p16/Ki-67 dual staining in cervico-vaginal cytology: Correlation with histology, Human Papillomavirus detection and genotyping in women undergoing colposcopy

Donà, Maria Gabriella; Vocaturo, Amina; Giuliani, Massimo; Ronchetti, Livia; Rollo, Francesca; Pescarmona, Edoardo; Carosi, Mariantonia; Vocaturo, Giuseppe; Benevolo, Maria

doi:10.1016/j.ygyno.2012.05.004

Cited by 57 publications

(49 citation statements)

References 19 publications

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“…The combined immunocytochemical detection of p16 INK4a and Ki-67 (CINtec® PLUS) shows higher positive predictive values (PPV) for cervical intraepithelial neoplasia (CIN) grade 2 or higher (CIN2+) than cytology or high-risk HPV test results in international studies [1,2,3]. Most studies examined the value of the p16/Ki-67 dual stain for the triage of atypical squamous cells of undetermined significance (ASC-US)/LSIL findings based on colposcopy and biopsy results [4,5,6,7,8,9,10], but only limited follow-up data were provided. Such studies are prone to be methodologically inaccurate [11,12] since prognostically relevant conclusions can only be drawn from prospective studies with follow-up investigations that are relevant for the individual patient management.…”

Section: Introductionmentioning

confidence: 99%

Predictive Value of the Combined p16<sup>INK4a</sup> and Ki-67 Immunocytochemistry in Low-Grade Squamous Intraepithelial Lesions

Ziemke¹,

Marquardt

Griesser³

2014

Acta Cytologica

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Objective: The reliability of cytological diagnoses, especially for low-grade squamous intraepithelial lesions (LSIL), is limited. This leads to uncertainty in patient management. The application of adjunctive biomarkers is meant to improve this situation. Therefore, we examined the prognostic value of p16/Ki-67 immunostaining of LSIL cytology specimens. Study Design: We analyzed the p16^INK4a and Ki-67 immunocytochemistry (CINtec® PLUS, dual stain) of 260 patients with LSIL. Cytology and dual-stain results were correlated with histology at the time of treatment or with cytological follow-up. Results: After an average duration of 24.9 months (1-58) and a histology rate of 36.2% [cervical intraepithelial neoplasia, grade 2 or higher (CIN2+) as positive], the statistical evaluation for cytology and dual stain resulted in a sensitivity of 98.3 and 90.0%, respectively, a specificity of 74.5% for dual stain, a positive predictive value (PPV) of 22.8 and 51.4%, and a negative predictive value (NPV) of 96.1% for dual stain. Conclusion: The combined immunocytochemical investigation of p16^INK4a and Ki-67 leads to a significantly better PPV and a very good NPV for CIN2+ in LSIL, especially in women 30 years of age and older. An objective individualized prognosis may not be achieved with p16^INK4a/Ki-67. Statistical data from our study, however, indicate that patient management can be significantly improved by the application of combined p16/Ki-67 immunocytochemistry as an adjunct to cytology.

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Section: Introductionmentioning

confidence: 99%

Predictive Value of the Combined p16<sup>INK4a</sup> and Ki-67 Immunocytochemistry in Low-Grade Squamous Intraepithelial Lesions

Ziemke¹,

Marquardt

Griesser³

2014

Acta Cytologica

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“…Overexpression of the cellular protein p16, a cyclin-dependent kinase inhibitor, and Ki-67, a cellular proliferation marker, within the same cell is associated with cell-cycle deregulation and indicates the oncogenic potential of HPV in cervical lesions [9,10,14]. Recent data from colposcopy clinics indicate that the detection of the coexpression of these biomarkers may allow for the efficient, morphology-independent identification of women that are at the highest risk for having an existing high-grade cervical precancerous lesion [8,11,12]. …”

Section: Discussionmentioning

confidence: 99%

“…Several recent studies have shown that p16/Ki-67 positivity is strongly associated with the presence of transforming HPV infections and histologic abnormalities [8,9,10,11,12,13,14]. To date, there are no data on the efficiency of this new diagnostic tool in prenatal care.…”

Section: Introductionmentioning

confidence: 99%

p16/Ki-67 Dual-Stained Cytology Testing May Predict Postpartum Outcome in Patients with Abnormal Papanicolaou Cytology during Pregnancy

