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1
Breast Imaging Section, Department of Radiology, Memorial Sloan-Kettering
Cancer Center, 1275 York Ave., New York, NY 10021.
2
Department of Pathology, Memorial Sloan-Kettering Cancer Center, New York, NY
10021.
Received October 12, 2000;
accepted after revision January 17, 2001.
Presented at the annual meeting of the American Roentgen Ray Society,
Seattle, WA, April-May 2001.
Abstract
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MATERIALS AND METHODS. One hundred thirty-nine women with calcifications highly suggestive of malignancy underwent diagnostic biopsy. Of these, 89 women had stereotactic biopsy with a 14-gauge automated needle (n = 25), 14-gauge vacuum-assisted probe (n = 17), or 11-gauge vacuum-assisted probe (n = 47); and 50 women had diagnostic surgical biopsy. Medical records were reviewed. Cost savings for stereotactic biopsy were calculated using Medicare data.
RESULTS. The median number of operations was one for women who had stereotactic biopsy versus two for women who had diagnostic surgical biopsy. The likelihood of undergoing a single operation was significantly greater for women who had stereotactic rather than surgical biopsy, among all women (61/89 [68.5%] vs. 19/50 [38.0%], p < 0.001) and among women treated for breast cancer (55/77 [71.4%] vs. 6/37 [16.2%], p = 0.0000001). Stereotactic 11-gauge vacuum-assisted biopsy, as compared with 14-gauge automated core or 14-gauge vacuum-assisted biopsy, was significantly more likely to spare a surgical procedure (36/47 [76.6%] vs. 16/42 [38.1%], p = 0.0005). Stereotactic 11-gauge vacuum-assisted biopsy resulted in the greatest cost reduction, yielding savings of $315 per case compared with diagnostic surgical biopsy; for women with solitary lesions, stereotactic 11-gauge biopsy decreased the cost of diagnosis by 22.2% ($334/$1502).
CONCLUSION. For women with calcifications highly suggestive of malignancy, the use of stereotactic rather than surgical biopsy decreases the number of operations. Stereotactic 11-gauge vacuum-assisted biopsy, as compared with 14-gauge automated core or 14-gauge vacuum-assisted biopsy, is significantly more likely to spare a surgical procedure and has the highest cost savings.
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A vacuum-assisted biopsy instrument is now available for performing stereotactic breast biopsy [12] and is particularly advantageous in the assessment of calcific lesions [13,14,15,16]. This study was undertaken to compare the usefulness and cost of diagnosis using stereotactic automated core biopsy, stereotactic vacuum-assisted biopsy, and surgical biopsy in women with calcifications highly suggestive of malignancy.
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For lesions technically amenable to both stereotactic and surgical biopsy, both methods were presented as diagnostic options to the patient and her referring physician; the final decision as to biopsy method was made by the patient and her doctor in consultation with the radiologist recommending the biopsy. Informed consent was obtained for all biopsy procedures. Specimen radiography was performed for all lesions that had surgical biopsy and for all calcific lesions that had stereotactic biopsy [20, 21].
Patient, lesion, and procedural data for stereotactic biopsy and needle localization and diagnostic surgical biopsy were prospectively collected by the radiologist performing the procedure using a standardized data collection form. Lesions were classified prospectively, before tissue diagnosis, in accordance with the final assessment categories of the Breast Imaging Reporting and Data System (BI-RADS) [22].
Stereotactic Biopsy
From July 23, 1993 to July 26, 2000, 1341 consecutive lesions underwent
stereotactic breast biopsy. Biopsies were performed with patients prone on a
dedicated table using digital imaging (StereoGuide with Digital Spot
Mammography; LoRad, Danbury, CT). From July 1993 to December 1995, 360
stereotactic biopsies were performed using a 14-gauge automated needle
(Biopty-Cut, Bard Urological, Covington, GA; Manan, Manan Medical Products,
Northbrook, IL; or Ultra-core, Medical Device Technologies, Gainesville, FL)
and an automated gun, with long excursion (Manan Pro-Mag 2.2 or Bard Biopty)
in 350 (97.2%) lesions and short excursion (Manan Pro-Mag 1.2) in 10 (2.8%)
lesions.
