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Original Research |
1 Department of Radiology, University of Washington Medical Center, Seattle,
WA.
2 Department of Radiology, University of Washington School of Medicine, Seattle
Cancer Care Alliance, 825 Eastlake Ave. E, G3-200, Seattle, WA
98109-1023.
3 Department of Pathology, University of Washington Medical Center, Seattle,
WA.
Received June 3, 2008;
accepted after revision July 26, 2008.
Address correspondence to P. R. Eby
(preby{at}u.washington.edu).
Abstract
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MATERIALS AND METHODS. We retrospectively reviewed the pathology results of 991 consecutive 9- or 11-gauge stereotactic vacuum-assisted breast biopsy procedures from February 2001 through June 2006 and identified lesions diagnosed as ADH. The final diagnosis after surgical excision was determined from medical records. The frequencies and upgrade rates to carcinoma were calculated for all ADH lesions and compared between 9- and 11-gauge procedures. The number of core samples was recorded and compared.
RESULTS. One hundred forty-one of 991 (14.2%) lesions yielded a diagnosis of ADH at 9- or 11-gauge stereotactic vacuum-assisted breast biopsy. Upgrade to ductal carcinoma in situ or invasive carcinoma occurred in 26 of 123 (21.1%) patients. The frequency of ADH was 83 of 600 (13.8%) lesions for 9-gauge and 58 of 391 (14.8%) lesions for 11-gauge vacuum-assisted breast biopsy. The 9-gauge upgrade rate was 16 of 74 (21.6%) lesions compared with 10 of 49 (20.4%) lesions for 11-gauge vacuum-assisted breast biopsy. There was no significant difference between the number of core samples obtained with each device (p = 0.40). Neither the frequency of ADH (p = 0.66) nor the upgrade rates (p = 0.87) were significantly different between 9- and 11-gauge vacuum-assisted breast biopsy.
CONCLUSION. Compared with an 11-gauge vacuum-assisted breast biopsy device, the use of a larger 9-gauge vacuum-assisted breast biopsy needle does not decrease the upgrade rate of ADH. Our frequency of ADH at vacuum-assisted breast biopsy is higher than any previously reported and may reflect regional differences in the incidence of breast cancer or practice patterns of the pathologist.
Keywords: atypical ductal hyperplasia • breast • cancer • core needle biopsy • imaging-guided intervention
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Upgraded lesions are those with an initial histopathologic diagnosis of ADH at imaging-guided biopsy that subsequently yield DCIS or invasive carcinoma after a surgical excision. The reported rates of upgrade for ADH lesions average 44% for 14-gauge spring-loaded stereotactic core biopsy, 24% for 14-gauge directional vacuum-assisted breast biopsy, and 19% for 11-gauge vacuum-assisted breast biopsy needles (range, 0-58%) [1-30]. The diagnosis of ADH after percutaneous needle sampling is an indication for surgical excision to exclude the diagnosis of breast carcinoma.
Advances in needle biopsy techniques, such as increasing needle diameter from 14- to 11-gauge and adding vacuum assistance, have allowed larger samples of tissue to be obtained [35, 36]. Research by Darling et al. [22] suggests that increased sample weights result in significantly decreased rates of upgrade. In addition, Sneige et al. [37] described an upgrade rate of only 7% for ADH obtained with 14- or 11-gauge vacuum-assisted breast biopsy.
The use of 9-gauge directional vacuum-assisted breast biopsy needles for percutaneous tissue biopsy is increasing. The weight of each sample acquired during a typical 9-gauge vacuum-assisted breast biopsy is significantly greater than that acquired during an 11-gauge vacuum-assisted breast biopsy [38]. A single study by Lourenco et al. [30] has provided data on upgrade rates for high-risk or malignant lesions discovered with 9-gauge stereotactic vacuum-assisted breast biopsy. The authors found no significant difference between 9- and 11-gauge vacuum-assisted breast biopsy diagnoses of ADH or upgrade rates. Additional data on the frequency and upgrade rate of ADH after 9-gauge stereotactic vacuum-assisted breast biopsy is needed to confirm prior results.
