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

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

Research output: Contribution to journalArticlepeer-review

Abstract

BACKGROUND Testing for the presence of the human papillomavirus (HPV) is widely accepted for triaging Papanicolaou cytology results categorized as atypical squamous cells of undetermined significance (ASC-US). In contrast, HPV testing has limited use in triaging cytological low-grade squamous intraepithelial lesions (LSILs) due to prevalence rates of typically >80%. In the current study, the authors assessed the diagnostic performance of p16/Ki-67 dual-stained cytology in triaging ASC-US and LSIL cases within the prospective, multicentric Primary ASC-US LSIL Marker Study (PALMS). METHODS A total of 575 ASC-US cases and 529 LSIL cases from a cohort of 27,349 women who were prospectively enrolled into the PALMS study in 5 European countries were tested with p16/Ki-67 dual-stained cytology and Hybrid Capture 2 (HC2) HPV testing. Colposcopy-guided biopsy results of cervical intraepithelial neoplasia of grade 2 or worse (CIN2+) were used as clinical endpoints. RESULTS p16/Ki-67 dual-stained cytology demonstrated comparable (ASC-US: 94.4% for dual-stained cytology vs 100% for HC2 testing; P =.317) or lower (LSIL: 85.7% for dual-stained cytology vs 98.4% for HC2 testing; P =.005) sensitivity for CIN2+, but higher levels of specificity compared with HC2 HPV testing in both ASC-US (78.7% vs 60.4%; P

Original languageEnglish
Pages (from-to)373-381
Number of pages9
JournalCancer cytopathology
Volume123
Issue number6
DOIs
Publication statusPublished - Jun 1 2015

Keywords

  • atypical squamous cells of undetermined significance (ASC-US)
  • cervical cytology
  • CINtec PLUS
  • human papillomavirus (HPV)
  • low-grade squamous intraepithelial lesion (LSIL)
  • p16/Ki-67 dual-stained cytology
  • Primary ASC-US LSIL Marker Study (PALMS)
  • triage

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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