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(Radiology. 2001;219:793-796.)
© RSNA, 2001

Breast Imaging

Nonpalpable Breast Cancer: Percutaneous Diagnosis with 11- and 8-gauge Stereotactic Vacuum-assisted Biopsy Devices1

Rachel F. Brem, MD, Joelle M. Schoonjans, MD, Steven N. Goodman, MD, PhD, Audrey Nolten, MD, Frederic B. Askin, MD and Olga M. B. Gatewood, MD

1 From the Department of Radiology, Breast Imaging and Interventional Center, George Washington University Medical Center, 2150 Pennsylvania Ave, Washington, DC 20037 (R.F.B.); the Russell H. Morgan Department of Radiology and Radiological Science (J.M.S., A.N., O.M.B.G.); and the Departments of Oncology (S.N.G.) and Pathology (F.B.A.), Breast Imaging and Interventional Center, Johns Hopkins Medical Institutions, Baltimore, Md. Received April 7, 2000; revision requested May 26; final revision received December 18; accepted January 4, 2001. Address correspondence to R.F.B. (e-mail: radrfb@gwumc.edu).


   ABSTRACT
TOP
 ABSTRACT
INTRODUCTION
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 REFERENCES
 
PURPOSE: To compare the accuracy of diagnosis of invasive breast cancer with 11- and 8-gauge stereotactic vacuum-assisted biopsy (SVAB) devices and to correlate lesion diameter and accuracy of breast cancer diagnosis at SVAB.

MATERIALS AND METHODS: During a 22-month period, 489 SVAB procedures were performed with an 11-gauge probe and 305 with an 8-gauge probe. SVAB and surgical pathologic results of 104 breast carcinomas were reviewed and correlated with lesion size, number of specimens obtained, and type of SVAB probe used.

RESULTS: Four of 38 ductal carcinoma in situ (DCIS) lesions diagnosed with 11-gauge SVAB demonstrated invasion at surgery, whereas one of 23 DCIS lesions diagnosed with 8-gauge SVAB demonstrated invasion at surgery (P = .6). A mean of 12 specimens per lesion were obtained in each group. In lesions 30 mm or larger, the underestimation rate for DCIS was 43% (three of seven) with 11-gauge SVAB and 17% (one of six) with 8-gauge SVAB (P = .6). Overall, the rate of underestimation for DCIS was significantly higher in lesions 30 mm or larger (four of 13) than in smaller lesions (one of 48, P = .006).

CONCLUSION: This study demonstrated no difference in breast cancer diagnosis with the 8- and 11-gauge SVAB systems, but the accuracy of breast cancer diagnosis was greater in lesions smaller than 30 mm than in larger lesions.

Index terms: Biopsies, technology, 00.1267 • Breast, biopsy, 00.1267 • Breast, diseases, 00.71, 00.72 • Breast neoplasms, diagnosis, 00.31, 00.32


   INTRODUCTION
TOP
 ABSTRACT
 INTRODUCTION
MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 REFERENCES
 
Stereotactic vacuum-assisted biopsy (SVAB) has been accepted as a reliable and cost-effective alternative to open surgical excision for the diagnosis of nonpalpable breast lesions (1–15). Among the advantages of SVAB over stereotactic large-core needle biopsy is the ability to retrieve contiguous samples that are as much as five times heavier with only a single probe insertion (1,6). With use of 14- and 11-gauge SVAB, underestimation of the presence of invasive carcinoma persists in lesions percutaneously diagnosed as ductal carcinoma in situ (DCIS) and atypical ductal hyperplasia (2,3,7,8,10–14). This underestimation is in part due to technical difficulties associated with the percutaneous diagnosis of mammographically detected microcalcifications (4,8), a common mammographic manifestation of atypical ductal hyperplasia and DCIS.

In contrast to the traditional two-step diagnostic and subsequent therapeutic surgical procedures, accurate percutaneous diagnosis of breast carcinoma allows planning of a single therapeutic surgical procedure. If percutaneously diagnosed DCIS is found to have an invasive component at surgery, a second surgical procedure is needed to assess lymph node involvement. The introduction of an 8-gauge SVAB system results in an increase in the amount of tissue retrieved per sample by 39% compared with the 11-gauge SVAB system (16).

The purpose of this study was to compare the accuracy of diagnosis of invasive breast cancer with 8- and 11-gauge SVAB devices and to correlate lesion diameter and accuracy of breast cancer diagnosis at SVAB.


