Usefulness of the Triple Test Score for
Palpable Breast Masses
Arch Surg. 2001;136:1008-1013
Katherine T. Morris, MD; Rodney F. Pommier, MD; Arden Morris, MD;
Waldemar A. Schmidt, MD, PhD; Gregory Beagle, MD; Priscilla W. Alexander, MD;
SuEllen Toth-Fejel, PhD; Josh Schmidt, BS; John T. Vetto, MD
Hypothesis The triple test score (TTS) is useful and accurate for evaluating
palpable breast masses.
Design Diagnostic test study.
Setting University hospital multidisciplinary breast clinic.
Patients Four hundred seventy-nine women with 484 palpable breast lesions
evaluated by TTS from 1991 through July 2000.
Main Outcome
Measures Physical examination,
mammography, and fine-needle aspiration were each assigned a score of 1, 2, or
3 for benign, suspicious, or malignant results; the TTS is the sum of these
scores. The TTS has a minimum score of 3 (concordant benign) and a maximum
score of 9 (concordant malignant). The TTS was correlated with subsequent
histopathologic analysis or follow-up.
Interventions The TTS was prospectively calculated for each mass. Lesions with a
TTS greater than or equal to 5 were excised for histologic confirmation,
whereas lesions with scores less than or equal to 4 were either excised (n =
60) or followed clinically (n = 255).
Results All lesions with TTS less than or equal to 4 were benign on
clinical follow-up, including 8 for which the fine-needle aspiration was the
suspicious component. Of the 60 biopsied lesions, 51 were normal breast tissue,
4 showed fibrocystic change, 1 was a papilloma, and 4 were atypical
hyperplasia. All lesions with a TTS greater than or equal to 6 (n = 130) were
confirmed to be malignant on biopsy. Thus, a TTS less than or equal to 4 has a
specificity of 100% and a TTS greater than or equal to 6 has a sensitivity of
100%. Of the 39 lesions (8%) with scores of 5, 19 (49%) were malignant, and 20
(51%) were benign.
Conclusions The TTS reliably guides evaluation and treatment of palpable
breast masses. Masses scoring 3 or 4 are always benign. Masses with scores
greater than or equal to 6 are malignant and should be treated accordingly.
Confirmatory biopsy is required only for the 8% of the masses that receive a
TTS of 5.
Arch Surg. 2001;136:1008-1013
THE TRIPLE test, initially described in 1975, is
the evaluation of palpable breast masses by physical examination, mammography,
and fine-needle aspiration (FNA) in women aged 40 years and older.1 The triple test is
accurate and can replace open surgical biopsy for diagnosis when all 3
components are concordant; that is, all benign or all malignant. We confirmed
this observation in 1995, resulting in a substantial reduction in the need for
open surgical biopsies at our institution.2 However, we found that
approximately 40% of cases in our experience had nonconcordant tests, thus
requiring biopsy. In 1998, we improved the triple test with the concept of a
triple test score (TTS), in which each component of the triple test was rated
as benign, suspicious, or malignant, and assigned 1, 2, or 3 points,
respectively. This scoring system further allowed us to reduce the number of
required open biopsies when evaluating women aged 40 years or older with
palpable breast masses.3
Our initial description of the TTS in 1998 has
lead us to consider several issues regarding the reliability of the test.
Specifically, we were interested in the safety of observing women with palpable
masses or performing definitive therapy based only on this nonsurgical
diagnostic test. In an effort to address these issues and further assess the
accuracy of this diagnostic tool, we report our continued experience with the
TTS in a multidisciplinary breast clinic.
PATIENTS
Women aged 40 years or older referred to our multidisciplinary breast clinic
between October 1, 1991, and February 1, 2000, for evaluation of palpable
breast masses underwent prospective assessment by simultaneous physical
examination, mammography, and FNA. All patients who underwent a complete TTS at
our institution were entered into the study. In the early part of the series
(October 1, 1991-June 30, 1997), patients who received a TTS of 4 or higher all
underwent open biopsy. In the later part of the series (July 1997-February
2000), patients with scores of 4 were observed clinically, as were most
patients with concordant benign tests, unless the patient or primary care
provider requested a biopsy.
