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Advisers Endorse HPV Test for Cervical Cancer Checks
January 09, 2015

 

THURSDAY, Jan. 8, 2015 (HealthDay News) -- An HPV test recently approved by U.S. health officials is an effective way to check for cervical cancer, two leading women's health organizations said Thursday.

The groups said the HPV test is an effective, one-test alternative to the current recommendation of screening with either a Pap test alone or a combination of the HPV test and a Pap test.

However, not all experts are in agreement with the move: the largest ob-gyn group in the United States, the American College of Obstetricians & Gynecologists (ACOG) is still recommending that women aged 30 to 65 be screened using either the Pap test alone, or "co-tested" with a combination of both the HPV test and a Pap test.

The new, so-called interim guidance report was issued by two other groups -- the Society of Gynecologic Oncology and the American Society for Colposcopy and Cervical Pathology. It followed U.S. Food and Drug Administration approval last year of the cobas HPV test as a primary test for cervical cancer screening.

The HPV test detects DNA from 14 types of HPV -- a sexually transmitted virus that includes types 16 and 18, which cause 70 percent of cervical cancers.

The two medical groups said the interim guidance report will help health care providers determine how best to include primary HPV testing in the care of their female patients until a number of medical societies update their guidelines for cervical cancer screening.

"Our review of the data indicates that primary HPV testing misses less pre-cancer and cancer than cytology [a Pap test] alone. The guidance panel felt that primary HPV screening can be considered as an option for women being screened for cervical cancer," interim guidance report lead author Dr. Warner Huh said in a news release from the Society of Gynecologic Oncology. Huh is director of the University of Alabama's Division of Gynecologic Oncology

The FDA approved the cobas HPV test last April as a first step in cervical cancer screening for women aged 25 and older. Roche Molecular Systems Inc., headquartered in Pleasanton, Calif., makes the test.

Thursday's interim report recommends that primary HPV testing should be considered starting at age 25. For women younger than 25, current guidelines recommending a Pap test alone beginning at age 21 should be followed.

The new recommendations also state that women with a negative result for a primary HPV test should not be tested again for three years, which is the same interval recommended for a normal Pap test result. An HPV test that is positive for HPV 16 and 18 should be followed with colposcopy, a procedure in which the cervix is examined under illumination and magnification.

"The introduction of cervical cytology screening [the Pap test] was truly one of the great breakthroughs in medicine, and has saved countless lives," Dr. Herschel Lawson, chief medical officer at the American Society for Colposcopy and Cervical Pathology, said in the news release.

"We are lucky that we have so many tools available now to improve cervical cancer prevention efforts and afford patients options depending on their individual situations. We'll continue to work to find the best way to combine screening tools with other prevention efforts like HPV vaccines, for the early detection and treatment of cervical cancer," he said.

"The most important message for providers and the community is that women should be screened for cervical cancer. Screening saves lives," Lawson added.

However, experts at ACOG said Thursday that it's too early to move to an HPV test-only screening model. They are standing by their recommendation for a combination of the HPV test and the Pap smear.

The reason? HPV infection is common among younger women, and often resolves on its own, so a positive test result might lead to too many invasive follow-up tests. While it's possible that the HPV test "can" replace the Pap smear altogether, there's not enough evidence at this time to say that it "should," ACOG said.

HPV 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.

The American Cancer Society estimates that there will be about 12,900 new cases of invasive cervical cancer diagnosed in 2015, and about 4,100 women will die from the disease.

According to the cancer society, cervical cancer was once a leading cause of cancer death for American women. But in the last three decades the death rate has dropped more than 50 percent. The Pap test is the big reason cited for the decline.

The interim guidance report was published online Jan. 8 in the journals Gynecologic Oncology, the Journal of Lower Genital Tract Disease and Obstetrics and Gynecology.

More information

The U.S. National Cancer Institute has more about cervical cancer screening.


SOURCES: Society of Gynecologic Oncology, news release, Jan. 8, 2015; American College of Obstetricians and Gynecologists...

