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Breast Imaging |
1 From the Depts of Radiology of Palo Alto Med Clinic, 795 El Camino Real, Palo Alto, CA 94301 (R.J.J.); Mission Breast Care Center, Mission Viejo, Calif (F.B.); Sally Jobe Breast Center, Englewood, Colo (S.H.P.); Susan G. Komen Breast Center, Dallas, Tex (W.P.E.); Park Nicollet Med Center, Minneapolis, Minn (M.C.L.); Fresno Breast Center, Calif (T.R.R.); Women’s Center Breast Care Clinic of Cox Health Systems, Springfield, Mo (A.A.S.); Mills-Peninsula Breast Center, San Mateo, Calif (H.B.B.); Yale Univ School of Medicine, New Haven, Conn (C.H.L.); South Texas Radiology Group, San Antonio (H.M.G.); Boca Raton Community Hosp, Fla (K.J.S.); Eastern Idaho Regional Med Center, Idaho Falls (A.B.W.); Johns Hopkins Med Institutions, Baltimore, Md (R.F.B.); Univ of Vienna, Austria (T.H.H.); CERIM, Buenos Aires, Argentina (D.E.L.); and Virginia Mason Med Center, Seattle, Wash (S.J.A.). From the 1998 RSNA scientific assembly. Received Aug 19, 1999; revision requested Oct 14; final revision received May 2, 2000; accepted May 22. Supported in part by an educational grant from Biopsys Medical to the Palo Alto Medical Foundation. Address correspondence to R.J.J. (e-mail: jackmanr@pamf.org).
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ABSTRACT |
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 TOP ABSTRACT INTRODUCTIONMATERIALS AND METHODSRESULTSDISCUSSIONREFERENCES |
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MATERIALS AND METHODS: Nonpalpable breast lesions at 16 institutions received a histologic diagnosis of DCIS after 14-gauge automated large-core biopsy in 373 lesions and after 14- or 11-gauge directional vacuum-assisted biopsy in 953 lesions. The presence of histopathologic invasive carcinoma was noted at subsequent surgical biopsy.
RESULTS: By performing the 
2 test, independent significant DCIS underestimation rates by biopsy device were 20.4% (76 of 373) of lesions diagnosed at large-core biopsy and 11.2% (107 of 953) of lesions diagnosed at vacuum-assisted biopsy (P < .001); by lesion type, 24.3% (35 of 144) of masses and 12.5% (148 of 1,182) of microcalcifications (P < .001); and by number of specimens per lesion, 17.5% (88 of 502) with 10 or fewer specimens and 11.5% (92 of 799) with greater than 10 (P < .02). DCIS underestimations increased with lesion size.
CONCLUSION: DCIS underestimations were 1.9 times more frequent with masses than with calcifications, 1.8 times more frequent with large-core biopsy than with vacuum-assisted biopsy, and 1.5 times more frequent with 10 or fewer specimens per lesion than with more than 10 specimens per lesion.
Index terms: Biopsies, technology, 00.1261, 00.1262 • Breast, biopsy, 00.1261, 00.1262 • Breast, diseases, 00.324, 00.719 • Breast, ducts, 00.324, 00.719 • Breast neoplasms, diagnosis, 00.126, 00.324, 00.719
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INTRODUCTION |
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TOPABSTRACTINTRODUCTIONMATERIALS AND METHODSRESULTSDISCUSSIONREFERENCES |
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A newer percutaneous biopsy technique—directional vacuum-assisted biopsy (hereafter, vacuum-assisted biopsy)—enables the extraction of more tissue more contiguously than does biopsy with a large-core needle (15,16). The vacuum-assisted device can be used with either 14- or 11-gauge probes.
We performed this multiinstitutional study to measure the effect of biopsy device, probe size, mammographic lesion type, lesion size, and number of samples obtained per lesion on the DCIS underestimation rate.
