Breast Cancer Screening and Diagnosis, Version 3.2018, NCCN Clinical Practice Guidelines in Oncology.

The NCCN Guidelines for Breast Cancer Screening and Diagnosis have been developed to facilitate clinical decision making. This manuscript discusses the diagnostic evaluation of individuals with suspected breast cancer due to either abnormal imaging and/or physical findings. For breast cancer screening recommendations, please see the full guidelines on NCCN.org.

Criteria for identifying radiologists with acceptable screening mammography interpretive performance on basis of multiple performance measures.

OBJECTIVE: Using a combination of performance measures, we updated previously proposed criteria for identifying physicians whose performance interpreting screening mammography may indicate suboptimal interpretation skills. MATERIALS AND METHODS: In this study, six expert breast imagers used a method based on the Angoff approach to update criteria for acceptable mammography performance on the basis of two sets of combined performance measures: set 1, sensitivity and specificity for facilities with complete capture of false-negative cancers; and set 2, cancer detection rate (CDR), recall rate, and positive predictive value of a recall (PPV1) for facilities that cannot capture false-negative cancers but have reliable cancer follow-up information for positive mammography results. Decisions were informed by normative data from the Breast Cancer Surveillance Consortium (BCSC). RESULTS: Updated combined ranges for acceptable sensitivity and specificity of screening mammography are sensitivity≥80% and specificity≥85% or sensitivity 75-79% and specificity 88-97%. Updated ranges for CDR, recall rate, and PPV1 are: CDR≥6 per 1000, recall rate 3-20%, and any PPV1; CDR 4-6 per 1000, recall rate 3-15%, and PPV1≥3%; or CDR 2.5-4.0 per 1000, recall rate 5-12%, and PPV1 3-8%. Using the original criteria, 51% of BCSC radiologists had acceptable sensitivity and specificity; 40% had acceptable CDR, recall rate, and PPV1. Using the combined criteria, 69% had acceptable sensitivity and specificity and 62% had acceptable CDR, recall rate, and PPV1. CONCLUSION: The combined criteria improve previous criteria by considering the interrelationships of multiple performance measures and broaden the acceptable performance ranges compared with previous criteria based on individual measures.

Effect of radiologists' diagnostic work-up volume on interpretive performance.

PURPOSE: To examine radiologists' screening performance in relation to the number of diagnostic work-ups performed after abnormal findings are discovered at screening mammography by the same radiologist or by different radiologists. MATERIALS AND METHODS: In an institutional review board-approved HIPAA-compliant study, the authors linked 651 671 screening mammograms interpreted from 2002 to 2006 by 96 radiologists in the Breast Cancer Surveillance Consortium to cancer registries (standard of reference) to evaluate the performance of screening mammography (sensitivity, false-positive rate [ FPR false-positive rate ], and cancer detection rate [ CDR cancer detection rate ]). Logistic regression was used to assess the association between the volume of recalled screening mammograms ("own" mammograms, where the radiologist who interpreted the diagnostic image was the same radiologist who had interpreted the screening image, and "any" mammograms, where the radiologist who interpreted the diagnostic image may or may not have been the radiologist who interpreted the screening image) and screening performance and whether the association between total annual volume and performance differed according to the volume of diagnostic work-up. RESULTS: Annually, 38% of radiologists performed the diagnostic work-up for 25 or fewer of their own recalled screening mammograms, 24% performed the work-up for 0-50, and 39% performed the work-up for more than 50. For the work-up of recalled screening mammograms from any radiologist, 24% of radiologists performed the work-up for 0-50 mammograms, 32% performed the work-up for 51-125, and 44% performed the work-up for more than 125. With increasing numbers of radiologist work-ups for their own recalled mammograms, the sensitivity (P = .039), FPR false-positive rate (P = .004), and CDR cancer detection rate (P < .001) of screening mammography increased, yielding a stepped increase in women recalled per cancer detected from 17.4 for 25 or fewer mammograms to 24.6 for more than 50 mammograms. Increases in work-ups for any radiologist yielded significant increases in FPR false-positive rate (P = .011) and CDR cancer detection rate (P = .001) and a nonsignificant increase in sensitivity (P = .15). Radiologists with a lower annual volume of any work-ups had consistently lower FPR false-positive rate , sensitivity, and CDR cancer detection rate at all annual interpretive volumes. CONCLUSION: These findings support the hypothesis that radiologists may improve their screening performance by performing the diagnostic work-up for their own recalled screening mammograms and directly receiving feedback afforded by means of the outcomes associated with their initial decision to recall. Arranging for radiologists to work up a minimum number of their own recalled cases could improve screening performance but would need systems to facilitate this workflow.