ALGORITHM
Each element of the TTS was given a score of 1, 2, or 3 points for benign,
suspicious, or malignant findings. Physical examination results were determined
by attending breast surgeons, staff radiologists reviewed mammography studies,
and FNAs were performed and analyzed by experienced cytopathologists. Each
element of the TTS was scored prospectively and independently. Patient data, the
results of clinical follow-up, and pathology results were then collected for
all patients and analyzed for this study.
STATISTICAL METHODS
Sensitivity and specificity rates for the TTS and its components were
determined from the standard formulas, as follows: sensitivity = TP/(TP + FN),
and specificity = TN/(TN + FP), where TP indicates true positive; TN, true
negative; FP, false positive; and FN, false negative.4 The criterion standard
was either the pathologic results or the results of clinical follow-up for the
patients who did not receive biopsy.
There were 479 women with 484 breast masses
evaluated. Mean patient age at time of evaluation was 49.5 years. The
presenting complaint for 84% of the women was a new breast mass; 13% presented
with an abnormal mammogram, and a corresponding mass was found in these women
by the clinician on breast examination. Breast pain was the chief complaint for
1.8% of the women, with nipple discharge (0.2%) and other various complaints
(1%) comprising the rest.
As summarized in Table 1,
315 breast masses (65%) had a TTS of 3 or 4 points. All were benign on biopsy
or clinical follow-up. There were no cases of ductal carcinoma in situ (DCIS)
diagnosed on either biopsy or follow-up in this group. The specifics regarding
masses with a TTS of 4 are given in Table 2.
Mean follow-up for patients with a TTS less than or equal to 4 was 14 months.
One hundred thirty breast masses (27%) had a TTS
of 6 points or more. All were invasive carcinoma on biopsy. There were no cases
of DCIS.
Thirty-nine breast masses (8%) had a TTS of 5
points. All had specimens obtained for biopsy, and 19 (49%) were malignant
(including 1 case of DCIS). The specifics of these cases are given in Table 3.
Counting "suspicious" scores as malignant and considering DCIS a
malignancy, FNA (9 FP; 9 FN) and mammography (12 FP; 6 FN) findings were more
accurate than findings from physical examination (17 FP; 7 FN). Thus, when the
TTS was less than or equal to 4, it had a specificity of 100%, and when the TTS
was greater than or equal to 6, it had a sensitivity of 100%. The sensitivity
and specificity of the individual test elements for all the data are summarized
in Table 4.
As of this report, we have used the TTS to
evaluate 484 palpable breast masses in 479 women. After nearly doubling the
size of our original series, the TTS retains its diagnostic sensitivity and
specificity of 100% when the score does not equal 5 points (Table 4).3 This encompasses 92%
of patients in our experience (Table 1).
Therefore, we continue to regard the TTS as a powerful clinical tool that
permits rapid, minimally invasive, and accurate diagnosis of palpable breast
masses.
Since its inception, however, 3 major areas of
clinical concern regarding the use of this scoring system have been identified
by others and us. These have been as follows: (1) whether definitive therapy
can be performed based on a TTS score of at least 6 points, without a
confirmatory frozen section, especially when the score is equal to 6 with
nonmalignant FNA findings; (2) whether it is safe to follow masses with a TTS
of 4 (1 component suspicious) without biopsy; and finally (3) whether weighting
the FNA would permit more definitive diagnosis for some patients with a TTS of
5 points, since FNA is the component with the highest sensitivity and
specificity in previous reports and the current series (Table 4).2-4
With regard to the first issue, the TTS has a
diagnostic accuracy of 100% among patients with malignant breast masses. We do
not believe that obtaining a confirmatory frozen section is necessary for these
patients. The diagnostic accuracy of frozen section for breast masses ranges
from 94.6% to 98.7%, with most incorrect diagnoses being FNs.5-11 We do offer
patients a frozen section biopsy intraoperatively, with the caveat that a FN
frozen section diagnosis is actually more likely than a FP TTS; such an event
might necessitate a second operation. Our department currently makes decisions
regarding confirmatory biopsies or frozen sections based on individual
consideration of the case by the attending surgeon and with an informed consent
process from the patient. Confirmatory biopsies or frozen sections are not
generally performed in patients whose TTS is greater than or equal to 6.
