Category Archives: Breast Cancer

Video explains panel’s new mammography recommendations

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FACTS AND MYTHS –

By the US Preventive Services Task Force

MYTH: The Task Force recommends against screening for breast cancer in women younger than 50.

FACT: Evidence shows that mammography screening can be effective for women in their 40s. Based on the science, the Task Force’s draft recommendation states that the decision to start regular mammography screening before age 50 is an individual one and should be made by a woman in partnership with her doctor. Continue reading

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So you have dense breasts. Now what?

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Catharine Becker at her home in Fullerton, California on April 14, 2014. Becker started to get mammograms at age 35 because she had a family history of breast cancer (Photo by Heidi de Marco/Kaiser Health News).

By Barbara Feder Ostrov
KHN

Earlier this year, Caryn Hoadley received an unexpected letter after a routine mammogram.

The letter said her mammogram was clean but that she has dense breast tissue, which has been linked to higher rates of breast cancer and could make her mammogram harder to read.

“I honestly don’t know what to think about the letter,” said Hoadley, 45, who lives in Alameda, Calif. “What do I do with that information?”

Millions of women like Hoadley may be wondering the same thing. Twenty-one states, including California, have passed laws requiring health facilities to notify women when they have dense breasts. Eleven other states are considering similar laws and a nationwide version has been introduced in Congress.

The laws have been hailed by advocates as empowering women to take charge of their own health. About 40 percent of women have dense or extremely dense breast tissue, which can obscure cancer that might otherwise be detected on a mammogram.

But critics say the laws cause women unnecessary anxiety and can lead to higher costs and treatment that doesn’t save lives or otherwise benefit patients. Continue reading

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Inviting patients to help decide their own treatment

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By Anna Gorman
KHN

SAN FRANCISCO — Rose Gutierrez has a big decision to make.

Gutierrez, who was diagnosed with breast cancer last spring, had surgery and 10 weeks of chemotherapy. But the cancer is still there.

Now Dr. Jasmine Wong, a surgeon at UC San Francisco, is explaining the choices – Gutierrez can either have another lumpectomy followed by radiation, or she can get a total mastectomy.

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Rose Gutierrez (Photo by Heidi de Marco/KHN).

 

“I think both options are reasonable,” Wong said. “It’s just a matter of how you feel personally about preserving your breast, how you feel about having radiation therapy.”

“I’m kind of scared about that,” said Gutierrez, 52, sitting on an exam table with her daughter on a chair beside her.

“Well if you made it through chemo, radiation is going to be a lot easier,” Wong told Gutierrez, who is from Merced, Calif.

In many hospitals and clinics around the country, oncologists and surgeons simply tell cancer patients what treatments they should have, or at least give them strong recommendations.

But here, under a formal process called “shared decision making,” doctors and patients are working together to make choices about care. Continue reading

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Two out of 3 people diagnosed with cancer survive 5 years or more – CDC

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A Norwegian study estimates that a many as 25 percent of cases of invasive breast cancers diagnosed by mammography screening are cases of overdiagnosis. (Photo/NCI)Two out of 3 people diagnosed with cancer survive five years or more, according to a study by the US Centers for Disease Control and Prevention published in today’s Morbidity and Mortality Weekly Report.

The report found that the most common cancer sites continue to be prostate, breast, lung, and colorectal cancer.

Among these common cancer sites 5-year relative survival was:

  • 97 percent for prostate cancer,
  • 88 percent for breast cancer,
  • 63 percent for colorectal cancer, and
  • 18 percent for lung cancer.

The authors noted that disparities in cancer incidence still persist, with greater rates among men than women and the highest rates among blacks.

Additionally, 5-year relative survival after any cancer diagnosis was lower for blacks (60 percent) than for whites (65 percent).

Data by state show incidence rates for all cancer sites ranged from 374 cases per 100,000 persons in New Mexico to 509 cases per 100,000 persons in the District of Columbia.

“These data are an important reminder that a key to surviving with cancer is making sure everyone has access to care from early diagnosis to treatment,” said Lisa Richardson, M.D., director of CDC’s Division of Cancer Prevention and Control.  “We know, for example, that early detection of colorectal cancer has had the largest impact on long-term survival rates.”’

Through the Affordable Care Act, more Americans will qualify to get health care coverage that fits their needs and budget, including important preventive services, including screening for some cancers, that may be covered with no additional costs.

Visit Healthcare.gov or call 1-800-318-2596 (TTY/TDD 1-855-889-4325) to learn more.

The full report, “Invasive Cancer Incidence and Survival – United States, 2011,” can be found at www.cdc.gov/mmwr. For more information about CDC’s efforts in cancer prevention and control, visit www.cdc.gov/cancer.

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Washington state to offer breast cancer license plates

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BC-MountainRibbonOLYMPIA – There’s a new way to donate and show your support for breast cancer screening and testing. Starting Oct. 16, you have a chance to bid on the first batch of breast cancer license plates before they go on sale to everyone, starting in January.

Money raised from the sale of the plates will pay for breast cancer screenings and follow up tests for women with limited or no insurance through the state Department of Health’s Breast, Cervical, and Colon Health Program.

Money raised from the sale of the plates will pay for breast cancer screenings and follow up tests for women with limited or no insurance.

The auction runs through the end of the month. More information about the auction and how to bid can be found online. After this month’s auction, breast cancer license plates will be available for purchase in January 2015 for $60 through the state Department of Licensing. Continue reading

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Quantifying the ‘Angelina Jolie effect’

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Actress’ impact on genetic testing for breast, ovarian cancer is ‘global and long lasting’

Angelina Jolie - Photo courtesy of the UK Foreign and Commonwealth Office

Angelina Jolie – Photo courtesy of the UK Foreign and Commonwealth Office

By Mary Engel / Fred Hutch News Service

Sept. 18, 2014

The so-called Angelina Jolie effect not only is real but has been “global and long lasting,” leading to a twofold increase in the number of women getting genetic testing to help determine their risk for hereditary breast cancer, according to new studies from the United Kingdom and Canada.

The number of women found to have a genetic mutation that increased their risk also has doubled.