From December 1995 to October 1996, 139 stereotactic biopsies were performed using a 14-gauge vacuum-assisted biopsy probe (Mammotome; Biopsys/Ethicon Endo-Surgery, Cincinnati, OH). From October 1996 to August 2000, stereotactic biopsies were performed using the 11-gauge vacuum-assisted probe (Mammotome) in 815 (96.8%) of 842 lesions and using the 14-gauge vacuum-assisted probe in 27 (3.2%) of 842 lesions, at the discretion of the radiologist performing the biopsy. A localizing clip was placed after 11-gauge vacuum-assisted biopsy if the lesion seen at mammography was removed, or if a large area was sampled and documenting the precise site of biopsy was desired.
Mammographic findings in these 1341 lesions were calcifications in 808, masses in 473, and masses with calcification in 60. Of 1341 lesions, 105 (7.8%) were calcifications highly suggestive of malignancy (BI-RADS category 5) without associated soft-tissue mass. Stereotactic biopsy was performed with a 14-gauge automated needle in 28 of these 105 lesions, a 14-gauge vacuum-assisted device in 20 of these 105 lesions, and an 11-gauge vacuum-assisted device in 57 of these 105 lesions. These 105 lesions, which occurred in 89 women, constitute the stereotactic biopsy group for this study.
Surgical Biopsy
Four hundred seventy-seven consecutive nonpalpable breast lesions had
diagnostic surgical biopsy without prior diagnostic percutaneous or excisional
biopsy from January 26, 1996 to November 29, 1996. This period corresponded to
approximately the midpoint of the study, after the introduction of
stereotactic vacuum-assisted biopsy to our practice. Mammographic findings in
these 477 lesions were calcifications in 308, masses in 158, and masses with
calcification in 11. Preoperative needle localization was performed with a
modified Kopans wire (Cook, Bloomington, IN). Of 477 lesions, 51 (10.7%) were
calcifications highly suggestive of malignancy (BI-RADS category 5) without
associated soft-tissue mass. These 51 lesions, which occurred in 50 women,
constitute the surgical biopsy group for this study.
Data and Cost Analysis
Medical records were reviewed to determine the number of operations
performed in all women and the frequency of sparing surgery in women who had
stereotactic biopsy. A woman was considered to have been spared a surgical
procedure if stereotactic biopsy yielded a benign diagnosis for which surgical
excision was neither recommended nor performed. A surgical procedure was
considered to have been spared for women in whom stereotactic biopsy yielded
carcinoma treated with one-stage lumpectomy and axillary surgery or with
mastectomy, or for women with carcinoma lesions measuring 1 cm or larger
treated with one-stage wide excision
[8,
9].
A woman was not considered to have been spared a surgical procedure if surgical biopsy was either recommended or performed after stereotactic breast biopsy, or if she had a small (<1 cm) carcinoma diagnosed at stereotactic biopsy and treated by surgical excision [8, 9]. A surgical procedure was not spared if stereotactic biopsy yielded ductal carcinoma in situ (DCIS) but surgery revealed infiltrating carcinoma, necessitating a separate operative procedure to assess the axilla; or if surgery for stereotactically proven carcinoma yielded tumor at the margins, requiring subsequent operations [8, 9].
Direct costs of all procedures were calculated using national Medicare average allowed amounts for Current Procedural Terminology codes [23] during the first two quarters of 2000 (Tables 1 and 2). Costs for stereotactic biopsy of one site were $764 or $695 (with or without a clip, respectively), and costs for stereotactic biopsy of two sites were $1345 or $1234 (with or without clips, respectively). For needle localization and surgical biopsy, costs for one site were $1502 or $1434 (with or without margin analysis, respectively), and costs for two sites were $2195 or $2127 (with or without margin analysis, respectively).
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Costs of diagnosis in women who had stereotactic biopsy were subtracted from the costs that would have been generated if diagnostic surgical biopsy had been performed as the initial diagnostic procedure [8, 9]. For women with stereotactic biopsy diagnosis of carcinoma who were spared surgery but had needle localization during breast-conserving treatment, the $333 cost of needle localization (Current Procedural Terminology codes 19290, 19290 SG, 76096, and 76098; Table 2) was subtracted from the savings.