The purpose of this study was to determine the frequency of diagnosis and upgrade rate of ADH at stereotactic 9-gauge vacuum-assisted breast biopsy. We also sought to determine if the use of 9-gauge vacuum-assisted breast biopsy devices would significantly decrease the upgrade rate for ADH when compared with 11-gauge vacuum-assisted breast biopsy devices.
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Clinical and patient data were collected from the electronic medical record system. The indication for stereotactic vacuum-assisted breast biopsy, patient age, the number of days between stereotactic vacuum-assisted breast biopsy and surgical biopsy, and histopathology results were recorded. Two histopathology results were collected for each lesion: the diagnosis at stereotactic vacuum-assisted breast biopsy and the diagnosis at surgical excisional biopsy. Similar to the study of Jackman et al. [25], lesions were excluded from the upgrade analysis if excision of the biopsy site could not be verified. Therefore, lesions without dedicated surgical excision for the site of ADH, because the patient either did not return to our center or chose mastectomy because of a concurrent diagnosis of cancer in the ipsilateral breast, were excluded from the upgrade analysis.
Four pathologists with a subspecialty focus in breast pathology reviewed cases during the study period. A lesion was designated as ADH at core biopsy according to the published criteria of Page and Rogers [31]. Lesions were included in the study if the vacuum-assisted breast biopsy pathology report indicated ADH without concomitant in situ or invasive cancer. We excluded lesions diagnosed as columnar cell change with atypia, flat epithelial atypia, or atypical lobular hyperplasia (ALH) if ADH was not also present. Alternatively, lesions were included if ADH was accompanied by other high-risk histology such as ALH or radial scar, a method previously used by other authors [25].
The number of vacuum-assisted breast biopsy samples obtained at each biopsy was recorded on a data sheet at the time of the procedure and included in the report. This number was extracted from the reports for each lesion and included in the statistical analysis. Chi-square, Fisher's exact, and Student's t tests for statistical significance were performed to compare the frequency of ADH, rates of upgrade, and the number of vacuum-assisted breast biopsy samples between 9- and 11-gauge procedures with SAS statistical software, version 9.1.3, and p < 0.05 was considered significant.
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The number of samples taken at 9-gauge vacuum-assisted breast biopsy was recorded in 49 of 74 (66.2%) vacuum-assisted breast biopsy procedures for a mean of 9.9 and median of 8.0 (range, 6-20, Table 2). A mean of 8.4 and median of 8.0 (range, 6-12) of 9-gauge samples were taken from the nine of 49 (18.4%) lesions that were upgraded, and a mean of 10.2 and median of 9.0 (range, 6-20) samples were obtained in the 40 of 49 (81.6%) lesions that were not upgraded. The odds of upgrade after 9-gauge vacuum-assisted breast biopsy were not related to the number of samples taken (odds ratio = 1.2; 95% CI, 0.9-1.6).
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11-Gauge Stereotactic Vacuum-Assisted Breast Biopsy
We calculated outcomes for 11-gauge vacuum-assisted breast biopsy to
determine if our frequency of ADH and upgrade rates were related to needle
size. Three hundred ninety-one procedures were performed with 11-gauge
stereotactic vacuum-assisted breast biopsy, yielding ADH in 58 of 391 (14.8%)
lesions (Table 1). All 58
lesions were suspicious calcifications. Records of breast surgery were
available for 52 of 58 (89.7%) lesions. Four patients did not return to our
institution, one deferred excision because of concurrent treatment for acute
myelogenous leukemia, and one deferred excision because an excisional biopsy
in the same breast 6 months prior revealed ADH and LCIS. Three lesions were
excluded because the patients underwent mastectomy for cancer in the
ipsilateral breast and upgrade at the site of ADH could not be determined
accurately. This left 49 lesions in patients with a median age of 55 years
(age range, 41-79 years) with ADH and follow-up histology for the upgrade
analysis. Five of 49 (10.2%) lesions were ADH with another high-risk pathology
(one ADH with ALH, two ADH with radial scar, and two ADH with LCIS), and none
of them were upgraded. The median number of days between stereotactic
vacuum-assisted breast biopsy and surgical excision was 41 (range, 10-173
days). The histopathologic results of surgical excision yielded cancer in 10
of 49 (20.4%) lesions, with seven of 10 (70.0%) resulting in DCIS and three of
10 (30.0%), invasive ductal carcinoma.
