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Upgrade rate of core biopsy-determined atypical ductal hyperplasia by open excisional biopsy
The American Journal of Surgery 182 (2001) 355–358
Upgrade rate of core biopsy-determined atypical ductal hyperplasia by open excisional biopsy Robert O. Maganini, M.D.a,b, David A. Klem, M.D.b, Bernard J. Huston, M.D.b, Elizabeth S. Bruner, M.D.b, H. Kurt Jacobs, Ph.D.b,* a
The Breast Health Center, DuPage Medical Group, 1250 N. Mill St., Naperville, IL 60563, USA b Central DuPage Hospital, 25 N. Winfield Rd., Winfield, IL 60190, USA Manuscript received June 29, 2001; revised manuscript July 16, 2001
Presented at the Second Annual Meeting of the American Society of Breast Surgeons, La Jolla, California, May 3– 6, 2001.
Abstract Background: Core biopsy finding of atypical ductal hyperplasia (ADH) are generally followed by open biopsy to avoid underestimation of malignant disease. Methods: Retrospective examination of 11 gauge stereotactic-guided vacuum-assisted core biopsies was made with respect to ADH diagnosis, follow-up open biopsy, and upgrade rate. Readily available clinical, mammographic, and pathologic features potentially contributory to an upgrade were studied. Results: This series of 1,313 patients had 43 ADH diagnoses. Thirty-two had open follow-up. There were 4 upgrades. Mammographic indication for biopsy, age, removal of calcifications, and the percentage of ADH in the specimen were not significant in predicting an upgrade with all probabilities over 0.10, odds ratios not different than 1, and 95% bounds all encompassing 1. Conclusions: These data indicate a high upgrade rate (13%) for ADH-positive core biopsies with no definitive predictive criteria for an upgrade. Our data support follow-up excision of ADH lesions diagnosed by core biopsy. © 2001 Excerpta Medica, Inc. All rights reserved. Keywords: Breast cancer; Stereotactic core biopsy; Atypical ductal hyperplasia; Breast biopsy
Early reports of large core needle biopsies (14-gauge automated systems) for nonpalpable breast lesions showed high rates (near or over 50%) of underdiagnosis when ADH was found [1– 4]. These authors decisively recommended open excisional follow-up. This continues to be the preferred treatment, but as technology has improved to larger volume, image-guided systems, rates of under diagnosis of ADH on the core samples has generally decreased [5–15]. Some authors are postulating that there may be a subset of patients with ADH found on core biopsy that does not need follow-up excisional biopsy [12,13]. These authors showed that criteria may exist that can be used to select patients for mammographic follow-up rather than excisional treatment. We reviewed our own experience to determine the incidence and upgrade rate of ADH. We sought which clinical, mammographic, and pathologic variables might be predic-
* Corresponding author. Tel.: ⫹1-630-933-5281; fax: ⫹1-630-9332700.
tive of an upgrade. We also examined follow-up data on the group of patients who were not excised.
