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1 All authors: Breast Imaging Section, Department of Radiology, Memorial Sloan-Kettering Cancer Center, 1275 York Ave., New York, NY 10021.
Received July 17, 2000;
accepted after revision September 7, 2000.
Supported by grant C015709 from the New York State Department of
Health.
Abstract
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MATERIALS AND METHODS. Retrospective review was performed of 923 consecutive lesions that underwent stereotactic breast biopsy performed by one of six radiologists. Four hundred fourteen lesions had 14-gauge automated core biopsy, and 509 subsequent lesions had vacuum-assisted biopsy (14-gauge in 163 and 11-gauge in 346). Medical records were reviewed to determine the technical success rate and false-negative rate as a function of operator experience.
RESULTS. For 14-gauge automated core biopsy, a significantly lower technical success rate was seen for the first five cases of each radiologist than for subsequent cases (25/30 = 83.3% versus 366/384 = 95.3%, p < 0.02) and for the first 20 cases than for subsequent cases (90/100 = 90% versus 284/296 = 95.9%, p < 0.05). For 11-gauge vacuum-assisted biopsy, a significantly lower technical success rate was seen for the first five cases than for subsequent cases (17/20 = 85.0% versus 310/322 = 96.3%, p < 0.05) and for the first 15 cases than for subsequent cases (54/60 = 90.0% versus 273/283 = 96.5%, p = 0.03). The false-negative rate was higher for the first 15 cases compared with subsequent cases both for stereotactic 14-gauge automated core biopsy (4/31 = 12.9% versus 3/115 = 2.6%, p < 0.04) and for stereotactic 11-gauge vacuum-assisted biopsy (2/27 = 7.4% versus 0/85 = 0%, p < 0.06).
CONCLUSION. A learning curve exists for stereotactic breast biopsy. Significantly higher technical success rates and lower false-negative rates were observed after the first five to 20 cases for 14-gauge automated core biopsy and after the first five to 15 cases for 11-gauge vacuum-assisted biopsy. Even after a radiologist has experience with stereotactic biopsy, changes in equipment may result in a new learning curve.
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From August 1992 to December 1995, all 414 stereotactic biopsies were performed using a 14-gauge automated needle with a long excursion gun (Manan Pro-Mag 2.2, Manan; or Biopty, Bard Urological) in 404 (97.6%) of 414 lesions and a short excursion gun (Manan Pro-Mag 1.2) in 10 (2.4%) of 414 lesions. From December 1995 to October 1996, all 139 stereotactic biopsies were performed with a 14-gauge directional vacuum-assisted biopsy probe (Mammotome, Biopsys/Ethicon Endo-Surgery). From October 1996 to June 1998, stereotactic biopsies were performed with the 11-gauge directional vacuum-assisted biopsy probe in 93.5% (346/370) of lesions and with the 14-gauge directional vacuum-assisted biopsy probe in 6.5% (24/370) of lesions, at the discretion of the radiologist performing the biopsy.
For stereotactic 14-gauge automated core biopsy, the median number of specimens obtained per lesion was five (range, 1-22 specimens); five or more specimens were obtained in 404 (97.6%) of 414 lesions [9]. For stereotactic 14-gauge directional vacuum-assisted biopsy, the median number of specimens obtained per lesion was 14 (range, 1-50 specimens); eight or more specimens were obtained in 149 (91.4%) of 163 lesions [10]. For stereotactic 11-gauge directional vacuum-assisted biopsy, the median number of specimens obtained per lesion was 15 (range, 4-43 specimens); eight or more specimens were obtained in 355 (97.5%) of 364 lesions [11]. For lesions evident as calcifications, specimen radiography was performed to confirm calcification retrieval [12, 13].
Radiologist Experience
Each biopsy was performed by one of six attending radiologists at an
academic institution where more than 30,000 mammograms were performed annually
during the study period. Five of the six radiologists specialized in breast
imaging and one specialized in sonography. At the outset of their
participation in the study, three of the radiologists had a median of 7 years
of breast imaging experience (individual levels of experience were 2, 7, and
11 years), one had 4 years of experience as an interventional radiologist, one
had completed a fellowship in breast and body imaging, and one had completed
residency training.
