Category Archives: Cervical Cancer and HPV

NCHR Comment on the USPSTF’s Draft Recommendations for Cervical Cancer Screening

2015

The National Center for Health Research is dedicated to improving the health and safety of adults and children by scrutinizing medical and scientific research. Based on our detailed analysis of currently available data, the Center strongly supports the existing USPSTF guidelines on cervical cancer screening which recommend Pap smears every 3 years starting at age 21, with the option of replacing that regimen starting at age 30 with a combination of a Pap smear and HPV test.

In response to the key systematic question regarding “the effectiveness of HPV testing, with or without cytology, as a primary screening strategy for reducing cancer mortality and incidence,” we strongly believe that this critical question must be divided into four questions: Is HPV testing effective with or without cytology (Pap smear) for women below 30 and for women above 30? Based on current data, the answers to those four questions seem to differ dramatically and more research will help answer those questions for different racial and ethnic groups.

Based on the research to date, HPV test without cytology should not be used as a screening tool. The HPV test by itself isn’t useful for women under 30 because many young women have HPV that will disappear without any treatment. Being objectively correct about whether HPV is present does not accurately predict whether infection with HPV will lead to cervical cancer.  On the contrary, the vast majority of women with HPV will never develop cervical cancer.   The only question is the extent to which HPV screening is useful for women over 30 and whether that is related to marital status or other measures associated with the number of sexual partners.

Positive results of an HPV test performed instead of a Pap smear, especially for women under 30, will add anxiety and lead to additional testing, as physicians follow a positive result on the HPV test with a colposcopy, an expensive and invasive procedure that could result in much lower compliance. Undergoing an HPV test without Pap smear is going to scare many women who are not at high or even moderate risk of cervical cancer.

The HPV test can only detect the presence of the virus, which in many cases will not result in cervical cancer; it cannot identify abnormal cells and it also cannot detect cancers of the cervix  that are not caused by HPV.

Although the FDA approved the use of the HPV test without cytology in 2014, it did not recommend replacing the safe and effective, well-established Pap screening regimen that has successfully prevented cervical cancer in the U.S.  FDA approval does not mean the HPV test is as good as the Pap smear, it only means it is better than placebo.

There has been little comparative effectiveness data comparing HPV-alone screening with HPV and cytology tests, known as co-testing. A new study published last month, conducted by scientists from the Quest Diagnostics laboratory and Magee-Women’s Hospital, analyzed data for over 256,000 women over 30[end Blatt AJ, Kennedy R, Luff RD, Austin RM, Rabin DS. Comparison of cervical cancer screening results among 256,648 women in multiple clinical practices. Cancer Cytopathol. 2015 May;123(5):282-8. Epub 2015 Apr 10.], and found that “approximately 19% of women with cervical cancer may be misdiagnosed by an HPV-only cervical screen.”  We urge the USPSTF to carefully review those data, and compare them to co-testing for women under 30 and those over 30.

The study data support co-testing in women ages 30 to 65 years as more effective at detecting pre-cancers and cancers. In addition, the study states that, “Co-testing performed better than HPV-alone or Pap-alone for cervical adenocarcinoma, a form of cervical cancer that is known to be harder to detect”.  It is important to consider and carefully scrutinize these data as the guidelines for cervical cancer screening undergo revision. We ask that USPSTF includes this study in its Proposed Research Approach — Evidence Review.

Current data indicate that HPV testing alone is likely to be much less accurate on women under 30, making the benefits of co-testing less likely for that age group.

In conclusion, based on current data and an excellent track record in the U.S., we believe Pap smear is an important screening tool, and that women should continue to rely on it every 3 years starting at age 21. Pap smears identify abnormalities in the cervix, which is useful by itself or together with an HPV test for women over 30. Most U.S. women who get cervical cancer did not have Pap smears within the last 5 years. In fact, some never had Pap smears. For that reason, women should continue to rely on Pap smears to screen for cervical cancer.  At the age of 30 or older, women may want to also be tested for HPV at the same time.

No more Pap smears?

By Diana Zuckerman, PhD
2014

If you’re a woman over 21, that headline probably got your attention. After all, who likes Pap smears? Wouldn’t it be great to never need one again?

Well, don’t get too excited because the alternative could be worse, if a Food and Drug Administration (FDA) advisory committee gets its way. The committee proposes replacing Pap smears with an equally invasive but less conclusive test, the HPV test, when women reach the age of 25. And then, if the HPV test indicates the presence of HPV (or human papillomavirus, which is very common in sexually active young women and usually goes away by itself), the committee proposes following up the test with an even more invasive procedure called a colposcopy. Patients describe a colposcopy as being like a Pap smear that takes 20 minutes instead of a few seconds.