The number of samples taken at 11-gauge vacuum-assisted breast biopsy was recorded in 31 of 49 (63.3%) cases for a mean of 10.5 samples and median of 12.0 (range, 6-16, Table 2). A mean of 11.5 and median of 12.0 (range, 8-12) 11-gauge samples were taken from the eight of 31 (25.8%) lesions that were upgraded, and a mean of 10.1 and median of 12.0 (range, 6-16) samples were obtained in the 23 of 31 (74.2%) lesions that were not upgraded. The odds of upgrade were not related to the number of samples taken at 11-gauge vacuum-assisted breast biopsy (odds ratio = 0.8; 95% CI, 0.5-1.1).
9-Versus 11-Gauge
The frequency of ADH was similar for 9- (13.8%) and 11-gauge (14.8%)
vacuum-assisted breast biopsy (p = 0.66, chi square test)
(Table 1). The difference in
upgrade rate between 9- (21.6%) and 11-gauge (20.4%) vacuum-assisted breast
biopsy was not significant (p = 0.87, chi square test)
(Table 1). The difference
between the mean number of samples taken at 9- (9.9) and 11-gauge (10.5)
vacuum-assisted breast biopsy was not significant (p = 0.4, Student's
t test) (Table 2).
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A single study by Lourenco et al. [30] has provided data on frequency and upgrade rates for high-risk or malignant lesions discovered with 9-gauge stereotactic vacuum-assisted breast biopsy. The authors describe the frequencies of ADH as 8.4% for 9-gauge vacuum-assisted breast biopsy and 7.5% for 11-gauge vacuum-assisted breast biopsy. Liberman et al. [40] and Orel et al. [41] reported frequencies of ADH at 9-gauge MR-guided vacuum-assisted breast biopsy of 6% and 9%, respectively. In our study, the frequency of ADH was 13.8% for 9- and 14.8% for 11-gauge stereotactic vacuum-assisted breast biopsy (Table 3). The combined frequency of ADH in our population undergoing 9- or 11-gauge vacuum-assisted breast biopsy was 14.2%. This is higher than any previously published results. In prior studies, the frequency of diagnosis of ADH ranges from 2% to 9% at 14-gauge biopsy and from 3% to 11% at 11-gauge biopsy [1-25]. In a meta-analysis of 14- and 11-gauge breast biopsy procedures, Jackman et al. [25] reported a 5% frequency of ADH (894/18,601).
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Our relatively high frequency of ADH translates to a significant clinical impact because we must recommend surgical excision for all of these patients. There are several potential hypotheses for our greater frequency of ADH. Perhaps it is attributable to the practice patterns of our pathologists, with a relative overcalling of ADH on vacuum-assisted breast biopsy samples. If so, we would expect a relatively low rate of upgrade after excisional biopsy. As previously reviewed, in the study by Jackman et al. [25], upgrade rates of ADH averaged 19% (range, 10-38%) at 11-gauge vacuum-assisted breast biopsy. Our upgrade rate of 20.4% for 11-gauge vacuum-assisted breast biopsy at excision is similar to that found in prior studies. In addition, the upgrade rate for 9-gauge vacuum-assisted breast biopsy in our population is 21.6%, which is comparable to that of biopsies performed with other needle sizes. Liberman et al. [40] and Orel et al. [41] reported upgrade rates of ADH at 9-gauge MR-guided vacuum-assisted breast biopsy of 38% and 25%, respectively. Lourenco et al. [30] reported an upgrade rate of 29.6% for 9-gauge stereotactic vacuum-assisted breast biopsy. The similarities in upgrade rates between our population and other published data suggest that our higher incidence of ADH is unlikely to be a result of overcalling of ADH by pathologists.