Data were entered into a computerized spreadsheet (Excel; Microsoft, Redmond, WA). The final histologic diagnosis was determined on the basis of all available histologic information: for women who had surgery after stereotactic biopsy, these data included both stereotactic and surgical histologic findings. Statistical analyses were performed with a computerized statistics program (Epi-Info; Centers for Disease Control, Atlanta, GA) using the chi-square and Fisher's exact tests.
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Cancer Diagnoses
Among 89 women with BI-RADS category 5 calcifications who had stereotactic
biopsy as the initial procedure, the final histologic diagnosis was carcinoma
in 79 (88.8%), including DCIS in 43 women (48.3%) and infiltrating carcinoma
and DCIS in 36 (40.4%). Median histologic size of infiltrating carcinoma,
known in 33 women, was 0.4 cm (range, 0.1-4.0 cm). Of 27 women with
infiltrating carcinoma who had axillary lymph node dissection (n =
21) or sentinel lymph node biopsy (n = 6), axillary metastases were
present in five (18.5%). In nine (10.1%) of 89 women who had stereotactic
biopsy, stereotactic biopsy diagnosis of carcinoma from two separate sites led
to mastectomy.
Among 50 women who had surgical biopsy as the initial procedure, the final histologic diagnosis was carcinoma in 37 (74.0%), including DCIS in 21 women (42.0%) and infiltrating carcinoma and DCIS in 16 women (32.0%). Median histologic size of infiltrating carcinoma was 0.5 cm (range, 0.1-2.2 cm). Axillary surgery, performed in 20 women, showed axillary metastases in five (25.0%). A final histologic diagnosis of cancer was obtained significantly more frequently in women who had stereotactic rather than surgical biopsy as the initial diagnostic procedure (79/89 [88.8%] versus 37/50 [74.0%]; p = 0.04; odds ratio, 2.8; 95% confidence interval [CI], 1.0-7.7).
Benign Biopsy Findings or Atypical Ductal Hyperplasia
Among 89 women with BI-RADS category 5 calcifications who had stereotactic
biopsy as the initial diagnostic procedure, the final histologic diagnosis was
benign without atypia in five (5.6%) and atypical ductal hyperplasia in five
(5.6%).
Stereotactic biopsy yielded benign findings without atypia in eight (9.0%) of 89 women (Table 3) including fibrosis in five, fat necrosis in one, ductal hyperplasia in one, and benign breast tissue in one. Surgical excision, performed in four of these eight women, yielded carcinoma in two women (in whom no calcifications were identified on specimen radiographs), atypical ductal hyperplasia in one woman, and benign findings without atypia in one woman. Four women did not undergo surgery after benign stereotactic biopsy, including two who had complete removal of calcifications at 11-gauge vacuum-assisted biopsy (with calcifications identified in areas of fibrosis) and two who had comorbid conditions; follow-up mammography (median, 19 months; range, 12-32 months) showed stable findings.
Stereotactic biopsy yielded atypical ductal hyperplasia in 10 women (Table 3); surgical excision, performed in all 10 women, yielded DCIS in five, infiltrating ductal carcinoma and DCIS in one, and atypical ductal hyperplasia in four.
Among 50 women who had diagnostic surgical biopsy as the initial procedure, benign findings without atypia were encountered in 12 (24.0%) (Table 3). In these 12 women, calcifications were present in a variety of processes including fibrosis, sclerosing adenosis, fat necrosis, ductal hyperplasia, apocrine metaplasia, fibroadenomatoid hyperplasia, fibroadenomas, and papillomas. In one woman who had diagnostic surgical biopsy, atypical ductal hyperplasia was identified at surgery (Table 3).
Number of Operations
The median number of operations was one (mean, 1.2; range, 0-4) among women
who had stereotactic biopsy and two (mean, 1.6; range, 1-2) among women who
had diagnostic surgical biopsy (Table
4). Two operations were performed in 31 (62.0%) of all 50 women
who had diagnostic surgical biopsy, and in 31 (83.8%) of the 37 women with
breast cancer who had diagnostic surgical biopsy
(Table 4).
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Subsequent surgery after diagnostic surgical biopsy included mastectomy in 19 women because of tumor at (n = 12) or close to (n = 5) the margins, history of prior breast-conserving surgery in the ipsilateral breast (n = 1), or patient preference (n = 1); reexcision in 11 women because of tumor at (n = 8) or close to (n = 3) the margins; and axillary lymph node dissection in one woman because of the presence of infiltrating carcinoma in the diagnostic biopsy specimen. Among 30 women who had mastectomy or reexcision as a second operation, 19 also had axillary lymph node dissection (n = 18) or sentinel lymph node biopsy (n = 1) during that second procedure.