Methods A retrospective review was conducted for all 11-gauge stereotactic-guided vacuum-assisted core biopsies (Biopsys, Ethicon Endo-Surgery, Johnson & Johnson, Cincinnati, Ohio) performed in our hospital between November 1996 and September 2000. Pertinent patient history, pathology records, and specimens, preprocedure and postprocedure mammograms, and patient follow-up information were examined. There were 1,313 patients with 1,553 core biopsies in this group. Variables examined for possible predictive value in predicting an upgrade of ADH were indication for biopsy (mass versus calcifications), patient age (menopausal status unknown), whether or not all calcifications were removed at initial biopsy, and an estimate of the percentage of ADH in
0002-9610/01/$ – see front matter © 2001 Excerpta Medica, Inc. All rights reserved. PII: S 0 0 0 2 - 9 6 1 0 ( 0 1 ) 0 0 7 2 7 - 9
356
R.O. Maganini et al. / The American Journal of Surgery 182 (2001) 355–358
Table 1 Atypical ductal hyperplasia (ADH) findings versus technique First author
Technique used*
Jackman Lieberman Dahlstrom Gadzala Moore Jackman
14 14 14 14 14 14 14 14 11 14 11 14 14 11 11 14 11 11 11
Lin Lieberman Jackman Brem Darling
Adrales O’hea Philpotts Cangiarella Current study
gauge gauge gauge gauge gauge gauge gauge gauge gauge gauge gauge gauge gauge gauge gauge gauge gauge gauge gauge
A A A A A A V, A V, A V, A V, V, V, A V, V, V,
Number of lesions (patients) sampled
Number (%) ADH diagnoses
Number (%) ADH followed by excisional biopsy
Number (%) ADH underdiagnosed
Year of study
450 264 206 (900) 510 1,400 2,093 539 112 483 422 3,873
19 (4.2) 25 (9) 9 (4.5) 39 (4.3) 23 (4.5) 55 (3.9) 88 (4.2) 21 (3.9) 10 (8.9) 25 (5.2) 20 (4.7) 148 (3.8)
1 2 3 4 5 6
1998 1998 1999 1999 2000
7 8 9 10 11
1,081
S S S
753 160 (1,313)
87 (8.1) 27 26 (3.5) 9 (5.6) 43 (3.3)
9 (56) 11 (52) 7 (88) 17 (47) 8 (38) 26 (48) 13 (18) 3 (17) 1 (10) 14 (58) 4 (25) 11 (44) 11 (39) 16 (19) 9 (15) 6 (32) 6 (23) 3 (38) 4 (13)
1994 1995 1996 1997 1997 1997
S S S
16 (84) 21 (84) 8 (89) 36 (92) 21 (91) 54 (98) 74 (84) 18 (86) 10 (100) 24 (96) 16 (80) 25 28 86 62 (71) 19 (70) 26 (100) 8 (89) 32 (74)
2000 2000 2000 2001
12 13 14 15
S S S
Reference citation
* Fourteen-gauge A signifies use of a stereotactic-guided, 22- or 23-mm excursion, automatically firing biopsy device; 14-gauge V, S signifies use of a vacuum-assisted, stereotactic-guided device; 11-gauge V, S is as above with a larger core needle.
the original biopsy specimen (total low power fields comprised of ADH divided by the total number of fields examined). Statistical evaluation was by means of both univariate and multivariate logistic regression. Data are presented as mean values ⫾ standard deviation or as numbers of patients and percentages positive for a given attribute. Systat 7.0.1 (SPSS, Chicago, Illinois) was used to assist data analysis. The definition employed for “upgrade” was any change in stereotactic core biopsy diagnosis from ADH to either DCIS or invasive carcinoma found at open excisional biopsy.
Results Indications for biopsy in this series of 1,313 patients were calcifications in 941 (60.6%) patients and masses in 612 (39.4%) patients. These patients had a total of 1,553 core biopsies. There were 43 patients (3.3%) and 44 core biopsies (2.8%) diagnosed as ADH. Of these 43 cases, 39 (91%) were from patients with calcifications and 4 (9%) were from patients with masses. Thirty-two patients (74%) were followed up with open biopsy. There were 4 upgrades (13% overall) with 3 cases of DCIS and 1 case of invasive carcinoma. All 11 patients (26%) who did not have open biopsy were followed up with mammograms or ultrasound at intervals ranging from 6 months to annually. The follow-up period range is 6 to 48 months with no further upgrades. In an attempt to determine which variables might be
important in predicting an upgrade, both univariate and multivariate logistic regression were used. Of the four variables examined (indication, age, completeness of removal of calcifications, and an estimate of ADH volume in original biopsy specimen), none was statistically significant. In the univariate analysis (upgrade versus selected variable), indication for biopsy was not testable as all four upgrades were from patients with calcifications. Total versus incomplete removal of calcifications at initial biopsy had an odds ratio of 0.774 with 95% bounds from 0.099 to 6.033, P ⫽ 0.807. Volume estimate of ADH had an odds ratio of 0.896 with 95% bounds from 0.772 to 1.040, P ⫽ 0.150. Age had an odds ratio of 1.096 with 95% bounds from 0.977 to 1.229, P ⫽ 0.118. Multivariate regression (automated, stepwise, backwards) using the four variables eliminated all variables except age (odds ratio of 1.113 with 95% bounds of 0.981 to 1.263, P ⫽ 0.096). With only four upgrades in our study, it is not surprising that none of our variables reached statistical significance via logistic regression. These data weakly suggest that a younger age (47 ⫾ 11years versus 58 ⫾ 12 years) may indicate a higher risk of an upgrade. Similarly, a higher proportion of ADH in the original biopsy specimen (13.3% ⫾ 11.7% versus 7.9% ⫾ 5.1%) might also contribute to a higher risk of upgrade.
