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Breast cancer deaths drop—but not because of mammography

Posted by medconsumers on November 25, 2011

Mammography screening is usually credited with the drop in breast cancer deaths recorded in many countries, including the U.S.  But a case is building for improvements in breast cancer treatment as the most likely cause. The decrease in deaths has occurred in many European countries that did not start  mammography screening until the 1990s, which happens to coincide with greater use of long-term adjuvant therapy (e.g., tamoxifen, chemotherapy) given after the initial treatment is over.  Researchers say the case for adjuvant therapy is made stronger by the fact that,  in some of these countries, the greatest decreases in breast cancer deaths were among young women (under 50), the age group that never received mammography screening.

As someone who has followed the “selling” of mammography screening to American women that started in the early 1970s, I offer some background for the new findings from Europe. Thanks to nearly 50 years of research, we know more about mammography than any other cancer screening test. Expert panels with no conflict of interest have concluded that the breast cancer mortality rate among mammography-screened women (in randomized trials) is only 16% lower than that of unscreened women. In the U.S., there was no reduction in breast cancer deaths until the early 1990s and about 2% a year thereafter.

Today, there is a greater understanding of cancer. Some abnormalities that look like cancer under the microscope do not become invasive, if left untreated. Many regress spontaneously, stay put, or grow so slowly they will never make their presence known.  At least as far back as the 1970s, pathologists knew about these non-progressive cancers that can occur in all major organs of the body.  But women weren’t hearing from them.  Instead, radiologists and surgeons dominated the promotion of mammography screening in the early years. Today, it is the radiologists who are often quoted in the media, warning us about the dangers of forgoing mammography screening while downplaying its harms.

Well, it is quite reasonable for women to forgo screening—that is, after becoming well-informed. Here are the highlights of several review articles published in the last few weeks.  See below for my sources.

  • There are usually dramatic increases in the discoveries of new breast cancers after mammography screening takes off. Tomorrow’s cancers are found today is the standard explanation.  This  ignores the fact that in every major randomized trial, some of the regularly screened women—who have had many previous “all-clear” mammograms—are nonetheless diagnosed with  invasive tumors that are fatal despite prompt treatment.  Recent studies conducted in many countries, including the U.S., show that mammography screening has not reduced the occurrence of large invasive cancers.
  • The aforementioned large increase in new cases of breast cancer without a large decrease in the rate of new cases of advanced cancer (over time) indicates that much of the increase is due to detection of non-progressive cancers (i.e., overdiagnosis). Here’s how the Cochrane review on mammography screening assessed the damage: “For every 2,000 women who are screened throughout 10 years, one will have her life prolonged. In addition, 10 healthy women, who would not have been diagnosed if there had not been screening, will be diagnosed as breast cancer patients and will be treated unnecessarily.”
  • Women are often told that mammography-detected breast cancers require less drastic treatment.  The opposite is true. Mastectomy rates were going down in some European countries in the years prior to the introduction of mammography screening but went up afterwards. Many countries, including the U.S., show 20% more mastectomies in the screened women compared to the unscreened women. One factor is the large increase in the detection of ductal carcinoma in situ, or stage 0 breast cancer, which was rare in all countries prior to the introduction of mammography but is now a common diagnosis.  DCIS  is treated increasingly with mastectomy, though it has long been known that only about 20% to 30% of DCIS will go on to become invasive breast cancer if left undetected, according to Susan Love, MD, author of Dr. Susan Love’s Breast Book.
  • Physicians at the Dartmouth Institute of Health Policy addressed a common misconception about mammography in a paper published online in Archives of Internal Medicine (see below). “The presumption often is that anyone who has had cancer detected has survived because of the test, but that’s not true,” according to co-author H. Gilbert Welch. “In fact, and I hate to have to say this, in screen-detected breast and prostate cancers, survivors are more likely to have been overdiagnosed than actually helped by the test …  It’s important to remember that of the 138,000 women found to have breast cancer each year as a result of mammography screening, 120,000 to 134,000 are not helped by the test.”

Maryann Napoli, Center for Medical Consumers©

Related post
There is aid for breast cancer patients who must decide about adjuvant therapy.  read more

Sources for above post
“Why mammography screening has not lived up to expectations from randomized trials.” Cancer Causes Control, published online November 10, 2011.  This is the source for virtually of the above.  Click here

Cochrane review that assessed the harms as well as benefit of mammography screening.  Click here   Want to know more about the Cochrane Collaboration?   Click here

“Likelihood that a woman with screen-detected breast cancer had her ‘life saved’ by that screening” Archives of Internal Medicine, published online October 24, 2011.  This is the source for the last bullet point.  click here    Better yet, Click here for an easier to read New York Times article about this study.  Added December 4, 2012:  YouTube vide0 explaining a new study that found mammograpy screening accounts for overdiagnosis and overtreatment of 1.3 million American women over the four decades since it was first introduced.

