The authors present data showing that ultrasound-guided needle core biopsy is a safe, accurate, efficient, and less expensive method of diagnosing a highly suspicious breast mass.
The objective of this study was to evaluate the role of
ultrasound (US)-guided core biopsy of highly suspicious breast
lesions in decreasing the cost of establishing the diagnosis. There
were 172 consecutive US-guided breast core biopsies performed
during the calendar year 1994, 35 of which were malignant. These 35
women are the subject of this analysis. Patient charts were
reviewed to determine the results of the core biopsies as well as
the number of surgical procedures performed. The management of
these patients was then contrasted with that of 38 patients
diagnosed with infiltrating carcinoma via needle localization and
open surgical biopsy during a similar time period. Twenty-nine of
the 35 women had a single surgical procedure after the diagnosis of
malignancy was made by US-guided core biopsy. Just 9 of the 38
patients in the needle localization (control) group had only one
surgical procedure. The cost of establishing the diagnosis and
treating patients with infiltrating carcinoma was substantially
less for those diagnosed via US-guided biopsy. US-guided core
biopsy of highly suspicious lesions reduces the number of
subsequent surgical procedures in most women. The cost savings
offer a significant advantage over conventional needle localization
and surgical excision.
Stereotactic core biopsy of breast masses has been shown to be
accurate in establishing a tissue diagnosis of mammographically
detected lesions.1-6 Recently, one group presented data showing
that stereotactic core biopsy of suspicious lesions significantly
reduced the number of surgical procedures performed to manage the
abnormalities.7 However, there are many institutions, such as our
own, that do not have access to a stereotactic unit.
When a nodule is detected by mammography or is palpable, we
perform ultrasound (US) of the relevant quadrant of the breast or
of the palpable nodule. Since 1993, we have been using US to guide
percutaneous needle core biopsy (NCB) of nodules that are visible
sonographically and appear solid. This study was undertaken to
examine the impact of this diagnostic procedure on the surgical
therapy of patients with infiltrating carcinoma of the breast and
to compare it with the management of a group of patients who
underwent needle localization and open surgical biopsy. An analysis
comparing the costs of each management also was undertaken.
Materials and methods
There were 172 US-guided 16-gauge NCBs performed between January
1, 1994 and December 31, 1994. Every patient had a sonographically
solid lesion that had been detected by physical exam, screening
mammography, or US. There were 137 benign lesions and 35 malignant
lesions. The 137 benign lesions are part of an ongoing 24-month
clinical follow-up study to determine the positive predictive value
of the benign diagnosis.
The 35 malignant lesions are the subject of this review. The
pathological diagnoses from the large NCBs in 33 of the 35 patients
who underwent a surgical procedure were compared with the final
pathological diagnoses from the lumpectomy or mastectomy specimens.
In addition, all surgical procedures performed after the NCBs were
reviewed. This study group of 35 patients with the diagnosis of
malignancy by NCB was compared with a control group.
The control group was obtained from 62 consecutive patients
diagnosed between March 1993 and December 1994 with an infiltrating
carcinoma of the breast in the conventional fashion, via needle
localization and open surgical biopsy. Twenty-three of the 62
patients were excluded, as the biopsy was performed for
microcalcifications. An additional patient was excluded because
only ductal carcinoma-in-situ was found. Thirty-eight of the 62
patients presented with a solid nodule on physical exam, screening
mammography, or US and underwent x-ray needle localization and open
surgical biopsy, which revealed infiltrating carcinoma. This route
of diagnosis was chosen because of patient preference or the
preference of the referring physician. This group of 38 patients
with a solid mass and infiltrating carcinoma make up the comparison
Informed consent was obtained prior to the US-guided 16-gauge
NCB. No laboratory studies were performed unless the patient had a
significant history for possible coagulopathy. Aspirin use was
specifically screened. The biopsy technique described previously by
Parker et al was employed.8 The patient was placed in a supine
oblique position with the breast elevated and the ipsilateral arm
extended above the head. The lesion was identified and a mark with
indelible ink was made just above the lesion.
A wide Betadine prep was then performed, centered on the mark.
The transducer was wiped clean with alcohol; a sterile cover was
not used, as it degrades visualization of the needle. Sterile gel
was used as the coupling agent. A 7.5-MHz linear array transducer
was used to localize the lesion in the center of the image. Local
anesthesia was given into the skin immediately adjacent to the end
of the transducer and was continued into the breast up to and
around the lesion.
With the sonographer lining up the lesion and the skin puncture
site, the 16-gauge biopsy needle was introduced and guided under
continuous US visualization to the edge of the lesion. The biopsy
gun was then fired, and US documenta
tion of the biopsy needle passing through the lesion was made.
The needle was removed, and the material obtained was placed in 10%
formalin (figure 1). A total of five passes were made into
different areas of the lesion.9 Manual pressure was maintained by
the sonographer between passes and by the patient for five minutes
after the biopsy. The patient was instructed to avoid aspirin use
for several days.