And contrary to concerns that women at low risk for hereditary breast cancer would flood testing centers, researchers said that those being tested are women like Jolie who have a family history of breast cancer or who have personal risk factors such as ethnicity.

Certain ethnic groups, including Ashkenazi Jews, have a higher prevalence of BCRA mutations, which significantly increase breast cancer risk.

Women got the correct message

“What surprised us was that we didn’t get the worried well,” said Dr. Andrea Eisen, head of preventive oncology for breast cancer care at the Sunnybrook Odette Cancer Centre in Toronto and an author of the Canadian study, in a phone interview.  “We got women who got the correct message. That was gratifying.”

Jolie disclosed in a May 2013 op-ed in The New York Times that she had undergone a preventive double mastectomy after finding that she carries the rare BRCA1 gene mutation, which dramatically raises her risk of breast and ovarian cancers. Continue reading

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Nipple aspirator

Nipple aspirate test is no substitute for mammogram – FDA

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Consumer Update from the US Food and Drug Administration

ucm378297Many women admit that getting a mammogram is no fun, and may wish there was an easier, more comfortable way to screen for breast cancer in its earliest and most treatable stages.

Some companies today are promoting a test in which a breast pump is used to collect fluid from a woman’s nipple to screen for abnormal and potentially cancerous cells. This test—called a nipple aspirate—is being marketed as the latest and greatest tool in early breast cancer screening, one that is easier, more comfortable and less painful than the mammogram.

However, there is no clinical evidence to support these claims, says David L. Lerner, M.D., a medical officer at the Food and Drug Administration (FDA) and a specialist in breast imaging.

“FDA’s concern is that the nipple aspirate test is being touted as a stand-alone tool to screen for and diagnose breast cancer as an alternative to mammography,” Lerner explains. “Our fear is that women will forgo a mammogram and have this test instead.” This could result in serious health consequences if breast cancer goes undetected, he notes.

FDA is unaware of any valid scientific data to show that nipple aspirate tests, when used on their own, are an effective screening tool for any medical condition, including the detection of breast cancer or other breast disease, Lerner says. Researchers are still studying whether these tests may one day be used, in conjunction with other medical devices, to screen for disease.

In February 2013 FDA issued a warning letter to Atossa Genetics, Inc. that, among other things, informed the company that their test was misbranded in that its labeling was false or misleading. The agency asked the firm to take prompt action to correct the violations addressed in the warning letter. In October 2013, Atossa initiated a voluntary recall to remove the ForeCYTE Breast Health Test from the market.

Unsubstantiated Claims

In addition to stating that the test can help women 18 years and older determine their risk level for breast cancer, Atossa claimed that its test was “literally a Pap smear for breast cancer.” According to FDA medical officer Michael Cummings, M.D., who reviews obstetrical and gynecological devices for the agency, this claim is unsubstantiated.

“The cervical Pap smear has a known clinical benefit supported by extensive clinical studies over many years,” Cummings says. “Its scientific ability to screen for cervical cancer is unquestioned.” The nipple aspiration test has no such evidence supporting it, he attests.

In addition, Lerner explains that if a Pap smear shows abnormal cells of the cervix, there are follow-up procedures that can be done to try to identify the location of those cells, after which a biopsy of the area is possible. With a breast nipple aspirate, if there are abnormal cells, the test does not target where those cells are coming from, so a biopsy may not be possible. Moreover, while the risk of abnormal cervical cells progressing to cancer is known, the risk of abnormal breast cells progressing to cancer is not.

Lerner says the test may produce results that are falsely positive or falsely negative. “False positives are possible because cells can be damaged in the aspiration process and look abnormal,” he notes. “We are even more concerned about false negatives,” he adds. Companies acknowledge that over 90% of their fluid samples may contain either very scant cells or no cells at all. Yet the companies call such results “diagnostically useful” and even conclude that a patient is healthy based on a cell-free sample, he says. “The test may be missing cancers and giving women dangerous false assurance,” Lerner says.

Mammography Still the Best

The mammogram can be uncomfortable for the woman being screened because it compresses the breast to flatten out the breast tissue and increase the clarity of the X-ray image. Still, FDA is not alone in believing that mammography is the most effective method for screening for breast cancer. Other organizations agree, including the American Cancer Society, the American College of Radiology (the professional society of physicians who specialize in medical imaging) and the National Cancer Institute, a division of the National Institutes of Health.

The National Cancer Institute states that screening mammography can help reduce the number of deaths from breast cancer among women ages 40 to 70. The National Comprehensive Cancer Network (NCCN) 2013 guidelines state that the clinical utility of nipple aspiration is still being evaluated and that it should not be used as a breast cancer screening technique.

FDA recommends that women who have received a nipple aspirate test as a form of breast cancer screening should also have a mammogram according to screening guidelines or as recommended by their doctor, and should talk to their health care professional about whether additional tests are needed.

“The bottom line is that women should not rely solely on these nipple aspirate tests for the screening or diagnosis of breast cancer, “Lerner says. “Mammography is still the gold standard.”

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

Dec. 12, 2013

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Women’s health – week 8: Breast cancer screening

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From the Office of Research on Women’s Health

Cancer is a term used for diseases in which abnormal cells divide without control and can invade other tissues. Breast cancer is a malignant tumor that starts in cells of the breast. The disease occurs almost entirely in women, but some men develop breast cancer.

Because cancer cells spread by breaking away from the original (primary) tumor and entering the bloodstream or the lymphatic system, breast cancer can spread to almost any other part of the body and be life threatening.

You can help with early detection by knowing your risk factors, including genetic ones, getting regular exams, and having mammograms of your breasts. It is also important to keep in mind that most women who have known risk factors do not get breast cancer.

Also, most women with breast cancer do not have a family history of the disease. If you think you may be at risk, you should discuss your concern with your health care provider. Your health care provider may be able to suggest ways to reduce your risk and can plan a schedule for checkups.