No woman in our series of 484 breast mass
evaluations underwent a modified radical mastectomy or axillary dissection for
DCIS or for a benign lesion. There was only 1 case of DCIS in this series, and
that lesion received a TTS of 5, therefore leading to diagnostic biopsy prior
to any treatment. In theory, it is possible that a woman could receive
overtreatment of a benign or premalignant lesion with this scoring system, and
we inform women of this possibility. However, in our 9 years of experience, no
such errors have occurred. We are therefore confident of the safety of basing
treatment decisions on this 3-part evaluation. In addition, it should be
stressed that women in this study did not receive definitive treatment based
solely on FNA. All therapeutic decisions were based on the results of the
completed TTS. Finally, we believe our low rate of DCIS in this series was
owing to the manner in which women were selected for TTS evaluation; that is,
by presence of a palpable lump. As stated by Harris, "an abnormal
mammographic result is the most common presentation of DCIS."12(p359) We therefore
were less likely to include cases of DCIS in this study.
There were a total of 7 patients with scores of
6 in which all elements (physical examinations, mammography, and FNA) were
suspicious but not definitely malignant. All 7 of these patients had invasive
cancer. In addition, there were 2 cases in which the FNA was scored benign, but
the patient received a TTS of 6 owing to the other test components being scored
as malignant. These patients also had confirmed malignancy on lumpectomy, thus
representing FN FNAs. These cases all illustrate the importance of scoring all
the elements equally, as well as the reliability of a score of 6. Certainly,
confirmatory biopsy with a core needle is an option for women with a TTS
greater than or equal to 6; however, we do not advocate these in general, as
they would only add a procedure and further expense to the workup of these
patients. A TTS greater than or equal to 6 has correlated with 100% malignancy
in this series of nearly 500 breast masses.
It is recognized that on FNA, an atypical
fibroadenoma could potentially result in a score of 2 or 3, resulting in a TTS
greater than or equal to 6 if 1 or more of the other components were labeled as
suspicious.13 Obviously,
this would lead to an incorrect diagnosis of malignancy and inappropriate
treatment of a benign lesion. This has yet to occur in our sample with nearly
500 patients successfully evaluated. However, because of such a possibility, we
inform all patients with a TTS greater than or equal to 6 that they are
entitled to an open or core biopsy or frozen section prior to definitive
treatment if they so choose.
A further advantage of our multidisciplinary
breast clinic is that the cytopathologists are present to perform all FNAs,
therefore reducing the frequency of nondiagnostic FNAs. They immediately assess
the sample for adequacy and then repeat the FNA if the initial sample does not
contain enough breast tissue to adequately place it in either the benign,
suspicious, or malignant categories. Any woman with a mass for which an
adequate FNA sample cannot be obtained is no longer a candidate for the TTS and
undergoes a diagnostic biopsy. This situation, fortunately, is rare for our
cytopathologists.
Regarding the second concern that patients whose
masses receive a score of 4 (1 suspicious component) are only receiving
clinical follow-up, we now report 39 cases with such scores with no
malignancies found either on biopsy or clinical follow-up (Table 2).
Four biopsies in this group did reveal atypical ductal hyperplasia. However,
while we recognize that this lesion is a marker of increased risk for the later
development of breast cancer, it is not a target lesion to be treated and not
considered a malignancy in and of itself.14
Regarding the issue that the FNA should be
weighted, we recognize that the FNA has the highest sensitivity and specificity
of the 3 TTS components and provides a tissue diagnosis.2-4 However, we have
elected not to do this for several reasons. Five patients in our series
received a benign reading of an FNA yet were found on biopsy to have an
invasive cancer (ie, FN FNA findings). Of the 22 patients who received
suspicious readings on FNA, 12 had benign lesions, and 10 had malignancies. It
should be noted, however, that all patients in our study who received a
malignant score for their FNA did, in fact, have a cancer on biopsy (n = 36).