FDA Approves Cervical Cancer Vaccine That Covers More HPV Strains
December 10, 2014

 

WEDNESDAY, Dec. 10, 2014 (HealthDay News) -- The U.S. Food and Drug Administration on Wednesday approved a new vaccine with expanded protection against the human papillomavirus (HPV), by far the leading cause of cervical and certain other cancers.

The agency said that Gardasil 9 can shield users against nine strains of the virus, compared to the four strains covered by Gardasil, the Merck & Co. vaccine approved in 2006. Merck also makes Gardasil 9.

"Gardasil 9 has the potential to prevent approximately 90 percent of cervical, vulvar, vaginal and anal cancers," the FDA said in an agency news release.

"Vaccination is a critical public health measure for lowering the risk of most cervical, genital and anal cancers caused by HPV," Dr. Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research, said in the release. "The approval of Gardasil 9 provides broader protection against HPV-related cancers."

The U.S. Centers for Disease Control and Prevention currently recommends the HPV vaccine for boys and girls at age 11 or 12, so they are protected before being exposed to the sexually transmitted virus. One other HPV vaccine, Cervarix, was also approved by the FDA in 2009. Cervarix is made by GlaxoSmithKline and protects against two HPV strains strongly linked to cancer, HPV 16 and 18.

According to the FDA, the approval of Gardasil 9 was based on a clinical trial involving more than 14,000 girls and women aged 16 to 26 who were not infected with HPV at the start of the trial. Participants were given either Gardasil or Gardasil 9.

"Gardasil 9 was determined to be 97 percent effective in preventing cervical, vulvar and vaginal cancers caused by the five additional HPV types [31, 33, 45, 52, and 58]," the FDA said. "In addition, Gardasil 9 is as effective as Gardasil for the prevention of diseases caused by the four shared HPV types (6, 11, 16 and 18)."

For younger people -- boys and girls aged 9 through 15 -- Garadsil 9 was determined to be effective from measurements of immune-system antibody responses to the vaccine, the FDA explained. "Based on these results, the vaccine is expected to have similar effectiveness when used in this younger age group," the agency said.

In terms of safety, the FDA said that the most common adverse effects were injection site pain, swelling, redness and headaches.

Like Gardasil, Gardasil 9 is administered as three separate shots, with the second and third doses given two and six months after the first one, respectively.

This year, about 12,360 new cases of invasive cervical cancer will be diagnosed, and about 4,020 women will die from the disease, according to the American Cancer Society.

More information

Find out more about HPV at the U.S Centers for Disease Control and Prevention.

Copyright © 2014 HealthDay. All rights reserved.


SOURCE: U.S. Food and Drug Administration, news release, Dec. 10, 2014...

11 Percent of U.S. Women Not Checked for Cervical Cancer in 5 Years
November 05, 2014

 

WEDNESDAY, Nov. 5, 2014 (HealthDay News) -- An estimated eight million American women ages 21 to 65 haven't been screened for cervical cancer in the past five years.

That's the finding of a federal report released Wednesday that noted that more than half of cervical cancer cases occur among women who've never or rarely been screened.

In 2012, about 11 percent (eight million) women ages 21 to 65 said they had not been screened for cervical cancer in the past five years. The percentage was higher among women without health insurance (23.1 percent) and among those without a regular health care provider (25.5 percent), according to the report.

Lack of screening was also higher among older women (12.6 percent), Asians/Pacific Islanders (19.7 percent), and American Indians/Alaskan Natives (16.5 percent), according to the Centers for Disease Control and Prevention Vital Signs report.

From 2007 to 2011, the cervical cancer rate nationwide fell by 1.9 percent a year and the death rate remained stable.

Still, the southern United States had the highest rate of cervical cancer (8.5 cases per 100,000 women), the highest cervical cancer death rate (2.7 deaths per 100,000 women), and the highest rate of non-screening in the past five years (12.3 percent).

"Every visit to a provider can be an opportunity to prevent cervical cancer by making sure women are referred for screening appropriately," CDC Principal Deputy Director Ileana Arias said in an agency news release.

"We must increase our efforts to make sure that all women understand the importance of getting screened for cervical cancer. No woman should die from cervical cancer," she added.