Posted in breast cancer, Cancer, Screening, testing, Women's Health | Tagged: , , , , , , , , , , | 9 Comments »

Cancer screening tests right to the grave

Posted by medconsumers on October 13, 2010

When my husband and I picked up his mother after yet-another hospitalization for complications of congestive heart failure, I read her discharge orders. “Be sure to schedule a Pap test and a mammogram after you get home.” Naturally, we ignored the directive as absurd for a woman in her mid-nineties who clearly had a condition that would soon cause her death.

Apparently, this is more common than I’d ever imagined. A new study, published today in the Journal of the American Medical Association, found “a sizeable proportion” of people with terminal cancer are given screening tests for common cancers. And the testing is beyond the two recommended to my mother-in-law. Nearly 9% of the advanced cancer patients in this study were tested for new cancers.

Here’s how the study, funded by the U.S. National Cancer Institute, was done. Researchers at Memorial Sloan-Kettering Cancer Center, New York, searched the data from Medicare claims to determine the number of cancer screening tests given for new cancers to people already diagnosed with an advanced cancer. The reseachers assessed data on 87,736 people ages 65 and older who had been diagnosed with advanced lung, colorectal, pancreatic, gastroesophageal, or breast cancer between 1998 and 2005. All were followed up until death or December 2005, whichever came first. Each was matched by age, sex, and race to Medicare enrollees without cancer.

Keep in mind that screening is the testing of people without symptoms, and the tests may have been ordered without much thought as to what would be done once a new cancer is detected. Would a surgeon do a prostatectomy on a man with an incurable cancer some place else and a life expectancy of less than two years? I suspect the answer is yes. Why else would the test be ordered?

The tests most commonly given to advanced cancer patients were predicable. Mammography was number one, received by nearly 9% of the women with advanced cancer, with the Pap test running a close second at nearly 6%. As for the men, 15% got a PSA test and nearly 2% of all got a colonoscopy. As for the age-matched people without cancer in the control group, 2-3 times more of them had at least one of the cancer screening tests.

Who are the most likely to be screened right to the grave? Married people with higher socioeconomic status. And people who were screened regularly before they were diagnosed with the cancer that would eventually cause their death.

On this last point the research team led by Camelia S. Sima, M.D., hypothesized that “efforts to foster adherence to screening have led to deeply ingrained habits. Patients and their health care practitioners accustomed to obtaining screening tests at regular intervals continue to do so even when the benefits have been rendered futile in the face of competing risk from advanced cancer.”

Maybe so, but I suspect that something more than mindless aggressive testing is at play here. America has a death-denying culture. Continued testing keeps hope alive and avoids that unpleasant conversation about the end-of-life. It’s not over until your doctor stops ordering cancer tests.

Maryann Napoli, Center for Medical Consumers©

Posted in breast cancer, Cancer, Doctors, Drug ads, Screening, testing, Women's Health | Tagged: , , , , , | Leave a Comment »

Improved treatment trumps mammography

Posted by medconsumers on September 24, 2010

Is there any point in writing about the latest mammography screening study? Opinions are entrenched on both sides—people who think the technology is lifesaving and people like me (a much smaller group) who follow the supporting research and see its lifesaving benefit as far outweighed by its well-documented risks. It is, however, worth mentioning a new study conducted in Norway that answers an important question that has nagged cancer researchers for years. Is the declining breast cancer death rate, seen in the U.S. and other Western countries, due to mammography screening or improvements in treatment? The findings, published yesterday in the New England Journal of Medicine, indicate that mammography accounts for only a small percentage of mortality reduction.

Norway did not start its national screening program until 1996 when women between the ages of 50 and 69 years were offered mammography every two years. In anticipation, the country set up what was described as “multidisciplinary breast cancer management teams [surgeons, pathologists, oncologists, radiologists, etc.] to provide comprehensive and integrated optimization of breast-cancer care.” Norway has a population of 6.8 million and a cancer registry that includes nearly 100% of its cancer patients.

The researchers led by Mette Kalager, MD, based their findings on registry data from over 40,000 women with breast cancer. They compared the breast cancer deaths among women diagnosed and treated in the nine-year period prior to, and the nine-period following, the introduction of mammography screening. Because the program had staggered implementation, the researchers were able to include women who lived in areas where mammography was still unavailable.