Thus, the FNA, while the most accurate individual test component (Table 4),
does have its share of false results, which could weaken the reliability of the
TTS if the FNA score were weighted.
Determining a way to diagnose patients with
scores of 5 without biopsy continues to elude us. The lack of any major
patterns in data from these patients and the frequent occurrences of both FPs
and FNs for each test element (Table 3),
along with small numbers, prevents us from making any recommendations within
this subgroup. Thus, we believe masses with a TTS equal to 5 will continue to
require biopsy until newer technology for evaluating them, such as improved
breast magnetic resonance imaging techniques, are more established.15
The sensitivity and specificity of the FNA as
performed in our department of pathology (Table 4)
reveal this component of the TTS to be highly accurate, with only an 8% rate of
FNs and 4% FPs in this patient population. Concern has been expressed that
other pathology departments may not be able to reproduce this level of
accuracy. This may or may not be the case, and we recommend each institution
assure their own FNA accuracy rates are similar to ours before incorporating
use of the TTS.
The TTS raises other intriguing clinical issues.
Given the shift toward minimally invasive therapy for breast cancer, it has
been noted by several authors that the sentinel lymph node (SLN) is more
frequently identified and has higher accuracy when performed on patients whose
tumors are still in place.16, 17 By allowing the
definitive diagnosis of malignancy prior to excision of the tumor, the TTS may
enhance the ability to perform SLN biopsy in patients with palpable tumors. In
addition, more patients may be able to have their entire surgical therapy
performed in 1 operation, as opposed to having a biopsy, followed by a
lumpectomy and an SLN biopsy or axillary node dissection.
Diagnosis by TTS may also offer an advantage to
women who elect to have their cancer treated by a modified radical mastectomy.
It is the standard of care for women who have had prior biopsy to have the
biopsy site excised along with the mastectomy. If the lesion were far away from
the nipple-areolar complex, this may require the excision of a considerable
amount of skin. Women who have their diagnosis without undergoing open biopsy
would be more often eligible for skin-sparing mastectomy with immediate
reconstruction.
Finally, as we have reported in a previous
article,2 the use of the
TTS can result in charge reductions of at least $1412 per case. As that
calculation was made at a time when 40% of our patients were still undergoing
open biopsy for definitive diagnosis, use of the TTS can be expected to further
lower patient charges.
In summary, we have used the TTS to successfully
diagnose 484 palpable breast lumps and allow more than 200 women with benign
lesions to avoid open diagnostic biopsy. Further, 130 women have had the option
of proceeding with definitive therapy for their breast cancer without the need
for separate biopsy.
Author/Article Information
From the Departments of Surgery (Drs K. Morris, Pommier, A. Morris, Toth-Fejel,
and Vetto, and Mr Schmidt), Radiology (Drs Beagle and Alexander), and Pathology
(Dr Schmidt), Oregon Health Sciences University, Portland.
Corresponding author and reprints: John T. Vetto, MD, Section of Surgical
Oncology, L223A, 3181 SW Sam Jackson Park Rd, Portland, OR 97201-3098 (e-mail: [log in to unmask]).
Presented at the 72nd Annual Meeting of the
Pacific Coast Surgical Association; Banff, Canada, February 18, 2001.
1.
Johansen C.
A clinical study with special reference to diagnostic procedures.
Acta Clin Scand.
1975;451(suppl):1-70.
2.
Vetto JT, Pommier RF, Schmidt WA, et al.
Use of the "triple test" for palpable breast lesion yields high
diagnostic accuracy and cost savings.
Am J Surg.
1995;169:519-522.
MEDLINE
3.
Morris A, Pommier RF, Schmidt WA, et al.
Accurate evaluation of palpable breast masses by the triple test score.
Arch Surg.
1998;133:930-934.
MEDLINE
4.