Alternatively, it is possible that our pathologists could have diagnosed ADH in lesions that other pathologists may have classified as DCIS, resulting in a relative undercalling of DCIS on core needle biopsies. It is likely that those lesions would be upgraded at the time of surgical excision, but this is not certain. This practice pattern could result in high rates of ADH and upgrade.
It is interesting to consider the variability that may exist in pathologists' practice patterns and how this variability affects patient care. The diagnosis of ADH is known to have significant interobserver variability even among experts in breast pathology [42]. Because this is a retrospective study involving four pathologists, it is impossible to know how consistently the criteria were being applied, and this is a weakness. A blinded review of all cases by a single pathologist with defined consistent diagnostic criteria could help to address this issue, but it is beyond the scope of the current study.
The acquisition of a larger volume of tissue at biopsy could contribute to a higher observed incidence of ADH if it was an incidental finding. It has been shown that a 14-gauge automated core biopsy device yields individual core samples weighing an average of 17.7 mg, whereas 14-gauge vacuum-assisted breast biopsy devices average 36.8 mg per core, and 11-gauge vacuum-assisted breast biopsy devices average 94.4 mg per core [35]. It follows that a 9-gauge vacuum-assisted breast biopsy device obtains yet more tissue per core, and Poellinger et al. [38] reported an average specimen weight of 132.7 mg for a 9-gauge vacuum-assisted breast biopsy system. Our frequency of ADH after 9-gauge vacuum-assisted breast biopsy (14.8%) is higher than that reported by Lourenco et al. [30] (8.4%), who used the same device (Table 3). This suggests that our higher observed frequency of ADH is not related to sample size.
We hypothesize that the increased incidence of ADH in our population may reflect the known regional difference in breast cancer incidence. The 2000-2004 age-adjusted Surveillance Epidemiology and End Results (SEER) incidence of breast cancer averages 127.8 per 100,000 and ranges from 110.8 to 145.8 across 19 regional registries [43]. The Seattle-Puget Sound registry has the highest incidence on the list. Therefore, we may expect a higher incidence of ADH in our population. If so, we should counsel patients specifically about the risks of a diagnosis of ADH and the recommendations that follow. In addition, it would be advantageous to identify biopsy-related factors, such as needle size, that may allow us to forgo surgical excision in some patients.
It has been theorized that a larger volume of tissue collected at core needle biopsy may negate sampling error and suffice for diagnostic purposes in the setting of ADH. Indeed, the reported rates of upgrade for ADH lesions average 44% for 14-gauge spring-loaded stereotactic core biopsy, 24% for 14-gauge vacuum-assisted breast biopsy, and 19% for 11-gauge vacuum-assisted breast biopsy needles (range, 0-58%) [1-29]. Research by Darling et al. [22] suggests that increased sample weights result in significantly decreased rates of upgrade. Sneige et al. [37] described an upgrade rate of only 7% for ADH obtained with 14- or 11-gauge vacuum-assisted breast biopsy. However, Lourenco et al. [30] reported an upgrade rate of 29.6% for ADH lesions initially sampled with 9-gauge vacuum-assisted breast biopsy. This contradicts some prior data that suggest larger samples result in more accurate diagnosis and less underestimation of disease. Our upgrade rates of 20.4% for 11-gauge and 21.6% for 9-gauge vacuum-assisted breast biopsy were not significantly different on the basis of needle size. Although the data are somewhat limited because the number of samples taken at the time of biopsy was reported for 65.0% of cases, the mean was less for 9-than for 11-gauge (9.9 vs 10.5 samples) but this was not statistically significant. Our data also indicate that the larger size of a 9-gauge vacuum-assisted breast biopsy device does not decrease upgrade rates.
In conclusion, there is no significant difference in the frequencies of ADH diagnosed with 9- and 11-gauge stereotactic vacuum-assisted breast biopsy, and the use of a larger 9-gauge needle does not decrease the upgrade rate of ADH. The high incidence of ADH and upgrade rate to carcinoma in our patient population may reflect regional differences in the incidence of cancer and precancerous lesions or the practice patterns of our pathologists.
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