In the editorial that accompanied this study, H. Gilbert Welch, MD, Dartmouth Medical School, observed that the Norwegian researchers could separate the mortality reduction effect of mammography from other other factors that may have changed over time, such as treatment improvements and awareness campaigns that now make women react more quickly to a new breast symptom than they would have in an earlier era. Mammography’s benefit was found to be “disappointingly small,” accounting for only a 10% reduction in breast-cancer death among women between the ages of 50 and 69 years. [Note: Hiding in plain sight---in the new study's abstract---was the fact that this small reduction is not statistically significant, i.e., the finding is due to chance. This was noted by Peter Gotzsche, MD, professor and director of the Nordic Cochrane Centre and the world's leading authority on the research basis for mammography screening. click here]

This is not the first study to find a marginal benefit to mammography screening. Nor is Norway the first country to use cancer registry data to see what happened after mammography screening was introduced. Denmark, for example, found that the mortality rate declined 1% per year in the screening areas, but—brace yourself for the unexpected—there was a bigger decline (2%) per year in the non-screening areas and breast cancer deaths decreased even in women too young to be screened click here.

Back to the Norwegian study, Kalager and colleagues make the point that mammography screening requires a back-up of good comprehensive care available to all: “Our results support the evidence that screening mammography reduces the rate of death from breast cancer. However, the magnitude of the benefit seems modest in the high-attendance, nationwide screening program we evaluated. Most important, the apparent benefit conveyed by optimized patient care may be missed unless mammography screening is integrated into a well-functioning health care system that is available to the entire population.”

This point was driven home when the researchers looked at women over the age of 70 years who, in Norway and virtually all other countries (except the U.S.), do not undergo mammography screening. The unscreened women in this age group had an 8% reduction in breast cancer deaths which was attributed to the comprehensive-care teams.

So what do these findings have to do with American women? Hard to say. Obviously, we don’t have universal access to medical care, much less to mammography screening. Women treated at academic medical centers might be seen by multidisciplinary teams, but it’s unlikely to be the norm. The breast cancer mortality rate in the U.S. has decreased by roughly 2% a year since the 1990s. This study indicates that the rate could drop further if we too had universal access and a medical care system that offers the same high-quality care for all.

This study gives us something else to think about—Is mammography screening a good use of limited financial resources? This is a technology that causes a high rate of false-alarms, biopsies, and unnecessary treatment of healthy women with breast cancers that would never progress had they been left undetected. With such a small lifesaving benefit in return, mammography screening may have already crowded out other, more promising ways to lower the breast cancer death rate.

Maryann Napoli, Center for Medical Consumer©

For previous articles on this topic, type the word mammography in the search box on our home page.

Posted in breast cancer, Cancer, hospitals, Screening | Tagged: , , , , , | Leave a Comment »

Breast biopsy: One type is much safer

Posted by medconsumers on January 22, 2010

When a woman needs a biopsy to determine whether a breast abnormality is benign or malignant, she is usually directed to one of two procedures. Which one is best in terms of accuracy and complications is unlikely to be discussed during the usual doctor/patient encounter. It is, however, the subject of a new review that concluded in favor of the core-needle biopsy because results “seem to be almost as accurate as open surgical biopsy, with lower complication rates.” The indefinite choice of words (“seem to be”) can be attributed to the fact that the 84 studies included in this review were judged to be of low quality (though the best of what has been done so far).

A core-needle biopsy can be done with equal success with either stereotactic- or ultrasonography-guidance. The review’s finding was based on studies that compared the diagnoses of women given the minimally invasive core-needle biopsy with the diagnoses of the same women subsequently given either an open surgical biopsy or a radiologic follow-up.

Complications can be: bleeding severe enough to require treatment; pain severe enough to require pain medication; and a hematoma that requires treatment. The complication rate for core-needle biopsy was extremely low—less than 1%; whereas the complication rate for the surgical open biopsy was in the range of 2% to 10%.

This review was led by Wendy Bruening, PhD, ECRI Institute in Plymouth Meeting, PA, and published online first at the Web site of Annals of Internal Medicine. It was funded by the U.S. Agency for Healthcare Research & Quality.

More information
The findings of this review support the outrage expressed one year ago in an editorial by surgeon Melvin J. Silverstein, MD. He was commenting on a new study showing that nearly 40% of the breast biopsies done at one prestigious academic medical center were open surgical biopsies. He estimated that well over 90% of women with suspicious breast abnormalities are appropriate candidates for a needle biopsy and described the circumstances that indicate an open surgical biopsy is appropriate. To read our 2009 interview with Dr. Silverstein, click here.

Maryann Napoli, Center for Medical Consumers©

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Posted in breast cancer, Cancer, Pain, surgery, Women's Health | Tagged: , , | 1 Comment »

Mammogram uproar

Posted by medconsumers on November 18, 2009

Ten years ago I opened my driver’s license renewal notice and out dropped a pink slip reminding me to have an annual mammogram. While it was touching to know that the New York State Department of Motor Vehicles cared about my breast health, I saw the pink slip as yet another example of over-the-top mammography promotion. (My husband has yet to receive any health instructions from the DMV.) When a test’s lifesaving benefit has been oversold to the public for over three decades—and the harms downplayed—any cutback in recommendations will be met with a firestorm of anger.