Scientists are still studying the exact causes of breast cancer. Research has shown that women with certain risk factors are more likely than others to develop breast cancer. These factors are:

  • Age: Risk increases with aging.
  • Personal history: Risk increases with previous history of breast cancers. A woman who had breast cancer in one breast has an increased risk of getting cancer in her other breast.
  • Family history: Risk is higher if a woman’s mother, sister, or daughter has had breast cancer. Risk is also higher if her father or brother or other relative (in either her mother’s or father’s family) has had breast cancer.
  • Genetics: Risk increases if there are changes in certain genes, including BRCA1, BRCA2, and others.
  • Childbearing: Risk may increase if a woman never had children or had her first child at an older age. Risk may also increase if a woman had her first period at an earlier age or menopause after 55 years.
  • Menopause: Risk may increase for women who take menopausal hormone therapy withestrogen plus progestin after menopause.
  • Obesity/weight: Risk increases with being overweight or obese after menopause.
  • Race/ethnicity: Risk increases based on a woman’s race/ethnicity. Breast cancer is diagnosed more often in white women than in Latina, Asian, or African American women.
  • Previous treatment with radiation: Risk increases for women who had radiation therapy to the chest (including the breasts) before age 30.
  • Breast density: Risk may increase for older women whose mammograms show more dense tissue than fatty tissue.
  • Physical fitness: Risk increases when a woman is physically inactive throughout her life.
  • Alcohol consumption: Risk increases with increased alcohol consumption. Studies suggest that the more alcohol a woman drinks, the greater her risk.
Diagram showing the breast and mammary glands.

Diagram showing the breast and mammary glands.

Common symptoms of breast cancer include:

  • A lump or thickening in or near the breast or in the underarm area.
  • Nipple tenderness.
  • A change in the size or shape of the breast.
  • A nipple turned inward into the breast.
  • Scaly, red, or swollen skin of the breast, areola, or nipple. Ridges or pitting so that it looks like the skin of an orange.
  • Nipple discharge.

Early breast cancer commonly does not cause pain. Still, you should consult with your health care provider about breast pain or any other symptom that concerns you. Most breast changes are not cancer, but it is important to check out any symptoms as early as possible.

Treatment

Surgery, radiation therapy, hormone therapy, chemotherapy, and biological therapy are all options for treating breast cancer. Be sure to consult with your health care provider before pursuing any option.

for more information: www.cancer.gov
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Women’s Health – Week 7: Breast cancer an overview

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From the Office of Research on Women’s Health

Cancer is a term used for diseases in which abnormal cells divide without control and can invade other tissues. Breast cancer is a malignant tumor that starts in cells of the breast. The disease occurs almost entirely in women, but some men develop breast cancer.

Because cancer cells spread by breaking away from the original (primary) tumor and entering the bloodstream or the lymphatic system, breast cancer can spread to almost any other part of the body and be life threatening.

Diagram showing the breast and mammary glands.

Diagram showing the breast and mammary glands.

You can help with early detection by knowing your risk factors, including genetic ones, getting regular exams, and having mammograms of your breasts. It is also important to keep in mind that most women who have known risk factors do not get breast cancer. Also, most women with breast cancer do not have a family history of the disease.

If you think you may be at risk, you should discuss your concern with your health care provider. Your health care provider may be able to suggest ways to reduce your risk and can plan a schedule for checkups.

Scientists are still studying the exact causes of breast cancer. Research has shown that women with certain risk factors are more likely than others to develop breast cancer. These factors are:

  • Age: Risk increases with aging.
  • Personal history: Risk increases with previous history of breast cancers. A woman who had breast cancer in one breast has an increased risk of getting cancer in her other breast.
  • Family history: Risk is higher if a woman’s mother, sister, or daughter has had breast cancer. Risk is also higher if her father or brother or other relative (in either her mother’s or father’s family) has had breast cancer.
  • Genetics: Risk increases if there are changes in certain genes, including BRCA1, BRCA2, and others.
  • Childbearing: Risk may increase if a woman never had children or had her first child at an older age. Risk may also increase if a woman had her first period at an earlier age or menopause after 55 years.
  • Menopause: Risk may increase for women who take menopausal hormone therapy withestrogen plus progestin after menopause.
  • Obesity/weight: Risk increases with being overweight or obese after menopause.
  • Race/ethnicity: Risk increases based on a woman’s race/ethnicity. Breast cancer is diagnosed more often in white women than in Latina, Asian, or African American women.
  • Previous treatment with radiation: Risk increases for women who had radiation therapy to the chest (including the breasts) before age 30.
  • Breast density: Risk may increase for older women whose mammograms show more dense tissue than fatty tissue.
  • Physical fitness: Risk increases when a woman is physically inactive throughout her life.
  • Alcohol consumption: Risk increases with increased alcohol consumption. Studies suggest that the more alcohol a woman drinks, the greater her risk.

Common symptoms of breast cancer include:

  • A lump or thickening in or near the breast or in the underarm area.
  • Nipple tenderness.
  • A change in the size or shape of the breast.
  • A nipple turned inward into the breast.
  • Scaly, red, or swollen skin of the breast, areola, or nipple. Ridges or pitting so that it looks like the skin of an orange.
  • Nipple discharge.

Early breast cancer commonly does not cause pain. Still, you should consult with your health care provider about breast pain or any other symptom that concerns you. Most breast changes are not cancer, but it is important to check out any symptoms as early as possible.

Treatment

Surgery, radiation therapy, hormone therapy, chemotherapy, and biological therapy are all options for treating breast cancer. Be sure to consult with your health care provider before pursuing any option.

for more information: www.cancer.gov
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8 Ways Young Women Benefit From Obamacare – Cosmopolitan

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By Phil Galewitz
KHN Staff Writer

This KHN story was produced in partnership with 

number 8You’ve heard people arguing about Obamacare (officially known as The Affordable Care Act or ACA) for months … but you may have tuned it all out, because it’s all so confusing and you don’t even know how — or if — it affects you.

But starting in 2014, the law will require people who can afford insurance to carry it or risk paying a fine, so now’s the time to pay attention.