   MATERIALS AND METHODS
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
RESULTS
 DISCUSSION
 REFERENCES
 
Between September 1996 and June 1999, 794 SVABs of nonpalpable breast lesions were performed at our institution. Of these, 489 were performed with an 11-gauge probe (Mammotome; Biopsys Medical, Irvine, Calif) followed by 305 with an 8-gauge probe (MIBB; United States Surgical/Tyco, Danbury, Conn). Biopsies were performed with patients prone on a dedicated biopsy table (Fisher Imaging, Denver Colo; Lorad, Danbury, Conn), as previously described (1). Radiographs of the specimens were obtained when the targeted lesion was microcalcifications. A metallic clip was placed at the biopsy site when the mammographic target was no longer visible at immediate postbiopsy stereotactic imaging. Core samples were submitted in formalin for pathologic examination, with the specimens containing microcalcifications placed in a separate holding cassette (17). Craniocaudal and true lateral mammograms were obtained immediately after biopsy.

Percutaneous and subsequent surgical pathologic results of the 104 carcinomas were reviewed by two radiologists (J.M.S., R.F.B.), without knowledge of the probe size, and correlated with the type of probe (11- vs 8-gauge SVAB probes). Any discrepancies were resolved by consensus. The ages of patients included in the 8- and 11-gauge SVAB series were evaluated. SVAB and surgical pathologic results were considered concordant for DCIS when DCIS, atypical ductal hyperplasia, or benign breast tissue were found at surgical excision of lesions diagnosed as DCIS at SVAB (18). Pathologic results were defined as discordant when a lesion diagnosed at SVAB as DCIS was found to have an invasive component at surgery. To evaluate complete removal of the mammographic target, the pre- and postbiopsy mammograms or the preoperative localization mammograms were reviewed by the same two radiologists, and any discrepancies were resolved by consensus. A lesion was classified as mammographically excised when no residual lesion was present on the immediate postbiopsy mammogram or on the localization mammogram before surgery.

The sensitivity of SVAB for the diagnosis of invasion in breast carcinoma was compared with respect to initial lesion size, successful calcification retrieval for targeted microcalcifications, complete excision of the mammographic target, number of core specimens obtained per lesion, and the type of SVAB probe used (11 vs 8 gauge). Statistical significance was determined with the Fisher exact test. All 95% CIs were calculated by using exact binomial formulas.


   RESULTS
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
 RESULTS
DISCUSSION
 REFERENCES
 
Of the 794 lesions sampled at SVAB, 106 (13.3%) were diagnosed as cancer. One hundred four (98.1%) of the 106 cancers were surgically excised. Two patients refused subsequent surgical treatment (one had invasive carcinoma and one had DCIS, both diagnosed with 11-gauge SVAB).

SVAB with 11-gauge Probes
The 69 patients in the 11-gauge group were 35–78 years old (mean, 58 years ± 12 [SD]) (Table 1). With use of the 11-gauge SVAB, a total of 69 cancers were diagnosed: 31 invasive carcinomas (16 masses and 15 microcalcifications: median size, 8.5 mm; range, 2–55 mm) and 38 DCIS lesions (one mass with microcalcifications and 37 microcalcifications: median size, 10 mm; range, 3–80 mm). Eleven cancers were 30 mm or larger (four invasive carcinomas, seven DCIS). A mean of 12 core specimens were obtained per lesion (range, four to 28 specimens). A metallic localizing clip was placed in five (7%) of the 69 lesions, in which review of postbiopsy mammograms demonstrated a residual lesion in two. A mean of 12 specimens were obtained in 15 (22%) of the 69 lesions (eight DCIS and seven invasive carcinomas: median size, 5 mm; range, 2–10 mm), in which no residual lesion was present on the postbiopsy mammogram. Complete excision was not seen after biopsy of 13 lesions; therefore, a metallic localizing clip was not placed. For these lesions, preoperative needle localization was performed by targeting a small residual hematoma or adjacent parenchymal landmarks.


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  		TABLE 1. Comparison of 8- and 11-gauge SVAB Systems

 
SVAB with 8-gauge Probes
The 35 patients in the 8-gauge group were 40–80 years old (mean, 55 years ± 12.0) (Table 1). With use of an 8-gauge probe, 12 invasive carcinomas (two architectual distortions, six masses, and four microcalcifications: median size, 12 mm; range, 4–25 mm) and 23 DCIS lesions (23 microcalcifications: median size, 12 mm; range, 2–50 mm) were identified. Six DCIS lesions were 30 mm or larger. A mean of 12 core specimens (range, two to 36 specimens) were obtained per lesion.

To facilitate identification of the biopsy site for subsequent surgery, a metallic localizing clip was placed in patients in whom complete lesion excision was seen on immediate postbiopsy images. A metallic clip was placed in 11 (31%) of the 35 lesions. In four of the 11 lesions, however, a residual lesion was noted on subsequent mammograms. In seven (20%) of the 35 lesions (four DCIS and three invasive carcinomas: median size, 5 mm; range, 3–7 mm) retrospective review of both postbiopsy and preoperative needle localization mammograms revealed that the mammographic target had been completely excised. A metallic localizing clip was placed at the biopsy site in all seven of these lesions.