Wider use of the human papillomavirus (HPV) vaccine could also help reduce cervical cancer cases and deaths from the disease, the CDC said. A recent study by the agency found that the vaccine is underused, with only 1 in 3 girls and 1 in 7 boys receiving the three-dose vaccination series in 2013.

The HPV vaccine is recommended for children ages 11 to 12. Studies show that HPV vaccination and cervical cancer screening combined could prevent as many as 93 percent of new cervical cancer cases, the CDC says.

One way to improve cervical cancer screening rates would be to eliminate financial and other barriers, the CDC says. The agency's National Breast and Cervical Cancer Early Detection Program provides low-income, uninsured and underinsured women access to cervical and breast cancer screening nationwide.

According to the U.S. National Cancer Institute:

  • Cervical cancer screening -- which includes the Pap test and HPV testing -- is a vital part of health care for women because it can detect malignancies or abnormalities that may lead to cancer of the cervix.
  • Current guidelines recommend that women have a Pap test every three years beginning at age 21. Women 30 to 65 years old should have HPV and Pap "co-testing" every five years or a Pap test alone every three years. Women with certain risk factors may need more frequent screening or to continue screening after 65 years of age.
  • Women who have received the HPV vaccine still need regular cervical screening.

An estimated 12,360 new cases of cervical cancer will be diagnosed among U.S. women this year and 4,020 will die from the disease, the American Cancer Society reports.

Dr. David Fishman is a gynecological oncologist at Mount Sinai Hospital in New York City. Responding to the new CDC findings, he said: "The Pap test is the most powerful tool ever developed that can save women's lives. The ability to detect precancerous change and intervene to prevent the development of a life-threatening cancer using a simple, minimally invasive test is the holy grail of medicine. The future of medicine is to prevent the development of disease, and the Pap test provides the opportunity to prevent women developing and dying from cervical cancer."

More information

The U.S. National Cancer Institute has more about cervical cancer screening.

Copyright © 2014 HealthDay. All rights reserved.


SOURCES: David Fishman, M.D., gynecological oncologist, Mount Sinai Hospital, New York City; U.S. Centers for Disease Control and Prevention, news release, Nov. 5,...

Experimental Cervical Cancer Vaccine Looks Promising in Trial
October 01, 2014

 

WEDNESDAY, Oct. 1, 2014 (HealthDay News) -- An experimental vaccine meant to protect against nine types of human papillomavirus (HPV) could prevent 90 percent of all cervical cancers, a new study suggests.

Researchers examined data from more than 2,500 women with precancerous cervical lesions and found that nearly all were caused by the nine types of HPV targeted by the vaccine being developed by Merck and Co.

The new vaccine, currently undergoing clinical trials, protects against more types of HPV than current vaccines, according to the study published Oct. 1 in the journal Cancer Epidemiology, Biomarkers & Prevention.

"We wanted to study how many cervical precancers could potentially be prevented by an investigational nine-valent HPV vaccine that provides protection against the HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58," Dr. Elmar Joura, an associate professor of gynecology at the Medical University of Vienna in Austria, said in a journal news release.

"Given the high vaccine efficacy that was observed in a large phase III clinical trial testing the nine-valent HPV vaccine, if vaccination programs with this new-generation vaccine are effectively implemented, approximately 90 percent of invasive cervical cancer cases worldwide could be prevented, in addition to the majority of precancerous lesions," he said.

Of the women aged 15 to 26 with precancers, about one-third were infected with more than one HPV type, the researchers said. Of women aged 24 to 45 with precancers, nearly one in five was infected with more than one HPV type, the investigators found.

HPV, which is spread through sexual contact, not only can lead to cervical cancer, but also cancers of the vulva, vagina and anus in women. In men, it can lead to cancers of the anus and penis.

The study was funded by Merck. Joura has received grant support to his institution, as well as advisory board and lecture fees from Merck and other drug companies.

Joura noted that even though current HPV vaccines (Gardasil and Cervarix) are known to be safe, their use in the United States and other wealthy nations has been "inadequate." He said the use of HPV vaccines must increase if their full potential to reduce cervical cancer is to be achieved.