And the fact is, you may discover that there are lots of benefits you’ll be able to take advantage of. Here’s a quick list of what’s great about the ACA, especially for young women:

  • You can stay on your parents’ health policy until you turn 26. Previously, most insurers did not allow young adults beyond age 21 to stay on their parents’ policies. More than 3 million young adults have gained coverage since this provision went into effect in 2010. Your parents will be charged the same rates as when you were younger. You can be covered by their policy even if you’re married, but the coverage won’t extend to your spouse.
  • You’re entitled to free preventive care, including birth control. Since 2012, nearly 30 million women have benefitted from free preventive services including checkups, screenings for diabetes and HIV, contraceptives and family planning counseling. The law requires plans to cover all FDA-approved birth control methods without co-pays. This includes pills, injectables, implants, intrauterine devices (IUDs), and sterilization procedures. Plans must cover all brand name contraceptives without generic equivalents, or where the generic equivalent is medically inappropriate. Certain religious employers are exempt from the birth control requirement.
  • You may be eligible for government discounts on insurance. Starting Oct. 1, new online health insurance exchanges will go live in every state, selling coverage that will take effect Jan. 1, 2014. The exchanges will allow you to compare prices and benefits to find an insurance plan you can afford that fits your needs; if you still feel you can’t afford it, you can find out whether you’re entitled to a federal tax credit based on your income. The lower your income, the higher the tax credit. You can get the discount at the time you enroll. Find information on your state exchange here.
  • You’ll have maternity coverage, no matter what. You may not know this but only about 12 percent of health plans sold on the individual market currently include coverage for maternity, according to Judy Waxman of the National Women’s Law Center. But starting next year, all individual health plans will have to include 10 essential health benefits including maternity care, as well as hospitalization, prescription drugs, mental health services and preventive services.
  • You can’t be charged more than a guy. In most states, insurers are currently allowed to charge women more than men for individual coverage. According to the National Women’s Law Center, in 30 percent of cases, nonsmoking women were charged more than men who smoked. Such gender rating will be outlawed starting next year.
  • You can’t be rejected for having a “pre-existing condition.” Today, insurers can deny you health insurance if you have a chronic condition such as asthma or diabetes (in which case you’re considered a health risk); if they do accept you regardless of these conditions, they can still charge you more for coverage. But starting next year it will be illegal for them to penalize you this way; health premiums may vary based on three factors only: age, where you live, and whether you’re a smoker.
  • If you are an individual who makes under $16,000 a year, you may be eligible for Medicaid. Medicaid is the state-federal health insurance program for the poor, and it’s being expanded by the law to those whose annual income is under the federal poverty level. However, because the Supreme Court ruled that the expansion is optional for states, only about half of them are participating. Check out this infographic to see if yours is one of them.
  • If you’re a breastfeeding mom, you can pump at work more comfortably. Since 2011, the law has required employers to provide a “reasonable break time” and a private place (not a bathroom) for you to pump breast milk during the workday. The law also requires health plans to cover the costs of breastfeeding equipment and breastfeeding counseling without a copay.

One final note: not everyone will see immediate coverage changes; many of you who get your insurance through your job are in “grandfathered” plans, which are exempt from some of the rules. Ask your company’s health benefits administrator if this is the case for you.

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Baby boomers can take steps to live long and healthy lives – CDC

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Aging and Health in America, 2013

Longer life spans and aging baby boomers will combine to double the population of older Americans during the next 25 years to about 72 million.

Heart disease, cancer, stroke, chronic lower respiratory diseases, Alzheimer’s disease and diabetes continue to be the leading cause of death among older adults.

State of Aging and Health in America 2013 Adobe PDF file [PDF – 3 MB] provides a snapshot of our nation’s progress in promoting prevention, improving the health and well-being of older adults, and reducing behaviors that contribute to premature death and disability.

The report looks at 15 key health indicators that address health status (physically unhealthy days, frequent mental distress, oral health and disability); health behaviors (physical inactivity, nutrition, obesity and smoking); preventive care and screening (flu and pneumonia vaccine, breast and colorectal cancer screening); and fall injuries for Americans aged 65 years or older.

As the baby boomer population ages, it is important to take steps to ensure older adults live long and healthy lives.

Get Screened

A man and woman huggingLess than half of men and women aged 65 years or older are up-to-date on preventive services including flu vaccine, pneumonia vaccine, colorectal cancer screening, and mammography for women.

Mammography is the best available method to detect breast cancer in its earliest, most treatable stage before it is big enough to feel or cause symptoms. Women aged 50-74 should get mammograms every two years.

Colorectal cancer screening tests can find precancerous polyps so that they can be removed before they turn into cancer.

They can also detect colorectal cancer early, when treatment works best. Older adults should be screened for colorectal cancer by having a fecal occult blood test (FOBT) during the past year, a flexible sigmoidoscopy within 5 years and FOBT within 3 years, or a colonoscopy within 10 years.

Get Vaccinated

Flu and pneumonia is the seventh leading cause of death among adults 65 years or older, despite the availability of effective vaccines. Older adults should get the flu vaccine every year and get the pneumonia vaccine at least once.

Be Physically Active

Women riding bicyclesRegular physical activity is one of the most important things older adults can do for their health. Physical activity can prevent many of the health problems that may come with age, including the risk of falls.

How Much Activity Do Older Adults Need?

2 hours and 30 minutes (150 minutes) of moderate-intensity aerobic activity (i.e., brisk walking) every week and muscle-strengthening activities on 2 or more days a week that work all major muscle groups.

OR

1 hour and 15 minutes (75 minutes) of vigorous-intensity aerobic activity (i.e., jogging or running) every week and muscle-strengthening activities on 2 or more days a week that work all major muscle groups.

OR

An equivalent mix of moderate- and vigorous-intensity aerobic activity and muscle strengthening activities on 2 or more days a week that work all major muscle groups.

Eat Fruits and Vegetables Daily

Diets rich in fruits and vegetables may reduce the risk of some cancers and chronic diseases, such as diabetes and cardiovascular disease. Fruits and vegetables provide essential vitamins and minerals, fiber, and other substances that are important for good health.

Adults aged 65 years or older should eat 5 or more fruits and vegetables daily.

Quit Smoking

Tobacco use remains the single largest preventable cause of disease, disability, and death in the United States. For help quitting, visit www.smokefree.govExternal Web Site Icon or call 1-800-Quit-Now.

Take Medication for High Blood Pressure

High blood pressure is a major risk factor for cardiovascular disease, the leading cause of illness and death among older adults. Of the almost 67 million Americans with high blood pressure, more than half do not have it under control.

