A Quality
Study on Mammography-guided Needle Localization Biopsy of Non-palpable Breast
Lesions
A Multi-center Cooperative and Collaborative
Action Research Study
Cathy S. Co,
MD
Orlino C.
Bisquerra, Jr., MD
George G.
Eufemio, MD, FPCS
Reynaldo O.
Joson, MD, MHA, MHPEd, MS Surg
Departments of
Surgery
Manila Doctors
Hospital
Cardinal
Santos Medical Center
Philippine
General Hospital
Reprint Requests: Reynaldo O. Joson,
MD, Department of Surgery, Manila Doctors Hospital, United Nations Avenue,
Ermita, Manila, Philippines.
Email:rjoson@maniladoctors.com.ph
Needle Localization Breast Biopsy
Abstract
Background:
There
is a need to monitor the quality parameter of mammography-guided needle
localization even just in term of malignancy rate.
Objectives: To determine
the malignancy rate of mammography-guided needle localization biopsy of
non-palpable breast lesions in three selected hospitals; to rationalize a
standard of acceptable malignancy rate in the country; and to recommend strategies on how to achieve an
acceptable malignancy rate.
Methods: The records
of three hospitals (2 private hospitals and 1 university hospital) on their
needle-localized breast biopsy were reviewed and analyzed for malignancy rate,
common mammographic findings for breast cancer, and factors in each hospital
that could have influenced the malignancy rate. The average malignancy rate was calculated and compared with
international rate to come out with a standard of acceptable rate for the
country. Strategies to achieve
acceptable rate were recommended.
Results: The overall
average malignancy rate was 21 per cent.
In the private hospitals, the malignancy rates were 22 per cent and 24
per cent while in the university hospital, only 11 per cent. The presence of clustered
microcalcifications on mammography was the main indication for the
needle-localized breast biopsy.
Although majority (76 per cent) of the breast cancers had clustered
microcalcifications, only 19 per cent of patients turned out to have breast
cancer.
Conclusion: An overall 20
per cent malignancy rate is being recommended as standard of quality care in
patients undergoing needle-localized breast biopsy. Recommended strategies
consisted of continuous training of radiologists and surgeons and periodic
tissue review to monitor the malignancy rate.
The primary intention of mammography is
to detect breast cancer in the non-palpable stage. Once findings suspicious for breast cancer are found on the
mammography plates, a mammography-guided needle localization biopsy is then
instituted.
Several large series of needle
localized biopsy of non-palpable breast lesions have been reported in the
literature, with a malignancy rate ranging from 8.7 per cent to 48 per cent
(1-7). The wide range is most likely
due to differences in patient selection criteria as the decision to do a
needle-localized biopsy is initiated by a finding on mammography that the radiologists
and the surgeons suspect to be cancer.
In the Philippines, starting early 90s,
mammography is increasingly being done. A mammography result can end up with
the patient being advised either to undergo needle-localized biopsy of a
detected non-palpable breast lesion or to be followed-up periodically. There is a scarcity of data on the frequency
of patients undergoing needle-localized biopsy after mammography as well as on
the malignancy rate of such a procedure.
As of 2003, there is only published article on the malignancy rate of needle-localized
biopsy so far in the country (9) which showed a 24 per cent malignancy. The authors felt there was a need to get
more data particularly on the malignancy rate of needle-localized biopsy of
non-palpable breast lesions as that a quality standard could be formulated and
promoted in the country. The authors’
concern was that if there is a lot of needle-localized biopsy procedure being
done with a low malignancy rate, then a
quality improvement program would be needed, principally, to reduce the number
of unnecessary procedures and their associated pain and expenses not only on
the part of the patients but also on
hospital resources.
Thus, the primary objective of this
study was to determine the malignancy rate
of mammography-guided needle localization biopsy of non-palpable breast
lesions in three selected hospitals.
The secondary objectives were 1) to determine the common mammographic
findings of breast cancer; 2) to attempt to rationalize a standard of
acceptable malignancy rate in the country; and 3) to recommend strategies on
how to achieve an acceptable malignancy rate in needle-localized breast biopsy.
The records of the three hospitals on
their mammography-guided needle localization biopsy of non-palpable breast
lesions were reviewed and analyzed for malignancy rate, common mammographic
findings for breast cancer, and factors in each hospital that could have
influenced the malignancy rate. The
average malignancy rate from the three selected hospitals was calculated and
compared with international rate to come out with a standard of acceptable rate
for the country. Strategies to achieve
the recommended acceptable rate and even surpass it were formulated after
analyzing the factors in each hospital.