Vetto JT, Pommier RF, Schmidt WA, Eppich H, Alexander PW.
Diagnosis of palpable breast lesions in younger women by the modified triple
test is accurate and cost-effective.
Arch Surg.
1996;131:967-974.
MEDLINE
5.
Fessia L, Botta G, Arisio R, et al.
Fine-needle aspiration of breast lesions: role and accuracy in a review of 7495
cases.
Diagn Cytopathol.
1987;3:121-125.
MEDLINE
6.
Bianchi S, Palli D, Ciatto S, et al.
Accuracy and reliability of frozen section diagnosis in a series of 672
nonpalpable breast lesions.
Am J Clin Pathol.
1995;103:199-205.
MEDLINE
7.
Ferreiro JA, Gisvold JJ, Bostwick DG.
Accuracy of frozen-section diagnosis of mammographically directed breast
biopsies: results of 1490 consecutive cases.
Am J Surg Path.
1995;19:1267-1271.
MEDLINE
8.
Sauter ER, Hoffman JP, Ottery FD, et al.
Is frozen section analysis of reexcision lumpectomy margins worthwhile?
Cancer.
1994;73:2607-2612.
MEDLINE
9.
Kaufman Z, Lew S, Griffel B, Dinbar A.
Frozen-section diagnosis in surgical pathology.
Cancer.
1986;57:377-379.
MEDLINE
10.
Fessia L, Ghiringhello B, Arisio R, Botta G, Aimone V.
Accuracy of frozen section diagnosis in breast cancer detection: a review of
4436 biopsies and comparison with cytodiagnosis.
Pathol Res Pract.
1984;179:61-66.
MEDLINE
11.
Caya JG.
Accuracy of breast frozen section diagnosis in the community hospital setting:
a detailed analysis of 628 cases.
Wis Med J.
1991;90:58-61.
MEDLINE
12.
Harris J.
Clinical management of ductal carcinoma in situ.
In: Harris J, Lippman ME, Morrow M, Hellman S, eds. Diseases of the Breast. Philadelphia, Pa: Lippincott-Raven;
1996:355-373.
13.
Kline TS, Kline IK, Howell LP.
Fibroadenoma in Guides to Clinical
Aspiration Biopsy: Breast.
Philadelphia, Pa: Lippincott, Williams & Wilkins; 1989:80-101.
14.
Simmons RM, Osborne MP.
The evaluation of high-risk and pre-invasive breast lesions and the decision
process for follow up and surgical intervention.
Surg Oncol.
1999;8:55-65.
MEDLINE
15.
Tilanus-Linthorst MM, Obdeijn IM, Bartels KC, de Koning HJ, Oudkerk M.
First experiences in screening women at high risk for breast cancer with MR
imaging.
Breast Cancer Res Treat.
2000;63:53-60.
MEDLINE
16.
Tafra L, Lannin DR, Swanson MS, et al.
Multicenter trial of sentinel node biopsy for breast cancer using both
technetium sulfur colloid and isosulfan blue dye.
Ann Surg.
2001;233:51-59.
MEDLINE
17.
Gervasoni JE Jr, Taneja C, Chung MA, Cady B.
Axillary dissection in the context of the biology of lymph node metastases.
Am J Surg.
2000;180:278-283.
MEDLINE
James E. Goodnight, Jr, MD,
PhD, Sacramento, Calif: It is an honor to
discuss this work. I follow Dr Vetto's work very closely, had the honor to
discuss it and go over it with him, and, clearly, he and his group have made
this test work very well. We have 3 presentations this afternoon on how we
efficiently get to a diagnosis and get on with the treatment of breast cancer.
The surgeon confronted with a patient who has a
breast mass has several issues. First is the accuracy of diagnosis. The
patient's welfare depends on this feature and, for that matter, so does
everyone else's, except possibly the unlucky plaintiff attorney who is frozen
out of a tight market. Second, efficiency of the diagnostic process. None of us
have time to waste. Third, cost-effectiveness. Our current market demands this
of us. Fourth, a definitive diagnostic result is essential. Both the surgeon
and the patient need closure. Fifth, patient satisfaction, satisfaction of the
referring MD, and sixth, getting paid for the work, all have to do with staying
in business.