Health care providers, such as doctors, nurses, and pharmacists, can track their patients’ blood pressure, prescribe once-a-day medications, and give clear instructions on how to take blood pressure medications.

Patients should take the initiative to monitor their blood pressure between medical visits, take medications as prescribed, tell their doctor about any side effects, and make lifestyle changes, such as eating a low-sodium diet, exercising, and stopping smoking.

 More Information

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5 things to know about breast implants

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A Consumer Update for the FDA

breast implantShould I get breast implants? Are there alternatives? Will they need to be replaced?

And if you decide to get implants, there are even more questions. Saline or silicone?  What style? How much monitoring is needed?

Researching breast implants can be overwhelming and confusing. The Food and Drug Administration (FDA) has online tools available to help women sort through the information and provides questions to consider before making the decision.

Know the Basics

FDA has approved implants for increasing breast size in women, for reconstruction after breast cancer surgery or trauma, and to correct developmental defects. Implants are also approved to correct or improve the result of a previous surgery.

A number of studies have reported that a majority of breast augmentation and reconstruction patients are satisfied with the results of their surgery.

FDA has approved two types of breast implants for sale in the U.S.: saline (salt water solution)-filled and silicone gel-filled. Both have a silicone outer shell and vary in size, shell thickness and shape.

Know the Risks

Silicone implants sold in the U.S. are made with medical-grade silicone.  These implants undergo extensive testing to establish reasonable assurance of safety and effectiveness. Nonetheless, there are risks associated with all breast implants, including:

  • additional surgeries
  • capsular contracture—scar tissue that squeezes the implant
  • breast pain
  • rupture (tears or holes in the shell) with deflation of saline-filled implants
  • silent (without symptoms) rupture of silicone gel-filled implants

FDA experts suggest five things women should know about breast implants.

1. Breast implants are not lifetime devices.

The longer a woman has them, the greater the chances that she will develop complications, some of which will require more surgery.  The patient can also request additional surgeries to modify the aesthetic outcome, such as size or shape.

“The life of these devices varies according to the individual,” says Gretchen Burns, a nurse consultant at FDA’s Center for Devices and Radiological Health (CDRH).  “All women with implants will face additional surgeries—no one can tell them when.” While a few women have kept their original implants for 20-30 years, “that is not the common experience.”

2. Research products.

Review the patient labeling. FDA advises that women look at the Summary of Safety and Effectiveness Data (SSED) for each implant to learn about their characteristics and the fillers used. SSEDs have been produced for all approved saline and silicone gel-filled breast implants. These summaries provide information on the indications for use, risks, warnings, precautions, and studies associated with FDA approval of the device. Look at the frequency of serious complications found in the SSED. The most serious are “those that lead to further surgeries, such as ruptures or capsular contracture,” says Tajanay Ki, a biomedical engineer in CDRH.

FDA advises health care providers to give women the full labeling—all of the patient information from the manufacturer—for an implant. Ask your surgeon for the most recent version of the labeling. You should have at least 1-2 weeks to review the information before making a decision, but with some reconstruction or revision surgery cases, it may be advisable to perform surgery sooner.

3. Communicate with the surgeon.

Surgeons must evaluate the shape, size, surface texture and placement of the implant and the incision site for each woman. Ask the surgeon questions about his or her professional experience, the surgical procedure, and the ways the implant might affect an individual’s life.

Also, tell the surgeon about previous surgeries and your body’s response—for example, whether surgeries resulted in excessive scar tissue—and discuss your expectations. This helps the surgeon make operative decisions that achieve the desired appearance (i.e., incision location and size, implant size and placement).  Many women undergo reoperation to change implant size.  To achieve optimal results after the first procedure, careful planning and reasonable expectations are necessary.

4. Learn about long-term risks. 

Some women with breast implants have experienced connective tissue diseases, lactation difficulties or reproductive problems. However, current evidence does not support an association between breast implants and these conditions. FDA has identified a possible association between breast implants and the development of anaplastic large cell lymphoma (ALCL), a rare type of non-Hodgkin’s lymphoma. Women who have breast implants may have a very small but increased risk of developing ALCL in the fluid or scar tissue surrounding the implant. Like other lymphomas, ALCL is a cancer of the immune system and not of breast tissue.

5. Monitoring is crucial. 

FDA recommends that women with breast implants:

  • promptly report any unusual signs or symptoms to their health care providers, and
  • report any serious side effects to MedWatch, FDA’s safety information and adverse event reporting program.

Furthermore, women with silicone implants should get MRI screenings to detect silent ruptures three years after their surgery and every two years after that.  Insurance may not cover these screenings.

Burns recommends that women with breast implants continue to perform self-examinations and get mammograms to look for early signs of cancer. “Just because you have implants doesn’t mean you can ignore other breast health recommendations,” she says.

FDA’s Online Resources

FDA has a breast implants web page (www.fda.gov/breastimplants) with resources that include:

  • Links to patient information and data for each product.
  • Information about risks and complications
  • Questions to ask health care professionals regarding breast implant surgery
  • Contact information for manufacturers of FDA-approved breast implants and related professional organizations

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

February 20, 2013

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Smith

Cancer rehab begins to bridge a gap for patients

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Smith

Smith

By Rachel Gotbaum

This story was produced in collaboration with NPR

It was her own experience with debilitating side effects after cancer treatment that led Dr. Julie Silver to realize there is a huge gap in care that keeps cancer patients from getting rehabilitation services.

Silver was 38 in 2003 when she was diagnosed with breast cancer. Even though she is a physician, she was shocked at the toll chemotherapy and radiation took on her body. Silver was dealing with extreme fatigue, weakness and pain.

“I was really, really sick, sicker than I ever imagined,” says Silver, who is an assistant professor at Harvard Medical School. “I did some exercise testing and I tested out as a woman in my 60s. So I had aged three decades in a matter of months through cancer treatment.”

Silver went to her oncology team for help. They told her to go home and heal. “The conversation should have been, ‘We’re going send you to cancer rehab to help you get stronger,’” she says. But that’s not what happened, and after Silver came to realize that her experience was typical, she set out to change the system for other patients.