Underestimation of Invasive Carcinoma with 11-gauge Probes
An invasive component was found at surgical excision in four (10%) of the 38 lesions diagnosed as DCIS with 11-gauge SVAB (Table 2). The median size of the DCIS lesions found to have an invasive component at surgery was 30 mm (range, 5–45 mm). A second surgical procedure (axillary dissection) was required for lymph node evaluation in two (50%) of the four DCIS lesions (size, 30 and 45 mm) subsequently shown to have an invasive component. No positive lymph nodes were found. Axillary dissection was performed at initial surgery for one DCIS lesion (30 mm) owing to lesion size and surgeon or patient preference. No axillary dissection or additional surgical procedure was performed for the 5-mm DCIS lesion in which a small (3-mm) focus of invasion was found at surgery.


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  		TABLE 2. Correlation of Histopathologic Findings at SVAB and Surgical Excision in DCIS Lesions from Which Biopsy Samples Were Obtained

 
Underestimation of Invasive Carcinoma with 8-gauge Probes
In one (4%) of 23 30-mm DCIS lesions mammographically depicted as microcalcifications, results of the 8-gauge SVAB underestimated the presence of a 3-mm invasive component (Table 2). In this case, axillary dissection was performed at the initial surgical excision owing to the size of the DCIS lesion.

Underestimation of Invasive Carcinoma Correlated with Initial Lesion Size
For DCIS lesions 30 mm or larger, the underestimation rate of the presence of an invasive cancer was 43% (three of seven; 95% CI: 10%, 82%) for the 11-gauge probe and 17% (one of six; 95% CI: 0.4%, 64.0%) for the 8-gauge probe (P = .6). For DCIS lesions smaller than 30 mm, the underestimation rate was 3% (one of 31; 95% CI: 0.08%, 16.7%) for the 11-gauge probe and 0% (0 of 17; 95% CI: 0%, 20%) for the 8-gauge SVAB probe. Although the error rate was lower for the 8-gauge system, the 95% CIs overlapped; therefore, there was no difference in the accuracy of demonstrating invasion (P = .6, Fisher exact test), perhaps owing to the small samples. Regardless of the type of SVAB probe used, the underestimation rate of invasion was significantly higher in DCIS lesions 30 mm or larger (four of 13, 31%) than in smaller DCIS lesions (one of 48, 2%) (P = .006, Fisher exact test) (Table 3).


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  		TABLE 3. Comparison of Underestimation of Invasive Carcinoma in DCIS Lesions of Different Size with SVAB

 
No difference was found in the number of specimens obtained in true- and false-negative DCIS lesions (mean, 12 specimens). Microcalcifications were retrieved in all five false-negative lesions initially diagnosed as DCIS at SVAB but found at surgery to be invasive. However, these lesions demonstrated residual calcifications on postbiopsy mammograms. The median size of the invasive component found at surgery was 3 mm (range, 3–15 mm; mean, 7.8 mm). A second surgical procedure was performed because of positive margins in four DCIS lesions (two diagnosed with 8-gauge and two with 11-gauge SVAB).

Sensitivity
The sensitivity of 11-gauge SVAB for diagnosis of invasive breast carcinoma is 89% (34 of 38; 95% CI: 75%, 97%) compared with 96% (22 of 23; 95% CI: 78.9%, 99.9%) for 8-gauge SVAB. Evaluation of lesion size and accuracy of breast cancer diagnosis with the 8- and 11-gauge SVAB systems combined demonstrates that 31% (four of 13) of DCIS lesions 30 mm or larger had an invasive cancer at surgical excision compared with 2% (one of 48) of DCIS lesions smaller than 30 mm.


   DISCUSSION
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
REFERENCES
 
The ability to harvest larger tissue specimens with 14- and 11-gauge SVAB compared with 14-gauge large-core needle biopsy has increased the reliability of histologic diagnosis of breast cancer (2,3,12,14). Compared with the multipass technique required with 14-gauge large-core needle biopsy, the advantages of 14-gauge SVAB include harvesting heavier and more numerous tissue specimens in less time and performing breast biopsy with a single needle insertion (1,6). Further limitations of the large-core needle biopsy system is that as many as 22% of the biopsy specimens do not contain breast tissue but rather contain only blood (19). The twofold increase in tissue specimen weight obtained with the 14-gauge SVAB system compared with the 14-gauge large-core needle biopsy system has resulted in improved accuracy of breast cancer diagnosis as demonstrated by fewer underestimations of invasive cancer in lesions initially diagnosed as DCIS. The underestimation rate of invasive cancers in lesions diagnosed as DCIS with the 14-gauge large-core needle biopsy and SVAB is as much as 35% and 19%, respectively (13,14).