Educational interventions to improve screening mammography interpretation: a randomized controlled trial.

OBJECTIVE: The objective of our study was to conduct a randomized controlled trial of educational interventions that were created to improve performance of screening mammography interpretation. MATERIALS AND METHODS: We randomly assigned physicians who interpret mammography to one of three groups: self-paced DVD, live expert-led educational seminar, or control. The DVD and seminar interventions used mammography cases of varying difficulty and provided associated teaching points. Interpretive performance was compared using a pretest-posttest design. Sensitivity, specificity, and positive predictive value (PPV) were calculated relative to two outcomes: cancer status and consensus of three experts about recall. The performance measures for each group were compared using logistic regression adjusting for pretest performance. RESULTS: One hundred two radiologists completed all aspects of the trial. After adjustment for preintervention performance, the odds of improved sensitivity for correctly identifying a lesion relative to expert recall were 1.34 times higher for DVD participants than for control subjects (95% CI, 1.00-1.81; p = 0.050). The odds of an improved PPV for correctly identifying a lesion relative to both expert recall (odds ratio [OR] = 1.94; 95% CI, 1.24-3.05; p = 0.004) and cancer status (OR = 1.81; 95% CI, 1.01-3.23; p = 0.045) were significantly improved for DVD participants compared with control subjects, with no significant change in specificity. For the seminar group, specificity was significantly lower than the control group (OR relative to expert recall = 0.80; 95% CI, 0.64-1.00; p = 0.048; OR relative to cancer status = 0.79; 95% CI, 0.65-0.95; p = 0.015). CONCLUSION: In this randomized controlled trial, the DVD educational intervention resulted in a significant improvement in screening mammography interpretive performance on a test set, which could translate into improved interpretative performance in clinical practice.

Diagnostic mammography: identifying minimally acceptable interpretive performance criteria.

PURPOSE: To develop criteria to identify thresholds for the minimally acceptable performance of physicians interpreting diagnostic mammography studies. MATERIALS AND METHODS: In an institutional review board-approved HIPAA-compliant study, an Angoff approach was used to set criteria for identifying minimally acceptable interpretive performance for both workup after abnormal screening examinations and workup of a breast lump. Normative data from the Breast Cancer Surveillance Consortium (BCSC) was used to help the expert radiologist identify the impact of cut points. Simulations, also using data from the BCSC, were used to estimate the expected clinical impact from the recommended performance thresholds. RESULTS: Final cut points for workup of abnormal screening examinations were as follows: sensitivity, less than 80%; specificity, less than 80% or greater than 95%; abnormal interpretation rate, less than 8% or greater than 25%; positive predictive value (PPV) of biopsy recommendation (PPV2), less than 15% or greater than 40%; PPV of biopsy performed (PPV3), less than 20% or greater than 45%; and cancer diagnosis rate, less than 20 per 1000 interpretations. Final cut points for workup of a breast lump were as follows: sensitivity, less than 85%; specificity, less than 83% or greater than 95%; abnormal interpretation rate, less than 10% or greater than 25%; PPV2, less than 25% or greater than 50%; PPV3, less than 30% or greater than 55%; and cancer diagnosis rate, less than 40 per 1000 interpretations. If underperforming physicians moved into the acceptable range after remedial training, the expected result would be (a) diagnosis of an additional 86 cancers per 100,000 women undergoing workup after screening examinations, with a reduction in the number of false-positive examinations by 1067 per 100,000 women undergoing this workup, and (b) diagnosis of an additional 335 cancers per 100,000 women undergoing workup of a breast lump, with a reduction in the number of false-positive examinations by 634 per 100,000 women undergoing this workup. CONCLUSION: Interpreting physicians who fall outside one or more of the identified cut points should be reviewed in the context of an overall assessment of all their performance measures and their specific practice setting to determine if remedial training is indicated.