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MATERIALS AND METHODS |
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TOPABSTRACTINTRODUCTIONMATERIALS AND METHODSRESULTSDISCUSSIONREFERENCES |
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For each lesion in the study group, patient, lesion, and procedural variables were coded. These variables were summarized and compared in different analyses. To the extent that some of these variables were correlated, statistical tests in this study were not performed independently. The only patient variable was age at time of biopsy. Mammographic lesion variables were maximum lesion diameter and lesion type (microcalcifications [without masses] or masses). Masses included asymmetric densities, areas of architectural distortion, and other space-occupying lesions, with or without associated calcifications. Procedural variables were biopsy device (large core or vacuum assisted), vacuum-assisted biopsy probe size (14- or 11-gauge), and number of specimens obtained per lesion. All large-core biopsies were performed with a variety of 14-gauge cutting needles and a variety of automated "guns" that were not coded. All vacuum-assisted biopsies were performed with 14- or 11-gauge probes by using the Mammotome biopsy device (Biopsys Medical/Ethicon Endo-Surgery, Cincinnati, Ohio). Other vacuum-assisted biopsy devices were available but not studied.
Two biopsy tables were used: The Mammotest (Fischer Imaging, Denver, Colo) was used exclusively at 12 institutions; the StereoGuide (LoRad Medical Systems, Danbury, Conn), at three institutions; and both tables, at one institution. Biopsy was performed in a total of 1,106 lesions by using Fischer tables and in 220 lesions by using LoRad tables.
Biopsy techniques involving large-core (15,17–23) and vacuum-assisted (15,21–24) devices have been described. At large-core biopsy, a separate needle insertion is required for each tissue specimen. At vacuum-assisted biopsy, a single probe insertion is required, and the probe is rotated to obtain successive tissue specimens.
Surgical histologic diagnoses of invasive breast carcinoma with or without associated DCIS were called "underestimations"; all other surgical histologic diagnoses were called "agreements" (9). Surgical diagnoses of high-risk (such as atypical ductal hyperplasia [ADH]) or benign lesions were considered agreements and implied that there had been percutaneous removal of the DCIS. The underestimation rate was determined by dividing the number of lesions percutaneously diagnosed as DCIS and subsequently excised into the number of those lesions found at surgery to be invasive carcinoma. The size of the invasive carcinoma and the types and number of surgeries per lesion were not coded.
Data were collected with a variety of software systems at the 16 participating institutions. All data were transferred to a single spreadsheet (EXCEL; Microsoft, Redmond, Wash) for data consolidation and then to a statistical analysis program (STATVIEW; Abacus Concepts, Berkeley, Calif). A P value of less than .05 was considered to indicate a significant difference. All P values were calculated by using the Fisher exact method. The 2 test was performed to compare mammographic lesion type and underestimation rates. The Student t test was performed to compare patient ages, lesion sizes, and the numbers of samples obtained per lesion.
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RESULTS |
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TOPABSTRACTINTRODUCTIONMATERIALS AND METHODSRESULTSDISCUSSIONREFERENCES |
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The DCIS underestimation rate was 11% (38 of 348) of lesions diagnosed at 14-gauge vacuum-assisted biopsy and 11% (69 of 605) of lesions diagnosed at 11-gauge vacuum-assisted biopsy. Because no significant difference was found in the underestimation rates for the 14- and 11-gauge vacuum-assisted probes (P > .9), data for these two techniques were combined throughout the study. Patient, lesion, and procedural variables for large-core and vacuum-assisted devices were compared (Table 2). No significant differences were found between the groups of patients who underwent stereotactic biopsy with the large-core and vacuum-assisted devices on the basis of patient age at the time of percutaneous biopsy (P > .45) or of maximum mammographic lesion diameter (P > .93) (Table 2). The mean number of specimens obtained per lesion was 39% more at vacuum-assisted biopsy than at large-core biopsy (Table 2). In lesions in which biopsy was performed, the percentage of microcalcification lesions, as compared with that of mass lesions, was significantly higher at vacuum-assisted than at large-core biopsy (P < .008) (Table 2). Data were not available for the maximum lesion diameter in 39 lesions nor for the number of specimens obtained per lesion in 25 lesions; these data were excluded from their respective analyses.
