HPV & cervical cancer screening

HPV test approved for cervical cancer screening

http://www.cnn.com/2014/04/24/health/hpv-test-approval/

By Elizabeth Landau and Val Willingham, CNN

(CNN) -- The FDA announced approval Thursday of the human papillomavirus DNA test as a primary screening method for cervical cancer.

The U.S. Food and Drug Administration initially approved the HPV DNA test in 2011, for use alongside or as a follow-up to a Pap test, but this is the first time it has been green-lighted as a primary screening technique.

The FDA announced approval of the method on Thursday after an FDA advisory committee unanimously recommended in March that the HPV test become the first line of screening for the deadly disease.

The approval is limited to women over the age of 24.

Developed by Roche Molecular Systems Inc., the cobas HPV Testcan be used to see if a woman needs additional screening for cervical cancer and to gather information about her future risk.

The Pap test -- the standard for 60 years -- is designed to look for abnormal squamous cells that could indicate cervical cancer, while the HPV test looks for DNA from the virus. A vaginal swab is required for both the Pap test and the HPV DNA test, so you won't notice a difference at the doctor's office.

"The potential benefit of (the HPV test) is that everybody that has a precancerous change or cervical cancer will have a positive test," said Dr. Kevin Ault, professor at the University of Kansas Medical Center in Kansas City. "You're not going to miss anybody."

There are other HPV tests out there, but this one can detect the most problematic strains -- HPV 16 and 18. The test can also detect DNA from 12 other types of HPV that are associated with an increased cancer risk. HPV causes more than 99% of all cervical cancers.

The problem with any HPV test is that a lot of women -- between 2% and 10% -- will test positive for the virus, Ault said. And most women who get HPV don't develop cervical cancer.

HPV is so common that at least 70% of people who are sexually active will get a genital HPV infection at some point in their lives, according to the National Cancer Institute.

"Most people who get HPV only have it for a few months or a year and then it goes away," Ault said. "It's really the people it persists in that are going to the problem."

But how do we know who with HPV will likely develop cervical cancer? Positive results on the HPV test will necessitate further screening, he said. Patients who test positive may have to have a Pap smear as well, and potentially biopsies and other procedures.

"The disadvantage is a lot of people are going to be scared," he said.

If this new test is adopted as the primary screening method, Ault said, doctors can focus their Pap examinations on women who are already known to have HPV.

In most cases, patients who don't have HPV are less likely to need a Pap, which is why the advisory committee felt it best to recommend the Roche test be administered as the first form of detection, women's health experts say.

If both the Pap smear and the HPV test are negative, that would mean the patient essentially has almost no chance of developing cervical cancer in the next five years, Ault said.

"Every year, 12,000 women are diagnosed in the U.S. with cervical cancer. This is especially tragic because cervical cancer is a largely preventable disease, and it is well established that HPV is the cause of almost all cervical cancers worldwide. Women need better access to screening tools that include primary HPV screening in order to reduce their risk of developing cervical cancer," said Dr. Thomas Wright Jr., an expert in gynecology and pathology at Columbia University Medical Center.

Many gynecologists are used to doing routine Pap tests, so the HPV test may take a little while to replace the traditional pap smear, Ault said.

But Thursday's approval of the test does not change current practice guidelines.

Cervical cancer screening guidelines are usually proposed through organizations such as the American Cancer Society or the American College of Obstetricians and Gynecologists. The FDA's role is in approval of the test itself.

#HPV Test for Women

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http://consumer.healthday.com/cancer-information-5/cervical-cancer-news-95/fda-panel-recommends-hpv-test-as-replacement-for-pap-smear-687178.html

FDA Approves HPV Test as Initial Screen for Cervical Cancer

Detects presence of high-risk strains of virus believed to cause disease

By Steven Reinberg HealthDay Reporter

THURSDAY, April 24, 2014 (HealthDay News) -- The U.S. Food and Drug Administration on Thursday approved a human papillomavirus (HPV) test as a first step in cervical cancer screening for women aged 25 and older.

