Prospective evaluation of p16/Ki‐67 dual‐stained cytology for managing women with abnormal Papanicolaou cytology: PALMS study results

Bergeron, Christine; Ikenberg, Hans; Sideri, Mario; Denton, Karin; Bogers, Johannes; Schmidt, Dietmar; Alameda, F; Keller, Thomas; Rehm, Susanne; Ridder, Ruediger

doi:10.1002/cncy.21542

Cited by 106 publications

(113 citation statements)

References 26 publications

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“…Together HPV16 and HPV18 along with HPV45 account for 75% of squamous cell carcinoma cases and 94% of adenocarcinomas; 11 b) expression of the oncoprotein E6 as a marker of neoplastic progression; 12 c) cytology for the detection of morphological changes; d) immunocytochemistry for the detection of markers of neoplastic progression like p16INK4a/Ki67, a test with high specificity in the diagnosis of cervical intraepithelial neoplasia of grade 2 or higher (CIN2+). 13,14 The available triage testing alternatives may help identify women who require further diagnostic testing and confirmation, cause less anxiety, and help to avoid unnecessary treatment and expenses in women who have a low risk of progressing to cancer. 1,15,16 In addition, beyond screening and triage, there is no agreement regarding the best method for the diagnostic confirmation of hrHPVpositive women.…”

Section: Triage Strategies In Cervical Cancer Detection In Mexico: Mementioning

confidence: 99%

Triage strategies in cervical cancer detection in Mexico: methods of the FRIDA Study

et al. 2016

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Objective. This paper describes the study design and baseline characteristics of the study population, including the first 30 829 women who enrolled in the Forwarding Research for Improved Detection and Access for Cervical Cancer Screening and Triage (FRIDA Study). This is a large population based study that is evaluating the performance and cost-effectiveness of different triage strategies for high-risk HPV (hrHPV) positive women in Mexico. Materials and methods. The target population is more than 100 000 women aged 30 to 64 years who attend the Cervical Cancer Screening Program in 100 health centers in the state of Tlaxcala, Mexico. Since August 2013, all women in the region have been invited to ResumenObjetivo.

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Section: Triage Strategies In Cervical Cancer Detection In Mexico: Mementioning

confidence: 99%

Triage strategies in cervical cancer detection in Mexico: methods of the FRIDA Study

et al. 2016

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Section: P16/ki-67 Dual-stained Cytologymentioning

confidence: 99%

“…Simultaneous expression of the antiproliferative p16 protein and the proliferation marker Ki-67 should exclude each other in cells under normal physiological conditions [61][62][63][64]. The simultaneous expression of p16 and Ki-67 in one cell is indicative for cell cycle dysregulation and appears indicative for a transforming hrHPV infection [61][62][63][64]. Three recent studies have addressed the performance of p16/Ki-67 dualstained cytology for triage of hrHPV-positive women, in population-based screening cohorts (n = 1509 [65] and n = 396 [66]) and a gynecologic outpatient population (n = 446 [67]).…”

Section: P16/ki-67 Dual-stained Cytologymentioning

confidence: 99%

Management of high-risk HPV-positive women for detection of cervical (pre)cancer

Luttmer

Strooper

Steenbergen

et al. 2016

Expert Review of Molecular Diagnostics

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Introduction: Primary HPV-testing has been shown to provide a superior detection of women at risk of cervical (pre)cancer compared to cytology-based screening. However, as most high-risk HPV infections are harmless, additional triage testing of HPV-positive women is necessary to identify those with cervical (pre)cancer. In this paper, we compare the performance, advantages and limitations of clinically relevant available triage strategies for HPV-positive women. Areas covered: Many different colposcopy triage strategies, comprising both microscopy-based and molecular (virus/host-related) markers, have been suggested: Pap cytology, p16/Ki-67 dual-stained cytology, HPV16/18 genotyping, viral DNA methylation and host cell DNA methylation. Literature search was limited to triage strategies that have achieved at least phase 2 of the five-phase framework for biomarker development and studies including large cohorts (≥100 hrHPV-positive women). Triage markers were stratified by sample type (cervical scrape, self-collected sample) and by study population (screening, non-attendee, referral). Expert commentary: At present, repeat Pap cytology and Pap cytology combined with HPV16/18 genotyping are the only triage strategies that have been robustly shown to be ready for implementation. Other strategies such as p16/Ki-67 dual-stained cytology and host cell DNA methylation analysis, with or without additional HPV16/18 genotyping, are attractive options for the near future. ARTICLE HISTORY

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“…Currently, the most often recommended triage strategy for primary HPV screening is cytology. However, HPV genotyping for HPV 16 and HPV 18 implies a risk for CIN 3+ of more than 15% which triggers immediate colposcopy according to the clinical threshold in most Western countries [23,24,25,26,27,28]. Another alternative which is recommended in the German guidelines includes p16/Ki-67 dual stain cytology that has improved accuracy when compared to cytology based on a limited number of studies [8,29].…”

Section: Cervical Cancer Screeningmentioning

confidence: 99%

Epidemiology and Early Detection of Cervical Cancer

Hillemanns

Soergel²,

Hertel³

et al. 2016

Oncol Res Treat

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The new German S3 guideline ‘Prevention of Cervical Cancer' published in 2016 is based on the latest available evidence about cervical cancer screening and treatment of cervical precancer. Large randomized controlled trials indicate that human papillomavirus (HPV)-based screening may provide better protection against cervical cancer than cytology alone through improved detection of premalignant disease in the first screening round prior to progression. Therefore, women aged 30 years and older should preferably be screened with HPV testing every 3-5 years (cytology alone every 2 years is an acceptable alternative). Co-testing is not recommended. Screening should start at 25 years using cytology alone every 2 years. The preferred triage test after a positive HPV screening test is cytology. Women positive for HPV 16 and HPV 18 should receive immediate colposcopy. Another alternative triage method is p16/Ki-67 dual stain cytology. The mean yearly participation rate in Germany is between 45 and 50%. Offering devices for HPV self-sampling has the potential to increase participation rates in those women who are at higher risk of developing cervical cancer. Regarding primary prevention, the 9-valent vaccine may provide protection against up to 85% of cervical intraepithelial neoplasia (CIN) 3 and 90% of cervical cancer, and is available in Europe as a 2-dose schedule from May 2016.

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Prospective evaluation of p16/Ki‐67 dual‐stained cytology for managing women with abnormal Papanicolaou cytology: PALMS study results

Cited by 106 publications

References 26 publications

Triage strategies in cervical cancer detection in Mexico: methods of the FRIDA Study

Triage strategies in cervical cancer detection in Mexico: methods of the FRIDA Study

Management of high-risk HPV-positive women for detection of cervical (pre)cancer

Epidemiology and Early Detection of Cervical Cancer

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