Five of the radiologists had no prior clinical experience with stereotactic breast biopsy before performing biopsies as attending radiologists at our hospital, and one had participated in approximately 30 stereotactic 14-gauge automated core breast biopsies during fellowship training under the direct supervision of an attending radiologist. All radiologists participated in hands-on training sessions using phantoms before performing clinical stereotactic biopsies with each new tissue acquisition device. These training sessions included at least one 0.5-hr group lesson with an applications specialist and additional individual sessions at the discretion of the radiologist. The median number of stereotactic biopsy procedures performed per radiologist during the study period of approximately 6 years was 180 (range, 30-295).
Management After Biopsy
Management after stereotactic biopsy was guided by the following protocol.
If stereotactic biopsy yielded benign findings concordant with the imaging
characteristics, the patient was referred for follow-up mammography, usually
at 1 year. If stereotactic biopsy yielded carcinoma, the patient was referred
for definitive treatment. Surgical excision was recommended if it was
suggested by the pathologist; if a specific disorder was encountered such as
atypical ductal hyperplasia, fibroepithelial lesions thought to represent
phyllodes tumors, or high-risk lesions such as radial scars; or if there was
discordance between histologic and imaging findings
[14,15,16,17,18].
Technical Success
Technical success was defined as retrieving calcifications documented by
specimen radiography (for calcifications) or obtaining a histologic diagnosis
concordant with imaging features (for masses). The technical success rate as a
function of operator experience was calculated: cumulatively for the group as
a whole, by summing the first n cases of each radiologist, with
n ranging from one to 30, for all radiologists who had performed at
least n cases; cumulatively for each individual radiologist; and
sequentially for each individual radiologist, by determining technical success
rates in sequential groups of five cases.
False-Negative Rate
The false-negative rate was defined as the proportion of pathologically
proven cancerous lesions that yielded benign stereotactic biopsy findings
without atypia or high-risk lesions
[7,
17]. Follow-up data were
obtained to calculate the false-negative rate. For 14-gauge automated core
biopsy, surgical (n = 188) or imaging (n = 171) follow-up
data were available in 359 (86.7%) of 414 lesions; the median duration of
imaging follow-up was 42 months (range, 6-87 months). For 14-gauge directional
vacuum-assisted biopsy, surgical (n = 67) or imaging (n =
64) follow-up data were available in 131 (80.4%) of 163 lesions; the median
duration of imaging follow-up was 36 months (range, 6-50 months). For 11-gauge
directional vacuum-assisted biopsy, surgical (n = 150) or imaging
(n = 147) follow-up data were available in 297 (85.8%) of 346
lesions; the median duration of imaging follow-up was 24 months (range, 6-42
months).
Data Analysis
Data were prospectively entered into a database using spreadsheet software
(Excel; Microsoft, Redmond, WA). Medical records were reviewed to determine
the technical success rate and false-negative rate as a function of operator
experience. Tests for statistical significance were performed with the
chi-square and Fisher's exact tests using statistics software (Epi-Info;
Centers for Disease Control, Atlanta, GA).
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14-Gauge Automated Core Breast Biopsy
The learning curves for stereotactic 14-gauge automated core breast biopsy
are shown in Figure
1A,1B,1C.
Comparison of technical success in early versus late experience for the group
as a whole is shown in Table 3,
and the sequential experience of each individual radiologist performing
stereotactic 14-gauge automated core biopsy is shown in
Table 4.
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For stereotactic 14-gauge automated core biopsy, a significantly lower technical success rate was observed for the first 20 cases of each radiologist as compared with subsequent cases (Table 3). A trend toward a higher technical success rate was noted in radiologists who performed an average of 12 or more cases per year than among radiologists who performed fewer than 12 cases (328/344 = 95.3% versus 63/70 = 90%; p < 0.09; odds ratio = 2.28 [95% confidence interval, 0.76-6.13]).
A steeper learning curve was observed for calcifications than for masses. The technical success rate for calcifications was 50.0% for the first calcification case of each radiologist, 72.2% for the first three cases, 80.0% for the first five cases, 93.3% for the first 10 cases, and 95.6% for the first 15 cases (Fig. 1B). The technical success rate for masses was 83.3% for the first mass case of each radiologist, 88.9% for the first three cases, 90.0% for the first five cases, 91.7% for the first 10 cases, and 94.7% for the first 15 cases (Fig. 1C).
