Mammography and Beyond Developing Technologies for the Early Detection of Breast Cancer (2001) / Chapter Skim
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Executive Summary
Executive Summary
Pages 1-14
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Clinical data show that women diagnosed with early-stage breast cancers are less likely to die of the disease than those diagnosed with more advanced stages of breast cancer. A thorough annual physical breast examination and monthly breast self-examination can often detect tumors that are smaller than those found in the absence of such examinations, but data on the ability of physical examinations alone to reduce breast cancer mortality are limited.
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As many as three-quarters of all breast lesions that are biopsied as a result of suspicious findings on a mammogram, turn out to be benign; that is, the mammographic findings were falsely positive. (Many tissue biopsies performed on lumps found by physical examination are also benign, but the false-positive rate for physical examination has not been carefully studied.)
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TECHNOLOGIES IN DEVELOPMENT Most of the progress thus far in the field of breast cancer detection has resulted in incremental improvements in traditional imaging technologies. These technical advances have likely led to more consistent detection of early lesions, but clinical trials have not been undertaken to determine whether their use has also resulted in a greater reduction in breast cancer mortality compared with that of older technologies.
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+ Clinical data suggest the technology could play a role in breast cancer detection, but more study is needed to define a role in relation to existing technologies ++ Data suggest that technology could be useful in selected situations because it adds (or is equivalent) to existing technologies, but not currently recommended for routine use +++ Technology is routinely used to make clinical decisions for the given application
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From page 5... ...
Furthermore, improved imaging technologies that allow detection of more lesions at an earlier, precancer stage may or may not lead to reduced breast cancer mortality and may lead to more overtreatment of women. The dilemma of overtreatment could potentially be overcome by coupling imaging technologies with biologically based technologies, such as functional imaging, that can determine which lesions are likely to become lethal.
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From page 8... ...
Moreover, in addition to the developers of new technologies, many groups participate in the process, including FDA, health care insurers and managed care organizations, and other technology assessment institutions. These public and private organizations and policy makers play a role in evaluating medical technologies at various points along the way, making decisions about FDA approval, insurance coverage, and reimbursement that ultimately determine whether new technologies will be adopted and disseminated.
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From page 9... ...
Adoption of new detection technologies for screening purposes before assessment of their effects on clinical outcome has been common and quite problematic for technologies used to screen for other diseases because data on detection accuracy are not adequate to assess the potential value of new technologies for screening. The ideal end points for assessment of screening technologies are reductions in disease-specific mortality or morbidity, or both, but the clinical trials needed to measure those end points are quite large, lengthy, and costly.
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Access to screening facilities may be particularly difficult for women who lack health insurance. The National Breast and Cervical Cancer Early Detection Program was established through the Centers for Disease Control and Prevention with the goal of providing screening examinations for uninsured women.
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1. Government support for the development of new breast cancer detection technologies should continue to emphasize research on the basic biology and etiology of breast cancer and on the creation of classification schemes for breast lesions based on molecular biology.
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From page 12... ...
Such an approach should prevent technologies that have been approved for diagnostic use from being used prematurely for screening in the absence of evidence of benefit. Technology sponsors generally lack the resources and incentive to undertake large, long-lasting, and expensive screening studies, but a coordinated approach would make it easier to conduct clinical trials to gather the necessary outcome data.
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From page 13... ...
However, given the length of time required to assess that end point and the fact that early detection by screening mammography has already been proven to reduce breast cancer mortality, a surrogate end point for breast cancer detection is appropriate in some cases. As a general rule, a screening technology that consistently detects early invasive breast cancer could be presumed efficacious for the purposes of FDA approval.
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From page 14... ...
Congress should expand the Centers for Disease Control and Prevention screening program to reach a much larger fraction of eligible women, and state legislatures should participate in the federal Breast and Cervical Treatment Act by providing funds for cancer treatment for eligible women. The Centers for Disease Control and Prevention should be expected to reach 70 percent of eligible women (as opposed to the current 15 percent)
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