The purpose of a Pap smear is to test for abnormal cells in your cervix that could eventually turn into cervical cancer. Two strains of HPV virus are responsible for 70 percent of cervical cancers. It’s very common for sexually active women to be infected with HPV, but usually the body gets rid of the virus within a year or two all on its own. HPV can only cause cancer when it lingers in the body for several years and starts to damage the cervix.

Even if a woman has had an HPV vaccine, she could still potentially develop cervical cancer, so experts advise women to get a Pap smear every three years, starting at age 21 and ending at age 65.  Starting at age 30, women are given the option of asking their doctor to use the same sample for a Pap smear and the test for HPV. If nothing suspicious is found, they can get screened using both tests every five years instead of every three for the Pap smear alone.

Current guidelines recommend that if a woman has an abnormal Pap smear and an HPV test indicating that she has the types of HPV that can cause cervical cancer, she should undergo a colposcopy to see if she needs surgery. Most women get Pap smears to screen for problems, and typically only get an HPV test if their Pap results indicate abnormal cells.

That’s why not many women currently get the HPV test. The company that makes HPV tests would like to sell more of them. So it’s asked the FDA to change the agency’s instructions for using the HPV test to screen healthy women. Instead of an optional use with Pap smears, it wants FDA approval to use the HPV test on its own to screen all healthy women starting at age 25.

Unfortunately, the HPV test by itself isn’t very useful because so many young women have HPV that will disappear without any treatment. Having an HPV test without also getting a Pap smear to check for problems is going to scare a lot of women who are not developing cervical cancer.  Instead of waiting a few months to see if the HPV goes away by itself (which it typically does), the company wants those women to get a colposcopy, which is as painful as a Pap smear but the pain lasts longer and the procedure costs more. And like a Pap smear, the test isn’t always accurate.

Otherwise, it’s a great idea.

We’re not the only ones who believe that the current guidelines should not be changed. The unbiased experts at the U.S. Preventive Services Task Force recommend that the HPV test only be used on women 30 and over, and only in combination with a Pap smear. They point out that if the HPV test is used on younger women, the results can’t distinguish between HPV that would go away on its own and HPV that could cause cancer. This would lead to unnecessary worry for young women and many unnecessary colposcopies.

At an FDA Advisory Committee meeting this month, Anna Mazzucco, PhD, from our staff expressed her concerns about replacing Pap smears with HPV tests. She pointed out that Pap smears provide inexpensive and and effective screening. In fact, the women who get cervical cancer are usually women who did not regularly get Pap smears or follow-up.

Research indicates that the way to save lives is to help women get screened with Pap smears, not to put them through unnecessary follow-up procedures. The American College of Gynecologists—the doctors who do Pap smears, HPV tests, and colposcopies—also expressed concerns about changing current policies, since there is no evidence that the proposed changes would save as many lives.

In addition, we believe that the more expensive and painful procedures would discourage women from getting screened or following up after receiving suspicious results.

What is going on at the FDA? Why are they choosing advisors who ignore the research evidence in favor of a new, unproven screening strategy? The FDA needs advisors who focus on scientific evidence and who make recommendations based on facts, rather than embracing every new “innovation” in health care, regardless of whether it will work.

When the “old ways” are effective, let’s not throw them out unless there is proof that the new, more expensive way is better.

 

A version of this post appeared in Huffington Post and Maria’s Country Kitchen.

Treatment options for cervical cancer

This article is from the National Cancer Institute website
Updated 2013

There are different types of treatment for patients with cervical cancer.

Different types of treatment are available for patients with cervical cancer. Some treatments are standard (the currently used treatment), and some are being tested in clinical trialsThe purpose of clinical trials are to see if the treatment being tested is better, worse, or equally safe and effective compared to other treatments.* Some clinical trials are open only to patients who have not started treatment. Some clinical trials are open only to patients who have not started treatment.

Three types of standard treatment are used:

Surgery

Surgery (removing the cancer in an operation) is sometimes used to treat cervical cancer. The following surgical procedures may be used:

  • Conization: A procedure to remove a cone-shaped piece of tissue from the cervix and cervical canal. A pathologist views the tissue under a microscope to look for cancer cells. Conization may be used to diagnose or treat a cervical condition. This procedure is also called a cone biopsy.
  • Total hysterectomy: Surgery to remove the uterus, including the cervix. If the uterus and cervix are taken out through the vagina, the operation is called a vaginal hysterectomy. If the uterus and cervix are taken out through a large incision (cut) in the abdomen, the operation is called a total abdominal hysterectomy. If the uterus and cervix are taken out through a small incision in the abdomen using a laparoscope, the operation is called a total laparoscopic hysterectomy.
  • Radical hysterectomy: Surgery to remove the uterus, cervix, part of the vagina, and a wide area of ligaments and tissues around these organs. The ovaries, fallopian tubes, or nearby lymph nodes may also be removed.
  • Modified radical hysterectomy: Surgery to remove the uterus, cervix, upper part of the vagina, and ligaments and tissues that closely surround these organs. Nearby lymph nodes may also be removed. In this type of surgery, not as many tissues and/or organs are removed as in a radical hysterectomy.
  • Bilateral salpingo-oophorectomy: Surgery to remove both ovaries and both fallopian tubes.
  • Pelvic exenteration: Surgery to remove the lower colon, rectum, and bladder. In women, the cervix, vagina, ovaries, and nearby lymph nodes are also removed. Artificial openings (stoma) are made for urine and stool to flow from the body to a collection bag. Plastic surgery may be needed to make an artificial vagina after this operation.
  • Cryosurgery: A treatment that uses an instrument to freeze and destroy abnormal tissue, such as carcinoma in situ. This type of treatment is also called cryotherapy.
  • Laser surgery: A surgical procedure that uses a laser beam (a narrow beam of intense light) as a knife to make bloodless cuts in tissue or to remove a surface lesion such as a tumor.
  • Loop electrosurgical excision procedure (LEEP): A treatment that uses electrical current passed through a thin wire loop as a knife to remove abnormal tissue or cancer.

Radiation therapy

Radiation therapy is a cancer treatment that uses high-energy x-rays or other types of radiation to kill cancer cells or keep them from growing. There are two types of radiation therapy. External radiation therapy uses a machine outside the body to send radiation toward the cancer. Internal radiation therapy uses a radioactive substance sealed in needles, seeds, wires, or catheters that are placed directly into or near the cancer. The way the radiation therapy is given depends on the type and stage of the cancer being treated.

Chemotherapy

Chemotherapy is a cancer treatment that uses drugs to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. When chemotherapy is taken by mouth or injected into a vein or muscle, the drugs enter the bloodstream and can reach cancer cells throughout the body (systemic chemotherapy). When chemotherapy is placed directly into the spinal column, an organ, or a body cavity such as the abdomen, the drugs mainly affect cancer cells in those areas (regional chemotherapy). The way the chemotherapy is given depends on the type and stage of the cancer being treated.

Clinical Trials

New types of treatment are being tested in clinical trials.

Information about clinical trials is available from the NCI Web site.

Patients may want to think about taking part in a clinical trial.

For some patients, taking part in a clinical trial may be the best treatment choice. Clinical trials are part of the cancer research process. Clinical trials are done to find out if new cancer treatments are safe and effective or better than the standard treatment.

Many of today’s standard treatments for cancer are based on earlier clinical trials. Patients who take part in a clinical trial may receive the standard treatment or be among the first to receive a new treatment.

Patients who take part in clinical trials also help improve the way cancer will be treated in the future. Even when clinical trials do not lead to effective new treatments, they often answer important questions and help move research forward.

Patients can enter clinical trials before, during, or after starting their cancer treatment.

Some clinical trials only include patients who have not yet received treatment. Other trials test treatments for patients whose cancer has not gotten better. There are also clinical trials that test new ways to stop cancer from recurring (coming back) or reduce the side effects of cancer treatment.

Clinical trials are taking place in many parts of the country. See the Treatment Options section that follows for links to current treatment clinical trials. These have been retrieved from NCI’s clinical trials database.

Follow-up tests may be needed.

Some of the tests that were done to diagnose the cancer or to find out the stage of the cancer may be repeated. Some tests will be repeated in order to see how well the treatment is working. Decisions about whether to continue, change, or stop treatment may be based on the results of these tests. This is sometimes called re-staging.

Some of the tests will continue to be done from time to time after treatment has ended. The results of these tests can show if your condition has changed or if the cancer has recurred (come back). These tests are sometimes called follow-up tests or check-ups.

This article is from the National Cancer Institute web site.

*Addition by Cancer Prevention and Treatment Fund

Physician Groups Make Recommendations to Reduce Healthcare Costs

Nyedra W. Booker, PharmD, MPH, Cancer Prevention and Treatment Fund

  • Does an 18-year-old girl need a pap smear?
  • Should a patient with a mild sinus infection be given antibiotics?

You might be surprised that the answer to both questions is NO according to leading physicians.

In an effort to improve medical care in the U.S. and save healthcare dollars at the same time, each of nine U.S. medical groups recently proposed a list of Five Things Physicians and Patients Should Question. This is a bold move by medical groups who collectively represent almost 375,000 physicians.  Currently, doctors are paid more for ordering more tests and diagnostic procedures, so these recommendations  are not financially beneficial to the physicians involved, but have the potential for reducing the cost of medical care for patients, health insurance companies, and government health programs such as Medicare, Medicaid, and Veterans healthcare.

The medical groups represent a wide range of medical care.  The nine groups include the American Academy of Allergy, Asthma & Immunology; American Academy of Family Physicians; American College of Cardiology; American College of Physicians; American College of Radiology; American Gastroenterological Association; American Society of Clinical Oncology; American Society of Nephrology and the American Society of Nuclear Cardiology.

