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Screening Mammograms Overdiagnosed More Than 1 Million Women

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Not a Complete Picture or the Last Word

This paper is going to create discussion and concern, and get people thinking again about mammography. But from my point of view it isn’t the final answer.



Dr. J. Leonard Lichtenfeld

There’s been a substantial amount of research and commentary on the role of mammography – discussion that has split people into two political camps: one saying it’s the major reason for the reduced mortality and one saying it has no value whatsoever.

I think the truth lies somewhere in between.

Something has clearly affected breast cancer mortality in the past few decades. Before the 1990s, the rate of breast cancer death in this country was a flat line that had not changed for decades. Then suddenly it began to drop, and it has continued to do so. We are clearly doing something right. The question is: What is it? Probably a combination of mammography, improvements in adjuvant chemotherapy, and a general increase in breast awareness.

In the 1970s, when I was beginning practice – and before that, as a family member – breast cancer was not something anyone spoke about. It was never mentioned publicly. Now we are much more aware. Women are tuned in to the topic and aware of the need to do self-exams. It’s a national discussion.

Both our surgeries and our chemotherapy are much improved. But even now, if a woman presents with a palpable breast lesion, the odds are that it’s going to be fairly sizable and have lymph node involvement. Can we assume that we are able to effectively treat every woman in this group? I’m not sure we can.

This leads us to mammography. There is no question that it identifies subclinical lesions. But we have to recognize the problem of overdiagnosis and overtreatment.

Mammography and other new imaging modalities are driving the point of detection to much earlier in the history of a woman’s breast cancer. We have recognized from autopsy studies that certain cancers can exist in the body for long periods of time without ever causing any problems. We know that most women with breast cancers don’t have any readily identifiable risk factors. And we don’t have a test that allows us to tell most women whether or not their particular cancer is likely to be aggressive.

The current study doesn’t really help us with these questions. There are severe limitations on these data. How often did the women actually have a mammogram? What we consider "regional disease" today is not the same as it was in 1975. Advanced disease today isn’t the same as it was in 1975. There are cultural and insurance barriers that affect access to care and, thus, affect mortality. All of these issues must be weighed into the equation.

Right now, we at the American Cancer Society are still confident in our recommendation for women older than 40 to have an annual screening mammogram and clinical breast exam. There are other recommendations from other groups, which may be a better fit for other women. The important thing is for a woman and her physician to pick a program and stay with it.

Everyone wants clear-cut answers in a world that is not clear-cut and is unlikely to become so. So women and doctors are left in the difficult position of weighing what is best for them.

I think we would all be reluctant to completely give this up. A breast cancer diagnosis in the 40s can kill a woman in her 50s. I’m concerned that we will begin missing breast cancers now that will kill in 10-15 years, and that we will lose the gains we’ve seen in mortality.

Dr. J. Leonard Lichtenfeld is the deputy chief medical officer for the national office of the American Cancer Society.


 

FROM THE NEW ENGLAND JOURNAL OF MEDICINE

In a "best-guess estimate," they assumed that breast cancer incidence increased by 0.25% over the study period. "This approach suggests that the excess detection attributable to mammography ... involved more than 1.3 million women in the past 30 years."

The "extreme" model assumed that incidence increased by 0.5% each year, an estimate that minimized surplus diagnoses of early-stage disease and maximized the deficit of late-stage cancer. This model found that screening mammography detected an excess of 1.2 million cancers over the study period.

The "very extreme assumption" model assumed that incidence increased by 0.5% each year, and that the baseline incidence of late-stage disease was the highest ever observed (113 cases per 100,000 women, in 1985). Even with this model – the most favorable toward mammography – the authors estimated overdiagnosis of slightly more than 1 million women.

"Our analysis suggests that whatever the mortality benefit, breast-cancer screening involved substantial harm of excess detection of additional early-stage cancers that was not matched by a reduction in late-stage cancers. This imbalance indicates a considerable amount of overdiagnosis involving more than 1 million women in the past 3 decades – and, according to our best-guess estimate, more than 70,000 women in 2008."

SEER breast cancer mortality data help put the findings into perspective, the authors said. There has been a substantial reduction in mortality, which fell from 71/100,000 to 51/100,000 over the study period. "This reduction in mortality is probably due to some combination of the effects of screening mammography and better treatment," they said. But because the absolute reduction in deaths (20/100,000) was larger than the absolute reduction in late-stage cancer (8/100,000), screening mammography can’t be the main driver of change.

"Furthermore ... the small reduction in cases of late-stage cancer that has occurred has been confined to regional (largely node-positive) disease – a stage that can now often be treated successfully, with an expected 5-year survival rate of 85% among women 40 years of age or older. Unfortunately, however, the number of women in the United States who present with distant disease, only 25% of whom survive for 5 years, appears not to have been affected by screening."

Better therapy may even have altered the impact of screening, they added.

"Ironically, improvements in treatment tend to deteriorate the benefit of screening. As treatment of [disease detected by methods other than screening] improves, the benefit of screening diminishes. For example, since pneumonia can be treated successfully, no one would suggest that we screen for pneumonia."

The findings show that there are not absolutes for women considering whether or not to get a mammogram.

"Proponents of screening should provide women with data from a randomized screening trial that reflects improvements in current therapy and includes strategies to mitigate overdiagnosis in the intervention group. Women should recognize that our study does not answer the question, ‘Should I be screened for breast cancer?’ However, they can rest assured that the question has more than one right answer."

Dr. Bleyer disclosed that he is a consultant and speaker for Sigma-Tau Pharmaceuticals. Dr. Welch disclosed that he speaks on the topic of overdiagnosis with universities and medical schools, as well as to the Pharmacy Benefit Management Institute; all honoraria were donated to charitable organizations.

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