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2 test) (Table 2). The data in Table 3 demonstrate that, in descending order of importance, lesion type, biopsy device, and number of specimens obtained per lesion each had a significant effect on DCIS underestimation rates. DCIS underestimations according to lesion type were 1.9 times more frequent in masses than in microcalcifications; according to biopsy device, 1.8 times more frequent with large-core devices than with vacuum-assisted devices; and according to number of specimens obtained per lesion, 1.5 times more frequent with 10 or fewer specimens than with more than 10.
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The data in Table 4 demonstrate that for mass and microcalcification lesions, the underestimation rate was lower for the vacuum-assisted device than for the large-core device. This was true whether the number of specimens obtained per lesion was 10 or fewer or greater than 10. That is, there was a consistent difference in the performance of the biopsy devices that was independent of the type of lesion in which biopsy was performed or the number of specimens obtained per lesion.
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2 test). As shown in the Figure, the underestimation rates in each size category were higher for the large-core device than for the vacuum-assisted device. When biopsy device was compared with lesion diameter, DCIS underestimations at large-core biopsy, as compared with those at vacuum-assisted biopsy, are 1.8 times more frequent in 1–10-mm lesions, 2.3 times more frequent in 11–20-mm lesions, and 1.2 times more frequent in lesions greater than or equal to 21 mm.
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DISCUSSION |
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TOPABSTRACTINTRODUCTIONMATERIALS AND METHODSRESULTSDISCUSSIONREFERENCES |
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We found the DCIS underestimation rate of lesions diagnosed at vacuum-assisted biopsy, 11.2% (107 of 953), to be lower than that of lesions diagnosed at 14-gauge large-core biopsy, 20.4% (76 of 373). By using the vacuum-assisted device, the greater weight per specimen and higher removal rate of lesions in which biopsy was performed suggested that the 11-gauge probe would produce a lower DCIS underestimation rate than would the 14-gauge probe. Instead, we found that both probes had an 11% DCIS underestimation rate. This lack of difference is difficult to understand. Although we found no difference between the probes as judged by using patient age and lesion type and size, we do know that, at seven of the 16 institutions, the 11-gauge probe was selectively rather than universally used once it became available. Perhaps selection bias according to lesion proximity to the chest wall and/or skin, lesion conspicuity, breast size, patient cooperation, and/or other factors that might have affected biopsy accuracy played a role. As an alternative, more tissue than we obtained with the 11-gauge probe or histologic evaluation of more slides from 11-gauge biopsy may be required to further reduce the DCIS underestimation rate.
The number of specimens per lesion, mean weight per individual specimen, and number of histologic slides evaluated from the paraffin block that contained the collective specimens all presumably affect the accuracy of diagnosis at 14- and 11-gauge vacuum-assisted biopsy. In recent studies (16,28,29), the individual mean specimen weight of 95 mg at 11-gauge biopsy was 2.6 times that of 37 mg at 14-gauge biopsy. By assuming an equal number of specimens per lesion, much of the expected 11-gauge-biopsy benefit might be lost if only three slides are obtained from the paraffin block. By assuming that slides are obtained at three equally spaced levels, the calculated surface area for three levels from one cylindrical specimen the size of the tissue collection bowl near the end of the probe is approximately 106 mm2 at 11-gauge biopsy, which is 1.3 times the approximate 80 mm2 at 14-gauge biopsy. If one instead obtains slides at equal depths of 0.4 mm, one obtains the same three slides at 14-gauge biopsy but five slides at 11-gauge biopsy. Those five 11-gauge biopsy slides will have a surface area of approximately 170 mm2, which is 2.1 times the 80 mm2 of the three 14-gauge biopsy slides. It will be interesting to see whether obtaining slides at equal depths in a specimen rather than an equal number of slides per specimen does increase the accuracy of diagnosis at 11-gauge biopsy.