Recommendations

Here are just a few of the groups’ recommendations:

Hives – Routine diagnostic testing (such as immunoglobulin E (IgE), a skin prick or blood test for allergies) is not recommended for patients with chronic hives, because such testing is usually ineffective at identifying the cause. [American Academy of Allergy, Asthma & Immunology]

Pap Smears – Routine pap smears to screen for cervical cancer are not recommended for women under the age of 21. [American Academy of Family Physicians]

Cardiac Stress Test – Cardiac stress test imaging (a procedure where dye is inserted into the blood stream and images show how well the blood is flowing through the heart) is not recommended for cardiac patients at their annual check-ups unless symptoms are present. [American College of Cardiology]

X-Rays and MRIs for Back Pain – Imaging (X-rays, MRIs) is not recommended for a patient with lower back pain unless a specific cause has been identified. [American College of Physicians]

MRIs and CCTs of the Brain – Imaging of the brain, including MRIs and CCTs (cranial computed tomography), is not recommended for a patient with a headache unless specific risk factors have been identified. [American College of Radiology]

Colorectal Cancer Screening– Colorectal cancer screening by any method (including flexible sigmoidoscopy, computed tomography colonography, double-contrast barium enema test) should be repeated every 10 years in low to average-risk patients who received a normal result at their last colonoscopy screening.  This is less frequently than previous recommendations.  It is recommended that people get their first colonoscopy at age 50. [American Gastroenterological Association]

Breast Cancer Testing – Imaging (PET, CT and radionuclide bone scans) is not recommended for patients with early-stage breast cancer at low risk for metastasis (cancer spreading to other parts of the body). [American Society of Clinical Oncology]

Cancer Screening – Routine cancer screenings (including colonoscopy, mammography and pap smears) are not recommended for patients on dialysis who have a short life expectancy, unless specific signs and symptoms are present. [American Society of Nephrology]

Chest Pains – Routine cardiac imaging including a stress echocardiogram (which  uses ultrasound to show how well the heart is pumping blood) is not recommended for a patient with chest pains who is at low risk for a heart attack or cardiac-related death, is able to exercise, and has a normal electrocardiogram (EKG).[American Society of Nuclear Cardiology][1]

A complete list of all 45 recommendations is available at: http://choosingwisely.org

How Will This Help?

Healthcare spending in the United States reached almost $2.6 trillion in 2010 and is expected to rise to around $4.6 trillion by 2020 unless major changes are made to eliminate unnecessary procedures, according to the Centers for Medicare & Medicaid Services.[2] An increase in the number of people living with chronic illnesses, rising prescription drug prices, and the high administrative costs of managing healthcare programs will contribute to increasing costs. While many continue to debate the exact reasons why healthcare spending is out of control, most agree that something needs to be done immediately.

In 2011, the American Board of Internal Medicine Foundation (ABIM) announced the Choosing Wisely campaign, and the National Physicians Alliance helped develop a multi-year initiative that would promote discussion among physicians, patients and consumer groups, aimed at decreasing healthcare costs by reducing unnecessary tests and procedures. Each participating group of physicians was asked to develop a list of five recommendations based on evidence from research findings. These recommendations were specific to their respective medical fields.

While many doctors and health experts understand that more medical care, and more expensive medical care, is not necessarily better medical care, studies show that the American public is wary of health care guidelines, even when they’re based on strong evidence. Patients and consumers tend to assume that running more tests and relying on newer, more costly technologies translate into health improvements (see Is Newer and More Expensive Care Better?).  As for doctors, the need to pay for expensive new imaging devices by charging for their use, the desire to give patients a clear diagnosis, and concerns about harming a patient by missing a diagnosis can all contribute to ordering unnecessary imaging and other tests.

Given this divide, it’s not surprising that Choosing Wisely has generated praise and concern. While many are praising the initiative as a step in the right direction to reduce the staggering cost of healthcare in the U.S., others question whether these cost-cutting strategies will come at the expense of good patient care.

Next Steps

The American Board of Internal Medicine Foundation and the National Physicians Alliance will continue to work with the nine medical specialty groups and several partnering organizations, including Consumer Reports and the American Association of Retired Persons (AARP), to develop tools and resources to help physicians discuss healthcare decisions with their patients. There will also be at least eight additional medical specialty groups joining the initiative and releasing their recommendations in the fall of 2012.

References:

  1. Choosing Wisely: An Initiative of the ABIM Foundation. Accessed April 04, 2012. http://choosingwisely.org/?page_id=13.
  2. Centers for Medicare & Medicaid Services. “National Health Expenditure Projections 2010-2020.” Accessed April 09, 2012. https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/NationalHealthExpendData/Downloads/proj2010.pdf