Nearly 25 million U.S. women between the ages of 14 and 59 are infected with HPV, and the annual cost of screening and treating cervical abnormalities is about $4 billion, according to a statement from the Society of Gynecologic Oncologists.

For many unvaccinated women HPV infections clear up naturally without causing any cervical problems, as do many pre-malignant lesions. In other cases, HPV prompts cell changes that can gradually put women at greater risk of cervical cancer.

A significant drop in abnormal Pap test results happened after girls and women were given the vaccine named Gardasil to prevent cervical cancer, according to a researcher at the University of Alabama at Birmingham (UAB).

While the findings are not definitive that Gardasil prevents cancer, they do signal the vaccine will spare thousands of women a diagnosis of cell abnormality or malignant changes that may lead to more tests and possibly surgery, said Warner Huh, M.D., associate professor in the UAB Division of Gynecologic Oncology and the doctor chosen to present the data.

In testing Gardasil reduced abnormal Pap test results by 43 percent compared to women not given the vaccine. The 43 percent reduction was for tests that found pre-cancerous changes called high-grade squamous intraepithelial lesions (HSIL) more than three years after women were given the vaccine.

Gardasil reduced other abnormal Pap results, including milder pre-malignant cell changes, by 16 to 35 percent compared to women not given the vaccine.

“Clearly the vaccine’s benefits include something that can be appreciated by women and daughters fairly quickly,” Huh said. “This is a positive first sign, and it will take many more years to know definitively if the vaccine prevents cancer.”

The results are a compilation of three separate trials involving more than 18,000 women, ages 16 to 26, in the United States, Europe and Asia. All test subjects had normal Pap smear readings at the start of the trial.

In addition to the drop in unwanted Pap results, the study found invasive procedures like cervical biopsies were performed up to 42 percent less in Gardasil recipients compared to women not given the vaccine, Huh said.

Gardasil is approved to fight the human papilloma virus (HPV) strains believed to cause 70 percent of cervical cancers and more than 90 percent of genital warts.

The findings were presented March 10 at the annual meeting of the Society of Gynecological Oncologists held in Tampa.

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The Pap test has been the standard screening tool for cervical cancer for years — and it still is. The test checks a sample of cervical cells under a microscope for abnormalities that may lead to cancer.

Lessons learned in the past several years are leading to changes in recommended screening frequency, and a new test is under study, according to the April issue of Mayo Clinic Women’s HealthSource.

First, Pap tests don’t need to be a yearly event for every woman. The American Cancer Society recommends that women over 30 who’ve had normal Pap results for three years can limit screening to once every two or three years. Women over age 70 who’ve had three normal tests in a row, no abnormal tests in 10 years and no new risk of cervical cancer (such as a new sexual partner) can opt to forgo cervical cancer screening.

Researchers are evaluating a human papillomavirus (HPV) screening as a way to detect cervical cancer earlier. Like the Pap test, the HPV test is conducted on a sample of cells collected from the cervix. The test looks for evidence of the HPV genetic material that can lead to cancer.

Two studies published in 2007 showed that the HPV test has promise. One found that the HPV test was nearly 40 percent better at identifying women with precancerous or cancerous abnormalities than the Pap test. The second study looked at using HPV and Pap screens together. This approach helped identify causes of precancerous lesions earlier than the Pap alone.

There are concerns with the HPV screen, too, including a higher percentage of false-positive results, where women who received positive HPV tests were referred for further tests that did not show any signs of cancer. HPV screening also identifies more precancerous lesions that are slow to develop into cancer or never develop into cancer.

For now, most doctors don’t support HPV testing as a primary screening tool until there’s more evidence to justify replacing the Pap test. Depending on a woman’s age and risk factors, the HPV test may be ordered after an uncertain Pap test or, in some circumstances, may be used in conjunction with a Pap test. Women should ask their doctor which screening is best.

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In a new collaborative study, the BC Cancer Agency, an agency of the Provincial Health Services Authority (PHSA), is trying to determine if a test for Human Papilloma Virus (HPV) can replace the standard Pap test as the primary method of cervical cancer screening, allowing women to be screened more effectively and less frequently.

The HPV FOCAL Study – the first long term and largest study of its kind in North America is conducted in collaboration with another PHSA agency, the BC Centre for Disease Control, as well as the UBC Department of Family Medicine and the Faculty of Medicine, McGill University department of Epidemiology, and about 100 family doctors in Greater Vancouver.

“Over the last 20 years, it has become apparent that infection from HPV is the primary cause of cervical cancer,” says Dr. Andy Coldman, BC Cancer Agency Vice President of Population Oncology, and Principal Investigator of the study. “If we can test for the presence of high-risk strains of this virus, we believe we can identify women who are truly at risk for developing cervical cancer and its precursors.”

“If HPV is found, we know a woman may be at higher risk. We can then further analyze her cervical sample with Pap testing in the laboratory to see what treatment, if any, she may require,” adds Dr. Coldman.

The study aims to enroll 33,000 participants over the next seven years. Women age 25-65 who attend one of the over 100 participating family practices will have the opportunity to be part of the study. Participants will have a cervical sample taken by their family doctor during their regular screening appointment, with appropriate follow-up depending on the test results. The sample is collected from a woman the same way as a Pap smear is obtained – the only difference is how the sample is processed in the laboratory.

The Pap test requires technicians to examine samples under a microscope to look for abnormal cells. The HPV test is read by a machine that detects presence or absence of DNA for high-risk strains of HPV.

“The Pap test is an effective screening tool, but it’s not perfect,” adds Dr. Coldman. “We believe the HPV test is superior to the Pap test as a screening tool, but its true benefits are still unknown until we
To compare HPV testing to the Pap test, cervical samples from study participants will be randomly assigned to one of the following testing methods:

- Pap test (using a liquid based collection medium)
- HPV test, and screened again in two years if no HPV is found
- HPV test, and screened again in four years if no HPV is found

For Janet Abe, whose parents were both diagnosed with cancer within three months of each other six years ago, taking part in a study that could help improve cancer outcomes in the future was an easy decision.

“This was really a no-brainer,” says Abe, a 38-year-old magazine production manager. “It’s so simple. I would be going for my regular Pap test anyway, but now I can participate in a study that could potentially make a difference for women and their families down the road.”

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