The overall average malignancy rate of
mammography-guided needle localization biopsy of non-palpable breast lesions in
the three selected hospitals was 21 per cent (Table 1). In the first private hospital, the
malignancy rate was 22 per cent; in the second private hospital, it was 24 per
cent; and in the university hospital, it was only 11 per cent.
The presence of clustered microcalcifications
on mammography was the main basis for suspecting breast cancer and, therefore,
the indication for the needle-localized breast biopsy (Table 2). Architectural distortion was the other
basis.
Although majority (76 per cent) of the
breast cancers had clustered microcalcifications (Table 3), only 19 per cent of
patients with suspected clustered microcalfications turned out to have breast
cancer (Table 4). Other the other hand,
only 24 per cent of the breast cancers had architectural distortion and 33 per
cent of patients with architectural distortion turned out to have breast
cancer.
Discussion
Comparing the malignancy rate of
needle-localized breast biopsy of the three selected hospitals, the university
hospital has the lowest at 11 per cent.
Looking at the setting of the hospitals, the main factor that could
explain the marked difference between the private and university hospitals was
the more active role played by consultants in the private hospitals in terms of
attention to details of the mammography plates or findings and in deciding
which patients really needed the procedure or just to observe
periodically. In the university
hospitals, there was a tendency for the surgical residents to just rely on the
interpretations of the radiologists and, as mentioned, for a less active role
in decision-making on the part of the consultants.
The usual scheme in a patient being
subjected to a needle-localized breast biopsy consists of the patient initially
undergoing a mammography for whatever reason.
After the procedure, a radiologist interprets the plates using either
the conventional way of reporting (highly suspicious, suspicious, and probably
benign) and lately, the Breast Imaging Reporting and Data System or BI-RADS
(10). Radiologist’s report of highly
suspicious, suspicious, BI-RADS 4 and 5 findings usually prompts the surgeon to
go for a needle-localized biopsy of non-palpable breast lesion. There are two types of surgeons in terms of
dealing with the radiologist’s report.
One type accepts the radiologist’s report hook, line and sinker and do
the needle-localized breast biopsy. The other type, because of experience in
reading mammography plates, scrutinizes the plates and makes a decision whether
to do a needle-localized breast biopsy or not.
It is in the hands of the second type of surgeons that a higher
malignancy rate is usually found.
The usual basis for suspecting
malignancy is the finding of clustered microcalcifications and architecteral
distortion or abnormality. From the study,
76 per cent of the documented breast cancers had clustered microcalcifications
whereas only 24 per cent had architectural distortion or abnormality. However,
given 100 patients with clustered microcalcifications, based on the aggregated
data in this study, only 19 per cent will turn out to have breast cancer. There is evidently a low degree of positive
predictive value using clustered microcalcifications and architectural
abnormality as parameters in the
diagnosis of the breast cancer from the mammograms. Unfortunately, these are the only two known parameters being used
at present. Compounding the diagnostic
problem is the variability of the readers, radiologists and surgeons alike, in
the interpretations of the parameters.
Despite the diagnostic difficulty,
since the number of patients presenting with non-palpable breast lesions on
mammography is increasing with rampant use of the procedure as a screening test
for breast cancer, a quality standard even just in terms of malignancy rate for
needle-localized biopsy should be made in order to improve patient care.
With the reported range of malignancy
rate being 9 per cent to 48 per cent in the literature (1-7) and with the
average malignancy rate for the three selected hospitals being 21 per cent, for
the moment, the authors suggest setting the acceptable malignancy rate in the
country at 20 per cent. Thus, with this
recommendation, an institution with a malignancy rate below 20 per cent is
considered not rendering quality care in the needle-localized breast biopsy
procedure and should improve. It is
recommended that all institutions, inclusive of all radiologists and all breast
surgeons, doing needle-localized breast biopsy should strive to at least
achieve a 20 per cent malignancy rate.
Gradually, this rate should be increased to as high as 50 per cent , as
this has been reported in one center (8), and even higher to 90 per cent if
possible, to minimize the so-called error of commission in mammography-guided needle localization
biopsy of non-palpable breast lesions.
In terms of quality patient care, this error of commission is translated
as unnecessary procedure with its associated anxiety, pain, and expenses.