That’s exactly what happened yesterday when a highly respected organization recently broke ranks with others that issue screening guidelines and advised women at average risk for breast cancer to begin having regular mammograms at age 50, not age 40. The U.S. Preventive Services Task Force also changed two longstanding recommendations: women age 50 to 74 should have a mammogram every two years rather than annually (cuts down on the biopsies without altering the number of lives saved), and doctors should stop teaching women how to do breast self-examination (no benefit, more biopsies). Shock, horror, and condemnations followed the announcement in the media on Monday. Not a surprising reaction considering the advice to the public preceded the science.

The recommendation to start mammography screening at age 40 was premature to begin with, dating back to the early 1970s. Incredibly, it was based on one clinical trial conducted in the 1960s that found a 30% reduction in breast cancer deaths in the women over age 50 but no benefit for women in their forties. That clinical trial, known as the Health Insurance Plan of Greater New York study, had followed the participants for three to five years. Not unreasonably, public health officials at the time thought that the younger women in this study would eventually show a reduction in breast cancer mortality with longer followup. They didn’t bother to wait and the aggressive promotion of mammography took off after President Nixon declared the “war on cancer.” Thus began a nationwide campaign, sponsored by the American Cancer Society and the National Cancer Institute, urging women over the age of 35 to seek yearly mammograms complete with the overly optimistic message that early detection will save their lives.

Radiation exposure was the only acknowledged harm in this era, and it was usually dismissed as unimportant in comparison to the benefit of finding breast cancer early. By the 1980s, mammographic techniques had improved and the radiation exposure greatly reduced. A modest reduction in breast cancer deaths in younger women was found in some, but not all, clinical trials done in other countries. The largest trial intended to answer the question of mammography’s value to women in their forties found no lifesaving benefit. Basing its estimate on the trials that did find a benefit, the U.S Preventive Services Task Force concluded that one in every 1,900 women who undergo an annual mammography over a ten-year period will avoid a breast cancer death.

In 2001 the Lancet published the first evidence indicating that mammography screening leads to overtreatment without reducing mortality. The authors, both researchers at the Nordic Cochrane Centre, did an in-depth assessment of the data generated by all the randomized mammography screening trials. To this day the Cochrane researchers continue to reassess the research (read a 2009 update of their findings). What they have found is entirely counterintuitive and not confined to women in the forties. Mammograms can detect tiny cancers, but not all of them would become deadly or even produce symptoms if left untreated. Yet virtually all are treated aggressively because no test can accurately sort out the potentially lethal cancers from those that do not progress. Overdiagnosis and overtreatment are the terms for this problem, which was quantified in a study published recently in the British Medical Journal, showing that one in three cancers found on a mammogram would not become life-threatening. This should have been the major reason for the change in recommendations, but the media coverage frequently presented mammography’s major harm as the anxiety from false alarms and breast biopsies. As for the other major harm—radiation exposure—the USPSTF cites this estimate, “annual mammography of 100,000 women for 10 consecutive years would result in up to 8 radiation-induced breast cancer deaths.”

The USPSTF based its revised recommendations on the findings of a panel of experts made up of research physicians and most crucially, biostatisticians who quantified some of the harms as well as the benefit. Their task was to assess the evidence generated by the world’s gold standard trials, as well as observational studies. While we all hope that our physicians are familiar with the evidence supporting their advice, the sad reality is that many are not. Most simply follow the advice of organizations like the American Cancer Society and the American College of Obstetricians and Gynecologists. What’s more, it’s as hard for them to change their thinking as it is for us. Here’s just one example. From the professional advice given my daughter and her friends, I know that the long-discredited American Cancer Society recommendation for women to have a baseline mammogram in their late thirties continues to live on. (The ACS quietly withdrew this recommendation in 1992, but it takes time for the word to get out.)

Other sources of information:
If you want to make an informed decision about mammography, go directly to the scientific evidence instead of your doctor. Here’s a timeline for the key studies and previous failed attempts to raise the starting age for mammography which was published recently in the New York Times. This is a “summary of the evidence” from the randomized trials and observational or population studies (i.e., mammography done in the real world), which formed the basis for the USPSTF’s revised recommendations. And this is the National Cancer Institute’s summary of pretty much the same clinical trials (note that the first trial that justified the advice to start mammography at age 40 is described as being of “poor quality”), as well as population studies. The NCI summary is difficult to read, but this sentence from the summary is easy to understand, “Screening for breast cancer does not affect overall mortality, and the absolute benefit for breast cancer mortality appears to be small.” This applies to women who start mammgraphy at age 50 as well as those who started at 40.

Using the same data, researchers at the Nordic Cochrane Centre have produced a more understandable summary for women that is available on the Web (see link within this article). To increase your chances of having a mammography performed skillfully, read How to Select a Mammography Facility . And to reduce your chances of an inaccurate diagnosis, read “When to get a 2nd pathology opinion.”