Comments The overall incidence of ADH of 3.3%, which we report, is somewhat lower than that seen in Table 1. Generally, core
R.O. Maganini et al. / The American Journal of Surgery 182 (2001) 355–358
breast biopsies are performed more for patients with calcifications than with masses. Initially, the practice at our institution was to use core biopsy for both masses and calcifications. Over the past 3 years, US-guided 14-gauge core biopsy is increasingly being performed for masses. In our 941 patients with calcifications, 39 were found with ADH. This is a rate of 4.1%, consistent with other studies (Table 1). Only 4 out of 612 patients with masses (0.7%) had a diagnosis of ADH. One factor which will affect the upgrade rate for ADH is the subjective nature of the diagnosis of ADH. A diagnosis of ADH is made when an intraductal lesion exhibits some, but not all, of the architectural and cytological features of DCIS. In addition to qualitative criteria, many pathologists also apply quantitative criteria and diagnose ADH rather than DCIS when only a single ductal space is involved by an epithelial proliferation that would otherwise meet the criteria for DCIS. These criteria are not precisely defined. Thus, the upgrade rate will be affected by how liberal or conservative the pathologist is in making a diagnosis of ADH from a stereotactic core biopsy [16]. The 13% upgrade rate found in this study is consistent with recent publications utilizing large core vacuum-assisted devices. As with other series, the majority of the upgrades were to DCIS. The one upgrade we report to invasive cancer was in a patient who refused open biopsy. This patient was followed with 6 month interval mammography until the redevelopment of calcifications at the original biopsy site at about 24 months prompted an open excisional biopsy. This patient is reported as an excisional follow-up in this study. The practice of following up patients with ADH diagnosed at core biopsy with open excisional biopsy is well founded. Practice and patient preferences, however, sometimes dictate against this. In many recent studies, 15% to 30% of the patients found to have ADH on core biopsy did not have reexcision (Table 1). This is well demonstrated in our series where 11 patients were followed up by mammogram or ultrasonography out to 4 years. Reasons for not performing open excisional biopsy included advanced patient age, very small size of lesion, patient refusal or practice preference. Follow-up data on these patients are essential to accurately determine the upgrade rate. Most of these upgrades appear in the first 24 months, but follow-up to a minimum of 36 months has been suggested by Jackman [9]. Even with improvements in core biopsy technology, the risk of an upgrade in a relatively high percentage of patients may well outweigh the benefits of careful follow-up examinations and imaging only. However, two recent reports [12,13] suggested that a subset of patients might exist who do not require open excision. Andrales et al [12] followed up 62 patients with ADH found on core biopsy with an overall rate of ADH in their patient group of 8.5%. They found an upgrade rate of 15% and examined a number of variables for predictive value. Marked atypia at biopsy, incomplete removal of calcifications at initial biopsy, and a
357
personal history of previous breast cancer all attained significance in predicting a benign versus a malignant pathology. O’Hea and Tornos [13] separated their ADH patients into three groups of ADH severity as defined by the pathologic criteria of Page and Rogers [16]. In their patients with “mild or focal atypia,” none of 8 patients had cancer on open excisional follow-up. Two of 6 patients with “true ADH” had cancer at excisional follow-up and 4 of 5 patients with “ADH, borderline DCIS” had cancer at follow-up. Their suggestion is that the latter two groups continue to have excisional follow-up procedures while the first group may be observed. We could not show statistically significant factors to select patients for more conservative treatment after a large core vacuum-assisted biopsy diagnosis of ADH. If generally acceptable criteria could be defined, excisional biopsy may be avoided in a small percentage of all large core vacuum assisted biopsies for calcifications. The question arises as to whether this sparing of a small percentage of patients outweighs the risk of missing DCIS or invasive cancer in an even smaller percentage of patients. Clearly, cases will occur where clinical judgment, patient preference or the use of previously suggested criteria [12,13], will result in patients who will not receive excision after a core biopsy finding of ADH. The risk/benefit ratio in these situations is affected by the likelihood that most of the upgrades will be DCIS and the availability and compliance of the patient for imaging follow-up. Mammographic follow-up should be done to 36 months in these cases as previously suggested [9]. Until more definitive data are developed that may define a subset of patients who do not require excisional biopsy, the practice of excisional biopsy remains the treatment of choice for patients with ADH diagnosed on core biopsy. Careful mammographic follow-up of any nonexcised patients is essential and should identify missed lesions.