In 2009 she started a program designed to offer cancer survivors rehabilitation therapy after treatment. It’s called STAR and is now offered in almost all 50 states. The program is growing, as is research showing that many of the quality-of-life problems cancer survivors have are physical and can be helped with rehab.

But even with the awareness of its benefits growing, there is still a disconnect for patients.

“Patients are getting stuck, and they don’t know where to go,” says Dr. Rebecca Lansky, a rehabilitation specialist at the University of Massachusetts Medical Center. She says the focus on cancer care is on treatment and that cancer patients suffering from major side effects often fall through the cracks. She recalls one patient who struggled with the side effects of tongue cancer treatment.

“He had radiation to the whole jaw and neck so he couldn’t open up his mouth for six months,” Lansky said. “He had a feeding tube, and he kept going to his oncologist saying, ‘How can I get better? What I can do? He finally got referred to me and we are now opening up his jaw six months after he has been unable to move.”

Dr. Rebecca Lansky examines a patient (Photo by Rachel Gotbaum/For KHN)

Dr. Rebecca Lansky examines a patient (Photo by Rachel Gotbaum/For KHN)

A 2008 study of breast cancer patients in the Journal of Clinical Oncology found that 90 percent of the patients needed rehab but only about one third were getting the therapy.

“I’ve seen cases where someone has had a lot of pain, and they’ve done scans and it’s not a malignancy and maybe they have done exploratory surgery to see what is happening and not really finding much except a lot of scar tissue,” says physical therapist Jennifer Goyette, a STAR trained therapist who works with cancer patients in Worcester, Massachusetts. “I am able to get them a lot of relief and a lot of times patients don’t need to have further intervention. They don’t want to be on the narcotics for the pain management. They would rather come here.”

One of Goyette’s clients is 56-year-old cancer survivor Deborah Leonard. For two years after her treatment for early stage breast cancer, Leonard had swelling, pain and a large mass in her breast –which was not cancer.

“Clearly I didn’t have that before the surgery, because the tumor was so small and this was much bigger, and it just kept getting bigger,” says Leonard. “By nighttime my breast was extremely swollen and very painful.”

At first doctors thought Leonard might have an infection and gave her antibiotics. When that didn’t work they did another surgery to remove scar tissue. But the problem returned. Her doctors were suggesting a third surgery when Leonard finally found Goyette.

After three sessions with Goyette doing what is called lymphatic drainage, Leonard felt much better. Goyette uses manual pressure to clear Leonard’s lymphatic system, allowing the build up of fluid causing Leonard’s pain and swelling to subside.

“I had a 6-inch mass that is now down to half its size,” says Leonard.

“I’m sleeping at night, I have energy again. More people need to know about this because you don’t have to be a martyr and grin and bear it. This works.”

The issues are different for every type of cancer – head and neck cancer patients may need swallowing and speech therapy; blood cancer patients may need therapy similar to cardiac rehab to rebuild their strength and stamina; and patients treated for colon cancer can get help from physical therapists with back pain and abdominal swelling.

Most insurers do cover rehab for cancer patients, but sometimes patients must battle to get more than the standard 9 to 12 sessions covered. Another barrier to care is that too few oncologists and cancer surgeons refer their patients to rehab.

The Commission on Cancer, the arm of the American College of Surgeons that accredits cancer programs in U.S. hospitals, recently announced new requirements aimed at improving care for survivors of cancer including better access to rehabilitation therapy.

This article was reprinted from kaiserhealthnews.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.

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U.S. cancer deaths continue long-term decline

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By Bill Robinson
NCI Cancer Bulletin

According to the latest national data, overall death rates from cancer declined from 2000 through 2009 in the United States, maintaining a trend seen since the early 1990s.

SR-inside

Mortality fell for most cancer types, including the four most common types of cancer in the United States (lungcolon and rectumbreast, and prostate), although the trend varied by cancer type and across racial and ethnic groups.

The complete “Annual Report to the Nation on the Status of Cancer, 1975–2009″ appeared January 7 in the Journal of the National Cancer Institute.

The report also includes a special section on cancers associated with the human papillomavirus (HPV) that shows that, from 2008 through 2010, incidence rates rose for HPV-associated oropharyngealanal, and vulvar cancers.

HPV vaccination rates in 2010 remained low among the target population of adolescent girls in the United States.

As in past years, NCI, the American Cancer Society (ACS), the Centers for Disease Control and Prevention (CDC), and the North American Association of Central Cancer Registries (NAACCR) collaborated on the annual report.

Cancer incidence data came from NCI’s Surveillance, Epidemiology, and End Results (SEER) database and the CDC, with analyses of pooled data by NAACCR. Mortality data came from the CDC’s National Center for Health Statistics.

Incidence Rates Vary, Death Rates Continue to Drop

Among men, the overall rate of cancer incidence fell by an average of 0.6 percent annually from 2000 through 2009. Cancer incidence rates were stable among women during the same time period and rose by 0.6 percent per year among children. (See the table.)

“The continuing drop in cancer mortality over the past two decades is reason to cheer . . . The challenge we now face is how to continue those gains in the face of new obstacles, like obesity and HPV infections.”

The declines in cancer mortality averaged 1.8 percent per year for men, 1.4 percent per year for women, and 1.8 percent for children (ages 0 to 14 years) from 2000 through 2009.

During the same period, death rates among men fell for 10 of the 17 most common cancers and rose for three types of cancer. Death rates among women fell for 15 of the 18 most common cancers and also rose for three types of cancer.

“The continuing drop in cancer mortality over the past two decades is reason to cheer,” said ACS Chief Executive Officer Dr. John R. Seffrin in a statement. “The challenge we now face is how to continue those gains in the face of new obstacles, like obesity and HPV infections. We must face these hurdles head on, without distraction, and without delay, by expanding access to proven strategies to prevent and control cancer.”

HPV Vaccination Rates Low

The special section on HPV-related cancers showed that from 2000 through 2009, incidence rates for HPV-associated oropharyngeal cancer increased among white men and women, as did rates for anal cancer among white and black men and women. Incidence rates for cancer of the vulva also increased among white and black women.

However, cervical cancer rates declined among all women except American Indian/Alaska Natives. In addition, cervical cancer incidence rates were higher among women living in lower-income areas.

