Tuesday, June 24, 2008

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The Wall Street Journal

June 24, 2008

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When a Mammogram Isn't Enough

For Higher-Risk Women, the Addition
Of MRI or Sonogram May Improve
Detection; a Problem With False Positives
By ANNA WILDE MATHEWS
June 24, 2008; Page D1

Mary Walls thought she was home-free after annual mammograms found no recurrence of the breast cancer she'd suffered in 1996. Then last fall she also got an ultrasound screening, which showed two questionable areas in her right breast.

ONLINE RESOURCES:
 
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 The American Cancer Society issued these guidelines1 on use of MRI for breast-cancer screening last year.
 Here is the abstract2 for a study published JAMA, the journal of the American Medical Association, that looked at the use of ultrasound.
 Here are abstracts for two studies published in the New England Journal of Medicine (here3 and here4) that look at the use of MRI for screening.

After a biopsy confirmed that the two spots were malignancies, the Matteson, Ill., human-resources consultant got a lumpectomy, chemotherapy and radiation. "I don't think I'll ever trust just mammography by itself again," says Ms. Walls, 62, who received the ultrasound after deciding to participate in a research study her doctor was helping to conduct.

For many years, women worried about breast cancer have been given a simple prescription: annual mammograms, or X-rays of the breasts, typically starting at age 40. Now, doctors are increasingly advising some women who may be at higher risk for the disease to consider supplementing a mammogram with other, potentially more sensitive tests.

For those women whose family background, genetics or other factors signal a high level of concern, a growing number of physicians are suggesting magnetic resonance imaging, or MRI, which is typically the most sensitive form of screening. Some doctors are also recommending ultrasound, the sound-wave technology often used during pregnancy to view a fetus. Ultrasound can cost $100 or less, compared with $1,000 or more for an MRI. But ultrasound also is less sensitive than an MRI. Health insurers say they generally pay for ultrasound screening, but guarantee coverage of MRI screening only for women at high risk.

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The heightened interest in additional screening follows new guidelines issued by the American Cancer Society last year. The cancer society recommended annual MRIs, in addition to mammograms, for women with certain genetic mutations tied to breast cancer and those whose family history signaled a significantly elevated lifetime danger of the disease, among other high-risk categories.

Backing the recommendation were a series of studies that showed an MRI could detect cancers missed by mammography. One study published in 2004 in the New England Journal of Medicine found that in high-risk women, MRIs detected 32 out of 45 breast cancers, while mammograms picked up 18, including some missed by the MRI screening. The two types of screening, plus physical exams, together found 41 of the cancers. The cancer society hasn't issued any recommendations regarding ultrasound screening, but says it continues to accumulate research data. One downside: the risk that MRI and ultrasound screenings can produce many false positives, creating needless anxiety in some patients.

After the cancer society's guidelines came out, Jerry Gehl, medical director of the St. Vincent Breast Center in Little Rock, Ark., started routinely recommending an MRI to high-risk patients, in addition to mammograms. In general, though, he doesn't urge patients to get an MRI if they face only a somewhat-elevated risk. "You have to draw that line somewhere," he says.

Stacy Adams, 36, got a breast-screening MRI for the first time in April at Dr. Gehl's suggestion after also getting a mammogram. Ms. Adams, a receptionist at a radiology clinic, says her mother was diagnosed with breast cancer at 31, and her grandmother was similarly diagnosed at 35. Ms. Adams says her tests showed there were no malignancies, and she plans to keep getting both screenings. "I'm just terrified I'm going to miss something," she says.

The American Cancer Society, in its 2007 guidelines, also identified a group of women at an above-average risk of developing breast cancer and for whom MRI might be helpful. But the society concluded there wasn't enough evidence to recommend for or against the scans. This group included breast-cancer survivors and women with dense breast tissue. Dense breasts, which are more common in younger women, are harder to read with a mammogram. Fatty tissue provides clearer contrasts.

"It's not very reassuring to hear 'your mammogram is normal, but it's only because we can't see anything at all,'" says Robert Smith, director of cancer screening at the cancer society. For women at average risk of breast cancer, the cancer society's guidelines opposed MRI as part of routine screening.

The cancer society also says that women can be separated into different screening-recommendation categories using computerized risk models that focus mainly on family history. Those with a lifetime breast-cancer risk of around 20% or more should supplement annual mammograms with MRI screenings, while those with a 15% to 20% risk are in the middle group, and women with a lifetime risk of less than 15% can stick with just the annual mammograms. More information is available at http://CAonline.AmCancerSoc.org5. Search for "MRI screening."

Major private insurers Aetna Inc., WellPoint Inc. and Cigna Corp. say they pay for annual MRI screening in women at high risk of breast cancer, typically using criteria close to those of the cancer society. For women who fall short of high risk, but who still have a somewhat elevated chance of developing breast cancer in their lifetimes, insurers may not always pay. "Our policies provide benefits in situations in which there is adequate evidence to make a specific recommendation," says Bob McDonough, Aetna's head of clinical policy research and development.

For ultrasound screening, Cigna doesn't require prior authorization, so "it's at the discretion of the physician," says Douglas Hadley, director of the company's coverage policy unit. Dr. McDonough of Aetna says the insurer is for the moment "simply covering [ultrasound] without scrutinizing its use." WellPoint says it also doesn't require prior authorization for breast ultrasound screening.

Medicare covers mammograms, but the federal insurance plan for older people won't pay for ultrasound or MRI as part of routine screening. The program can pay for the exams if a doctor feels they are medically necessary, a plan spokesman says.

A study published in May in JAMA, the journal of the American Medical Association, highlighted the use of ultrasound as a supplement to mammograms. The study, conducted by American College of Radiology researchers, looked at women at a somewhat-elevated level of risk. It found that of 40 women diagnosed with breast cancer, mammograms raised red flags for 20, while mammography plus ultrasound detected 31.

But the study also highlighted a downside of ultrasound -- it generated many false positive readings. MRI screenings also carry this risk. Though the false alarms may result simply in extra time and stress pursuing additional scans, some women also get unnecessary biopsies. Often, these involve little more than a needle stuck into the breast, with no scarring or long-term effects.

But biopsies can also be quite invasive. Sharon Nelson, 54, who had cancer in her right breast nearly a decade ago, had a scare when an MRI in 2003 picked up potential trouble spots in both breasts. Alarmed that her disease may have returned, and worried about her health while her two daughters were still young, she got biopsies that involved removal of significant tissue. There was no cancer, but she was left with a visible indentation in her healthy left breast. "It's hard to have a surgery that wasn't necessary," says Ms. Nelson, a nurse at a breast-health nonprofit center in Arcata, Calif.

Medical practitioners are divided about the proper role of ultrasound in breast-cancer screening. Wendie Berg, a radiologist at a clinic in Lutherville, Md., who was the lead author of the study published in JAMA, says she recommends ultrasound screening to some women who don't have evidence of very high risk that would justify an MRI. "It is a judgment call. The denser the breast, the more difficult the mammogram is to read, the more likely I am to recommend an ultrasound," she says.

But Constance Lehman, a University of Washington professor of radiology who led a study published last year in the New England Journal on MRI screening, says she never advises ultrasound for patients. "We find it ineffective as a screening tool," she says. "It's not even in the same ballpark" as an MRI.

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Write to Anna Wilde Mathews at anna.mathews@wsj.com6

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