References [1] Jackman RJ, Nowels KW, Shepard MJ, et al. Stereotaxic large-core needle biopsy of 450 nonpalpable breast lesions with surgical correlation in lesions with cancer or atypical hyperplasia. Radiology 1994; 193:91–5. [2] Liberman L, Cohen MA, Dershaw DD, et al. Atypical ductal hyperplasia diagnosed at stereotaxic core biopsy of breast lesions: an indication for surgical biopsy. AJR Am J Roentgenol 1995;164: 1111–13. [3] Dahlstrom JE, Jain S, Sutton T, Sutton S. Diagnostic accuracy of stereotactic core biopsy in a mammographic breast cancer screening programme. Histopathology 1996;28:421–7. [4] Gadzala DE, Cederbom GJ, Bolton JS, et al. Appropriate management of atypical ductal hyperplasia diagnosed by stereotactic core needle breast biopsy. Ann Surg Oncol 1997;4:283– 6. [5] Moore MM, Hargett CW, Hanks JB, et al. Association of breast cancer with the finding of atypical ductal hyperplasia at core breast biopsy. Ann Surg 1997;225:726 –33. [6] Jackman RJ, Burbank F, Parker SH, et al. Atypical ductal hyperplasia diagnosed at stereotactic breast biopsy: improved reliability with
358
[7]
[8]
[9]
[10]
R.O. Maganini et al. / The American Journal of Surgery 182 (2001) 355–358 14-gauge, directional, vacuum-assisted biopsy. Radiology 1997;204: 485– 8. Lin PH, Clyde JC, Bates DM, et al. Accuracy or stereotactic coreneedle breast biopsy in atypical ductal hyperplasia. Am J Surg 1998; 175:380 –2. Liberman L, Smolkin JH, Dershaw DD, et al. Calcification retrieval at stereotactic, 11 gauge, directional, vacuum-assisted breast biopsy. Radiology 1998;208:251– 60. Jackman RJ, Nowels KW, Rodriguez-Soto J, et al. Stereotactic, automated, large-core needle biopsy of nonpalpable breast lesions: false-negative and histologic underestimation rates after long-term follow-up. Radiology 1999;210:799 – 805. Brem RF, Behrndt VS, Sanow L, Gatewood OMB. Atypical ductal hyperplasia: histologic underestimation of carcinoma in tissue harvested from impalpable breast lesions using 11-gauge stereotactically guided directional vacuum-assisted biopsy. AJR Am J Roentgenol 1999;172:1405–7.
