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«PacifiCare’s medical management guidelines represent the recommendation of the PacifiCare Medical Management Guideline (MMG) committee. They are ...»

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However, the diagnostic accuracy of digital mammography was 15% higher for women under the age of 50, 11% higher in women with dense breast tissue, and 15% higher in premenopausal and perimenopausal women. The researchers concluded that these results justify the use of digital mammography in these subsets of women. (Pisano et al., 2005)

Breast Imaging- Commercial Medical Management Guideline

Heddson et al. retrospectively compared SFM and digital radiography (photon-counting and computed radiography) for 52,172 mammography examinations. Cancer detection rates were 0.31% for film, 0.49% for photon-counting, and 0.38% for computed radiography. The investigators concluded that digital radiography performs better than screen-film mammography and is a valid alternative to conventional mammography. (Heddson et al., 2007) Evidence from the available clinical trials suggests that FFDM has similar efficacy as SFM for the diagnosis and screening of breast cancer. Although there are some conflicting results, FFDM generally results in a lower recall rate and a lower number of biopsies in screening populations.

However, the breast cancer detection rates are similar between FFDM and SFM.

The Technology Evaluation Center (TEC) Blue Cross Blue Shield Association (BCBSA) completed a technology assessment for full-field digital mammography. The report concluded that there is strong evidence that FFDM is as accurate as SFM for screening. Furthermore, FFDM performs better than SFM precisely in those populations for whom SFM is weaker. FFDM meets the TEC criteria.

(Technology Evaluation Center (TEC) Blue Cross Blue Shield Association, February 2006a) The National Institute for Health and Clinical Excellence has issued a clinical guideline for familial breast cancer that states that in women younger than age 50, digital mammography should be used in preference to conventional mammography when it is available. (National Institute for Health and Clinical Excellence, 2006)

Professional Societies/Organizations:

American College of Radiology (ACR): In its practice guidelines for the performance of FFDM, the ACR states that digital mammography images must be substantially equivalent to or superior compared with high quality SFM images in the portrayal of clinically significant detail before the technique can be used in the routine clinical setting for breast cancer diagnosis and screening. (ACR, 2002) American Cancer Society (ACS): The ACS guidelines assign an evidence level of B for breast cancer screening with full-field digital mammography (there is some clinical evidence for effectiveness or equivalence to screen-film mammography for screening). (Smith et al., 2003) Positron Emission Mammography (PEM): Berg et al. prospectively assessed the diagnostic performance of a high-resolution positron emission tomography (PET) scanner using mild breast compression (positron emission mammography [PEM]). At four centers, 94 consecutive women with known breast cancer or suspicious breast lesions received 18F-fluorodeoxyglucose (FDG) intravenously, followed by PEM scans. PEM identified 10 of 11 (91%) ductal carcinoma in situ (DCIS) and 33 of 37 (89%) invasive cancers. PEM sensitivity for detecting cancer was 90%, specificity 86%, positive predictive value (PPV) 88%, negative predictive value (NPV) 88%, accuracy 88%, and area under the receiver-operating characteristic curve (Az) 0.918. In three

Breast Imaging- Commercial Medical Management Guideline

patients, cancer foci were identified only on PEM, significantly changing patient management.

Excluding eight diabetic subjects and eight subjects whose lesions were characterized as clearly benign with conventional imaging, PEM sensitivity was 91%, specificity 93%, PPV 95%, NPV 88%, accuracy 92%, and Az 0.949 when interpreted with mammographic and clinical findings. FDG PEM has high diagnostic accuracy for breast lesions, including DCIS. (Berg et al., 2006) Although early studies show promising results with this technology, larger studies are needed to evaluate efficiency of the PEM scanner.

Breast Ultrasonography:

Screening Ultrasonography: Studies evaluating breast cancer screening with ultrasound are generally limited to women with dense breasts or at increased risk for breast cancer.

