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p16 Immunohistochemistry in Colposcope-Directed and Random Cervical Biopsies of CIN2 and CIN3

Arvizo, Cynthia MD; Chen, Qing MD; Du, Hui MD; Wang, Chun MD; Tang, Jinlong MD; Yang, Bin MD, PhD; Pretorius, Robert G. MD; Wu, Ruifang MD; Belinson, Jerome Leslie MD

Journal of Lower Genital Tract Disease: July 2016 - Volume 20 - Issue 3 - p 197–200
doi: 10.1097/LGT.0000000000000181
Original Research Articles: Cervix and HPV

Objective The aim of this study was to determine if there is a different p16 expression pattern between colposcope-directed and random (colposcope-undetectable) biopsies of cervical intraepithelial neoplasia (CIN2) and CIN3.

Methods Cervical biopsies that were positive for CIN2 or CIN3 were selected from a database of samples acquired during a large population-based clinical trial in Guangdong Province in China (Shenzhen Cervical Cancer Screening Study II). Blocks were recut, reread, and then immunostained for p16. Biopsies were categorized as either colposcope-directed or random biopsies. Diffuse staining was considered p16 positive, whereas focal or no staining was considered p16 negative. Differences were determined by the Fisher exact test.

Results Among the patients with CIN3, there were 232 individual biopsies of CIN3. Sixty were randomly collected, and 172 were colposcopy directed. p16 positivity for the colposcope-directed and random biopsies was 97.7% and 91.7%, respectively (p = 0.052). Like the CIN3 biopsies, colposcope-directed and random CIN2 samples expressed p16 similarly (86.8% [46/53] and 82.6% [19/23], p = .73, respectively).

Conclusions Based on our data, even small colposcope-undetectable biopsies of CIN3 are significant. Random biopsies of CIN2 or CIN3 demonstrate similar p16 positivity as visible lesions and therefore might be expected to have a similar natural history.

p16 immunostainings of colposcope-directed and random (colposcope-undetectable) biopsies of CIN2 and CIN3 are similar.

1Women’s Health Institute, Cleveland Clinic, Cleveland, OH, USA; 2Department of Obstetrics and Gynecology, Peking University Shenzhen Hospital, Shenzhen, China and the Key Laboratory on Technology for Early Diagnosis of Major Gynecological diseases, Shenzhen, PR China; 3Department of Anatomic and Molecular Pathology, Cleveland Clinic, Cleveland, OH, USA; 4Department of Obstetrics and Gynecology, Kaiser Fontana California, Fontana, CA, USA; and 5Preventive Oncology International, Inc., Cleveland Heights, OH, USA

Correspondence to: Jerome L. Belinson, MD, 2762 Fairmount Blvd, Cleveland Heights, OH 44118. E-mail:

The authors of this study do not have any conflicts of interest to report.

Cynthia Arvizo, MD, and Qing Chen, MD, contributed equally to this work.

Preventive Oncology International, Inc. (POI) and Science and Technology Innovation Committee Foundation of Shenzhen City study ID number JCYJ20120619145419556 provided funding for this study.

The human subject review boards of the Cleveland Clinic (Cleveland, OH) and the Peking University Shenzhen Hospital (Shenzhen, China) approved the original SHENCCAST II protocol as well as this current study. Patient approval for use of deidentified SHENCCAST II study samples and data was included in the original consents.

Copyright © 2016 by the American Society for Colposcopy and Cervical Pathology