Technical failures occurred in 23 (5.6%) of 414 lesions that had stereotactic 14-gauge automated core biopsy, including 15 (10.3%) of 146 calcific lesions and eight (3.0%) of 268 masses. Subsequent surgical excision, performed in 15 of these technical failures, revealed carcinoma in 11 lesions (73.3%), including eight (88.9%) of nine calcific lesions and three (50%) of six masses. Stereotactic biopsy histologic findings in these 11 lesions were atypical ductal hyperplasia in four and benign lesion in seven; surgical histologic findings were ductal carcinoma in situ in six and infiltrating carcinoma in five. The remaining eight lesions in which technical failure occurred remained stable at mammographic follow-up (range, 12-69 months; median, 26 months).
Among 146 pathologically proven cancerous lesions that underwent stereotactic 14-gauge automated core biopsy, false-negative results were encountered in seven (4.8%). All seven false-negative cases were identified promptly because of failure to sample calcifications (n = 4) or discordant results in a mass lesion (n = 3). In four of these false-negative cases, surgery revealed infiltrating carcinoma (ductal in two and lobular in two) with a median size of 0.8 cm (range, 0.6-1.0 cm); axillary lymph node dissection, performed in three of these four infiltrating carcinomas, revealed axillary metastases in one. In the remaining three false-negative cases, surgery revealed ductal carcinoma in situ. The false-negative rate was significantly higher for the first 10 cases of each radiologist than for subsequent cases (4/20 = 20.0% versus 3/126 = 2.4%; p < 0.01; odds ratio = 10.25 [95% confidence interval, 1.54-74.30]) and for the first 15 cases than for subsequent cases (4/31 = 12.9% versus 3/115 = 2.6%; p < 0.04; odds ratio = 5.53 [95% confidence interval, 0.87-39.37]).
14-Gauge Directional Vacuum-Assisted Breast Biopsy
For stereotactic 14-gauge vacuum-assisted biopsy, a trend was noted toward
a lower technical success rate for the first 10 cases of each radiologist than
for subsequent cases (36/40 = 90% versus 111/114 = 97.4%, p <
0.08). A lower (but not significantly lower) technical success rate was
observed for the first 15 cases of each radiologist than for subsequent cases
(55/60 = 91.7% versus 92/94 = 97.9%, p = 0.11).
A learning curve was observed for calcifications: the technical success rate was 80.0% for the first five calcification cases of each radiologist, 87.5% for the first 10 cases, and 91.7% for the first 15 cases. No appreciable learning curve was observed for mass lesions, in which the technical success rate was 100% for the first five, 10, and 15 mass cases, respectively, of each radiologist.
Technical failures occurred in seven (4.3%) of 163 lesions that underwent stereotactic 14-gauge vacuum-assisted biopsy, including six (7.0%) of 86 calcific lesions and one (1.3%) of 77 masses. Surgical excision, performed in five technical failures (four calcific lesions and one mass), revealed carcinoma in one lesion (20%). Of the remaining two technical failures, follow-up is pending in one; the other showed stable mammographic findings at 50 months.
Among 58 pathologically proven cancerous lesions that underwent stereotactic 14-gauge directional vacuum-assisted biopsy, false-negative results were encountered in one (1.7%). This was a calcific lesion yielding benign findings with no calcifications at stereotactic biopsy; surgery revealed infiltrating ductal carcinoma measuring 2 mm and ductal carcinoma in situ with negative findings in nodes. The false-negative rate was higher among the first 15 cases of each radiologist than among subsequent cases (1/21 = 4.8% versus 0/31 = 0%, p = 0.4), but this difference did not achieve statistical significance.
11-Gauge Directional Vacuum-Assisted Breast Biopsy
The learning curves for stereotactic 11-gauge directional vacuum-assisted
biopsy are shown in Figure
2A,2B,2C.