More information

The U.S. National Cancer Institute has more about HPV vaccines.
Copyright © 2014 HealthDay. All rights reserved.


SOURCE: Cancer Epidemiology, Biomarkers & Prevention, news release, Oct. 1, 2014...

Avastin Approved for Late-Stage Cervical Cancer
August 15, 2014

 

FRIDAY, Aug. 15, 2014 (HealthDay News) -- The anti-cancer drug Avastin (bevacizumab) has been newly approved to treat aggressive and late-stage cervical cancer, the U.S. Food and Drug Administration said in a news release.

Cervical cancer is most often caused by the sexually spread human papillomvirus (HPV). More than 12,000 women in the United States will be diagnosed with the disease this year and more than 4,000 women will die from the illness, according to U.S. National Cancer Institute statistics.

Avastin works by interfering with the development of blood vessels that fuel cancerous cell growth. The new approval is for use in combination with other anti-cancer drugs, including paclitaxel, cisplatin and topotecan, the FDA said.

Avastin's safety and effectiveness in treating cervical cancer were evaluated in clinical studies involving 452 people with persistent, recurring or late-stage disease, the agency said. Average survival among those who took Avastin and chemotherapy drugs was 16.8 months, compared to 12.9 months among those receiving chemotherapy alone.

The most common side effects of Avastin included fatigue, loss of appetite, high blood pressure, increased blood sugar, decreased blood magnesium, urinary tract infection, headache and weight loss. Some users also developed perforations or abnormal openings of the gastrointestinal tract and vagina, the FDA said.

Avastin is marketed by San Francisco-based Genentech, a member of the Roche Group.

More information

Visit the FDA to learn more.
Copyright © 2014 HealthDay. All rights reserved.


...

Millions Given Access to Breast, Cervical Cancer Screening: CDC
August 07, 2014

 

THURSDAY, Aug. 7, 2014 (HealthDay News) -- Millions of American women have benefited from a breast and cervical cancer screening program offered by the U.S. Centers for Disease Control and Prevention, according to a new report.

The program was launched in 1991 to serve women with limited access to health care. It has provided screening for more than 4 million women in its first 20 years. During that time, the program identified more than 56,000 breast cancers, approximately 3,200 cervical cancers, and over 152,000 precancerous cervical lesions.

In more than 90 percent of these cases, women received proper and timely follow-up care, according to the CDC report.

The estimated cost of the screening program was $145 per woman.

"Today, millions of women have benefited from the timely screening and diagnostic services offered by CDC's National Breast and Cervical Cancer Early Detection Program," Ursula Bauer, director of the CDC's National Center for Chronic Disease Prevention and Health Promotion, said in an agency news release.

"This program has made tremendous contributions in public health through strengthening partnerships, health care collaborations, and quality of care, but also at a personal level by serving women directly," she added.

The report was published online and in an Aug. 15 supplement edition of the journal Cancer. The report features 13 new studies evaluating numerous features of the screening program.

More information

The U.S. National Cancer Institute has more about breast cancer screening.
Copyright © 2014 HealthDay. All rights reserved.


SOURCE: U.S. Centers for Disease Control and Prevention, news release, Aug. 6, 2014...

Cervical Cancer Vaccine Doesn't Boost Clot Risk: Study
July 08, 2014

 

TUESDAY, July 8, 2014 (HealthDay News) -- Concerns that the human papillomavirus vaccine may increase the risk of serious blood clots seem unfounded, a new study says.

The study of half a million Danish women who received the HPV vaccine, which protects against cervical cancer and other health problems, found no link between the shots and the formation of blood clots known as venous thromboembolisms. In the United States it's called the Gardasil vaccine. Concerns about such a link had been raised in previous research.

"Our results found no evidence to support that exposure to the HPV vaccine is associated with an increased risk of [venous thromboembolisms] in the period following vaccination," said Nikolai Madrid Scheller, a researcher at Statens Serum Institute in Copenhagen.

HPV vaccines are recommended for 11- and 12-year-olds because they work best before the start of sexual activity.