We found the DCIS underestimation rate to be lower with the vacuum-assisted device than with the large-core device in masses and microcalcifications. With each type of lesion, the accuracy of the vacuum-assisted device was increased whether the number of specimens per lesion was 10 or fewer or more than 10 (Table 4). We found a tendency to obtain more specimens from larger lesions. In some of the larger lesions, two or more skin entry sites may be necessary to adequately sample the lesion. The Figure shows that use of the vacuum-assisted device resulted in fewer underestimations for lesions of all sizes, but the improved accuracy for lesions greater than or equal to 21 mm in maximum diameter was minimal and not significant. This suggests that larger lesions need even more thorough tissue sampling. We suspect that sampling should be performed by using more skin entry sites rather than by obtaining more samples from the same site. "The goal in this sampling strategy is to obtain samples at uniform distances throughout the lesion so that representative material is obtained for all aspects of the lesion" (23).
ADH "histologic underestimations" (9) (ie, detection of carcinoma at the same site at a subsequent surgery) also occur at stereotactic breast biopsy (1,3–7,25,26,31–42). There are some interesting similarities between DCIS underestimation rates in the current study and ADH underestimation rates in a previous study (25), in which 14-gauge stereotactic biopsy procedures with large-core and vacuum-assisted devices were compared.
Table 3 demonstrates the ADH and DCIS underestimation rates for the same three variables. In both cases, underestimations were more likely in mass lesions than in microcalcification lesions, in lesions in which biopsy was performed with the large-core device than in those in which biopsy was performed with the vacuum-assisted device, and with 10 or fewer specimens per lesion rather than with greater than 10 specimens per lesion.
DCIS underestimations are also known to occur at percutaneous biopsy in which the Advanced Breast Biopsy Instrumentation device (United States Surgical, Norwalk, Conn) (43) is used and at needle-localized surgical biopsy (44,45). Until lesions diagnosed as DCIS with those more interventional types of biopsy are routinely subjected to repeat excision, the DCIS underestimation rates will not be known.
A cost analysis of the various breast biopsy methods was beyond the scope of this study; DCIS underestimations are but one small component of such an analysis. In addition to the cost of the initial biopsy, which includes equipment and supplies, the prevalence of carcinoma at biopsy, false-positive and false-negative rates, ADH underestimation rate, mammographic and histologic discordance rate, repeat biopsy rate, percentage of malignancies treated with two-stage surgery, and follow-up methods are among the factors to be considered when deciding which biopsy methods are the most cost-effective. Because lesions in which biopsy is performed have variable characteristics, which include palpability, size, type (microcalcification vs mass), breast imaging reporting and data system assessment categories (46), and depiction with various imaging modalities (eg, mammography, US, and magnetic resonance imaging), we presume that there will not be a universally cost-effective biopsy method that is best for all lesions.
In conclusion, DCIS underestimations were 1.9 times more likely in masses than in microcalcifications, 1.8 times more likely with a large-core device than with a vacuum-assisted device, and 1.5 times more likely if the number of specimens obtained per lesion was 10 or fewer rather than greater than 10. The DCIS underestimation rate was unexpectedly just as high at vacuum-assisted biopsy with 11-gauge probes as at biopsy with 14-gauge probes. DCIS underestimation rates increased as the maximum lesion diameter increased.
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ACKNOWLEDGMENTS |
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FOOTNOTES |
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Author contributions: Guarantors of integrity of entire study, R.J.J., F.B.; study concepts, all authors; study design, R.J.J., F.B.; definition of intellectual content, R.J.J., F.B.; literature research, R.J.J., F.B.; clinical studies, all authors; data acquisition, all authors; data analysis, R.J.J., F.B.; statistical analysis, F.B.; manuscript preparation, R.J.J., F.B.; manuscript editing and review, all authors.
R.J.J. and W.P.E. are former shareholders in and former clinical consultants to Biopsys Medical. F.B., S.H.P., W.P.E., T.R.R., A.A.S., K.J.S., and A.B.W. are shareholders in Johnson & Johnson.
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REFERENCES |
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TOPABSTRACTINTRODUCTIONMATERIALS AND METHODSRESULTSDISCUSSIONREFERENCES |
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