[11] Rosenfield Darling ML, Smith DN, et al. Atypical ductal hyperplasis and ductal carcinoma in situ as revealed by large-core needle breast biopsy: results of surgical excision. AJR Am J Roentgenol 2000:175:1341– 6. [12] Andrales G, Turk P, Wallace T, et al. Is surgical excision necessary for atypical ductal hyperplasia of the breast diagnosed by mammotome? Am J Surg 2000;180:313–15. [13] O’Hea BJ, Tornos C. Mild ductal atypia after large-core needle biopsy of the breast: is surgical excision always necessary? Surgery 2000;128:738 – 43. [14] Philpotts LE, Lee CH, Horvath LJ, et al. Underestimation of breast cancer with 11-gauge vacuum suction biopsy. AJR Am J Roentgenol 2000;175:1047–50. [15] Cangiarella J, Waisman J, Symmans WF, et al. Mammotome core biopsy for mammary microcalcification. Cancer 2001;91:173–7. [16] Page DL, Rogers LW. Combined histologic and cytologic criteria for the diagnosis of mammary atypical ductal hyperplasia. Hum Pathol 1992;23:1095–7.
Upgrade rate of core biopsy-determined atypical ductal hyperplasia by open excisional biopsy Robert O. Maganini, M.D.a,b, David A. Klem, M.D.b, Bernard J. Huston, M.D.b, Elizabeth S. Bruner, M.D.b, H. Kurt Jacobs, Ph.D.b,* a
The Breast Health Center, DuPage Medical Group, 1250 N. Mill St., Naperville, IL 60563, USA b Central DuPage Hospital, 25 N. Winfield Rd., Winfield, IL 60190, USA Manuscript received June 29, 2001; revised manuscript July 16, 2001
Presented at the Second Annual Meeting of the American Society of Breast Surgeons, La Jolla, California, May 3– 6, 2001.
Abstract Background: Core biopsy finding of atypical ductal hyperplasia (ADH) are generally followed by open biopsy to avoid underestimation of malignant disease. Methods: Retrospective examination of 11 gauge stereotactic-guided vacuum-assisted core biopsies was made with respect to ADH diagnosis, follow-up open biopsy, and upgrade rate. Readily available clinical, mammographic, and pathologic features potentially contributory to an upgrade were studied. Results: This series of 1,313 patients had 43 ADH diagnoses. Thirty-two had open follow-up. There were 4 upgrades. Mammographic indication for biopsy, age, removal of calcifications, and the percentage of ADH in the specimen were not significant in predicting an upgrade with all probabilities over 0.10, odds ratios not different than 1, and 95% bounds all encompassing 1. Conclusions: These data indicate a high upgrade rate (13%) for ADH-positive core biopsies with no definitive predictive criteria for an upgrade. Our data support follow-up excision of ADH lesions diagnosed by core biopsy. © 2001 Excerpta Medica, Inc. All rights reserved. Keywords: Breast cancer; Stereotactic core biopsy; Atypical ductal hyperplasia; Breast biopsy
Early reports of large core needle biopsies (14-gauge automated systems) for nonpalpable breast lesions showed high rates (near or over 50%) of underdiagnosis when ADH was found [1– 4]. These authors decisively recommended open excisional follow-up. This continues to be the preferred treatment, but as technology has improved to larger volume, image-guided systems, rates of under diagnosis of ADH on the core samples has generally decreased [5–15]. Some authors are postulating that there may be a subset of patients with ADH found on core biopsy that does not need follow-up excisional biopsy [12,13]. These authors showed that criteria may exist that can be used to select patients for mammographic follow-up rather than excisional treatment. We reviewed our own experience to determine the incidence and upgrade rate of ADH. We sought which clinical, mammographic, and pathologic variables might be predic-
* Corresponding author. Tel.: ⫹1-630-933-5281; fax: ⫹1-630-9332700.
tive of an upgrade. We also examined follow-up data on the group of patients who were not excised.