Pathologic outcomes of nonmalignant papillary breast lesions diagnosed at imaging-guided core needle biopsy.

PURPOSE: To determine the upstage rate from nonmalignant papillary breast lesions obtained at imaging-guided core needle biopsy (CNB) and if there are any clinical, imaging, or pathologic features that can be used to predict eventual upstaging to malignancy. MATERIALS AND METHODS: This retrospective case review was institutional review board approved and HIPAA compliant, with a waiver of informed consent. A database search (from January 2001 to March 2010) was performed to find patients with a nonmalignant papillary breast lesion diagnosed at CNB. Of the resulting 128 patients, 86 (67%) underwent surgical excision; 42 (33%) patients were observed with imaging, for a median observation time of 4.1 years (range, 1.0-8.6 years). Chart review was performed to determine pertinent features of each case. RESULTS: Fourteen of 128 patients were subsequently found to have malignancy at excision, for an upstage rate of 11%. Nine (7%) of the 128 patients were subsequently found to have atypia at excision. Comparisons between patients with upstaged lesions and patients whose lesions were not upstaged demonstrated patients with upstaged lesions to be slightly older (65 vs 56 years, P=.01), more likely to have a mass than calcifications at imaging (P=.03), and to have had less tissue obtained at biopsy (three vs five cores obtained, P=.02; 14- vs 9-gauge needle used, P<.01; no vacuum assistance used, P<.01). Most strongly predictive of eventual malignancy, however, was whether the interpreting pathologist qualified the benign diagnosis at CNB with additional commentary (P<.01). CONCLUSION: Given the substantial upstage rate (11%) of papillary lesions diagnosed at imaging-guided CNB, surgical excision is an appropriate management decision; however, careful evaluation in concert with an expert breast pathologist may allow for observation in appropriately selected patients.

Is confidence of mammographic assessment a good predictor of accuracy?

OBJECTIVE: Interpretive accuracy varies among radiologists, especially in mammography. This study examines the relationship between radiologists' confidence in their assessments and their accuracy in interpreting mammograms. MATERIALS AND METHODS: In this study, 119 community radiologists interpreted 109 expert-defined screening mammography examinations in test sets and rated their confidence in their assessment for each case. They also provided a global assessment of their ability to interpret mammograms. Positive predictive value (PPV) and negative predictive value (NPV) were modeled as functions of self-rated confidence on each examination using log-linear regression estimated with generalized estimating equations. Reference measures were cancer status and expert-defined need for recall. Effect modification by weekly mammography volume was examined. RESULTS: Radiologists who self-reported higher global interpretive ability tended to interpret more mammograms per week (p = 0.08), were more likely to specialize (p = 0.02) and to have completed a fellowship in breast or women's imaging (p = 0.05), and had a higher PPV for cancer detection (p = 0.01). Examinations for which low-volume radiologists were "very confident" had a PPV of 2.93 times (95% CI, 2.01-4.27) higher than examinations they rated with neutral confidence. Trends of increasing NPVs with increasing confidence were significant for low-volume radiologists relative to noncancers (p = 0.01) and expert nonrecalls (p < 0.001). A trend of significantly increasing NPVs existed for high-volume radiologists relative to expert nonrecall (p = 0.02) but not relative to noncancer status (p = 0.32). CONCLUSION: Confidence in mammography assessments was associated with better accuracy, especially for low-volume readers. Asking for a second opinion when confidence in an assessment is low may increase accuracy.

Effect of transition to digital mammography on clinical outcomes.