The annual report also showed that, in 2010, fewer than half (48.7 percent) of girls ages 13 through 17 had received at least one dose of the HPV vaccine, and only 32 percent had received all three recommended doses, a rate that fell well short of the Department of Health and Human Services’ Healthy People 2020 target of 80 percent.

The rate is also much lower than vaccination rates reported in Canada (50 to 85 percent) and the United Kingdom and Australia (both higher than 70 percent).

Vaccination series completion rates were generally lower among certain populations, including girls living in the South, those living below the poverty level, and Hispanics.

“The influence that certain viral infections can have on cancer rates is significant and continued attention to the effect[s] of HPV infection, in particular, on cervical cancer rates is critical,” said NCI Director Dr. Harold Varmus in a statement. “It is important, however, to note that the investments we have made in HPV research can only have the tremendous payoff of which they are capable if vaccination rates … increase.”

Cancer Incidence and Mortality Rates, 2000–2009

Men Women
Incidence Increase

  • kidney
  • pancreas
  • liver
  • thyroid
  • melanoma
  • myeloma

Decrease

  • prostate
  • lung
  • colorectal
  • stomach
  • larynx
Increase

  • thyroid
  • melanoma
  • kidney
  • pancreas
  • leukemia
  • liver
  • corpus and uterus

Decrease

  • lung
  • colorectal
  • bladder
  • cervix
  • oral cavity and pharynx
  • ovary
  • stomach
Mortality Increase

  • melanoma
  • liver
  • pancreas

Decrease

  • lung
  • prostate
  • colon and rectum
  • non-Hodgkin lymphoma
  • kidney
  • stomach
  • myeloma
  • oral cavity and pharynx
  • larynx
  • leukemia
Increase

  • pancreas
  • liver
  • corpus and uterus

Decrease

  • lung
  • breast
  • colon and rectum
  • leukemia
  • non-Hodgkin lymphoma
  • brain and other nervous system
  • myeloma
  • kidney
  • stomach
  • cervix
  • bladder
  • esophagus
  • oral cavity and pharynx
  • ovary
  • gallbladder

The NCI Cancer Bulletin is an award-winning biweekly online newsletter designed to provide useful, timely information about cancer research to the cancer community. The newsletter is published approximately 24 times per year by the National Cancer Institute (NCI), with day-to-day operational oversight conducted by federal and contract staff in the NCI Office of Communications and Education. The material is entirely in the public domain and can be repurposed or reproduced without permission. Citation of the source is appreciated.

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Lung Cancer

A glimpse into future of cancer screening

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Lung Cancer

X-ray showing lung cancer – Photo/NCI

By Elia Ben-Ari
NCI Cancer Bulletin

Ask experts to predict the future of cancer screening, and you’ll get a range of answers.

But all would agree that we need better ways to detect cancers early in the course of disease, and these new tools should improve on the benefits of screening while limiting the harms.

“There have been some improvements in triaging patients with new molecular approaches, but with the possible exception of spiral CT screening for lung cancer, we haven’t had any major breakthroughs in early detection” for more than two decades, noted Dr. David Sidransky, director of head and neck cancer research at the Johns Hopkins University School of Medicine.

The dearth of such advances is not for lack of trying. Developing new screening approaches and rigorously establishing their validity is challenging, however, and there are many potential stumbling blocks along the way.

“The bar for ‘proof’ that a particular screening strategy is clinically effective is very high,” noted Dr. Mark Greene, chief of the Clinical Genetics Branch in NCI’s Division of Cancer Epidemiology and Genetics (DCEG). “A screening test must be shown to reduce the death rate from the disease for which screening is being done.”

Much of the search for new screening tests focuses on biomarkers—proteins, DNA, RNA, or other molecules that can signal the presence of cancer and be detected noninvasively in blood, urine, or other readily obtained patient samples or tissues.

Researchers are also developing new imaging methods that could be used for early detection, either alone or in concert with biomarkers.

Whatever the approach, “screening is moving away from detecting an advanced consequence of cancer, which is the formation of a mass [or tumor], toward detecting the very earliest changes in the cancer process,” said Dr. Larry Norton, deputy physician-in-chief for breast cancer programs at Memorial Sloan-Kettering Cancer Center.

Dr. Norton chairs the external consulting team for the Early Detection Research Network (EDRN), an initiative of NCI’s Division of Cancer Prevention that supports efforts to discover and validate new cancer biomarkers and technologies.

“Molecular detection of cancer is possible only through evidence-based strategies and implementation,” commented Dr. Sudhir Srivastava, who directs the EDRN. “It takes a village to meet the challenges of early-detection research.”

The Post-PSA Era

Microscopic view of prostate cancer

Prostate Cancer

In the case of some cancers, researchers are developing new screening tests because the value of existing tests for those cancers has been called into question, perhaps most notably in the case of prostate specific antigen (PSA) testing for prostate cancer.

“The idea that one biomarker such as PSA is going to be useful for all settings has evolved. We now believe that we’ll need panels of biomarkers,” said Dr. Mark Rubin, a professor of pathology at Weill Cornell Medical College.

To identify those biomarkers, researchers are using methods such as microarrays and whole-genome sequencing, which rapidly yield a wealth of information, to profile changes that occur in cancer.

Using such an approach, Dr. Rubin, Dr. Arul Chinnaiyan of the University of Michigan, and their colleagues discovered the fusion gene TMPRSS2-ERG, which is found in about half of all prostate cancers.

“That fusion gene is seen only in cancer, and, in particular, only in prostate cancer,” said Dr. Rubin, whose team has developed a test to assess the levels of this fusion gene in urine samples. “Our approach now is to try to explain the other 50 percent of prostate cancers with other cancer-specific molecular events” that could eventually form a screening test based on a panel of genetic markers.

For example, Dr. Rubin co-led a recent study that identified a gene called SPOP that is mutated in about 10 percent of prostate cancers.

“We can add that gene mutation to the gene fusion to improve on the test,” he explained. “This is the sort of approach we think will be useful for prostate cancer, as well as other cancers in the future.”