The researchers conducted the new study, published July 9 in the Journal of the American Medical Association, after earlier research found a risk of blood clots in the weeks after vaccination.

Experts can't explain how the vaccine could elevate the blood clot risk, Scheller said.

For the new study, the researchers looked at data on 1.6 million Danish females ages 10 through 44. There were 4,375 cases of blood clots among more than 500,000 teens and women who got the vaccine. Of these, one-fifth were vaccinated during the study period, from 2006 to 2013.

The researchers analyzed the cases in multiple ways. They first looked at all patients with blood clots -- those who did and didn't get the vaccine.

They also looked only at patients who had received the vaccine. They analyzed different age groups and adjusted for oral contraceptive use, which is known to increase blood clot risk. They zeroed in on the 42-day window after vaccination, considered the most high-risk period for clots, and also looked at a control period, before and after the vulnerable period.

Despite the different analyses, no link was found between the vaccine and a higher risk of getting a blood clot in the vulnerable time period.

Of the vaccinated females who got blood clots, 860 developed them outside that window. Just 29 developed them during the six weeks after receiving the vaccine, the study found.

HPV vaccines are given in a series of three shots over six months. Two vaccines, Gardasil and Cervarix, are available to protect against cervical cancers. Gardasil -- called a quadrivalent vaccine, which was the focus of the study -- also protects from genital warts and anal, vaginal and vulvar cancers. Women can have either vaccine, while only Gardasil is available for males.

While Scheller can't say if this study is the last word on the issue, he said it "expands considerably" on existing evidence.

Dr. Jennifer Wu, an obstetrician-gynecologist at Lenox Hill Hospital in New York City, agrees that the study shows "there is no link between the HPV vaccine and blood clot formation."

Initial concerns about the safety data on the HPV vaccine led many parents to decline vaccination, said Wu, who was not involved in the study.

Her advice? "Health care providers need to discuss with patients and their parents about the benefits of the HPV vaccine and the low risk profile," she said.

The link reported in previous research may have resulted because researchers didn't consider birth control pill use, which boosts clot risk, she said. This study took use of birth control pills into account.

No funding for the study came from vaccine makers, pharmaceutical companies or other sources for the study, Scheller said.

More information

To learn more about the HPV vaccine, visit the U.S. Centers for Disease Control and Prevention.

Copyright © 2014 HealthDay. All rights reserved.


SOURCES: Nikolai Madrid Scheller, M.B., researcher, Statens Serum Institute, Copenhagen, Denmark; Jennifer Wu, M.D., obstetrician-gynecologist, Lenox Hill Hospital, New York City; July 9, 2014, Journal of the American Medical Associ...

Immune-Based Treatment May Fight Advanced Cervical Cancer
June 02, 2014

 

MONDAY, June 2, 2014 (HealthDay News) -- A new type of therapy shows promise in treating some women with advanced cervical cancer, researchers say.

The majority of cervical cancers are caused by the human papillomavirus (HPV). This new treatment -- called HPV-targeted adoptive T cell therapy -- boosts the body's natural immune response to HPV in cervical cancer tumors, the study authors explained.

First, HPV-targeted T cells -- immune cells that specifically attack tumor cells that contain HPV proteins -- are grown from a patient's tumor in the laboratory. The T cells are then put back into the patient's body to fight her cancer.

In this U.S. National Cancer Institute-supported study, nine women with advanced cervical cancer underwent the therapy, and three responded to it. One of those three patients had a 39 percent reduction in tumor volume, while the other two had complete remissions that had lasted for 11 months and 18 months by the time the study was written.

"This proof-of-principle study shows that adoptive transfer of HPV-targeted T cells can cause complete remission of metastatic cervical cancer and that this remission can be long-lasting," lead author Dr. Christian Hinrichs, an assistant clinical investigator at the U.S. National Cancer Institute, said in a news release from the American Society of Clinical Oncology (ASCO).

The therapy was linked to serious side effects, however, including low blood counts, infections and metabolic disorders, the researchers said. Hinrichs and colleagues were scheduled to present the findings Monday in Chicago at the ASCO annual meeting.