PURPOSE: To determine the effect of transition to digital screening mammography on clinical outcome measures, including recall rate, cancer detection rate, and positive predictive value (PPV). MATERIALS AND METHODS: Institutional review board approval and the need for informed consent were waived for this HIPAA-complaint study. Practice audit data were obtained for three breast imaging radiologists from 2004 to 2009. These data were sorted by time period into the following groups: baseline (2004-2005), digital year 1 (2007), digital year 2 (2008), and digital year 3 (2009). The χ(2) and Fisher exact tests were used to assess differences in proportions among and between years. Clinical outcomes based on lesion type from 2004 to 2008 were also compared. Computer-aided detection was used. RESULTS: The three radiologists interpreted 32 600 screen-film mammograms and 33 879 digital mammograms. Recall rates increased from 6.0% at baseline to 7.1% in digital year 1 (P < .0001) and continued to increase in subsequent years to 8.5%. The cancer detection rate increased from 3.3 at baseline to 5.3 in digital year 1 (P = .0061), and it remained higher than that at baseline in subsequent years. PPV after screening mammogaphy (PPV(1)) increased from 5.6% at baseline to 7.5% in digital year 1 and returned to baseline levels in digital year 3. In contrast, PPV after biopsy (PPV(3)) decreased from 44.5% at baseline to 30.3% in digital year 3 (P = .0021). From 2004 to 2008, 3444 patients with 3493 lesions were recalled. The percentage of recalls for calcifications increased from 13.8% at baseline to a peak of 23.9% in digital year 1 and 17.9% in digital year 2. Both PPV(1) and PPV(3) decreased for calcifications after the digital transition. CONCLUSION: Recall rate and cancer detection rate increase for at least 2 years after the transition to digital screening mammography. PPV(3) is significantly reduced after digital transition, primarily in patients with microcalcifications.

Influence of annual interpretive volume on screening mammography performance in the United States.

PURPOSE: To examine whether U.S. radiologists' interpretive volume affects their screening mammography performance. MATERIALS AND METHODS: Annual interpretive volume measures (total, screening, diagnostic, and screening focus [ratio of screening to diagnostic mammograms]) were collected for 120 radiologists in the Breast Cancer Surveillance Consortium (BCSC) who interpreted 783 965 screening mammograms from 2002 to 2006. Volume measures in 1 year were examined by using multivariate logistic regression relative to screening sensitivity, false-positive rates, and cancer detection rate the next year. BCSC registries and the Statistical Coordinating Center received institutional review board approval for active or passive consenting processes and a Federal Certificate of Confidentiality and other protections for participating women, physicians, and facilities. All procedures were compliant with the terms of the Health Insurance Portability and Accountability Act. RESULTS: Mean sensitivity was 85.2% (95% confidence interval [CI]: 83.7%, 86.6%) and was significantly lower for radiologists with a greater screening focus (P = .023) but did not significantly differ by total (P = .47), screening (P = .33), or diagnostic (P = .23) volume. The mean false-positive rate was 9.1% (95% CI: 8.1%, 10.1%), with rates significantly higher for radiologists who had the lowest total (P = .008) and screening (P = .015) volumes. Radiologists with low diagnostic volume (P = .004 and P = .008) and a greater screening focus (P = .003 and P = .002) had significantly lower false-positive and cancer detection rates, respectively. Median invasive tumor size and proportion of cancers detected at early stages did not vary by volume. CONCLUSION: Increasing minimum interpretive volume requirements in the United States while adding a minimal requirement for diagnostic interpretation could reduce the number of false-positive work-ups without hindering cancer detection. These results provide detailed associations between mammography volumes and performance for policymakers to consider along with workforce, practice organization, and access issues and radiologist experience when reevaluating requirements.

Identifying minimally acceptable interpretive performance criteria for screening mammography.