To minimize such error of commission,
the radiologists and the surgeons should work closely together to learn and
master the reliable mammographic signs of malignancy by reviewing the plates
after each biopsy. In other words, they
should correlate the biopsy results with the mammographic findings so as to
progressively increase their butting average.
Another important strategy to minimize error of commission is for the
surgeon to play an active role in mastering the reliable mammographic signs of
malignancy and in deciding when a needle-localized breast biopsy is needed or
not. Still another strategy, on an
institutional level, is to have a periodic review of the malignancy rate of the
department of surgery. The authors hope
this paper will be the start of a program to initiate quality care in patients
undergoing mammography-guided needle localization biopsy of non-palpable breast
lesions suspected of being breast cancer.
1. Bigelow R,
Smith R, Goodman PA, Wilson GS. Needle
localization of non-palpable breast masses.
Arch Surg 1985;120:565.
2. Papatestas AE,
Hermann D, Hermann G, Tsevdos C, Lesnick G.
Surgery for non-palpable breast lesions. Arch Surg 1990;125:399.
3. Rusnak CH,
Pengelly DB, Hosie RT, Rusnak CN.
Preoperative needle localization to detect early breast cancer. Am J Surg 1989;157:505.
4. Tresadern JC,
Asbury D, Hartley G, Sellwood RA, Borg-Grech A, Watson RJ. Fine-wire localization and biospy of
non-palpable breast lesions. Br J Surg
2990;77:320.
5. Griffen MM,
Welling RE. Needle-localized biopsy of
the breast. Surg Gynecol Obstet
1990;170:145.
6. Chousair RJ,
Holcomb MB, Mathews R, Hughes TG.
Biopsy of non-palpable breast lesions.
Am J Surg 1988;156:453.
7. Symmonds RE,
Roberts JW. Management of non-palpable breast abnormalities. Ann Surg 1987; 205:520.
8. Vourela AL,
Kettunen S, Punto L. Preoperative hook-wire localization of non-palpable breast
lesions by use of standard and stereotactic technique. Anticancer Res 1993; 13:1873.
9. Eufemio GG,
Tia RC, Liboro MJM, Mercado LA, Billote JB.
A cross-sectional study of non-palpable mammographically detected breast
lesions and the role of needle localization biopsy with frozen section
examination. Philipp J Surg Spec 2002;
57(3): 87-90.
10. American
College of Radiology. Breast Imaging
Reporting and Data System (BI-RADS). 2nd ed. Reston, VA.
American College of Radiology, 1995.
Table 1. Malignancy rates of
mammography-guided needle localization biopsy in the three selected hospitals.
|
|
PH1
(1994-2002) |
PH2 (1994-2000) |
UH (1999-2002) |
Total |
|
Total no. of subjects |
49 |
41 |
27 |
117 |
|
Age range |
27-75 |
32-79 |
33-66 |
|
|
Mean age |
51 |
53 |
49 |
|
|
Malignant |
11 (22%) |
11(24%) |
3 (11%) |
25(21%) |
|
Benign |
38(78%) |
30(73%) |
24(88%) |
92(79%) |
Table 2. Findings of mammography that
led to biopsy.
|
|
PH1
(1994-2002) |
PH2 (1994-2000) |
UH (1999-2002) |
Total |
|
Total no. of subjects |
49 |
41 |
27 |
117 |
|
Microcalcifications (clustered) |
36 (73%) |
35 (85%) |
27 (100%) |
98 (84%) |
|
Architectural distortion |
13 (27%) |
6 (15%) |
0 |
19 (16%) |
Table 3. Proportion of cancer cases with clustered microcalcifications and
architectural distortion.
|
|
PH1
(1994-2002) |
PH2 (1994-2000) |
UH (1999-2002) |
Total |
|
Total no. of cancer subjects |
11 |
11 |
3 |
25 |
|
Microcalcifications (clustered) |
7 (64%) |
9 (82%) |
3 (100%) |
19 (76%) |
|
Architectural distortion |
4 (36%) |
2(18%) |
0 |
6 (24%) |
Table 4. Proportion of clustered microcalcifications
and architectural distortion that turned out to be cancer.
|
|
PH1
(1994-2002) |
PH2 (1994-2000) |
UH (1999-2002) |
Total |
|
Total no. of subjects |
49 |
41 |
27 |
117 |
|
Microcalcifications (clustered) |
7/36 (19%) |
9/35 (26) |
3/27 (11%) |
19/98 (19%) |
|
Architectural distortion |
4/13 (30%) |
2/6 (33%) |
0 |
6/19 (32%) |