Maryann Napoli, Center for Medical Consumers(c)

Postscript
Two days after the USPSTF issued its recommendations, HHS Secretary Kathleen Sebelius issued a statement distancing the Obama Administration from the new guidelines. In short, she told women to ignore them and claimed disingenuously that more research is needed. This is very disappointing to those of us who had high hopes that health care reform would mean that medical treatment and screening decisions, as well as cost-cutting measures, would be evidence-based. Once again, mammography’s evidence is clouded by politics. This time around, however, the politics make sense. No doubt, Secretary Sebelius did not want to derail the current health care reform efforts.

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Posted in Cancer, Screening, Women's Health | Tagged: , , , , , , , , | 17 Comments »

When to get a 2nd pathology opinion

Posted by medconsumers on September 10, 2009

News Flash: American Cancer Society will warn of screening’s harms.

If I had my way, there would be a moratorium on mammography screening until doctors fully understand the natural history of what they’re looking for in the breasts of women without symptoms. The term natural history is medical jargon for knowing what would happen if breast abnormalities that look cancerous under the microscope were left untreated. At least one in every three breast cancers diagnosed via mammography screening would not progress; yet virtually all are treated aggressively as if they will. From the mammography screening clinical trials, we know that this includes not only ductal carcinoma in situ but also invasive breast cancers. Until about 40 years ago, it was thought that all cancers become lifethreatening if left untreated.

There are two breast pathologists in the U.S. who have spent their professional lives distinguishing the lethal from the nonlethal. Both have published widely on this topic. Both head second pathology opinion services that deal directly with women, who send in their tissue slides, mammograms…and their payments. In the usual situation, the pathologist and the patient do not interact. Dr. David L. Page, Vanderbilt University Medical Center, Nashville, TN, and Dr. Michael Lagios, St. Mary’s Hospital, San Francisco, CA, have, no doubt, spared many a woman the overtreatment that follows in the wake of any and all mammography screening activities. The overtreatment can involve unnecessary radiation therapy, unnecessary breast removal, and a lifetime of worrying about the recurrence of a cancer that would have been better off left undetected.

Every five or so years, I write about these two second opinion services. I decided to do it again when I heard recently from a long-time reader who was diagnosed with “ductal carcinoma in situ [DCIS] with scattered calcifications and atypical cells” at one of the top cancer centers in the U.S. She was told that a total mastectomy is necessary. Instead of following the advice, she paid for a second pathology opinion from each of the above experts who both assured her that she did not have DCIS and required only periodic follow-ups. When calling me about the revised diagnosis, she said, “My joy in learning that I didn’t need a mastectomy was overshadowed by the thought of so many women who are overtreated because of mammography screening.”

Each breast pathologist describes his service below:

David L. Page, MD Breast Consultants

“Our experienced professionals have reviewed over 50,000 consultative requests for pathologists, clinicians, and patients…. Our group has had a major interest in defining and diagnosing special breast conditions that are not truly malignant, but can recognize an increased risk of later breast cancer development, as well as minimally or low malignant lesions that may be successfully treated with local therapy alone.”

Michael D. Lagios, MD The Breast Cancer Consultation Service

“The Breast Consultation Service is designed to help self-referred women with newly diagnosed breast carcinoma or atypia with formal written review of their pathology slides, mammograms and other imaging studies. No physician referral or permission is needed to access this service.”

Disclosure: When writing this article I was surprised to see that Dr. Page has a 2004 article from our newsletter HealthFacts on his home page. It addressed the latest study about overdiagnosis and overtreatment, as well as the above second opinion services. I am flattered that Dr. Page thought enough of my article to post it. I am discouraged that it’s not out of date.

Maryann Napoli Center for Medical Consumers©

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Posted in Cancer, Screening, surgery, Women's Health | Tagged: , , , , , , | 1 Comment »

Reduce your risk of breast cancer: Avoid mammograms

Posted by medconsumers on July 14, 2009

Want to know the best way to cut your chances of becoming a breast cancer patient? Stop having screening mammograms. Sure, the researchers who recently published a five-country study in the British Medical Journal would never express their findings in this manner.  But read their results and decide for yourself.  And keep in mind, many breast cancers detected by mammography will not become deadly or even produce symptoms if left untreated.  Now it is known, one in three screening-detected breast cancers fit that description.

Two Danish researchers conducted a systematic review of the breast cancer incidence in the seven years before a mammography screening program was introduced and the seven years after the screening program had been in full swing. The women in this review began having mammograms at the age of 50 years in the United Kingdom, Manitoba, Canada, New South Wales, Australia, Sweden and parts of Norway. The researchers were looking specifically at the number of women diagnosed with breast cancer after mass screening began. Although they expected a lower breast cancer incidence among the women as they grew older, this was not the case.

