Predictive value of p16/Ki-67 immunocytochemistry for triage of women with abnormal Papanicolaou test in cervical cancer screening

A systematic review and meta-Analysis

Cheng Chieh Chen, Lee Wen Huang, Chyi Huey Bai, Chin Cheng Lee

Research output: Contribution to journalReview article

7 Citations (Scopus)

Abstract

Background: The Papanicolaou (Pap) test is one screening strategy used to prevent cervical cancer in developed countries. The p16/Ki-67 immunocytochemistry is a triage test performed on Pap smears in women with atypical squamous cells of undetermined significance (ASCUS) or low grade squamous intraepithelial lesion. Ob jective: Our objective was to review studies investigating the diagnostic performance of p16/Ki-67 dual stain for triage of women with abnormal Pap tests. Design: We conducted a systematic review and meta-Analysis of diagnostic test accuracy studies. Settings: We followed the protocol of systematic review of diagnostic accuracy studies. Patients AND Methods: We searched PubMed, The Cochrane Library, BioMed Central, and ClinicalTrials.gov for relevant studies. We included research that assessed the accuracy of p16/Ki-67 dual stain and high risk human papillomavirus testing for triage of abnormal Pap smears. Review articles and studies that provided insufficient data to construct 2×2 tables were excluded. Data synthesis was conducted using a random-effects model. Main Outcome Measures: Sensitivity and specificity. Results: In seven studies encompassing 2628 patients, the pooled sensitivity and specificity of p16/Ki-67 for triage of abnormal Pap smear results were 0.91 (95% CI, 0.89 to 0.93) and 0.64 (95% CI, 0.62 to 0.66), respectively. No study used a case-control design. A subgroup analysis involving liquid-based cytology showed a sensitivity of 0.91 (95%CI, 0.89 to 0.93) and specificity of 0.64 (95%CI, 0.61 to 0.66). Conclusions: Our meta-Analysis of p16/Ki-67 dual stain studies showed that the test achieved high sensitivity and moderate specificity for p16/Ki-67 immunocytochemistry for high-grade squamous intraepithelial lesion and cervical cancer. We suggest that p16/Ki-67 dual stain might be a reliable ancillary method identifying high-grade squamous intraepithelial lesions in women with abnormal Pap tests. Limitations: No study in the meta-Analysis examined the accuracy of the p16/Ki-67 dual stain for interpretation of glandular neoplasms.

Original languageEnglish
Pages (from-to)245-251
Number of pages7
JournalAnnals of Saudi Medicine
Volume36
Issue number4
DOIs
Publication statusPublished - Jul 1 2016

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Papanicolaou Test
Triage
Early Detection of Cancer
Uterine Cervical Neoplasms
Meta-Analysis
Immunohistochemistry
Coloring Agents
Sensitivity and Specificity
Glandular and Epithelial Neoplasms
Routine Diagnostic Tests
Developed Countries
PubMed
Libraries
Cell Biology
Outcome Assessment (Health Care)
Research
Squamous Intraepithelial Lesions of the Cervix

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Predictive value of p16/Ki-67 immunocytochemistry for triage of women with abnormal Papanicolaou test in cervical cancer screening : A systematic review and meta-Analysis. / Chen, Cheng Chieh; Huang, Lee Wen; Bai, Chyi Huey; Lee, Chin Cheng.

In: Annals of Saudi Medicine, Vol. 36, No. 4, 01.07.2016, p. 245-251.

Research output: Contribution to journalReview article

@article{ac477d6e85464aa4baff27a5e6d266f1,
title = "Predictive value of p16/Ki-67 immunocytochemistry for triage of women with abnormal Papanicolaou test in cervical cancer screening: A systematic review and meta-Analysis",
abstract = "Background: The Papanicolaou (Pap) test is one screening strategy used to prevent cervical cancer in developed countries. The p16/Ki-67 immunocytochemistry is a triage test performed on Pap smears in women with atypical squamous cells of undetermined significance (ASCUS) or low grade squamous intraepithelial lesion. Ob jective: Our objective was to review studies investigating the diagnostic performance of p16/Ki-67 dual stain for triage of women with abnormal Pap tests. Design: We conducted a systematic review and meta-Analysis of diagnostic test accuracy studies. Settings: We followed the protocol of systematic review of diagnostic accuracy studies. Patients AND Methods: We searched PubMed, The Cochrane Library, BioMed Central, and ClinicalTrials.gov for relevant studies. We included research that assessed the accuracy of p16/Ki-67 dual stain and high risk human papillomavirus testing for triage of abnormal Pap smears. Review articles and studies that provided insufficient data to construct 2×2 tables were excluded. Data synthesis was conducted using a random-effects model. Main Outcome Measures: Sensitivity and specificity. Results: In seven studies encompassing 2628 patients, the pooled sensitivity and specificity of p16/Ki-67 for triage of abnormal Pap smear results were 0.91 (95{\%} CI, 0.89 to 0.93) and 0.64 (95{\%} CI, 0.62 to 0.66), respectively. No study used a case-control design. A subgroup analysis involving liquid-based cytology showed a sensitivity of 0.91 (95{\%}CI, 0.89 to 0.93) and specificity of 0.64 (95{\%}CI, 0.61 to 0.66). Conclusions: Our meta-Analysis of p16/Ki-67 dual stain studies showed that the test achieved high sensitivity and moderate specificity for p16/Ki-67 immunocytochemistry for high-grade squamous intraepithelial lesion and cervical cancer. We suggest that p16/Ki-67 dual stain might be a reliable ancillary method identifying high-grade squamous intraepithelial lesions in women with abnormal Pap tests. Limitations: No study in the meta-Analysis examined the accuracy of the p16/Ki-67 dual stain for interpretation of glandular neoplasms.",
author = "Chen, {Cheng Chieh} and Huang, {Lee Wen} and Bai, {Chyi Huey} and Lee, {Chin Cheng}",
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T1 - Predictive value of p16/Ki-67 immunocytochemistry for triage of women with abnormal Papanicolaou test in cervical cancer screening

