Effectiveness of Noninvasive Diagnostic Tests for Breast Abnormalities - Executive Summary | AHRQ Effective Health Care Program

Effectiveness of Noninvasive Diagnostic Tests for Breast Abnormalities

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Background

Breast cancer is the second most common malignancy in women. The American Cancer Society estimated that in the United States in 2005, 212,930 women would be newly diagnosed as having breast cancer and there would be 40,870 deaths due to this disease. Because early breast cancer is asymptomatic, the only way to detect it is through screening. Mammography is a widely accepted method for breast cancer screening. As a screening test, mammography is used to rule out cancer by missing very few cases of cancer—i.e., by having a low false negative rate. As a result, most women who have an abnormal mammogram do not have cancer.

Because an abnormal screening mammogram requires a diagnostic test to confirm whether cancer is present, many women who do not have cancer will undergo diagnostic tests. Typically, suspicious lesions are evaluated with tissue biopsy, either by excision or by needle sampling. If a noninvasive diagnostic test were available that could accurately exclude malignancy, many women with an abnormal mammogram who do not have cancer could avoid biopsy. However, such a test must be sufficiently accurate not to miss cancer in those women who have it. Positron emission tomography (PET) scanning, scintimammography, magnetic resonance imaging (MRI), and ultrasonography (US) have been proposed for this purpose, yet the accuracy of these noninvasive diagnostic technologies in excluding breast cancer in women at average risk remains unclear.

An ideal diagnostic test to evaluate breast abnormalities found by mammography or breast examination would distinguish women who need to have a biopsy from those who can safely avoid one. A woman who has a negative test result should be very confident that she does not have breast cancer before deciding to forgo a biopsy. To help patients, policymakers, and clinicians determine whether these noninvasive tests are sufficiently accurate to be appropriate for evaluation of women with an abnormal mammogram or exam finding, this report summarizes available data on the performance of these tests in the evaluation of women presenting with breast abnormalities that suggest the possibility of breast cancer. The report addresses the following questions:

1.What are the sensitivity and specificity of the tests for diagnosis of breast cancer in women presenting with an abnormal mammogram or a palpable breast abnormality?
2.For women with relevant demographic risk factors (e.g., age, family history) and clinical risk factors (e.g., Breast Imaging Reporting and Data System [BIRADS] status or morphologic characteristics of the lesion), what are the positive and negative predictive values of the above diagnostic tests?
3.Are there other factors that affect the accuracy or acceptability of the tests considered in Questions 1 and 2?

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Effectiveness of Noninvasive Diagnostic Tests for Breast Abnormalities - Executive Summary | AHRQ Effective Health Care Program