Comparison of technical success in early versus late experience for the group
as a whole is shown in Table 3,
and the sequential experience of each individual radiologist performing
11-gauge vacuum-assisted biopsy is shown in
Table 4. For 11-gauge
vacuum-assisted biopsy, a significantly lower technical success rate was
observed for the first five to 15 cases of each radiologist than for
subsequent cases (Table 3).
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A learning curve was more evident for calcifications than for mass lesions. Among calcification lesions, the technical success rate was 60.0% for the first calcification case of each radiologist, 75.0% for the first three cases, 85.0% for the first five cases, 90.0% for the first 10 cases, and 93.3% for the first 15 cases (Fig. 2B). Among mass lesions, the technical success rate was 100% for the first mass case, 95.0% for both the first five and the first 10 cases, and 97.8% for the first 15 cases (Fig. 2C).
Technical failures occurred in 15 (4.3%) of 346 lesions that had stereotactic 11-gauge directional vacuum-assisted biopsy, including 10 (3.9%) of 256 calcific lesions and five (5.6%) of 90 masses. Surgical excision, performed in 10 technical failures, revealed carcinoma in three (30%), including two (50%) of four masses and one (16.7%) of six calcific lesions. In the calcific lesion, which yielded atypical ductal hyperplasia at stereotactic biopsy, surgery revealed infiltrating ductal carcinoma and ductal carcinoma in situ; in the two masses, which yielded benign findings at stereotactic biopsy, ductal carcinoma in situ was found at surgery. Of the remaining five lesions in which technical failure occurred, follow-up data are available in four: one had a successful second stereotactic biopsy with benign results, and three have remained stable at mammographic follow-up (range, 14-27 months; median, 24 months).
Among 113 pathologically proven cancerous lesions that underwent stereotactic 11-gauge directional vacuum-assisted breast biopsy, false-negative results were encountered in two (1.8%). Both lesions were evident as areas of architectural distortion on mammography and yielded benign stereotactic biopsy results that were considered discordant with the imaging features. Prompt surgical excision was suggested in both cases; both lesions yielded a radial scar and ductal carcinoma in situ. The first 15 cases of each radiologist as compared with subsequent cases had a trend toward a higher false-negative rate (2/28 = 7.1% versus 0/85 = 0%, p < 0.06).
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Previous investigators have suggested that a learning curve exists for stereotactic breast biopsy. In a multiinstitutional study of stereotactic 14-gauge automated core biopsy, Brenner et al. [6] found a higher frequency of failing to diagnose the lesion during early experience (defined as the first 20 cases per institution) than during later experience (3/37 = 8% versus 4/142 = 3%, p = 0.16). In a study of lesions not diagnosed at stereotactic 14-gauge automated core biopsy, Liberman et al. [7] found that four (80%) of five cases in which inaccurate needle placement led to failure to diagnose cancer occurred during the first 9 months of experience. In a study of stereotactic 14-gauge directional vacuum-assisted biopsy, Liberman et al. [8] found a higher frequency of failure to retrieve calcifications during the first 4 months of experience than during the second 4 months (5/24 = 21% versus 0/31 = 0%, p = 0.01).
Our data support the existence of a learning curve for stereotactic breast biopsy with the automated needle and with the directional vacuum-assisted biopsy probes. We observed a significantly lower technical success rate and a higher false-negative rate among the first five to 20 cases than with subsequent cases for stereotactic 14-gauge automated core biopsy, and among the first five to 15 cases as compared with subsequent cases for stereotactic 11-gauge directional vacuum-assisted biopsy. For both methods, a technical success rate of greater than 95% was achieved after the first five cases for the group of radiologists as a whole; however, examination of the data of the individual radiologists indicates that the performance of the individual radiologists showed further improvement after the first five to 20 cases for 14-gauge automated core biopsy and after the first five to 15 cases for 11-gauge vacuum-assisted biopsy.
Our findings have several implications. First, training programs should endeavor to allow trainees to perform an adequate number of biopsies under supervision to achieve sufficiently high technical success and sufficiently low false-negative findings. Our data suggest that this number may be between five and 20 cases, but further work is needed to determine if these results can be generalized. Second, a better outcome may be achieved if stereotactic biopsy is performed by a small number of individuals with more experience rather than by a large number of individuals with less experience. Third, when embarking on the performance of stereotactic biopsy, close supervision by an experienced individual during the early cases may be desirable. Finally, the learning curve, although present, is relatively short. That stereotactic biopsy can be learned relatively rapidly contributes to its potential usefulness in general clinical practice.
