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Abstract

The cumulative risk of a false positive result from a breast-cancer screening test is unknown. We performed a 10-year retrospective cohort study of breast-cancer screening and diagnostic evaluations among 2400 women who were 40 to 69 years old at study entry. Mammograms or clinical breast examinations that were interpreted as indeterminate, aroused a suspicion of cancer, or prompted recommendations for additional workup in women in whom breast cancer was not diagnosed within the next year were considered to be false positive tests. A total of 9762 screening mammograms and 10,905 screening clinical breast examinations were performed, for a median of 4 mammograms and 5 clinical breast examinations per woman over the 10-year period. Of the women who were screened, 23.8 percent had at least one false positive mammogram, 13.4 percent had at least one false positive breast examination, and 31.7 percent had at least one false positive result for either test. The estimated cumulative risk of a false positive result was 49.1 percent (95 percent confidence interval, 40.3 to 64.1 percent) after 10 mammograms and 22.3 percent (95 percent confidence interval, 19.2 to 27.5 percent) after 10 clinical breast examinations. The false positive tests led to 870 outpatient appointments, 539 diagnostic mammograms, 186 ultrasound examinations, 188 biopsies, and 1 hospitalization. We estimate that among women who do not have breast cancer, 18.6 percent (95 percent confidence interval, 9.8 to 41.2 percent) will undergo a biopsy after 10 mammograms, and 6.2 percent (95 percent confidence interval, 3.7 to 11.2 percent) after 10 clinical breast examinations. For every 100 dollars spent for screening, an additional 33 dollars was spent to evaluate the false positive results. Over 10 years, one third of women screened had an abnormal test result that required additional evaluation, even though no breast cancer was present. Techniques are needed to decrease false positive results while maintaining high sensitivity. Physicians should educate women about the risk of a false positive result from a screening test for breast cancer.

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Psychological and behavioral implications of abnormal mammograms.

C. Lerman, B. Trock, B K Rimer … (1991)

To evaluate women's psychological responses to abnormal mammograms and the effect on mammography adherence. To identify psychological responses and other factors that predict mammography adherence in women with normal or abnormal mammograms. Survey study with prospective analysis of factors associated with mammography adherence. Health Maintenance Organization of Pennsylvania and New Jersey (HMO PA/NJ). Study patients, members of HMO PA/NJ who were 50 years of age or older, and who had had mammography done 3 months earlier, included women with normal mammograms (n = 121), women with low-suspicion mammograms (n = 119), and women with high-suspicion mammograms (n = 68), but not women with breast cancer. Psychological responses 3 months after mammography and adherence to subsequent annual mammography were assessed. Women with high-suspicion mammograms had substantial mammography-related anxiety (47%) and worries about breast cancer (41%). Such worries affected the moods (26%) and daily functioning (17%) of these women, despite diagnostic evaluation excluding malignancy. For each variable, a consistent trend (P greater than 0.05) was seen with degree of mammogram abnormality. Sixty-eight percent of women with normal results, 78% of women with low-suspicion results, and 74% of women with high-suspicion results obtained their subsequent annual mammograms (P greater than 0.05). The number of previous mammograms (odds ratio, 3.2; 95% CI, 1.6 to 6.2) and the effect of the previous results on concerns about breast cancer (odds ratio, 0.5; CI, 0.2 to 1.0) were independent predictors of adherence in logistic regression analyses (P less than 0.05). A substantial proportion of women with suspicious mammograms have psychological difficulties, even after learning that they do not have cancer. Such sequelae do not appear to interfere with subsequent adherence.

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Report of the International Workshop on Screening for Breast Cancer.

Peggy L R Harris, B K Rimer, Aaron D. Black … (1993)

Over the past 30 years, eight major randomized controlled trials of breast cancer screening--with mammography and/or clinical breast examination--have been conducted. Results from several trials have been updated during the past year, and initial results of three other trials have been reported. The National Cancer Institute held an International Workshop on Screening for Breast Cancer in February 1993 to conduct a thorough and objective critical review of the world's most recent clinical trial data on breast cancer screening, consider the new evidence, assess the current state of knowledge, and identify issues needing further research. Investigators representing the eight randomized controlled trials of breast cancer screening in women aged 40-74 presented published and unpublished data. Evidence relating to the effectiveness of breast cancer screening in different age groups, especially women aged 40-49, was presented. For women aged 40-49, randomized controlled trials consistently demonstrated no benefit from screening in the first 5-7 years after study entry. A meta-analysis of six trials found a relative risk of 1.08 (95% confidence interval = 0.85-1.39) after 7 years' follow-up. After 10-12 years of follow-up, none of four trials have found a statistically significant benefit in mortality; a combined analysis of Swedish studies showed a statistically insignificant 13% decrease in mortality at 12 years. Only one trial (Health Insurance Plan) has data beyond 12 years of follow-up, and results show a 25% decrease in mortality at 10-18 years. Statistical significance of this result is disputed, however. In women aged 50-69, all studies show mortality reductions; three of four studies show reductions of about 30% at 10-12 years after study entry. Results from two of these trials were statistically significant. Too few women over age 70 have been included in studies for adequate analysis. For women aged 40-49, randomized controlled trials of breast cancer screening show no benefit 5-7 years after entry. At 10-12 years, benefit is uncertain and, if present, marginal; thereafter, it is unknown. For women aged 50-69, screening reduces breast cancer mortality by about a third. Currently available data for women age 70 or older are inadequate to judge the effectiveness of screening. Randomized trials have provided stronger scientific evidence regarding the effectiveness of screening for breast cancer than for any other cancer. However, much still needs to be learned. Periodic gatherings of scientists in the field should speed the process.