Drs Morris, Vetto, and their colleagues, by this
presentation and their work of long standing, would seem to have satisfied
themselves on the first 3 issues: accuracy, efficiency, and cost-effectiveness,
and happily they are still in business. The triple test works well for them.
They are a multidisciplinary breast clinic where the surgeon, mammographer, and
cytopathologist are quite skillful and work side by side. Their results suggest
that they communicate quite effectively. For this group, a nondefinitive
result, that is, a score of 5, is distinctly uncommon, and a Hardway 6, that
is, a score of 2, 2, and 2, is a definitive diagnosis of cancer. At issue is
whether the obvious utility of the triple test is limited to a well-staffed
multidisciplinary breast clinic, or is it applicable to other practice
settings? The central question is how big will the group of 5 scores be, and
will scores of 4 and 6 be definitive splits between benign and malignant in
someone else's hands?
I will launch quickly into questions for the
authors because I am very interested in their thoughts. (1) Is a dedicated
cytopathologist who examines the patient with you essential for these crisp results?
(2) Do your mammographers use standard mammographic reporting terminology such
as the BIRADS system? (3) Does your pathologist and/or your mammographer know
the surgeon's impression, that is, benign, suspicious, or malignant, when they
evaluate the patient? (4) Do the surgeons, mammographers, and pathologists
communicate verbally rather freely with each other on all or most of the
patients?
I think presumptuously that the answer to each
of these questions is yes, which I believe will indeed decrease the number of 5
scores and increase the sensitivity of the Hardway 6. But, obviously, I want to
know your thoughts. I would also take advantage of the opportunity at the
podium to ask a few practice-related questions. (1) You obviously do FNA
[fine-needle aspiration] biopsies on patients where the surgeon and the
mammographer have each graded the patient as 1, but I presume not all of these
patients. How do you decide who gets the triple test or the FNA biopsy? (2)
Even though it did not occur in your series, a patient with a score of 6 or
greater may have a chance of having ductal carcinoma in situ. How do you decide
before surgery whether you will do a sentinel lymph node biopsy of the axilla?
(3) Do you ever use core needle biopsy? (4) Does your clinic return patients
with a score of 3 and, in particular, 4 to their primary care provider for the
on-going follow-up? And, finally, do your mammographers or do you routinely
ultrasound very discrete smoothly rounded lesions that would seem to be breast
cysts?
Howard Silberman, MD, Los
Angeles, Calif: I am very much
concerned on clinical and medicolegal grounds about the propriety of ignoring a
suspicious FNA despite apparently nonworrisome physical examination and
imaging. There is considerable subjectivity in the criteria for assigning the
reading of "suspicious," depending upon the experience and
self-confidence of the cytopathologist. The senior cytopathologist at the
USC/Norris Cancer Hospital has reported to me that 80% to 90% of the lesions
she regards as "suspicious" on FNA turn out to be malignant on
excisional biopsy. I would like the authors to comment on this if they would.
Similarly, to perform a mastectomy without a definitive histologic confirmation
of a "suspicious" but not definitive FNA seems very risky business to
me. We would always do a frozen section examination if not a prior core or
excisional biopsy.
I. Benjamin Paz, MD, Duarte,
Calif: This shows how
important and how effective you can be by applying the triple test in the
management of breast cancer. I am sure also that these patients were managed in
a prospective breast conference where the concordance was established.
My question is, in ADH [atypical ductal
hyperplasia], the authors said these patients do not require treatment. True,
they don't require treatment for breast cancer. In the NSABP P1 trial,
tamoxifen was shown to reduce 86% the incidence of breast cancer on these
patients. Shouldn't these patients be offered that? If that is the case, should
they be biopsied?
Richard Bold, MD, Sacramento: You specifically applied the triple test score to women over the
age of 40, yet, it is women under the age of 40 who are the most common source
of medicolegal complications from missed breast cancers. Why or cannot this
triple test score be applied to women under 40 and, if it is a limitation in
mammography, are there other imaging modalities that could supplant this for
application of this scoring system to younger women with palpable lesions?