Kuhl et al. conducted a surveillance cohort study of 529 asymptomatic women at high familiar risk for breast cancer and found that mammography alone or combined with ultrasound was insufficient for early diagnosis of breast cancer in women at increased risk for hereditary cancer. (Kuhl et al., 2005) Corsetti et al. evaluated the usefulness of routine ultrasound in women with negative mammography and dense breasts. Out of 17,626 negative mammograms, 6,449 were classified as dense breasts and underwent ultrasound that detected 29 cancers. (Corsetti et al., 2006) Another study evaluated 1,517 asymptomatic women with dense breasts with normal mammography who underwent ultrasonography. Seven breast cancers were diagnosed with ultrasound. (Crystal et al., 2003) A study evaluating 27,825 screening sessions in 11,130 asymptomatic women found that the use of ultrasound with mammography significantly detected more cancers at a smaller size than does physical examination. (Kolb et al., 2002) Ohlinger et al. conducted a prospective double blind study of 448 asymptomatic women who had ultrasound and mammogram. Three non-palpable breast cancers were detected by both methods. All 3 were smaller than 1 cm. The false positive rate was slightly higher for ultrasound than for mammography. The investigators concluded that breast ultrasound is capable of detecting breast cancer in asymptomatic women at an early stage with a low rate of unnecessary biopsies. (Ohlinger et al., 2006) Interim results of a multi-center study comparing clinical breast examination (CBE), mammography, ultrasonography, and MRI for screening were reported for 278 women at high risk for breast cancer.

Sensitivity was 50% for CBE, 59% for mammography, 65% for ultrasound, and 94% for MRI.

Positive predictive value was 82% for CBE, 77% for mammography, 65% for ultrasound, and 63% for MRI. (Sardanelli et al., 2007)

Breast Imaging- Commercial Medical Management Guideline

Diagnostic Ultrasonography: Ultrasound of the breast is frequently used as a diagnostic examination focusing on distinguishing between cystic and solid masses and benign and malignant lesions. Based on 8 cohort studies evaluating ultrasonography for suspicious breast lesions, the sensitivity of ultrasound was 86.1%, the specificity was 66.4%, and the negative predictive value was 93.3%.

(AHRQ, 2006) In a controlled trial, 102 women presenting with breast cancer underwent bilateral whole breast ultrasonography (BBUS). These women were compared with a control group of 124 women who had undergone targeted breast ultrasound. Contralateral breast cancer was diagnosed in 4 women in the BBUS group and none of the women in the control group. (Wilkinson et al., 2005) Fifty patients with microcalcifications were examined by ultrasound prior to biopsy. The study found that ultrasound is unsuitable for the diagnosis of microcalcifications because it fails to visualize a mass in one-third of cancers. Also, ultrasound does not correct the false-negative errors of mammography. (Balu-Maestro et al., 2006) Chiou et al. evaluated 193 patients with non-palpable lesions by ultrasound before and during biopsy. Ultrasound detected irregular border and had a sensitivity of 88% for predicting malignancy. (Chiou et al., 2006) Five hundred and forty-two patients younger than age 30 with a palpable breast lesion were evaluated, and ultrasound was found to be useful for differentiation between normal nodularity and benign breast disease. (Vargas et al., 2005) A prospective study of 434 women found that ultrasonography is more accurate than mammography is evaluating tumor size in dense breasts.

(Fasching et al., 2006) The National Institute for Health and Clinical Excellence has issued a clinical guideline for familial breast cancer that states that on the basis of current evidence, ultrasound should not be used in routine surveillance, but may have a role in problem-solving abnormalities found on mammogram. (National Institute for Health and Clinical Excellence, 2006)

Professional Societies/Organizations:

American Cancer Society (ACS): The ACS guidelines assign an evidence level of B for breast cancer screening with ultrasonography (there is some clinical evidence for effectiveness or equivalence to screen-film mammography for screening). (Smith et al., 2003) National Cancer Institute (NCI): The NCI states that the primary role of ultrasound is the evaluation of breast masses identified by physical examination or mammogram. According to the NCI, a review of literature and expert opinion concludes that there is little evidence to support the use of ultrasound for breast cancer screening. (NCI, 2007) American College of Radiology (ACR): In its practice guidelines for the performance of a breast ultrasound examination, the ACR states that indications for breast ultrasonography include the Breast Imaging- Commercial Medical Management Guideline evaluation and characterization of palpable masses and other breast signs or symptoms, evaluation of suspected or apparent abnormalities detected on other imaging studies such as MRI or mammography, initial imaging evaluation of palpable masses in women under age 30 and in pregnant and lactating women, evaluation of breast implant problems, evaluation of breasts with microcalcifications or architectuaral distortions suspicious for malignancy in patients with dense fibroglandular tissue, guidance for breast biopsy, and radiation treatment planning. The guideline also states that the use of ultrasound as a screening study for occult masses in dense breasts of high risk women or women with suspected or newly diagnosed breast cancer is under investigation.

