The aim of the study was to determine whether p16 positive/cervical intraepithelial neoplasia (CIN) 2, 3, and cancer (p16 + CIN 2/3+) detected by colposcopy-directed or random biopsy differ by age, referral cytology, human papillomavirus (HPV) 16, and lesion size.
Data from the Shenzhen Cervical Cancer Screening Trial II where, at colposcopy, women who had directed and random cervical biopsies were reviewed to find women with CIN 2, 3, or cancer; 227 such women identified had their paraffin-embedded tissue blocks recut, reviewed, and then immune stained for p16. Data were analyzed by χ2, Fisher exact test, and linear regression.
After histopathologic review and p16 staining of CIN 2, 175 women were diagnosed with p16 + CIN 2/3+. When compared with those diagnosed by colposcopy-directed biopsy (n = 138), those diagnosed by random biopsy (n = 37) were more likely to have Cytology-Lo (cytology of negative, atypical squamous cells of undetermined significance, or low-grade squamous intraepithelial lesion; p = .07), less likely to have HPV 16 (p = .041), more likely to be 51 years or older (p = .022), and more likely to have 1 quadrant lesions (p < .001). Logistic regression analysis showed p16 + CIN 2/3+ diagnosed by random biopsy was predicted by 1 quadrant lesions (p < .0001) and age of 51 years or older (p = .03) but not by Cytology-Lo (p = .71) nor HPV 16 (p = .26).
Women with p16 + CIN 2/3+ diagnosed by random biopsy are older and less likely to have HPV 16; hence, CIN diagnosed by random biopsy may not be as virulent as CIN diagnosed by colposcopy-directed biopsy. Regardless, we advise that CIN diagnosed by random biopsy be viewed like CIN diagnosed by colposcopy-directed biopsy.
P16 + CIN 2/3+ patients, detected by random biopsy, are older and less likely to have human papillomavirus 16.
1Department of Obstetrics and Gynecology, Peking University Shenzhen Hospital; 2Shenzhen Key Laboratory on Technology for Early Diagnosis of Major Gynecological Diseases, Shenzhen, PR China; 3Department of Obstetrics and Gynecology, Kaiser Fontana California, Fontana, CA; 4Department of Anatomic and Molecular Pathology, Cleveland Clinic; 5Women's Health Institute, Cleveland Clinic, Cleveland; and 6Preventive Oncology International, Inc, Cleveland Heights, OH
Correspondence to: Ruifang Wu, MD, Peking University Shenzhen Hospital, 1120 Lianhua Road, Shenzhen 518000, China. E-mail: email@example.com
The authors have declared they have no conflicts of interest.
The study was funded by the Shenzhen Municipal Science and Technical Innovation Committee (Number JCYJ 20120619145419556, GJHZ 20130417100103783) and Preventive Oncology International, Inc (The Preventive Oncology International).
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.