of comprehensive data for comparing their performance. Methods: Among 30,066 results from liquid-based cervical cancer screening tests, a cohort of 332 cases was meticulously selected based on available high-risk human papillomavirus (HPV) test results, limited genotyping for HPV 16 and 18, liquid-based cytology, DS, and histology outcomes from standardized colposcopy with biopsy. For cases positive for 12 other high-risk HPV genotypes, three retrospective triage approaches were analyzed. We computed the positive predictive value (PPV) for the detection of high-grade squamous intraepithelial lesions or worse (HSIL+). Results: Both triage models employing DS (reflex cytology followed by DS and reflex DS alone in all cases) exhibited significantly higher PPV for HSIL+ compared to the strategy with reflex cytology alone (35.9%/33.3% vs. 18.8%; <i>p</i> < 0.0001). Additionally, these DS-based models showed higher negative predictive values (NPV) (100%/96.2% vs. 69.2%; <i>p</i> = 0.0024/0.0079). In the DS-inclusive models, fewer colposcopies were necessitated (103/102 vs. 154), and fewer cases of HSIL+ were overlooked (0/3 vs. 8). Conclusions: Our findings suggest that p16/Ki67 dual-stain, either as a standalone or combined triage test, holds promise for the effective detection of HSIL+ in patients with minor screening abnormalities in primary HPV-based cervical cancer screening.https://www.mdpi.com/2072-6694/15/20/5095cervical cancer screeninghigh-risk HPVp16/Ki67 dual stainingDSpreventiontriage |
| spellingShingle | Karolina Mazurec Martyna Trzeszcz Maciej Mazurec Joanna Streb Agnieszka Halon Robert Jach Triage Strategies for Non-16/Non-18 HPV-Positive Women in Primary HPV-Based Cervical Cancer Screening: p16/Ki67 Dual Stain vs. Cytology Cancers cervical cancer screening high-risk HPV p16/Ki67 dual staining DS prevention triage |
| title | Triage Strategies for Non-16/Non-18 HPV-Positive Women in Primary HPV-Based Cervical Cancer Screening: p16/Ki67 Dual Stain vs. Cytology |
| title_full | Triage Strategies for Non-16/Non-18 HPV-Positive Women in Primary HPV-Based Cervical Cancer Screening: p16/Ki67 Dual Stain vs. Cytology |
| title_fullStr | Triage Strategies for Non-16/Non-18 HPV-Positive Women in Primary HPV-Based Cervical Cancer Screening: p16/Ki67 Dual Stain vs. Cytology |
| title_full_unstemmed | Triage Strategies for Non-16/Non-18 HPV-Positive Women in Primary HPV-Based Cervical Cancer Screening: p16/Ki67 Dual Stain vs. Cytology |
| title_short | Triage Strategies for Non-16/Non-18 HPV-Positive Women in Primary HPV-Based Cervical Cancer Screening: p16/Ki67 Dual Stain vs. Cytology |
| title_sort | triage strategies for non 16 non 18 hpv positive women in primary hpv based cervical cancer screening p16 ki67 dual stain vs cytology |
| topic | cervical cancer screening high-risk HPV p16/Ki67 dual staining DS prevention triage |
| url | https://www.mdpi.com/2072-6694/15/20/5095 |
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