Thirty-five patients had a diagnosis of malignancy of the breast
established by US-guided 16-gauge needle core biopsy (table 1).
There were 34 cases of infiltrating carcinoma and 1 case of
lymphoma. All 35 cases had adequate tissue in the needle core
biopsies to establish the diagnosis; no re-biopsies were necessary,
and pathologic diagnoses were not equivocal.
Thirty-four of the 35 cases diagnosed as infiltrating carcinoma
were confirmed in the subsequent resections (33 breast excisions, 1
pleural biopsy). There were two diagnoses of lobular carcinoma and
one diagnosis of tubular carcinoma; all were confirmed in the
larger resected specimens. Although lymphatic vascular invasion
(LVI) was seen occasionally in the core biopsies, it was more
common for LVI to be found in the resected specimen rather than in
the core. The core biopsies adequately diagnosed infiltrating
carcinoma; however, the amount of in-situ component, ductal or
lobular, could not be evaluated in the cores. Extensive intraductal
component (EIC), when present in the resected specimen, was not
present in the cores.
The single case of lymphoma diagnosed by core biopsy was
compared to a previous biopsy from another site in the patient. No
additional breast tissue was removed. The histologic appearance of
the lymphoma on the needle core biopsy was identical to an
extramammary biopsy performed 12 years earlier.
Two of the 35 had no subsequent breast surgical procedure; the
patient diagnosed with lymphoma was treated with radiation and
chemotherapy; and one patient with a positive pleural biopsy was
thought to have widely metastatic breast cancer and, thus, was not
a surgical candidate. Twenty-nine of the 35 patients had a single
surgical procedure following the US-guided 16-gauge needle core
biopsy. Eleven of the 29 had mastectomies. Eighteen of the 29 had
lumpectomies plus or minus axillary node dissection. Three of the
35 patients had 2 surgical procedures: initial excision followed by
re-excision or mastectomy.
One of the 35 patients had 3 surgical procedures: excision,
re-excision, and completion mastectomy.
Of the 35 US-guided 16-gauge needle core biopsies performed,
there were no significant hematomas. (The only significant hematoma
during the study period occurred in a patient taking high doses of
aspirin for low back pain. The hematoma resolved completely without
intervention. At follow-up exam, the lesion was re-biopsied and was
found to be a fibroadenoma.) There were no infections, and there
were no clinically significant complications that required medical
or surgical intervention. This is similar to the very low incidence
(6 out of 3,765) of clinically significant complications reported
by Parker et al.1
Nine of the 38 patients in the control group had a single
surgical procedure: the initial surgical biopsy. Five of the nine
had indications for additional surgery, but this was not performed
because of patient refusal (one out of five) or severe medical
conditions that prevented further surgery (four out of five).
Twenty-seven out of 38 patients had 2 surgical procedures
(re-excision, mastectomy, plus or minus axillary node dissection).
Two of the 38 patients had 3 surgical procedures (re-excision,
mastectomy, plus or minus axillary
The cost of establishing the diagnosis of infiltrating carcinoma
was much less in the US-guided 16-gauge needle core biopsy group
than in the conventional needle localization and open surgical
biopsy group (table 2). The total Medicare payment for the
US-guided needle core biopsy was $661.98 in contrast to the total
Medicare payment for needle localization and open surgical biopsy,
which was $2,211.32. Thus, the US-guided NCB provides a 70% savings
under the current Medicare fee structure. This actual savings
corresponds closely to the savings estimated by Parker4 and
The procedure of percutaneous breast biopsy, using either
stereotactic or US guidance, has been demonstrated to be a
reproducible and reliable alternative to surgical biopsy.1-6,11 The
discussion now centers upon the question of which lesions to pursue
with percutaneous biopsy. Some advocate that only indeterminate
lesions be biopsied and not probably benign lesions that previously
would undergo short-term follow-up.3 Franquet et al argue that
aspiration of nonpalpable, probably benign lesions offers the
advantages of immediately relieving patient anxiety and obviating
the need for the patient to comply with mammographic follow-up.12
Disagreement also exists regarding the management of highly
Some authors state that they routinely do not perform core
biopsies in patients with suspicious lesions, as "in most of these
cases, our surgeons request that the lesions be excised to help in
planning of therapy."5
Gisvold et al state that in their practice they recommend
surgical excision for lesions if the likelihood of malignancy is
high, as "core biopsy is considered an unnecessary expenditure of
time and money."3 They do not explain how they arrived at this
Liberman et al came to a different conclusion; they showed that
stereotactic core biopsy of spiculated breast masses resulted in
many fewer surgical procedures.7 However, they did not estimate
cost savings for their patients.