The likelihood of undergoing a single operation was significantly greater for women who had stereotactic biopsy rather than diagnostic surgical biopsy, among all women (61/89 [68.5%] vs. 19/50 [38.0%]; p < 0.001; odds ratio, 3.6; 95% CI, 1.6-7.8) and among women who had breast cancer surgery (55/77 [71.4%] vs. 6/37 [16.2%]; p = 0.0000001; odds ratio, 12.9; 95% CI, 4.4-42.2) (Table 4). The likelihood of achieving tumor resection with clear margins at the first operation was greater if the initial diagnostic procedure was stereotactic rather than surgical biopsy, among all women with breast cancer (58/77 [75.3%] vs. 8/37 [21.6%]; p = 0.0000002; odds ratio, 11.1; 95% CI, 4.0-32.3) and among women treated with breast-conserving surgery (24/42 [57.1%] vs. 6/18 [33.3%]; p = 0.16; odds ratio, 2.7; 95% CI, 0.7-10.3) (Table 4).
A surgical procedure was spared in 52 (58.4%) of 89 women who had stereotactic biopsy, including 10 (40.0%) of 25 women who had 14-gauge automated core biopsy, six (35.3%) of 17 women who had 14-gauge vacuum-assisted biopsy, and 36 (76.6%) of 47 women who had 11-gauge vacuum-assisted biopsy. Reasons surgery was not spared in 37 (41.6%) of 89 women who had stereotactic biopsy are shown in Table 5. Stereotactic 11-gauge vacuum-assisted biopsy, as compared with 14-gauge automated core or 14-gauge vacuum-assisted biopsy, was significantly more likely to spare a surgical procedure (36/47 [76.6%] vs. 16/42 [38.1%]; p = 0.0005; odds ratio, 5.3; 95% CI, 1.9-14.8) (Table 6) (Fig. 1A,1B,1C).
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Cost Analysis
Although stereotactic 14-gauge automated core biopsy and 14-gauge
vacuum-assisted biopsy increased the cost of diagnosis in women with
calcifications highly suggestive of malignancy, stereotactic 11-gauge
vacuum-assisted biopsy lowered the cost of diagnosis by $315 per case
(Table 6). Savings were $334
for each woman who had stereotactic 11-gauge vacuum-assisted biopsy of a
single site, a decrease of 22.2% ($334/$1502) in the cost of diagnosis
compared with surgical biopsy. Savings were $247 for each woman who had
stereotactic 11-gauge vacuum-assisted biopsy of two sites, a decrease of 11.3%
($247/$2195) in cost of diagnosis compared with surgical biopsy.
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Our data suggest that stereotactic biopsy is more efficient than diagnostic surgical biopsy in women with calcifications highly suggestive of malignancy. Among those who had diagnostic surgical biopsy, a single operation was performed in 38.0% (19/50) of women and in 16.2% (6/37) of women with breast cancer. Among those who had stereotactic biopsy, a single operation was performed in 68.5% (61/89) of women and in 71.4% (55/77) of women surgically treated for breast cancer. The significantly greater likelihood of undergoing a single operation after stereotactic biopsy reflects the better treatment planning made possible by preoperative diagnosis, usually allowing the surgeon to anticipate the need for wider excision, mastectomy, or histologic evaluation of the axilla [25].
We found that for women with calcifications highly suggestive of malignancy, stereotactic 11-gauge vacuum-assisted biopsy, as compared with 14-gauge automated core or 14-gauge vacuum-assisted biopsy, had a significantly greater likelihood of sparing surgery (76.6% vs. 38.1%, p = 0.0005). The greater efficacy of 11-gauge vacuum-assisted biopsy as compared with 14-gauge automated core biopsy supports the observations of previous small series. In prior reports of women with calcifications highly suggestive of malignancy, the likelihood of sparing surgery was 90% (9/10) for stereotactic 11-gauge vacuum-assisted biopsy [26] versus 42% (13/31) to 55% (6/11) for stereotactic 14-gauge automated core biopsy [9, 11].
