Is Primary HPV with Secondary p16/Ki67 Dual-Stain an Alternative HSIL-Risk Detection Strategy in Cervical Cancer Screening for Women under 30 Years?

Trzeszcz, Martyna; Mazurec, Maciej; Jach, Robert; Mazurec, Karolina; Jach, Zofia; Kotkowska-Szeps, Izabela; Kania, Magdalena; Wantuchowicz, Mariola; Prokopyk, Anna; Barcikowski, Piotr; Przybylski, Marcin; Wach, Joanna; Hałoń, Agnieszka

doi:10.3390/diagnostics11112012

Cited by 10 publications

(15 citation statements)

References 23 publications

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“…Not without significance is the availability of a wide range of diagnostic services, including cytology taken by a doctor or midwife and the possibility of performing LBC or HPV DNA tests. A study based on 30,066 screening tests (LBC, hrHPV, p16/Ki67) performed in private outpatient gynecological clinics showed that the private model can be effectively used for CC prevention [12]. The unfavorable prognosis we discovered regarding the implementation of the publicly funded CC-screening program in Poland allows us to propose the following corrective actions presented in Table 11.…”

Section: Cervical Cancer Screeningmentioning

confidence: 98%

“…Screening for CC is based on the use of cervical cytology, which can be done with a Pap smear or liquid-based cytology (LBC), or via more sensitive HPV DNA testing [9,10]. A currently postulated extension of the above approaches is double immunocytochemical staining in cervical cytology samples for the antiproliferative proteins p16 and Ki67 [11,12].…”

Section: Introductionmentioning

confidence: 99%

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Cervical Cancer Prevention in the Era of the COVID-19 Pandemic

Poniewierza¹,

Panek

2022

Medicina

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Background and Objectives: Cervical cancer (CC) is the fourth most common cause of cancer-related morbidity and mortality among women worldwide. CC prevention is based on screening and HPV vaccination. The COVID-19 pandemic has caused difficulties in implementing CC-preventative measures. The aim of this study was to collect data on the implementation of CC prophylaxis in Poland provided by public and private health care with a particular focus on the impact of the COVID-19 pandemic and attempt to estimate the level of CC-screening implementation by 2026 under public and private health care. Materials and Methods: Data on the implementation of privately funded (2016–2021) and publicly funded (2014–2021) CC-preventative measures in Poland were examined. The Prophet algorithm, which positions itself as an automatic forecasting procedure and represents a local Bayesian structural time-series model, was used to predict data. The correlation test statistic was based on Pearson’s product moment correlation coefficient and follows a t distribution. An asymptotic confidence interval was given based on Fisher’s Z transform. Results: In 2021, a significantly higher population screening coverage was observed in private health care (71.91%) than in the public system (12.6%). Our estimation assumes that the adverse downward trend of population coverage (pap smear CC screening) in the public system will continue to 5.02% and in the private health system to 67.92% in 2026. Correlation analysis showed that with the increase in the sum of HPV tests and LBC, the percentage of Pap smear coverage in the private healthcare sector decreases r = −0.62, p = 0.260 df = 3, CI = [−0.97, 0.57]. The amount of HPV vaccinations provided in private health care is steadily increasing. Immunization coverage of the population of girls aged 9–18 years under private health care at the end of the observation period was 4.3% (2021). Conclusions: It is necessary to reorganize the public CC-screening system in Poland based on a uniform reporting system for tests performed in both public and private health care using the model of action proposed by us. We recommend the introduction of a national free HPV vaccination program funded by the government and implemented in public and private health care facilities.

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Section: Cervical Cancer Screeningmentioning

confidence: 98%

Section: Introductionmentioning

confidence: 99%

Cervical Cancer Prevention in the Era of the COVID-19 Pandemic

Poniewierza¹,

Panek

2022

Medicina

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“…This is another study in the series, the methodology was described in detail previously. 19,24 This retrospective analysis concerns the results of…”

Section: Study Design and Participantsmentioning

confidence: 99%

“…p16/Ki67 testing is characterized by high sensitivity and high specificity for the detection of CIN2+. p16/Ki67 has been proposed as secondary screening testing for minor cytological abnormalities, 15,17 for NILM HRHPV‐positive cases 14,18 and for HRHPV‐positive cases in primary HPV screening 18–21 . p16/Ki67 evaluation by a qualified pathologist has been approved by the Food and Drug Administration (FDA) as a triage method for HRHPV‐positive N16/N18 cases in primary HPV screening and for HRHPV‐positive N16/N18 NILM women who undergone cotesting 22 .…”

Section: Introductionmentioning

confidence: 99%

“…p16/Ki67 has been proposed as secondary screening testing for minor cytological abnormalities, 15,17 for NILM HRHPV-positive cases 14,18 and for HRHPV-positive cases in primary HPV screening. [18][19][20][21] p16/Ki67 evaluation by a qualified pathologist has been approved by the Food and Drug Administration (FDA) as a triage method for HRHPVpositive N16/N18 cases in primary HPV screening and for HRHPVpositive N16/N18 NILM women who undergone cotesting. 22 The Polish Interim cervical cancer screening guidelines have recommended a wider p16/Ki67 usage during the SARS-CoV-2 pandemic.…”