Parker et al reported a series of patients with mammographically
suspicious lesions who underwent stereotactic biopsies;6 they note
that a few of their surgeons have "referred patients with nearly
certain malignant lesions as determined mammographically for
stereotactic gun biopsy so that they could proceed with definitive
In our series, the US-guided 16-gauge NCB of suspicious lesions
significantly changed the surgical management of the patients by
decreasing the number of surgical procedures by 89%, with an
attendant significant decrease in health care costs. Only 4 out of
35 patients in the US-guided NCB group required more than one trip
to the operating room, whereas in the control group diagnosed by
open surgical biopsy, 29 out of 38 patients required more than one
trip to the operating room.
A very important consideration in the treatment of patients with
breast carcinoma is the accuracy of the preoperative diagnosis,
which can enable the surgeon to have a definitive preoperative
discussion with the patient in order to achieve complete surgical
management with a single operative procedure. There was 100%
correlation between the pathological diagnoses of infiltrating
carcinoma made on the US-guided NCBs and the final surgical
resection specimens. Therefore, the positive predictive value of
infiltrating carcinoma of the US-guided NCB was 100%. Parker et al
had a similar positive predictive value of 100% for the diagnosis
of carcinoma using 14-gauge US-guided NCBs.8
In this era of breast cancer treatment oriented towards breast
conservation, complete removal of nonpalpable breast tumors with
radiologic localization is aided by a definitive preoperative
diagnosis of malignancy. In diagnostic localization biopsies, the
surgeon tries to avoid significant cosmetic defect.
However, when one knows the lesion is malignant, the goal is to
accomplish complete removal of the tumor with clear pathologic
margins. This can be accomplished both by making a wider resection
than is customarily done in a diagnostic biopsy, as well as by
taking secondary tissue samples from the biopsy cavity with careful
marking of location to document complete removal of the tumor
Axillary lymph node dissection can then be done through a
separate axillary incision or an en-bloc technique for those
patients in whom an upper outer quadrantectomy is indicated.
Because not all patients desire breast conservation, a definitive
preoperative diagnosis enables those patients to proceed directly
to mastectomy as a single operative event.
Since we began performing US-guided breast biopsies in 1993, our
surgeons have supported enthusiastically the percutaneous biopsy of
highly suspicious lesions. By making a histologic diagnosis of
cancer with NCB, they can use the results to counsel the patient
more accurately prior to definitive surgery, allowing for a more
Prior to our performing NCBs of the suspicious lesion, the
surgeon would have to schedule an appointment with the patient to
discuss the long list of therapeutic options, dependent upon
whether the lesion turned out to be malignant or benign, and then
another appointment after obtaining the results of the open
surgical biopsy to discuss therapy definitively. With the NCB
results in hand, the initial office consultation is more focused
and efficient, and the initial surgical intervention becomes a
definitive therapy rather than a diagnostic test.
These data show that US-guided NCB is a safe, accurate,
efficient, and less expensive method to diagnose a highly
suspicious breast mass. The procedure of US-guided NCB had a 100%
positive predictive value for the diagnosis of infiltrating
carcinoma. It enabled 89% of patients to make a single trip, or
less, to the operating room, and it provided these advantages at
30% of the cost of the conventional approach. AR
The authors would like to thank Ruth McNeill for preparation of
1. Parker SH, Burbank F, Jackman RJ, et al: Percutaneous
large-core breast biopsy: A multi-institutional study. Radiology
2. 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 193:91-95, 1994.
3. Gisvold JJ, Goellner JR, Grant CS, et al: Breast biopsy: A
comparative study of stereotaxically guided core and excisional
techniques. AJR 162:815-820, 1994.
4. Parker SH, Lovin JD, Jobe WE, et al: Stereotactic breast
biopsy with a biopsy gun. Radiology 176:741-747, 1990.
5. Elvecrog EJ, Lechner MC, Nelson MT: Nonpalpable breast
lesions: Correlation of stereotaxic large-core needle biopsy and
surgical biopsy results. Radiology 188:453-455, 1993.
6. Parker SH, Lovin JD, Jobe WE, et al: Nonpalpable breast
lesions: Stereotactic automated large-core biopsies. Radiology
7. Liberman L, Dershaw DD, Rosen PP, et al: Stereotaxic core
biopsy of impalpable spiculated breast masses. AJR 165:551-554,
8. Parker SH, Jobe WE, Dennis MA, et al: Ultrasound-guided
automated large-core breast biopsy. Radiology 187:507-511,
9. Liberman L, Dershaw DD, Rosen PP, et al: Stereotaxic 14-gauge
breast biopsy: How many core biopsy specimens are needed? Radiology
10. Dowlatshahi K, Yaremko ML, Klushens LF, et al: Nonpalpable
breast lesions: Findings of stereotaxic needle-core biopsy and
fine-needle aspiration cytology. Radiology 181:745-750, 1991.
11. Dronkers DJ: Stereotaxic core biopsy of breast lesions.
Radiology 183:631-634, 1992.
12. Franquet T, Cozcolluela R, DeMiguel C: Stereotaxic
fine-needle aspiration of low-suspicion, nonpalpable breast
nodules: Valid alternative to follow-up mammography. Radiology