"Today's approval offers women and physicians a new option for cervical cancer screening," Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health at the FDA's Center for Devices and Radiological Health, said in an agency news release.

HPV, a sexually transmitted virus, is thought to cause the majority of cervical cancers. Certain strains, such as HPV 16 and 18, are most strongly tied to these tumors. The virus also causes genital warts in both men and women and certain head and neck cancers.

Roche Molecular Systems Inc. makes the cobas HPV test. Women who test positive for the two high-risk HPV strains (16 and 18) would then be asked to undergo a colposcopy. This involves using a device that allows a doctor to get a clear view of the vulva, vagina and cervix and take a sample for further testing.

Women who don't have HPV 16 or 18 but have other high-risk types of the virus would have a Pap test to see if a colposcopy is needed, the FDA said.

One expert welcomed the test's approval.

Dr. Jill Rabin, head of urogynecology at Long Island Jewish Medical Center in New Hyde Park, N.Y., called the FDA approval "quite exciting."

But she tempered her enthusiasm with "some caveats," noting that "in many cases an HPV infection may resolve on its own." Rabin also stressed that "most -- but not all -- cervical cancers are caused by HPV," so the test is not foolproof.

The data the FDA reviewed for its decision came from a trial that included more than 47,000 women.

The FDA first approved the cobas HPV test in 2011, to be used with or as a follow-up to a Pap test. Thursday's approval expands the use of the test as either a "co-test" or as an initial screening test for cervical cancer. But, it doesn't change current guidelines for cervical cancer screening.

According to the U.S. Department of Health and Human Services, women should have a Pap test every two years starting at age 21. Women aged 30 and older who've had three normal Pap tests in a row can now have one every three years. Women older than 65 may be able to stop having Pap tests, but should discuss the matter first with their doctor.

Typically, an HPV infection clears up on its own and doesn't lead to health problems. But, about 10 percent of women infected with high-risk HPV develop a persistent infection that may put them at risk of cancer, the FDA said in the news release.

The FDA approval followed a unanimous vote by the agency's Medical Devices Advisory Committee Microbiology Panel in March that concluded the test was safe and effective as a first-line screen for cervical cancer.

Testifying before that expert panel, Dr. David Chelmow, chair of the department of obstetrics and gynecology at Virginia Commonwealth University School of Medicine, said that "cervical cancer screening has been a huge success in decreasing cervical cancer incidence and death."

Chelmow, representing the American College of Obstetricians and Gynecologists, added that "the college strongly supports further improving cervical cancer screening through the introduction of new paradigms such as HPV testing for primary screening. HPV testing as a primary screening method for cervical cancer is very promising, and appears effective for screening for cervical cancer."

Dr. Andrew Menzin, a gynecologic oncologist at North Shore University Hospital in Manhasset, N.Y., told HealthDay that "HPV testing has been a remarkable advance in cervical cancer screening."

Its greatest value is helping to decide whether a follow-up colposcopy is needed, he said. "The idea of reversing the order of testing is an approach to try to refine and minimize who [unnecessarily] goes on to colposcopy," he said.

Whether doctors will accept using an HPV test first instead of a Pap test will depend upon the clinical trial data supporting it and on doctors and patients being educated about it, Menzin said.

He noted that current guidelines still favor using the Pap test first, "but the guidelines continue to evolve."

There are two approved vaccines, Gardasil and Cervarix, that can protect against HPV. The U.S. Centers for Disease Control and Prevention recommends that all girls and boys be vaccinated between the ages of 9 and 11.

More information

For more on cervical cancer, visit the American Cancer Society.

HPV-Linked Throat Cancer May Have Telltale Signs

Hi friends, This article from WebMd is very important - I hope you all get a chance to read it.

-- Dr. Dale

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http://www.webmd.com/sexual-conditions/hpv-genital-warts/news/20140320/hpv-linked-throat-cancer-may-have-telltale-first-symptoms?page=2

Signs of potential trouble could be different in people without the virus, study suggests

The first symptoms of throat and mouth cancer -- also known as oropharyngeal cancer -- may differ depending on whether the condition is caused by the human papillomavirus (HPV), a small study suggests.