Adoptive T cell therapy has previously shown promise in treating melanoma, leukemia and sarcoma, but this is the first time it has been tested in cervical cancer patients.

"Cellular therapy might have application to a broader range of tumor types than previously recognized," Hinrichs said. However, he added, "this treatment is still considered experimental and is associated with significant side effects. We also need to explore why this therapy worked so well in certain women, and not in others."

Studies presented at medical meetings are typically considered preliminary until published in a peer-reviewed journal, but two experts in the field remained cautiously optimistic about the new therapy.

"I think that this small pilot study provides an important proof-of-concept," said Dr. Louis Weiner, director of the Georgetown Lombardi Comprehensive Cancer Center in Washington, D.C.

"Engineered T cells can identify and destroy metastatic cancer cells when those cells express a truly cancer-relevant target," Weiner said. "While the field is still young, and this study is preliminary, these results provide optimism that people's T cells can be reprogrammed to treat many types of cancer."

Dr. Krzysztof Misiukiewicz, assistant professor of medical oncology at the Icahn School of Medicine at Mount Sinai in New York City, agreed. He said the research is a step forward in the treatment of cancers linked to HPV, but added that more studies are needed to help bring "regulatory approval of adoptive T cell therapy as a standard of care."

Misiukiewicz also stressed that more work must be done to help predict which patients will benefit most from the treatment, to shorten the time needed to culture the necessary T cells in the laboratory, and to boost the "memory" of the T cells so they can best fight tumor cells.

In the ASCO news release, expert oncologist Dr. Don Dizon added: "These preliminary data demonstrate, not only the viability of this approach, but that gains in survival can be realized in a cancer where patients have little to no effective treatment options and where median survival is usually less than two years."

More information

The U.S. National Cancer Institute has more about cervical cancer.
Copyright © 2014 HealthDay. All rights reserved.


SOURCES: Krzysztof J. Misiukiewicz, M.D., assistant professor, medicine, hematology, medical oncology, otolaryngology, Icahn School of Medicine at Mount Sinai, New York City; Louis M. Weiner, M.D., director, Georgetown Lombardi Comprehensive Cancer Center...

U.S. Cervical Cancer Rates Higher Than Thought
May 12, 2014

 

MONDAY, May 12, 2014 (HealthDay News) -- A new study finds that cervical cancer rates in the United States are much higher than previously reported, especially among women in their 60s and black women.

Previous studies had estimated that the U.S. cervical cancer rate was about 12 cases per 100,000 women, that the highest rates were in women between ages 40 and 44 and that they then leveled off.

But those estimates included women who had hysterectomies, in which the cervix was removed. For the new study, researchers excluded this group of women, because they were no longer at risk, and then concluded that the overall rate of cervical cancer was 18.6 cases per 100,000 women. They also found that the incidence rose steadily with age and peaked at ages 65 to 69.

The incidence of cervical cancer among women ages 65 to 69 was 84 percent higher than previously reported, according to the study, published online May 12 in the journal Cancer.

"Our corrected calculations show that women just past 65, when current guidelines state that screenings can stop for many women, have the highest rate of cervical cancer," study lead author Anne Rositch, an assistant professor of epidemiology and public health at the University of Maryland School of Medicine, said in a university news release.

The current rate among white women ages 65 to 69 was less than half what it was for black women of the same age. Black women had higher cervical cancer rates at nearly all ages than white women, and this difference was greatest among older women.

"The higher rates of cervical cancer after correction for hysterectomy highlight the fact that, although a large proportion of cervical cancer has been prevented through early detection and treatment, it remains a significant problem," the researchers wrote.

They noted that current U.S. cervical cancer screening guidelines do not recommended routine Pap smears for women older than 65 who have had normal findings on previous tests.

"It will be important to consider these findings when reevaluating risk and screening guidelines for cervical cancer in older women and the appropriate age to stop screening," added Rositch, a researcher at the University of Maryland Cancer Center.

She also said future studies need to determine "whether the continued increase in cervical cancer rates with age and the higher rates in African-American women represent a failure in our screening programs or a failure of the women to be screened so that appropriate interventions can be applied."