Section: Introductionmentioning

confidence: 99%

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p16/Ki67 dual stain triage versus cytology in primary human papillomavirus‐based cervical cancer screening with limited genotyping

Trzeszcz,

Mazurec,

Jach

et al. 2023

Journal of Medical Virology

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The introduction of primary human papillomavirus (HPV) cervical cancer screening requires the implementation of an appropriate triage strategy that will be effective in detecting high‐grade cervical disease without losing diagnostic specificity. From the 30.066 screening tests results, a total of 1086 with available high‐risk human papillomavirus (HRHPV) with limited genotyping, cytology, and p16/Ki67 dual‐stain were selected. Two triage strategies for primary HPV screening were analyzed retrospectively based on the study group. Performance characteristics for p16/Ki67 and cytology triage in the detection of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) and grade 3 or worse (CIN3+) were calculated, detected in colposcopic biopsy. In HPV16/18‐positive cases, primary HPV with p16/Ki67 triage was significantly more specific than cytology (53.1%/16.8% for CIN2+; p < 0.0001; 45.9%/17.0% for CIN3+; p < 0.0001), with yielded sensitivity (95.7%/84.8% for CIN2+; p = 0.0955; 100.0%/87.5% for CIN3+; p = 0.0832). In other HRHPV‐positive cases (N16/N18), p16/Ki67 triage was also significantly higher specific (51.3%/15.3% for CIN2+; p < 0.0001; 44.5%/16.5% for CIN3+; p < 0.0001), with sensitivity (92.3%/74.4% for CIN2+; p = 0.0522; 90.9%/81.8% for CIN3+; p = 0.5637). Diagnostic predictive values were significantly higher for p16/Ki67 triage with the highest PPV in HPV16/18‐positive cases for CIN2+ (45.4%; 95% confidence interval [CI]: 35.2–55.8; p < 0.0001) and very high NPV in all HPV‐positive cases regardless of detected genotype (96.3%–100.0%). The risk (1‐NPV) for CIN3+ in HRHPV16/18‐positive/p16/Ki67‐negative women was 0.0%. Superior diagnostic performance compared to cytology for detecting cervical cancer precursors indicates that p16/Ki67 dual‐immunostain may be a highly effective tool of triage in primary HPV screening with limited HPV 16/18 genotyping in secondary cervical cancer prevention.

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Should we use risk selection tests for HPV 16 and/or 18 positive cases: Comparison of p16/Ki67 and cytology

Mazurec,

Trzeszcz,

Mazurec

et al. 2024

Journal of Medical Virology

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Major screening abnormalities in precolposcopic stage are tests results that imply direct referral to colposcopy (and/or expedited treatment) without performing additional high‐grade squamous intraepithelial lesions or worse (HSIL+) risk selection testing. Currently, both clinically validated HSIL+ risk selection tests, reflex cytology and reflex p16/Ki67 dual staining (DS), are being compared for use in primary human papillomavirus (HPV)‐based screening to avoid possible overtreatment, but there is still no sufficient data available for their performance. Among 30 066 liquid‐based cervical cancer screening tests results, a group of 332 women was selected with available high‐risk types of HPV tests results with 16/18 limited genotyping, liquid‐based cytology, DS, and histology results from standardized colposcopy with biopsy. In HPV 16/18+ cases, three triage approaches were retrospectively analyzed. Predictive values for detection of HSIL+ were calculated and number of colposcopies required in each strategy. Both triage models with DS used (reflex cytology followed by DS, and reflex DS alone in all cases) had significantly higher positive predictive value for HSIL+ than strategy with reflex cytology alone (44.2%/45.7% vs. 28.3%; p < 0.0001). In models with DS, less colposcopies were required (95/92 vs. 152) and less colposcopies were needed per HSIL+ detection (2.26/2.19 vs. 3.54). Only one HSIL+ case was missed in both triage models with DS incorporation. p16/Ki67 dual‐stain may be an effective, alone or combined with cytology, triage test to detect HSIL+ in patients with major screening abnormalities in primary HPV‐based cervical cancer screening. Performing cytology as the first triage test improves the strategy by enabling referrals to expedited treatment in selected cases.

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Is Primary HPV with Secondary p16/Ki67 Dual-Stain an Alternative HSIL-Risk Detection Strategy in Cervical Cancer Screening for Women under 30 Years?

Cited by 10 publications

References 23 publications

Cervical Cancer Prevention in the Era of the COVID-19 Pandemic

Cervical Cancer Prevention in the Era of the COVID-19 Pandemic

p16/Ki67 dual stain triage versus cytology in primary human papillomavirus‐based cervical cancer screening with limited genotyping

Should we use risk selection tests for HPV 16 and/or 18 positive cases: Comparison of p16/Ki67 and cytology

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