We encountered a learning curve for stereotactic 11-gauge vacuum-assisted biopsy among our radiologists who had a collective experience of more than 500 prior stereotactic 14-gauge automated core or 14-gauge vacuum-assisted biopsy procedures. This finding engenders respect for changes in technology. Even for radiologists experienced at performing stereotactic biopsy, new equipment poses new challenges. With the introduction of new devices, hands-on training sessions with phantoms, as pioneered in the work of Georgian-Smith et al. [24], may be helpful. For stereotactic biopsy, lesion targeting can be practiced using commercially available phantoms (e.g., Stereotactic Breast Biopsy Phantom Model 164; Gammex/RMI, Middleton, WI), and the process of tissue acquisition can be practiced using a home-built phantom, such as a pepper stuffed with pizza dough.
We found a steeper learning curve for stereotactic biopsy of calcifications than for masses, with a lower technical success rate in the early calcification cases than in early mass cases. The technical difficulties encountered during stereotactic biopsy of calcifications have been extensively discussed in the literature and relate to the target being tiny and discontinuous [25,26,27]. Our observed differences in learning curves for calcifications and masses may also in part reflect our definition of technical success: calcification retrieval (for calcific lesions) is a more objective and stringent criterion for success than imaging and histologic concordance (for masses). We found, as have others [26, 27], that the use of stereotactic 11-gauge directional vacuum-assisted biopsy rather than 14-gauge automated core biopsy resulted in a higher technical success rate for the biopsy of calcifications, but did not eliminate the learning curve.
A higher false-negative rate was observed during early than during late experience. Our false-negative findings were identified promptly on review of stereotactic biopsy findings because of the failure to retrieve calcifications or imaging—histologic discordance. In previous studies, imaging—histologic discordance has been reported in 0.9-6.2% of lesions undergoing stereotactic breast biopsy; of lesions yielding discordant results, subsequent excision revealed carcinoma in 0-63.6% [14,15,16,17,18]. Correlation of imaging and histologic findings is important to prevent a deleterious delay in the diagnosis of breast cancer and should be emphasized during training. The false-negative rate may be minimized by close coordination with more experienced operators while ascending the learning curve.
To initially qualify to perform stereotactic breast biopsy under the accreditation program of the American College of Radiology, the physician is required to have performed at least 12 stereotactic breast biopsies, or at least three hands-on stereotactic breast biopsy procedures under the supervision of a physician who is qualified to interpret mammography under the Mammography Quality Standards Act and who has performed at least 24 stereotactic biopsies [28]. To maintain accreditation, a physician is required to perform at least 12 stereotactic breast biopsies per year or to refulfill the initial requirements. Our findings support both the usefulness of establishing guidelines for the number of cases required for initial accreditation and the specific requirements of the American College of Radiology. The guideline of 12 cases for initial qualification is within the five to 20 range suggested by our data, and the guideline of 24 cases for those providing supervision corresponds to the plateau of the learning curve (Figs. 1A,1B,1C and 2A,2B,2C).
In summary, a learning curve exists for stereotactic breast biopsy, but it is relatively short. In our experience, significantly higher technical success rates and lower false-negative rates were achieved after the first five to 20 cases for stereotactic 14-gauge automated core biopsy and after the first five to 15 cases for stereotactic 11-gauge vacuum-assisted biopsy. Even after experience with stereotactic breast biopsy, changes in equipment can result in a new learning curve. The learning curves reported here are those of academic radiologists specializing in breast imaging. Further work is necessary to determine the learning curves for stereotactic breast biopsy in other settings, to assess the number of cases required to maintain proficiency, to determine the impact of training and supervision on the learning curve, and to evaluate the learning curves for new breast biopsy technology as it becomes available.
Acknowledgments
We thank Hiram S. Cody III for critical review of the manuscript and David
C. Perlman for invaluable assistance.
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