Oropharyngeal cancer arises in the throat, soft palate, tonsils or base of the tongue. Smoking is a major risk factor, as is chronic infection with certain strains of HPV -- which causes warts in the genitals, mouth and anus, and is the most common sexually transmitted disease in the United States.

Although oropharyngeal cancer is relatively uncommon, the rate of HPV-linked cases has been rising -- particularly among white adults younger than 55. The reasons aren't clear, but experts suspect that changes in oral sex practices have a lot to do with it.

The U.S. Centers for Disease Control and Prevention estimates that each year about 8,400 Americans are diagnosed with HPV-related oropharyngeal cancer.

"We're seeing this in younger, healthy people who don't smoke," said Dr. Terry Day, senior researcher on the new study and a specialist in head and neck cancers at the Medical University of South Carolina, in Charleston.

Despite the concerning rise in oropharyngeal cancers, Day said, there has been a lack of research into the initial symptoms -- including whether the signs of HPV-linked tumors are distinct.

So his team looked at records for 88 patients diagnosed with oropharyngeal cancer at their center between 2008 and 2013. Most -- 71 -- had HPV-positive cancer, and for them the most common first symptom was a lump in the neck.

Half of those patients had a "mass" in the neck, versus only 18 percent of patients with HPV-negative cancer, Day's team reported in the March 20 online issue of JAMA Otolaryngology--Head & Neck Surgery.

For the patients without HPV infection, a persistent sore throat and difficulty swallowing were the most common first signs. More than half complained of a sore throat, while 41 percent had problems with swallowing.

Some patients with HPV-linked cancer had those symptoms, too, but less commonly: 28 percent had a stubborn sore throat, and only 10 percent had trouble swallowing, the findings showed.

An expert who reviewed the study called the findings "interesting," but said they should be interpreted with caution.

Larger studies are needed to confirm the results, said Maria Worsham, research director in the department of otolaryngology/head and neck surgery at Henry Ford Hospital, in Detroit.

Plus, Worsham said, the symptoms these study patients reported are not unique to cancer. So people should not assume that a lump in the neck means they have cancer -- or oral HPV, she said.

Another expert not involved with the study said that a lump could indeed be an infection that just needs a round of antibiotics.

But if the mass persists, see your doctor again, added Dr. Dennis Kraus, director of the Center for Head and Neck Oncology at Lenox Hill Hospital, in New York City.

According to Kraus, the findings help "codify" what many doctors have noted: that people with HPV-positive oropharyngeal cancer tend to have no symptoms, but instead notice a lump.

The "good news," Kraus said, is that HPV-positive cancers generally have a better prognosis. Patients with HPV-negative cancers tend to have a more-aggressive disease -- and, therefore, obvious symptoms like an irritated throat and difficulty swallowing.

Kraus agreed with Day that the face of oropharyngeal cancer has changed from years ago. HPV-positive tumors are now more common than HPV-negative ones, he said.

According to the CDC, about 7 percent of Americans have oral HPV, though only 1 percent have the particular strain (HPV-16) that's linked to oropharyngeal cancer.

Usually, the immune system is able to clear HPV from the body, and most people never know they were infected.

But for reasons that aren't clear, some people harbor chronic HPV infections. Persistent infection with a cancer-linked strain is the big worry: Nearly all cases of cervical cancer, for instance, are caused by HPV.

There are, however, two vaccines against the most common cancer-linked HPV strains -- including HPV-16. Experts recommend all children ages 11 and 12 be vaccinated. Older girls and women up to age 26 should get "catch-up" shots if they've never been vaccinated. The same advice goes for boys and men ages 13 to 21.

The vaccines -- Gardasil and Cervarix -- are known to ward off genital and anal HPV infections. Studies on whether the vaccines prevent oral infections are just starting. But, Kraus noted, they do target the major HPV strain linked to oropharyngeal cancer.