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Title: HPV Testing With P16INK4A Expression Increases Detection of Precancerous Cervical Lesions Compared With Cytology
URL: http://www.pslgroup.com/dg/22B6F2.htm
Doctor's Guide
September 8, 2008

NEW YORK -- September 8, 2008 -- Human papillomavirus (HPV) testing with P16INK4A expression increases the sensitivity for detection of high-grade, precancerous cervical lesions compared with conventional cytology, without increasing referral to colposcopy, according to findings from a substudy of the New Technologies for Cervical Cancer Screening (NTCC) study, published early online and in the October issue of The Lancet Oncology.

Guglielmo Ronco, MD, Centre for Cancer Prevention, Turin, Italy, and Francesca Carozzi, MD, Centre for Cancer Study and Prevention, Florence, Italy, and colleagues did a substudy of women who were enrolled in the NTCC trial that compared HPV testing with that of conventional cytology.

For the substudy, researchers assessed whether HPV testing with triage according to overexpression of the cellular protein P16INK4A maintains the increased sensitivity of HPV testing compared with cytology but increases its specificity.

They obtained cervical cell samples from women who had tested positive for the presence of this virus. Most of the women (94%) had undergone colposcopy. Samples from 1,170 women were tested for P16INK4A overexpression by use of immunostaining and histological analyses. Results were available for 1,137 of these women, 50 of whom had cervical intraepithelial neoplasia (CIN) grade 2 and 42 of whom had CIN grade 3 or cancer.

Sensitivity of P16INK4A triage for women who tested HPV positive was 88%. Specificity of triage was 61%.

For women aged 35 to 60 years, sensitivity of HPV testing and P16INK4A triage to detect >= CIN grade 2 was significantly higher than for cytology (1.53; 95% confidence interval [CI], 1.15-2.02]), but it is important to note that frequency of referral to colposcopy did not differ between triage and conventional cytology (relative referral rate 1.08 [0.96-1.21]).

In the group with patients aged 25 to 34 years, sensitivity was also significantly higher for triage than for cytology (3.01 [1.82-5.17]) and referral to colposcopy was about the same between groups (1.15 [0.96-1.37]).

"Our data show that in HPV-positive women, P16INK4A overexpression is strongly associated with the presence of histologically confirmed CIN 2+, suggesting that it actually is a marker of progression," said Dr. Ronco. "This study supports the application of triage by P16INK4A immunostaining in HPV-positive women."

SOURCE: The Lancet Oncology

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