PURPOSE: To develop criteria to identify thresholds for minimally acceptable physician performance in interpreting screening mammography studies and to profile the impact that implementing these criteria may have on the practice of radiology in the United States. MATERIALS AND METHODS: In an institutional review board-approved, HIPAA-compliant study, an Angoff approach was used in two phases to set criteria for identifying minimally acceptable interpretive performance at screening mammography as measured by sensitivity, specificity, recall rate, positive predictive value (PPV) of recall (PPV(1)) and of biopsy recommendation (PPV(2)), and cancer detection rate. Performance measures were considered separately. In phase I, a group of 10 expert radiologists considered a hypothetical pool of 100 interpreting physicians and conveyed their cut points of minimally acceptable performance. The experts were informed that a physician's performance falling outside the cut points would result in a recommendation to consider additional training. During each round of scoring, all expert radiologists' cut points were summarized into a mean, median, mode, and range; these were presented back to the group. In phase II, normative data on performance were shown to illustrate the potential impact cut points would have on radiology practice. Rescoring was done until consensus among experts was achieved. Simulation methods were used to estimate the potential impact of performance that improved to acceptable levels if effective additional training was provided. RESULTS: Final cut points to identify low performance were as follows: sensitivity less than 75%, specificity less than 88% or greater than 95%, recall rate less than 5% or greater than 12%, PPV(1) less than 3% or greater than 8%, PPV(2) less than 20% or greater than 40%, and cancer detection rate less than 2.5 per 1000 interpretations. The selected cut points for performance measures would likely result in 18%-28% of interpreting physicians being considered for additional training on the basis of sensitivity and cancer detection rate, while the cut points for specificity, recall, and PPV(1) and PPV(2) would likely affect 34%-49% of practicing interpreters. If underperforming physicians moved into the acceptable range, detection of an additional 14 cancers per 100000 women screened and a reduction in the number of false-positive examinations by 880 per 100000 women screened would be expected. CONCLUSION: This study identified minimally acceptable performance levels for interpreters of screening mammography studies. Interpreting physicians whose performance falls outside the identified cut points should be reviewed in the context of their specific practice settings and be considered for additional training.

The impact of breast MRI on surgical decision-making: are patients at risk for mastectomy?

BACKGROUND AND OBJECTIVES: The goal of the current study was to determine whether MRI impacts multidisciplinary treatment planning and if it leads to increased mastectomy rates. METHODS: A retrospective review was conducted of 441 patients treated for breast cancer between January 2005 and May 2008 who underwent breast MRI. Data included number of additional findings and their imaging and pathologic work-up. This was analyzed to determine impact of MRI on treatment planning. RESULTS: Of 441 patients, 45% had > or =1 additional finding on MRI. Of 410 patients with complete records, 29% had changes in the treatment plan, including 36 patients who were initially considered for breast conservation but proceeded directly to mastectomy based on MRI findings of suspected multicentricity. Twenty-three of those patients did not have a biopsy of the MRI lesion, with 87% having unicentric disease on final pathology. Overall, the mastectomy rate was 44%, which was significantly increased compared to patients not undergoing MRI (32%, P < 0.05). CONCLUSIONS: Breast MRI alters the treatment planning for many patients with newly diagnosed breast cancer. Mastectomy rates are increased when MRI results alone direct surgical planning. Biopsy of MRI-identified lesions should be performed to avoid over-treatment.

Breast Cancer Screening in Women at Higher-Than-Average Risk: Recommendations From the ACR.

Early detection decreases breast cancer mortality. The ACR recommends annual mammographic screening beginning at age 40 for women of average risk. Higher-risk women should start mammographic screening earlier and may benefit from supplemental screening modalities. For women with genetics-based increased risk (and their untested first-degree relatives), with a calculated lifetime risk of 20% or more or a history of chest or mantle radiation therapy at a young age, supplemental screening with contrast-enhanced breast MRI is recommended. Breast MRI is also recommended for women with personal histories of breast cancer and dense tissue, or those diagnosed by age 50. Others with histories of breast cancer and those with atypia at biopsy should consider additional surveillance with MRI, especially if other risk factors are present. Ultrasound can be considered for those who qualify for but cannot undergo MRI. All women, especially black women and those of Ashkenazi Jewish descent, should be evaluated for breast cancer risk no later than age 30, so that those at higher risk can be identified and can benefit from supplemental screening.

Educational intervention for women undergoing image-guided breast biopsy: results of a randomized clinical trial.

BACKGROUND: The process of informed consent has been examined for patients undergoing various procedures but not breast biopsy. Our study was a randomized trial that examined the effect of an educational flip chart as part of the informed consent. METHODS: A total of 122 patients referred for stereotactic or ultrasound-guided core breast biopsy were randomly assigned to receive an informed consent discussion with or without an illustrated flip chart. The chart included information about breast anatomy, pathology, and diagnostic procedures. Outcome measures included objective knowledge, subjective knowledge, anxiety, and satisfaction. RESULTS: Analysis showed few significant main effects of the intervention. However, results showed interactions between experimental condition and race/ethnicity, indicating that the intervention was effective in enhancing objective and subjective knowledge for African American but not Caucasian patients. Anxiety after consultation was higher among patients assigned to the flip chart condition, possibly because they were better informed about the risks of the procedure. Patients who underwent biopsy sooner after learning they needed one were more satisfied with their care. CONCLUSIONS: The usual care consent process is effective for many but not all patients. Informed consent that employs visual aids may help overcome characteristics of the consent process that are ineffective for some patients.