A recent report (5) comparing the accuracy of breast cancer diagnosis with the 11- and 14-gauge SVAB systems has demonstrated comparable accuracy. Although 11-gauge SVABs yield specimens that are twofold heavier, this difference did not demonstrate a significant effect on the accuracy of breast cancer diagnosis (1).

Recently, an 8-gauge SVAB probe was introduced. Cow udder samples obtained with the 8-gauge system showed a 39% increase in weight compared with those obtained with the 11-gauge system (mean, 0.106 and 0.076 g, respectively [16]).

To our knowledge, no studies describing the use of the 8-gauge SVAB system have been reported. This study demonstrates no difference in DCIS the underestimation rate with the 8- and 11-gauge SVAB probes (10% [four of 38] vs 4% [one of 23], respectively). For both the 8- and 11-gauge probes, the DCIS lesions diagnosed at SVAB were of similar size. In addition, there were no differences in the number of specimens obtained for each lesion with the 8- and 11-gauge probes.

No underestimation of invasive carcinoma in DCIS lesions occurred with either the 8- or 11-gauge probes when the entire mammographic target was completely removed. Among DCIS lesions 30 mm or larger, however, invasive carcinoma was found at surgical excision in 43% (three of seven) of lesions with the 11-gauge SVAB and 17% (one of six) with the 8-gauge SVAB. This difference, was not statistically significant. These findings concur with those in prior reports (8,20) in which underestimation of the presence of an invasive carcinoma occurred more frequently in large DCIS lesions. Not only is there greater sampling error in larger DCIS lesions, there is also a greater frequency of invasive cancer in larger DCIS lesions (20). Pathologic analysis of breast tissue from 53 mastectomy specimens performed for DCIS diagnosed at surgical excisional biopsy demonstrated invasive cancer in 11 (46%) of 24 lesions 25 mm or larger and in none of 29 DCIS lesions smaller than 25 mm (20). In this study, no DCIS lesions in either the 8- or 11-gauge groups were between 21 and 29 mm; therefore, 30 mm was used as the size determinant for grouping of these lesions.

In our study, 13 DCIS lesions were 30 mm or larger (seven sampled at 11-gauge SVAB and six at 8-gauge SVAB). Of these lesions, four (31%) were found to have an invasive cancer at surgical excision; three were sampled with 11-gauge probes and one with an 8-gauge probe. In two patients, an additional surgical procedure was performed to assess lymph node involvement. In addition, a second surgical procedure was required in four patients for repeat excision of DCIS lesions because of positive specimen margins at initial surgical resection.

When both 11- and 8-gauge series were analyzed together, the accuracy of diagnosis of invasive breast cancer was significantly greater for lesions smaller than 30 mm (one of 48, 2%) than for lesions 30 mm or larger (four of 13, 31%) (P = .006, Fisher exact test). Although the majority of DCIS lesions found to have an invasive component at surgical excision were 30 mm or larger, one 5-mm lesion, which was diagnosed as DCIS with 11-gauge SVAB, had a 3-mm invasive component at surgical excision. In part, this may be due to the intrinsic difficulties in targeting of small lesions, a finding that has been reported previously (14). Thus, larger lesions and resultant sampling limitations do not entirely explain the underestimation of invasive cancer in DCIS lesions diagnosed at SVAB. Difficulties in lesion targeting, patient motion during the procedure, and operator experience are other factors that may affect the accuracy of this procedure.

This study demonstrates no difference in accuracy of breast cancer diagnosis with the 8- and 11-gauge probe systems, and, regardless of the type of SVAB system used, the accuracy of breast cancer diagnosis is significantly greater in lesions smaller than 30 mm compared with larger lesions.


   FOOTNOTES
 
Abbreviations: DCIS = ductal carcinoma in situ, SVAB = stereotactic vacuum-assisted biopsy

Author contributions: Guarantor of integrity of entire study, R.F.B.; study concepts, R.F.B.; study design, R.F.B., J.M.S.; literature research, J.M.S., R.F.B.; clinical studies, F.B.A., R.F.B., J.M.S., O.M.B.G.; data acquisition, R.F.B., O.M.B.G., J.M.S.; data analysis/interpretation, R.F.B., J.M.S., S.N.G.; statistical analysis, R.F.B., J.M.S., S.N.G.; manuscript preparation, J.M.S., R.F.B., O.M.B.G., A.N., S.N.G.; manuscript definition of intellectual content, R.F.B., J.M.S., O.M.B.G.; manuscript editing, O.M.B.G., J.M.S., R.F.B., F.B.A.; manuscript revision/review, R.F.B., J.M.S., O.M.B.G., A.N.; manuscript final version approval, all authors.


   REFERENCES
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 REFERENCES
 

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