Because the human papillomavirus (HPV) is responsible for almost all cervical cancers, the researchers also stressed the need for greater use of the HPV vaccine.

More information

The American Cancer Society has more about cervical cancer.


SOURCE: University of Maryland, news release, May 12, 2014...

Cervical Cancer Vaccine Program in England a Success, Researchers Report
April 14, 2014

 

MONDAY, April 14, 2014 (HealthDay News) -- A sharp drop in the number of young women infected with the two strains of human papillomavirus (HPV) most likely to cause cervical cancer occurred in England after the 2008 launch of a national vaccination program there, a new study shows.

The high-risk HPV types 16 and 18 cause 70 percent to 80 percent of cervical cancers. Protection against infection from these two types is included in HPV vaccines.

The British researchers analyzed test results from more than 4,000 young women between 2010 and 2012. Before the start of the HPV vaccination program, about one in five sexually active women aged 16 to 18 had at least one of the two high-risk HPV types. That dropped to one in 15 after the vaccination program began.

The investigators also found that this age group had the highest rate of infection with the two high-risk HPV strains before the start of the immunization program, but had the highest vaccination rate and lowest infection rate once the program began.

The study was to be presented Monday at the Society for General Microbiology annual conference in Liverpool, England. Research presented at meetings should be considered preliminary until published in a peer-reviewed medical journal.

"This study provides an early indication that the national HPV immunization program is successfully reducing vaccine-type HPV infections in sexually active young women in England, and also suggests herd immunity may be benefiting non-vaccinated young women and men," David Mesher, of Public Health England, said in a society news release.

Herd immunity happens when vaccination of a large portion of a population affords some protection against infection to those in the population who are not vaccinated.

More information

The U.S. Centers for Disease Control and Prevention has more about HPV vaccination.


SOURCE: Society for General Microbiology, news release, April 13, 2014...

FDA Panel Recommends HPV Test As Replacement for Pap Smear
March 13, 2014

 

WEDNESDAY, March 12, 2014 (HealthDay News) -- A U.S. Food and Drug Administration advisory panel voted unanimously on Wednesday that a new HPV test could be used before or instead of the Pap smear as a first step in cervical cancer screening.

In three separate 13-0 votes, the agency's Medical Devices Advisory Committee Microbiology Panel concluded that the cobas HPV (human papillomavirus) test, made by Roche Molecular Systems, is safe and effective as a first-line screen for cervical cancer.

Although the FDA is not required to follow the recommendations of its advisory panels, it typically does.

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 was looking for the FDA to approve its HPV test as a first-line diagnostic tool. Women who test positive for the two high-risk HPV strains would then be asked to undergo colposcopy, which involves using a device that allows the doctor to get a clear view of the vulva, vagina and cervix and take a sample for further testing.

In addition, women who did not have HPV 16 or 18 but had other high-risk types of the virus would then have a Pap test to see if a colposcopy was needed. The data the committee reviewed in its decision comes from a trial called ATHENA, which included more than 47,000 women.

Testifying before the panel, Dr. David Chelmow, chair of the department of obstetrics and gynecology at Virginia Commonwealth University School of Medicine in Richmond, noted 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."

Currently, the cobas HPV test is approved for use among women aged 21 and older who have already received an abnormal Pap test. It is also approved as an add-on to a standard Pap test in women aged 30 to 65. According to Roche, the cobas HPV test is able to screen for a variety of high-risk strains of HPV.

Dr. Andrew Menzin, a gynecologic oncologist at North Shore University Hospital in Manhasset, N.Y., said 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 believes.

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

Although screening for cervical cancer is vital, it is not the only reason women should have a gynecological exam, Menzin added.

"Women should follow the current guidelines and have routine gynecological examinations," he said. "Gynecological care is more than cervical cancer screening."

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 young girls and boys be vaccinated beginning at ages 9 to 11.

More information

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


SOURCES: David Chelmow, M.D., chair, department of obstetrics and gynecology, Virginia Commonwealth University School of Medicine, Richmond; Andrew Menzin, M.D., gynecologic oncologist, North Shore University Hospital, Manhasset, N.Y. ...

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