Persistent Untreated Screening-Detected Breast Cancer: An Argument Against Delaying Screening or Increasing the Interval Between Screenings.

PURPOSE: The aim of this study was to investigate the natural history of untreated screen-detected breast cancer. METHODS: A prospective cohort survey of Society of Breast Imaging fellows concerning the appearance on subsequent mammography of untreated breast cancer detected on screening mammography was conducted. RESULTS: A representative sample of the 108 actively practicing Society of Breast Imaging fellows (n = 42 [39%]) participated, each reporting outcomes data from his or her entire screening mammography practice. Among all practices, 25,281 screen-detected invasive breast cancers and 9,360 cases of screen-detected ductal carcinoma in situ were reported over the past 10 years. Among these cancers, there were 240 cases of untreated invasive breast cancer and 239 cases of untreated ductal carcinoma in situ, among which zero were reported to have spontaneously disappeared or regressed at next mammography. CONCLUSIONS: Among 479 untreated breast cancers detected on screening mammography, none spontaneously disappeared or regressed. An unknown percentage of these cancers represent overdiagnosis, but because all untreated screen-detected cancers were visible and suspicious for malignancy at next mammographic examination, delaying the onset of screening or increasing the interval between screenings should not reduce the frequency of overdiagnosis.

Breast Cancer Screening for Average-Risk Women: Recommendations From the ACR Commission on Breast Imaging.

Breast cancer is the most common non-skin cancer and the second leading cause of cancer death for women in the United States. Before the introduction of widespread mammographic screening in the mid-1980s, the death rate from breast cancer in the US had remained unchanged for more than 4 decades. Since 1990, the death rate has declined by at least 38%. Much of this change is attributed to early detection with mammography. ACR breast cancer screening experts have reviewed data from RCTs, observational studies, US screening data, and other peer-reviewed literature to update our recommendations. Mammography screening has consistently been shown to significantly reduce breast cancer mortality over a variety of study designs. The ACR recommends annual mammography screening starting at age 40 for women of average risk of developing breast cancer. Our recommendation is based on maximizing proven benefits, which include a substantial reduction in breast cancer mortality afforded by regular screening and improved treatment options for those diagnosed with breast cancer. The risks associated with mammography screening are also considered to assist women in making an informed choice.

Correlation Between Screening Mammography Interpretive Performance on a Test Set and Performance in Clinical Practice.

RATIONALE AND OBJECTIVES: Evidence is inconsistent about whether radiologists' interpretive performance on a screening mammography test set reflects their performance in clinical practice. This study aimed to estimate the correlation between test set and clinical performance and determine if the correlation is influenced by cancer prevalence or lesion difficulty in the test set. MATERIALS AND METHODS: This institutional review board-approved study randomized 83 radiologists from six Breast Cancer Surveillance Consortium registries to assess one of four test sets of 109 screening mammograms each; 48 radiologists completed a fifth test set of 110 mammograms 2 years later. Test sets differed in number of cancer cases and difficulty of lesion detection. Test set sensitivity and specificity were estimated using woman-level and breast-level recall with cancer status and expert opinion as gold standards. Clinical performance was estimated using women-level recall with cancer status as the gold standard. Spearman rank correlations between test set and clinical performance with 95% confidence intervals (CI) were estimated. RESULTS: For test sets with fewer cancers (N = 15) that were more difficult to detect, correlations were weak to moderate for sensitivity (woman level = 0.46, 95% CI = 0.16, 0.69; breast level = 0.35, 95% CI = 0.03, 0.61) and weak for specificity (0.24, 95% CI = 0.01, 0.45) relative to expert recall. Correlations for test sets with more cancers (N = 30) were close to 0 and not statistically significant. CONCLUSIONS: Correlations between screening performance on a test set and performance in clinical practice are not strong. Test set performance more accurately reflects performance in clinical practice if cancer prevalence is low and lesions are challenging to detect.