Here is what the researchers concluded, based on women who began screening at age 50 years. For every 2,000 women who undergo regular mammography screening over the next ten years, one will avoid a breast cancer death; 10 women will be diagnosed with a non-lethal breast cancer and treated unnecessarily; 10 to 15 women will be told they have breast cancer earlier than they would otherwise have been told, though this will have no affect on their prognosis (i.e., whether a woman’s breast cancer is found on a mammogram at age 55 or she finds it herself at age 65, her destiny is unchanged); and 100 to 500 women will have at least one “false alarm” that in about half the cases leads to a biopsy.

This review was conducted by Karsten Juhl Jorgensen and Peter C. Gotzsche, MD, of the Nordic Cochrane Centre in Copenhagen. Both have written extensively on the topic of overdiagnosis, which they define as “the detection of cancers that will not cause death or symptoms.” There is no foolproof way to determine which mammography-detected cancers do not progress. Virtually all are treated as if they will.

The lead author, Dr. Jorgensen, was asked by e-mail whether it is reasonable for a woman to decide not to have screening mammograms as a means of reducing her chance of having breast cancer. “In the light of our estimates of overdiagnosis, I would say that we now have to consider mammography screening as a major risk factor for getting a breast cancer diagnosis. And a preventable one, too,” he responded. “Of course, the breast cancers overdiagnosed through screening differ from the symptomatic ones by being non-lethal, but the individual woman cannot know this and the remaining consequences are the same (the surgery, radiotherapy and psychological stress).”

This is not the first time mammography screening was shown to cause more harm than good. Overdiagnosis and overtreatment were first identified in a 2000 systematic review of all seven trials worldwide that had randomly assigned women to receive mammograms or not. That review, which originally appeared in the British journal Lancet, has been updated as a Cochrane review (see the Web site of the Nordic Cochrane Centre).

Safest course of action? Seek medical attention at the first sign of a breast symptom.

ADDENDUM: A 2010 study published in the New England Journal of Medicine lends support to this suggestion. See this New York Times report about the study, entitled “Mammograms’ value in cancer fight at issue.”

Note: after this article was written, a federal committee set new mammography screening guidelines for women under 50, read Mammogram Uproar.

Maryann Napoli, Center for Medical Consumers(c)

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Posted in Cancer, Screening, surgery | Tagged: , , , , , , | 1 Comment »

Oral vs. Standard Chemotherapy To Prevent Recurrent Breast Cancer

Posted by medconsumers on June 1, 2009

Older people are underrepresented in clinical trials, a problem that is particularly acute where it concerns breast cancer. This is a disease that strikes women who are average age 63 years at diagnosis; and the overwhelming majority of deaths occur over the age of 65 years. A new study fills an important information gap about adjuvant drug treatment for older women with breast cancer. It also clears up lingering questions about oral vs. intravenous (IV) chemotherapy.

In 1998, Xeloda (capecitabine) became the first oral chemotherapy drug to be approved by the FDA for metastatic breast, i.e., late-stage cancer that has spread beyond the breast. Xeloda is produced by Roche Laboratories, which partly funded this study, published last month in The New England Journal of Medicine.

Two Questions Asked

Can Xeloda benefit women at earlier stages of breast cancer? How does it compare with standard chemotherapy? These questions were answered by the new study, led by Hyman B. Muss, MD, University of Vermont, Burlington, and conducted at many academic medical centers in the U.S. and Canada.

After their initial treatment for breast cancer, the 600 study participants were randomly assigned to Xeloda or one of two standard IV chemotherapy regimens (One known by the acronym, CMF—cyclophosphamide, methotrexate, and fluorouracil, or another regimen that combines cyclophosphamide and doxorubicin). The participants had been diagnosed with breast cancers that ranged from stage I through stage IIIB.

First, the researchers looked at the number of participants who were recurrence-free at 3 years. It was 68% of the women in the Xeloda group and 85% of the women in the IV chemotherapy group.

When the researchers looked at overall survival, IV chemotherapy again proved better than Xeloda. The survival rate at three years was 86% for the women in the Xeloda group versus 91% for those in the IV chemotherapy group. Two women in the Xeloda group died of treatment-related complications.

Although IV chemotherapy came out on top regarding recurrence and survival, it was worse when it came to side effects. Twice as many women in the chemotherapy group suffered moderate to severe toxic effects, such as nausea and vomiting (64% vs. 33%). More women on IV chemotherapy (38%) could not complete the six cycles of treatment because of severe toxic side effects, compared with 20% who could not finish the six planned cycles of Xeloda.

The greatest benefit to taking Xeloda was shown for the women in this trial who had hormone-receptor negative tumors. This is consistent with the results from earlier research conducted at Oxford University.

The new study provides more fodder for the contentious issue of drug costs. Both private and public health plans in the U.S. are requiring patients to pay more out of pocket for cancer drugs. Many plans, including Medicare, will reimburse for IV drugs, but not for oral drugs. This leads some cancer patients to suspect that they are being steered away from the newer and better oral drugs for cost-saving reasons.