Methods A retrospective review was conducted for all 11-gauge stereotactic-guided vacuum-assisted core biopsies (Biopsys, Ethicon Endo-Surgery, Johnson & Johnson, Cincinnati, Ohio) performed in our hospital between November 1996 and September 2000. Pertinent patient history, pathology records, and specimens, preprocedure and postprocedure mammograms, and patient follow-up information were examined. There were 1,313 patients with 1,553 core biopsies in this group. Variables examined for possible predictive value in predicting an upgrade of ADH were indication for biopsy (mass versus calcifications), patient age (menopausal status unknown), whether or not all calcifications were removed at initial biopsy, and an estimate of the percentage of ADH in
0002-9610/01/$ – see front matter © 2001 Excerpta Medica, Inc. All rights reserved. PII: S 0 0 0 2 - 9 6 1 0 ( 0 1 ) 0 0 7 2 7 - 9
356
R.O. Maganini et al. / The American Journal of Surgery 182 (2001) 355–358
Table 1 Atypical ductal hyperplasia (ADH) findings versus technique First author
Technique used*
Jackman Lieberman Dahlstrom Gadzala Moore Jackman
14 14 14 14 14 14 14 14 11 14 11 14 14 11 11 14 11 11 11
Lin Lieberman Jackman Brem Darling
Adrales O’hea Philpotts Cangiarella Current study
gauge gauge gauge gauge gauge gauge gauge gauge gauge gauge gauge gauge gauge gauge gauge gauge gauge gauge gauge
A A A A A A V, A V, A V, A V, V, V, A V, V, V,
Number of lesions (patients) sampled
Number (%) ADH diagnoses
Number (%) ADH followed by excisional biopsy
Number (%) ADH underdiagnosed
Year of study
450 264 206 (900) 510 1,400 2,093 539 112 483 422 3,873
19 (4.2) 25 (9) 9 (4.5) 39 (4.3) 23 (4.5) 55 (3.9) 88 (4.2) 21 (3.9) 10 (8.9) 25 (5.2) 20 (4.7) 148 (3.8)
1 2 3 4 5 6
1998 1998 1999 1999 2000
7 8 9 10 11
1,081
S S S
753 160 (1,313)
87 (8.1) 27 26 (3.5) 9 (5.6) 43 (3.3)
9 (56) 11 (52) 7 (88) 17 (47) 8 (38) 26 (48) 13 (18) 3 (17) 1 (10) 14 (58) 4 (25) 11 (44) 11 (39) 16 (19) 9 (15) 6 (32) 6 (23) 3 (38) 4 (13)
1994 1995 1996 1997 1997 1997
S S S
16 (84) 21 (84) 8 (89) 36 (92) 21 (91) 54 (98) 74 (84) 18 (86) 10 (100) 24 (96) 16 (80) 25 28 86 62 (71) 19 (70) 26 (100) 8 (89) 32 (74)
2000 2000 2000 2001
12 13 14 15
S S S
Reference citation
* Fourteen-gauge A signifies use of a stereotactic-guided, 22- or 23-mm excursion, automatically firing biopsy device; 14-gauge V, S signifies use of a vacuum-assisted, stereotactic-guided device; 11-gauge V, S is as above with a larger core needle.
the original biopsy specimen (total low power fields comprised of ADH divided by the total number of fields examined). Statistical evaluation was by means of both univariate and multivariate logistic regression. Data are presented as mean values ⫾ standard deviation or as numbers of patients and percentages positive for a given attribute. Systat 7.0.1 (SPSS, Chicago, Illinois) was used to assist data analysis. The definition employed for “upgrade” was any change in stereotactic core biopsy diagnosis from ADH to either DCIS or invasive carcinoma found at open excisional biopsy.