Applying Lessons Learned

To avoid unnecessary biopsies or treatment of prostate and other screen-detected cancers, researchers are trying to find biomarkers that better identify which cancers are likely to progress, noted Dr. Joshua LaBaer, director of the Center for Personalized Diagnostics at the Biodesign Institute at Arizona State University and co-chair of EDRN’s steering committee.

“What we’ve learned from PSA is that if we’re going to come up with new screening tools, we also have to develop tools that give us a better idea of disease prognosis.”

Whereas some cancers detected by screening will progress and metastasize, others may never cause illness during a person’s lifetime.

“What we’ve learned from PSA is that if we’re going to come up with new screening tools, we also have to develop tools that give us a better idea of disease prognosis,” said Dr. James Brooks, a professor of urology at Stanford University.

Dr. Brooks and Dr. Sanjiv Gambhir, chair of the department of radiology at Stanford, lead a project to deploy new technologies that could form the basis for the next generation of prostate cancer screening tests.

To pave the way for tests that rely on panels of blood-based diagnostic or prognostic protein biomarkers, they are starting to test the performance of a magneto-nanosensor chip technology developed at Stanford.

The sensor, which detects proteins tagged with magnetic particles, can measure the levels of up to 64 different proteins simultaneously, in very small sample volumes.

The Stanford team also hopes to adapt an imaging technology being studied in Dr. Gambhir’s lab to improve the accuracy of prostate cancer detection by transrectal ultrasound.

The method uses gas “microbubbles” that are encased in a lipid shell to which specific antibodies are attached as a contrast material for ultrasound imaging.

The antibodies target a receptor for vascular endothelial growth factor, which is a protein found in newly formed tumor blood vessels. The patented antibody-labeled microbubbles are awaiting Food and Drug Administration approval for human testing.

The Stanford team’s long-term goal is to combine their blood-based biomarker and imaging methods to improve early detection and prognostic assessment of prostate cancer and eventually other cancers.

Combining molecular biomarkers and imaging for cancer screening “is a very powerful approach,” commented Dr. Sidransky. “We used to believe in the power of a marker to do everything,” he added. “We now know that’s not true.”

A Sense of Urgency

Researchers have long sought an effective screening strategy for ovarian cancer, and numerous candidate biomarkers for the disease have fallen short of expectations.

“Ovarian cancer is the paradigm for why we need early detection,” said Dr. Michael Birrer, a professor of medicine at Harvard Medical School. The disease can be cured by surgery if discovered early. But “75 percent of tumors are detected at the advanced stage, and those patients are hard to cure,” said Dr. Birrer.

Dr. Birrer and Dr. Steven Skates, an associate professor of medicine at Harvard, are leading a two-pronged effort to discover new biomarker candidates that may ultimately lead to a blood test for the early detection of ovarian cancer.

We used to believe in the power of a marker to do everything. We now know that’s not true.—Dr. David Sidransky

The first strategy will use extensive proteomic profiling of fluids from benign and malignant tissues, such as ovarian cysts, “to find candidate biomarkers that are systematically different between the two,” Dr. Skates explained.

The second strategy involves genomic analyses to identify genes that are expressed differently in ovarian cancer tissue samples than they are in normal tissues that may give rise to ovarian cancer, and then bioinformatic analyses to look for genes whose protein products are also likely to be secreted into the bloodstream.

Using either the proteomic or genomic approach, or a combination of both, the researchers hope to come up with a short list of candidate biomarkers for further testing and refinement.

“We may be lucky to find that some of those candidates are actually early-detection biomarkers that can be measured in blood,” Dr. Skates said.

Those biomarkers could form the basis of a blood test to screen postmenopausal women, and other women at increased risk of ovarian cancer, at regular intervals.

For women who test positive on the blood test, a follow-up test, such as transvaginal ultrasound or newer imaging methods, might be used as part of an overall screening approach in the future, Drs. Birrer and Skates suggested.

Gazing into the Crystal Ball

3d Chromosome with DNA visible insideNo one can predict with certainty which types of tests will be most effective for screening for particular cancers. However, “if you want to prognosticate the future of cancer screening, my guess is that nucleotide [RNA or DNA]-based tests are going to be the most promising, at least in the short term,” Dr. Brooks said. “The power of nucleic acids is that you can amplify them to an extraordinary degree, which you can’t do with proteins,” Dr. LaBaer added.

Future DNA-based screening tests might detect methylation or other epigenetic modifications of DNA that occur specifically in cancer. “For example, we published a paper last year showing widespread and reproducible changes in DNA methylation in prostate cancer,” Dr. Brooks said.

And future screening tests may detect biomarkers in patient samples other than blood or urine. “One area where I think you’re going to see a change is in…tumors that affect the gastrointestinal tract” or other parts of the digestive system, Dr. LaBaer predicted. “You can look in stool for aberrant nucleic acids [from cells shed by tumors].” Researchers are also investigating sputum-based tests to detect lung cancer early.

“A possibility for the future is that we may stop thinking about cancers in terms of organ sites and may think more in terms of disrupted pathways or molecular variants of cancer,” Dr. LaBaer continued. In that case, “the biomarker people are going to have to work closely with the imaging people to very quickly turn a biomarker discovery into identifying where the tumor is.”

“We’re rapidly changing our concept of what cancer is,” noted Dr. Norton. “You can’t separate screening from understanding biology, from therapy, from prevention. The biggest challenge is weaving it all together [into] the big picture.”

Furthermore, he added, “we may find out that early detection is not helpful in certain situations, and that’s also important. We may not want to screen for certain cancers if we find out that prevention may be a better place to put our resources.”

“Mortality rates for some cancers have remained constant for the past 40 years, and in some of these cancers, new therapies have extended life for a few years but are not increasing the cure rates,” Dr. Skates noted. “Improved early detection for these cancers could shift that number so that more people are cured…. The payoff could be so big.”

The NCI Cancer Bulletin is an award-winning biweekly online newsletter designed to provide useful, timely information about cancer research to the cancer community. The newsletter is published approximately 24 times per year by the National Cancer Institute (NCI), with day-to-day operational oversight conducted by federal and contract staff in the NCI Office of Communications and Education. The material is entirely in the public domain and can be repurposed or reproduced without permission. Citation of the source is appreciated.

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