News Flash:
A cancer patient on Xeloda was detained by U.S. immigration officials because his fingerprints had mysteriously disappeared, according to May 26, 2009 Annals of Oncology online. The drug can cause chronic inflammation of the palms or soles that can over time eradicate finger prints.

Maryann Napoli, Center for Medical Consumers(c) June 2009

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Alternatives to Open Breast Biopsies

Posted by medconsumers on February 1, 2009

Excessive Use of Open Breast Biopsies: An Interview

Too many U.S. women are having the more drastic, more expensive open biopsy once a mammogram detects an abnormality, according to a new study conducted at one academic medical center. This is diagnostic overkill given the facts that 80% of all such breast abnormalities eventually prove to be benign and that minimally invasive needle biopsy techniques have been available for years.

Overuse of the open biopsy means that women’s health is unnecessarily compromised because the procedure can have serious complications. The development of scar tissue, for example, may inhibit the diagnosis of a future breast cancer. Incredibly, 1.6 million breast biopsies are performed yearly in the U.S. If this study is representative of the rest of the country, nearly 40% are open biopsies.

“Where’s the Outrage?” asked surgeon Melvin J. Silverstein, MD. In the editorial that accompanied the new study, he reminded readers that the women’s movement of the mid-1970s eventually put an end to the drastic one-step diagnosis/treatment procedure. Up to that era, women with a breast lump had to sign a consent form before going under anesthesia, allowing their surgeons to determine malignancy on the basis of a quick frozen biopsy and to do an immediate radical mastectomy when results showed cancer. (Years later, the frozen-section biopsy was acknowledged to be unreliable.)

Now there’s another pressing need for advocacy, says Dr. Silverstein, Director of the Breast Program at Hoag Memorial Hospital Presbyterian, Newport Beach, California, and professor of surgery at the Keck School of Medicine, University of Southern California. He is interviewed by Maryann Napoli, Center for Medical Consumers.

MN: A shockingly high 40% of the breast biopsies done at one Manhattan teaching hospital were open (excisional) biopsies, according to the new study, conducted by Emily M. Clarke-Pearson, MD, and colleagues at Beth Israel Medical Center and Columbia University Medical Center (January 2009, Journal of the American College of Surgeons). How can a woman tell whether she truly requires an open biopsy?

MJS: She needs to know that well over 90% of all breast abnormalities can be biopsied with a needle. Very few people need an open biopsy. For example, if the abnormality is in an extremely difficult place, such as right on the chest wall, a needle biopsy may not be possible. Another possibility is that the patient may not be able to lie on her abdomen thereby making stereotactic biopsy nearly impossible. More and more, needle biopsies are being done with ultrasound guidance and they’re much easier.

MN: You were appalled to learn that so many women in this study with palpable or mammography-detected abnormalities were going straight to the operating room for diagnostic open surgical breast biopsy. What is the typical scenario?

MJS: If the radiologist has control of the patient and the radiologist is an interventionalist—that is, one who knows how to put needles in, then he or she will do a needle biopsy*. But the radiologists often do not control the patients in the U.S. The patients “belong” to the referring doctor. Many breast centers won’t do a mammogram without a doctor’s prescription. In general, a patient goes to a radiologist with a doctor’s prescription that says “bilateral mammography”. If an abnormality is found, the radiologist typically calls the referring doctor, and most of the time, he or she will say, “go ahead and do the biopsy.” But often that referring doctor is a surgeon, and he or she will do an open surgical biopsy because they do not know how to do a needle biopsy.

MN: Breast biopsies are so lucrative., I assume there’s a turf war between the radiologists and the surgeons.

MJS:
Yes, when the needle biopsy came along in the early 1990s, the radiologists captured the market, and the surgeons didn’t care. But as time went on, the surgeons said, “I used to do 280 biopsies a year, but now I’m not doing any because the radiologists do them all. I’d better learn.” So the American Society of Breast Surgeons formed, mainly to teach surgeons how to do ultrasound-guided biopsies and stereotactic biopsies. Now there are probably 3,000-4,000 surgeons in U.S. who are competent to do needle biopsies, but there also [another] 30,000 surgeons who do open breast biopsies because they don’t know how to do needle biopsies. It comes down to this: If I don’t know how to do a needle biopsy, then I either have to send the patient to someone who does or do an open biopsy myself.

MN: And the cost differences?

MJS:
I used to do 225 open biopsies a year for diagnosis and now I do only two or three a year. An open biopsy in New York City is probably $2,000 to $3,000 [just the surgeon’s fee]. If I lived there, I would have given up $600,000 in billing fees**. So you can understand the motivation. A lot of surgeons now know how to do needle biopsies and those who know how will do it. Open biopsy costs rise to $5,000 to $7,000 once you include the operating room fee and the anesthesia, which can be either local or general. A needle biopsy in New York City is about $2,000. In a smaller city, it will probably be between $1,000 and $1,500.