The greater usefulness of stereotactic 11-gauge vacuum-assisted biopsy in women with calcifications highly suggestive of malignancy is probably multifactorial. A larger volume of tissue is removed at 11-gauge vacuum-assisted biopsy, both because of the larger size of each specimen (average specimen weight, 17 mg for 14-gauge automated core biopsy, 35 mg for 14-gauge vacuum-assisted biopsy, and 100 mg for 11-gauge vacuum-assisted biopsy) and the ease of obtaining a greater number of specimens [27]. The 11-gauge vacuum-assisted method also results in a higher calcification retrieval rate [13, 14, 16] and lower rates of histologic underestimation [28,29,30,31] and imaging-histologic discordance [32]. We hypothesize that these factors accounted for the higher likelihood of sparing surgery and achieving greater cost savings. Our experience indicates that although the 11-gauge device was more expensive than the 14-gauge instruments, it resulted in greater cost savings in these women.
We suggest several steps that may minimize the number of operations necessary in women with calcifications highly suggestive of malignancy. First, an adequate volume of tissue should be obtained at stereotactic biopsy. Previous investigators have suggested that obtaining 1-1.5 g of tissue (i.e., 10-15 specimens with an 11-gauge probe) may minimize the frequency of histologic underestimation and increase diagnostic yield [17, 28]. Second, for women with large (>2 cm) lesions or multiple lesions, sampling more than one site with stereotactic biopsy may decrease the likelihood of sampling error and help to determine the need for more extensive surgery (wider excision or mastectomy) [33] (Fig. 2). Third, if carcinoma is found at stereotactic biopsy of a large (>2 cm) lesion, delineating the lesion borders with bracketing wires during needle localization for definitive surgery may help the surgeon achieve clear histologic margins [34] (Fig. 3A,3B,3C). Finally, for some women with larger areas of stereotactically proven DCIS or DCIS with microinvasion, the surgeon should consider performing sentinel lymphadenectomy during definitive surgery. In a series of selected cases, Klauber-Demore et al. [35] reported sentinel node metastases in 12% (9/76) of women with DCIS and 10% (3/31) of women who had DCIS with microinvasion. The usefulness of these measures in minimizing the number of surgeries should be confirmed in future work.
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Our study has several limitations. Patients were not randomized to stereotactic or surgical biopsy. Differences in the patient populations were evident, including a greater frequency of cancer among the women who had stereotactic rather than surgical biopsy as the initial procedure; for this reason we analyzed outcomes not just for each group as a whole, but for the women with cancer in each group. The improved outcome of stereotactic 11-gauge vacuum-assisted biopsy as compared with other stereotactic biopsy methods may in part reflect our learning curve [36], caused by the sequential use of 14-gauge automated core, 14-gauge vacuum-assisted, and 11-gauge vacuum-assisted technology during the study. Our cost comparisons do not include some potential hidden costs, such as the additional work required for histologic analysis of the larger volume of tissue obtained at vacuum-assisted biopsy as compared with automated core biopsy, work that is generally not reimbursed under current protocols. Finally, because of rapid changes in technology and in reimbursement, the impact of percutaneous biopsy on cost of diagnosis continues to evolve.
Approximately 1 million breast biopsies will be performed this year in the United States; of these, it can be estimated that at least 300,000 will be for nonpalpable lesions identified at screening mammography, approximately 10% of which will be calcifications highly suggestive of malignancy [24, 26]. Stereotactic biopsy decreases the number of operations performed in these women; furthermore, stereotactic 11-gauge vacuum-assisted biopsy, compared with 14-gauge biopsy, has a significantly greater likelihood of sparing surgery and providing greater cost savings. If our results were generalized nationally, the use of stereotactic 11-gauge vacuum-assisted biopsy rather than surgical biopsy for women with calcifications highly suggestive of malignancy would result in annual national savings of $9,450,000. In addition to savings in cost, stereotactic 11-gauge vacuum-assisted biopsy would allow this group of women, most of whom have minimal breast cancer, to benefit from a less invasive diagnostic technique that can expedite definitive treatment.
Acknowledgments
We thank Benson Dutton of the Health Care Financing Administration for
insightful interpretation of Medicare data and David C. Perlman for invaluable
assistance.
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