(ACR, 2007) ACR appropriateness criteria assigns a rating of 8 for ultrasound examination of palpable breast mass in a woman 30 years of age or older and a rating of 9 for palpable breast mass in a woman less than 30 year of age, with 9 being the most appropriate rating. (ACR Appropriateness Criteria, 2006) Agency for Healthcare Research and Quality (AHRQ): The AHRQ published a report developed by ECRI, titled Effectiveness of Noninvasive Diagnostic Tests for Breast Abnormalities. The report concluded that for every 1,000 women who had a negative ultrasound, approximately 950 women would have avoided an unnecessary biopsy, but 50 women would have missed cancers. The report concluded that noninvasive tests such as ultrasonography may not be accurate enough to routinely replace biopsies in women with abnormal mammograms or physical examinations. (AHRQ, 2006) National Comprehensive Cancer Network (NCCN): The NCCN Breast Cancer Screening and Diagnosis Clinical Practice Guidelines in Oncology state that there is limited data supporting the use of ultrasound for breast cancer screening as an adjunct to mammography in women with dense breast tissue or for high risk women. The NCCN recommends ultrasound for diagnosing breast cancer for

the following:

- breast mass in patient 30 years of age or older and mammography is negative or indicates benign or probably benign findings,

- breast mass in patient younger than 30 years of age,

- asymmetric breast thickening or nodularity, and

- breast skin changes such as peau d'orange, erythema, nipple excoriation, or eczema. (NCCN Breast Cancer Screening and Diagnosis Guidelines, 2007)

Computer-Aided Detection (CAD) for Mammography:

Hayes reviewed data from 16 studies involving 493,473 asymptomatic patients and found that when used for interpreting screening screen-film mammography (SFM), single reading with CAD is relatively effective in detecting breast cancer and may nonsignificantly increase recall rate, biopsy rate, cancer detection rate, and actual and relative sensitivity, compared with single readings alone.

Data from a few of these studies indicate that single reading with CAD may nonsignificantly increase recall rate, cancer detection rate, and actual sensitivity and decrease relative sensitivity versus double reading. However, single reading with CAD is associated with low specificity due to the occurrence of false-positive CAD marks on most mammograms. (Hayes Directory, Computer-Aided Detection

Breast Imaging- Commercial Medical Management Guideline

for Screening Mammography, 2007) Definitive patient selection criteria for the use of CAD for screening mammography have not been established. However, there is sufficient evidence to support the use of CAD when used as an adjunct to single reading for interpreting screening mammograms obtained by SFM, when CAD is used in the recommended manner (initial interpretation without CAD followed by consideration of CAD findings before final interpretation) in asymptomatic patients 40 years of age or older without risk factors or younger than 40 years of age with risk factors. (Hayes Directory, Computer-Aided Detection for Screening Mammography, 2007) Fenton et al. calculated the specificity, sensitivity, and PPV of screening mammography with and without CAD obtained from 429,345 mammograms in 222,135 patients at 43 Breast Cancer Surveillance Consortium facilities located in three states in the U.S. This study compared single reading alone before installation of CAD (n=84,462 mammograms) and single reading alone after installation of CAD (n=31,186 mammograms) at the same 7 centers, as well as single reading alone among 36 centers that never implemented CAD (n=313,259 mammograms). Implementation of CAD technology was associated with a drop in diagnostic specificity from 90.2% to 87.2%, and the PPV decreased from 4.1% to 3.2%. Analysis of the data from all facilities showed that the use of CAD was associated with approximately 31% higher false positive rates and significantly lower overall accuracy than was nonuse of CAD. Overall, standard mammography and mammography with CAD found approximately the same number of cancers. The investigators concluded that the increased rate of biopsy with the use of CAD is not associated with improved breast cancer detection. (Fenton et al.,

2007) A flaw in this study was the failure to account for a learning curve of the radiologist in using CAD. Another area of concern is that the study was not designed to assess whether CAD helped detect cancers earlier and at a lower stage.

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