MN: There are plenty of downsides to the open biopsy besides the expense.

MJS: I’m a professor of surgery. I get a lot of referred patients and half have already had open surgical biopsies. Many times the incision was done in wrong place, and it compromises what I’m going to do, or the margins are not done well because the biopsy was done simply as a diagnostic procedure, not as a therapeutic procedure.. On the other hand, when I get a patient who has had a needle biopsy, nothing has been compromised. Studies have shown that in competent hands, the needle biopsy is just as accurate as the open biopsy.

MN: And many inconveniences are avoided.

MJS: Yes, when a woman has a needle biopsy, she is in and out in one or two hours. She doesn’t need someone to drive her home; she can go to work; she can lift things. When she has an open biopsy, the wound has to heal. She has to be careful of what she does for a few days or a week.

MN: You seemed to be counting on consumer advocacy to change doctors’ practices.

MJS: Yes, the study was done at Beth Israel Hospital, an academic medical center where the work should be top of the line and it’s in New York City, which has some of the most demanding consumers of medicine in the world. And yet nearly 40% were getting open biopsies [in 2007]—that’s outrageous. Once women all over America know about this, that number will drop precipitously.

MN: Your editorial and the study are circulating on the Internet among breast cancer advocates.

MJS: Remember about 10 or 15 years ago, there was a new procedure called sentinel node biopsy. Instead of doing a full axillary node dissection [removal of 20 or so nodes near the armpit], the surgeon could remove only one or two lymph nodes. And surgeons said, “We don’t know if it works.” And you know what happened? Women heard about it and they demanded it. And if the surgeon didn’t offer it, she came down the street to me. The surgeons were losing their patients so they learned how to do it. Now everyone does it.

*Dr. Silverstein said that the term needle biopsy refers to several different minimally invasive techniques including core biopsy, vacuum-assisted biopsy, ultrasound-assisted biopsy (most common and easiest to perform) and the MRI-assisted biopsy (most difficult and least common).

** Billing fee is different from what the physician actually receives. According to one New York City breast surgeon, Medicare and many insurance companies will reimburse only 20% of the billing fee.

Maryann Napoli, Center for Medical Consumers© February 2009


More on Breast Biopsy
One co-author of the breast biopsy study is Susan K. Boolbol, MD, Chief, Appel-Venet Comprehensive Breast Service and Director, Breast Surgery Fellowship, Beth Israel Medical Center, New York City. In a telephone interview Dr. Boolbol was asked whether her study is representative of care in the rest of the country.

SKB: Yes, I do think so. First, keep in mind that the overwhelming majority of breast abnormalities are benign and the introduction of new needle biopsy techniques means that women do not have to go the operating room for diagnosis any more.

MN: But your study was done at one teaching hospital. Do we know how women are treated in the real world?

SKB: When you look at our study, you will see that we have three separate sets of physicians. First, the academic breast surgeons like me; second, the breast surgeons in private practice who don’t work for the hospital, but perform surgery there; and third, the general surgeons who do all types of surgery, including breast surgery.

MN: It does provide a window into what’s going on in the real world. During the seven-month study period, the academic breast surgeons did only 10% of their breast biopsies as open biopsies; compared with the breast surgeons in private practice (35%) and general surgeons (37%).

SKB:
Another study showed that the majority of women with breast cancer in New York State are not operated on by breast surgeons. That could be true of the rest of the country. Educating women is the whole issue raised by our study. [If told they should have an open biopsy] they need to ask the question: Is there another way to do the biopsy? Women should know that the operating room is for treatment, not diagnosis.

Note: Read this 2010 update on this topic: “Breast biopsy: one type is much safer.”

Maryann Napoli, Center for Medical Consumers©

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Posted in Cancer, surgery, Women's Health | Tagged: , , , , , | Leave a Comment »

Breast Cancer Incidence Drops in U.S.

Posted by medconsumers on January 15, 2009

The incidence of breast cancer in postmenopausal women has been decreasing since 2002, probably because so many women have given up hormone therapy, say researchers who assessed the follow-up data from the Women’s Health Initiative. This is the landmark trial that was that stopped early in 2002 because the women taking the combination estrogen plus progestin showed a higher incidence of heart disease, stroke, and breast cancer than the women taking placebos. Many of them stopped taking hormones immediately, and all were followed up until 2005.

The authors of this report said they are fairly confident that the falling breast cancer incidence was caused by the decreased use of hormones, not by the other opt-proposed possibility—the drop in the number of American women going for screening mammograms. One question remains: Why did the decline in breast cancer incidence occur so rapidly after the trial was stopped? The authors speculate that some of the tiny “pre-clinical cancers” found during mammography spontaneously regressed once women stop taking hormones.

N Engl J Med 2009;360:573-87

Posted in Cancer, Women's Health | Tagged: , | Leave a Comment »

 
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