Trutnovsky¹,

Kolovetsiou-Kreiner²,

Reich³

2014

Acta Cytologica

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Objective: To evaluate the use of a new immunocytochemical dual-staining protocol, which allows for the detection of coexpression of the p16^INK4a (p16) and Ki-67 biomarkers in prenatal care. It was hypothesized that dual-staining cytology may predict postpartum outcome in patients with abnormal cervical Papanicolaou (Pap) smears during pregnancy. Study Design: In this retrospective pilot study, 27 abnormal Pap smears collected from women during early pregnancy were destained and subsequently stained for p16/Ki-67. Results were correlated with histologic outcome collected during postpartum follow-up. Results: Fourteen of 20 abnormal Pap smears during pregnancy showed a positive p16/Ki-67 dual-stained cytology result, whereas 6 specimens tested negative. Seven cases were excluded due to technical reasons. All 14 patients who were positive for p16/Ki-67 dual stain had cervical intraepithelial neoplasia (CIN) on postpartum histology. In contrast, 5 out of 6 patients negative for p16/Ki-67 dual-staining had a negative histology postpartum and during follow-up, and the remaining patient showed a CIN1 (p < 0.001). Conclusion: p16/Ki-67 dual-stained cytology may provide a valuable novel approach to identify pregnant women with persistent or progressing CIN disease and may help improve the management of abnormal Pap cytology results during pregnancy.

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“…La tinción dual p16/Ki67 en citología constituye, por tanto, una de las pruebas más prometedores para identificar lesiones cervicales premalignas [162][163][164][165][166][167][168][169][170][171] . En la actualidad se han publicado diez estudios en los que, a pesar de las notables diferencias en los criterios de inclusión, se observa una sensibilidad y especificidad muy altas (aproximadamente del 90 y del 80%, respectivamente).…”

Section: Otros Marcadores Molecularesunclassified

Guía de cribado del cáncer de cuello de útero en España, 2014

Bladé

Saladrigues

Gimferrer³

et al. 2014

Progresos de Obstetricia y Ginecología

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Justificación de la Guía de cribado del cáncer de cuello de útero en España, 2014El cáncer de cuello uterino (CCU) es la tercera neoplasia más frecuente en el mundo en las mujeres. El cribado de mujeres sanas mediante citología cervical ha demostrado claramente su eficacia, puesto que su aplicación de forma adecuada y sistemática en determinados paí-ses ha conseguido reducir en un 70-80% la incidencia y mortalidad por CCU. Este beneficio se debe a la detección de lesiones premalignas asintomáticas cuyo diagnóstico y tratamiento evita su progresión a carcinoma invasor.En las dos últimas décadas, múltiples estudios han aportado una só-lida evidencia que confirma al virus del papiloma humano (VPH) como agente causal de la práctica totalidad de los casos de CCU y de sus lesiones precursoras. Un número limitado de genotipos de VPH de alto riesgo oncogénico (VPH-AR) está causalmente implicado. Concretamente, los VPH 16 y 18 explican el 70% de los CCU y otros 10 tipos (VPH 45,31,33,52,58,35,59, 56, 51 y 39) explican el 25-35% de los casos restantes. Esta información ha permitido establecer un nuevo modelo de carcinogénesis basado en la persistencia de la infección por VPH como elemento necesario para el desarrollo de lesiones precursoras y CCU. Sin embargo, más del 90% de las infecciones por VPH son transitorias y, por tanto, irrelevantes desde el punto de vista oncogénico. Durante los primeros años de vida sexual se observa una elevada incidencia de infección, pero la mayoría de estas infecciones son transitorias y desaparecen espontáneamente. Las mujeres mayores de 30 años experimentan una clara disminución de la prevalencia de la infección por VPH, pero un

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p16/Ki-67 dual staining in cervico-vaginal cytology: Correlation with histology, Human Papillomavirus detection and genotyping in women undergoing colposcopy

Cited by 57 publications

References 19 publications

Predictive Value of the Combined p16<sup>INK4a</sup> and Ki-67 Immunocytochemistry in Low-Grade Squamous Intraepithelial Lesions

Predictive Value of the Combined p16<sup>INK4a</sup> and Ki-67 Immunocytochemistry in Low-Grade Squamous Intraepithelial Lesions

p16/Ki-67 Dual-Stained Cytology Testing May Predict Postpartum Outcome in Patients with Abnormal Papanicolaou Cytology during Pregnancy

Guía de cribado del cáncer de cuello de útero en España, 2014

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