Results Indications for biopsy in this series of 1,313 patients were calcifications in 941 (60.6%) patients and masses in 612 (39.4%) patients. These patients had a total of 1,553 core biopsies. There were 43 patients (3.3%) and 44 core biopsies (2.8%) diagnosed as ADH. Of these 43 cases, 39 (91%) were from patients with calcifications and 4 (9%) were from patients with masses. Thirty-two patients (74%) were followed up with open biopsy. There were 4 upgrades (13% overall) with 3 cases of DCIS and 1 case of invasive carcinoma. All 11 patients (26%) who did not have open biopsy were followed up with mammograms or ultrasound at intervals ranging from 6 months to annually. The follow-up period range is 6 to 48 months with no further upgrades. In an attempt to determine which variables might be
important in predicting an upgrade, both univariate and multivariate logistic regression were used. Of the four variables examined (indication, age, completeness of removal of calcifications, and an estimate of ADH volume in original biopsy specimen), none was statistically significant. In the univariate analysis (upgrade versus selected variable), indication for biopsy was not testable as all four upgrades were from patients with calcifications. Total versus incomplete removal of calcifications at initial biopsy had an odds ratio of 0.774 with 95% bounds from 0.099 to 6.033, P ⫽ 0.807. Volume estimate of ADH had an odds ratio of 0.896 with 95% bounds from 0.772 to 1.040, P ⫽ 0.150. Age had an odds ratio of 1.096 with 95% bounds from 0.977 to 1.229, P ⫽ 0.118. Multivariate regression (automated, stepwise, backwards) using the four variables eliminated all variables except age (odds ratio of 1.113 with 95% bounds of 0.981 to 1.263, P ⫽ 0.096). With only four upgrades in our study, it is not surprising that none of our variables reached statistical significance via logistic regression. These data weakly suggest that a younger age (47 ⫾ 11years versus 58 ⫾ 12 years) may indicate a higher risk of an upgrade. Similarly, a higher proportion of ADH in the original biopsy specimen (13.3% ⫾ 11.7% versus 7.9% ⫾ 5.1%) might also contribute to a higher risk of upgrade.
Comments The overall incidence of ADH of 3.3%, which we report, is somewhat lower than that seen in Table 1. Generally, core
R.O. Maganini et al. / The American Journal of Surgery 182 (2001) 355–358
breast biopsies are performed more for patients with calcifications than with masses. Initially, the practice at our institution was to use core biopsy for both masses and calcifications. Over the past 3 years, US-guided 14-gauge core biopsy is increasingly being performed for masses. In our 941 patients with calcifications, 39 were found with ADH. This is a rate of 4.1%, consistent with other studies (Table 1). Only 4 out of 612 patients with masses (0.7%) had a diagnosis of ADH. One factor which will affect the upgrade rate for ADH is the subjective nature of the diagnosis of ADH. A diagnosis of ADH is made when an intraductal lesion exhibits some, but not all, of the architectural and cytological features of DCIS. In addition to qualitative criteria, many pathologists also apply quantitative criteria and diagnose ADH rather than DCIS when only a single ductal space is involved by an epithelial proliferation that would otherwise meet the criteria for DCIS. These criteria are not precisely defined. Thus, the upgrade rate will be affected by how liberal or conservative the pathologist is in making a diagnosis of ADH from a stereotactic core biopsy [16]. The 13% upgrade rate found in this study is consistent with recent publications utilizing large core vacuum-assisted devices. As with other series, the majority of the upgrades were to DCIS. The one upgrade we report to invasive cancer was in a patient who refused open biopsy. This patient was followed with 6 month interval mammography until the redevelopment of calcifications at the original biopsy site at about 24 months prompted an open excisional biopsy. This patient is reported as an excisional follow-up in this study. The practice of following up patients with ADH diagnosed at core biopsy with open excisional biopsy is well founded. Practice and patient preferences, however, sometimes dictate against this. In many recent studies, 15% to 30% of the patients found to have ADH on core biopsy did not have reexcision (Table 1). This is well demonstrated in our series where 11 patients were followed up by mammogram or ultrasonography out to 4 years. Reasons for not performing open excisional biopsy included advanced patient age, very small size of lesion, patient refusal or practice preference. Follow-up data on these patients are essential to accurately determine the upgrade rate. Most of these upgrades appear in the first 24 months, but follow-up to a minimum of 36 months has been suggested by Jackman [9]. Even with improvements in core biopsy technology, the risk of an upgrade in a relatively high percentage of patients may well outweigh the benefits of careful follow-up examinations and imaging only. However, two recent reports [12,13] suggested that a subset of patients might exist who do not require open excision. Andrales et al [12] followed up 62 patients with ADH found on core biopsy with an overall rate of ADH in their patient group of 8.5%. They found an upgrade rate of 15% and examined a number of variables for predictive value. Marked atypia at biopsy, incomplete removal of calcifications at initial biopsy, and a