T2 - A systematic review and meta-Analysis

AU - Chen, Cheng Chieh

AU - Huang, Lee Wen

AU - Bai, Chyi Huey

AU - Lee, Chin Cheng

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N2 - Background: The Papanicolaou (Pap) test is one screening strategy used to prevent cervical cancer in developed countries. The p16/Ki-67 immunocytochemistry is a triage test performed on Pap smears in women with atypical squamous cells of undetermined significance (ASCUS) or low grade squamous intraepithelial lesion. Ob jective: Our objective was to review studies investigating the diagnostic performance of p16/Ki-67 dual stain for triage of women with abnormal Pap tests. Design: We conducted a systematic review and meta-Analysis of diagnostic test accuracy studies. Settings: We followed the protocol of systematic review of diagnostic accuracy studies. Patients AND Methods: We searched PubMed, The Cochrane Library, BioMed Central, and ClinicalTrials.gov for relevant studies. We included research that assessed the accuracy of p16/Ki-67 dual stain and high risk human papillomavirus testing for triage of abnormal Pap smears. Review articles and studies that provided insufficient data to construct 2×2 tables were excluded. Data synthesis was conducted using a random-effects model. Main Outcome Measures: Sensitivity and specificity. Results: In seven studies encompassing 2628 patients, the pooled sensitivity and specificity of p16/Ki-67 for triage of abnormal Pap smear results were 0.91 (95% CI, 0.89 to 0.93) and 0.64 (95% CI, 0.62 to 0.66), respectively. No study used a case-control design. A subgroup analysis involving liquid-based cytology showed a sensitivity of 0.91 (95%CI, 0.89 to 0.93) and specificity of 0.64 (95%CI, 0.61 to 0.66). Conclusions: Our meta-Analysis of p16/Ki-67 dual stain studies showed that the test achieved high sensitivity and moderate specificity for p16/Ki-67 immunocytochemistry for high-grade squamous intraepithelial lesion and cervical cancer. We suggest that p16/Ki-67 dual stain might be a reliable ancillary method identifying high-grade squamous intraepithelial lesions in women with abnormal Pap tests. Limitations: No study in the meta-Analysis examined the accuracy of the p16/Ki-67 dual stain for interpretation of glandular neoplasms.

AB - Background: The Papanicolaou (Pap) test is one screening strategy used to prevent cervical cancer in developed countries. The p16/Ki-67 immunocytochemistry is a triage test performed on Pap smears in women with atypical squamous cells of undetermined significance (ASCUS) or low grade squamous intraepithelial lesion. Ob jective: Our objective was to review studies investigating the diagnostic performance of p16/Ki-67 dual stain for triage of women with abnormal Pap tests. Design: We conducted a systematic review and meta-Analysis of diagnostic test accuracy studies. Settings: We followed the protocol of systematic review of diagnostic accuracy studies. Patients AND Methods: We searched PubMed, The Cochrane Library, BioMed Central, and ClinicalTrials.gov for relevant studies. We included research that assessed the accuracy of p16/Ki-67 dual stain and high risk human papillomavirus testing for triage of abnormal Pap smears. Review articles and studies that provided insufficient data to construct 2×2 tables were excluded. Data synthesis was conducted using a random-effects model. Main Outcome Measures: Sensitivity and specificity. Results: In seven studies encompassing 2628 patients, the pooled sensitivity and specificity of p16/Ki-67 for triage of abnormal Pap smear results were 0.91 (95% CI, 0.89 to 0.93) and 0.64 (95% CI, 0.62 to 0.66), respectively. No study used a case-control design. A subgroup analysis involving liquid-based cytology showed a sensitivity of 0.91 (95%CI, 0.89 to 0.93) and specificity of 0.64 (95%CI, 0.61 to 0.66). Conclusions: Our meta-Analysis of p16/Ki-67 dual stain studies showed that the test achieved high sensitivity and moderate specificity for p16/Ki-67 immunocytochemistry for high-grade squamous intraepithelial lesion and cervical cancer. We suggest that p16/Ki-67 dual stain might be a reliable ancillary method identifying high-grade squamous intraepithelial lesions in women with abnormal Pap tests. Limitations: No study in the meta-Analysis examined the accuracy of the p16/Ki-67 dual stain for interpretation of glandular neoplasms.

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