HPV Screening Better Predictor of Cervical Cancer Risk Than Pap Result

Julia Gage, PhD

Researchers at the National Cancer Institute (NCI) have found that a negative HPV screening test is better at evaluating cervical cancer risk than a negative Pap test.

The study, which was published in the Journal of the National Cancer Institute and involved more than 1 million women, found that the risk of developing cervical cancer within 3 years following a negative HPV test was about half of the already low risk following a negative Pap test.

“Our results demonstrate the superior predictive value of a negative HPV test, compared with a negative Pap test,” Julia Gage, PhD, first author of the study report and a research fellow in the Clinical Genetics Branch at the NCI’s Division of Cancer Epidemiology and Genetics, said in a statement. “Our findings provide evidence to support the currently recommended cotesting guidelines, as well as the possibility of primary HPV testing as another alternative for cervical screening.”

Since 2003, women between the ages of 30 and 64 enrolled in Kaiser Permanente Northern California’s healthcare system have had cervical cancer screening with concurrent HPV and Pap testing (called cotesting).

In 2011, NCI researchers and their colleagues published findings on screening outcomes for approximately 300,000 of the women in this group. Those data were used to inform current US cervical screening and management guidelines, including those of the US Preventive Services Task Force, which recommend Pap testing every 3 years (between the ages of 21 to 65) or cotesting every 5 years (between the ages of 30 to 65) for women with normal screening results.

In the new study, the researchers extended their 2011 analysis to more than 1 million women who were screened through December 31, 2012. Researchers found that cervical cancer risk within 3 years of a negative HPV test was similar to the risk of developing cancer within 5 years following a negative cotest.

In April, the FDA approved the cobas HPV Test as a first-line screening tool for cervical cancer in women 25 and older.

The approval was based on results from the large ATHENA study, which demonstrated that the cobas HPV test was 15.63% more sensitive at detecting cervical intraepithelial neoplasia grade 3 (CIN3) when compared with liquid-based cytology. The FDA initially approved the cobas HPV test in 2011 as a secondary or adjunctive cervical screening tool.

"Using the cobas HPV Test as a primary screen means that women will have the opportunity to receive a better and more accurate standard of care," Mark H. Stoler, MD, professor emeritus of Pathology and Clinical Gynecology at the University of Virginia Health System, said at the time of the FDA approval. "Clinically validated HPV screening detects the virus that causes cervical cancer and does a better job identifying women at risk than Pap testing alone. But most importantly, women found to be HPV-negative are provided a greater sense of security that they are safe from the disease."