357
personal history of previous breast cancer all attained significance in predicting a benign versus a malignant pathology. O’Hea and Tornos [13] separated their ADH patients into three groups of ADH severity as defined by the pathologic criteria of Page and Rogers [16]. In their patients with “mild or focal atypia,” none of 8 patients had cancer on open excisional follow-up. Two of 6 patients with “true ADH” had cancer at excisional follow-up and 4 of 5 patients with “ADH, borderline DCIS” had cancer at follow-up. Their suggestion is that the latter two groups continue to have excisional follow-up procedures while the first group may be observed. We could not show statistically significant factors to select patients for more conservative treatment after a large core vacuum-assisted biopsy diagnosis of ADH. If generally acceptable criteria could be defined, excisional biopsy may be avoided in a small percentage of all large core vacuum assisted biopsies for calcifications. The question arises as to whether this sparing of a small percentage of patients outweighs the risk of missing DCIS or invasive cancer in an even smaller percentage of patients. Clearly, cases will occur where clinical judgment, patient preference or the use of previously suggested criteria [12,13], will result in patients who will not receive excision after a core biopsy finding of ADH. The risk/benefit ratio in these situations is affected by the likelihood that most of the upgrades will be DCIS and the availability and compliance of the patient for imaging follow-up. Mammographic follow-up should be done to 36 months in these cases as previously suggested [9]. Until more definitive data are developed that may define a subset of patients who do not require excisional biopsy, the practice of excisional biopsy remains the treatment of choice for patients with ADH diagnosed on core biopsy. Careful mammographic follow-up of any nonexcised patients is essential and should identify missed lesions.
References [1] Jackman RJ, Nowels KW, Shepard MJ, et al. Stereotaxic large-core needle biopsy of 450 nonpalpable breast lesions with surgical correlation in lesions with cancer or atypical hyperplasia. Radiology 1994; 193:91–5. [2] Liberman L, Cohen MA, Dershaw DD, et al. Atypical ductal hyperplasia diagnosed at stereotaxic core biopsy of breast lesions: an indication for surgical biopsy. AJR Am J Roentgenol 1995;164: 1111–13. [3] Dahlstrom JE, Jain S, Sutton T, Sutton S. Diagnostic accuracy of stereotactic core biopsy in a mammographic breast cancer screening programme. Histopathology 1996;28:421–7. [4] Gadzala DE, Cederbom GJ, Bolton JS, et al. Appropriate management of atypical ductal hyperplasia diagnosed by stereotactic core needle breast biopsy. Ann Surg Oncol 1997;4:283– 6. [5] Moore MM, Hargett CW, Hanks JB, et al. Association of breast cancer with the finding of atypical ductal hyperplasia at core breast biopsy. Ann Surg 1997;225:726 –33. [6] Jackman RJ, Burbank F, Parker SH, et al. Atypical ductal hyperplasia diagnosed at stereotactic breast biopsy: improved reliability with
358
[7]
[8]
[9]
[10]
R.O. Maganini et al. / The American Journal of Surgery 182 (2001) 355–358 14-gauge, directional, vacuum-assisted biopsy. Radiology 1997;204: 485– 8. Lin PH, Clyde JC, Bates DM, et al. Accuracy or stereotactic coreneedle breast biopsy in atypical ductal hyperplasia. Am J Surg 1998; 175:380 –2. Liberman L, Smolkin JH, Dershaw DD, et al. Calcification retrieval at stereotactic, 11 gauge, directional, vacuum-assisted breast biopsy. Radiology 1998;208:251– 60. Jackman RJ, Nowels KW, Rodriguez-Soto J, et al. Stereotactic, automated, large-core needle biopsy of nonpalpable breast lesions: false-negative and histologic underestimation rates after long-term follow-up. Radiology 1999;210:799 – 805. Brem RF, Behrndt VS, Sanow L, Gatewood OMB. Atypical ductal hyperplasia: histologic underestimation of carcinoma in tissue harvested from impalpable breast lesions using 11-gauge stereotactically guided directional vacuum-assisted biopsy. AJR Am J Roentgenol 1999;172:1405–7.
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