Dr Vetto: I want to thank the Association for the pleasure of presenting
the data today, and I congratulate Dr Morris on an excellent presentation. I
thank Dr Goodnight for his many fine comments and on his kindness in reviewing
the manuscript for us, and I appreciate the other excellent questions from the
other discussants.
As we expected, the questions on our work
generally fall into 3 categories. The first are about the safety and accuracy
of the test. The second group questions the transferability of the test to
other clinical or practice settings. And finally, there were miscellaneous
questions about other applications of the test. So let me take these in order.
First, the safety and accuracy questions. To
begin with Dr Goodnight's, What about scores of greater than or equal to 6
equaling DCIS? We found no such cases in our series. Palpable DCIS is
distinctly unusual, and I think we have shown that. As Dr Goodnight probably
knows, Cox and others have described that using sentinel node for pure DCIS,
one finds a higher-than 6% risk of positive lymph nodes, probably attributable
to what is now called microinvasive DCIS. We think that, especially among
patients who are choosing breast preservation therapy, the triple test lends
itself very nicely to subsequent lumpectomy and sentinel lymph node biopsy
regardless of whether one actually encounters the unusual case of palpable
DCIS.
In terms of follow-up, we do send these patients
back to the primary care providers, particularly if the score is concordant
negative (3). In reports that I have published separately, we are working in
Oregon to educate primary care providers on clinical breast examination so that
patients come to the clinic with more clearly defined worrisome lesions and so
that clinical breast exam can be dealt with more comfort in the community among
patients who are either being primarily followed or have been to the clinic and
now come back to their primary care provider. We have published previously the
finding that teaching primary care providers clinical breast exam by means of a
CME course such as is being sponsored by OHSU increases breast exam accuracy.
In terms of the role of ultrasound for obvious
cysts, we do use in-clinic ultrasound for obvious cysts and aspirate them.
Those patients were not in this series, and the use of ultrasound for triple
testing is a separate issue, which I will discuss at the end.
I would like to thank Dr Silberman for
emphasizing the very reason we developed the triple test score: because no 1
element of the triple test can be safely relied upon as the sole basis for
diagnosis. This includes FNA, which, while the most accurate element, is still
marred by false positives and false negatives. As Dr Silberman points out, by
saying the FNA is "suspicious," the cytopathologist is saying that
the lesion is either benign or malignanthe or
she can't say which for sure. Thus, our scoring system takes this unreliable
piece of information and places it in the context of the other 2 elements of
the score to make it useful.
As you noticed, the suspicious FNA categories,
ie, tests with scores of 4 (early in our experience) that had a suspicious FNA
and all tests with scores of 5 that had suspicious FNA, did go to biopsy. In
terms of scores of 6, the provider still has the option, and this is in the
manuscript, to offer a frozen section prior to definitive therapy, but as we
have shown you so far, we have found no malignancies in that setting. Our test
clearly allows one to proceed with treatment planning and then do the frozen on
the table if desired. In terms of frozen section for mastectomy, same comment.
These are patients that I feel should probably get frozen section prior to proceeding
on the table, especially those patients in whom one is planning bilateral
mastectomy (where the patient has elected contralateral prophylactic
mastectomy) based on a lower malignant score (6 and 7).
In terms of ADH, I believe that the data, when
one looks at subset analysis of the NSABP's study, was fairly weak for the
recommendation of tamoxifen. Yes, if we do encounter ADH, which is typically
found by accident on a biopsy done for another reason, we do counsel that
patient for tamoxifen. In my experience, many of those patients actually do not
go on tamoxifen after they hear the data and/or meet with the genetic
counselor.
In terms of transferability, Dr Goodnight asked
about a dedicated cytopathologist. We showed in 1995 that obtaining the
services of a dedicated cytopathologist is cost-effective, and I would
recommend that to you. Do our radiologists use the BIRADS system? Yes, they do.
In my opinion their task with the triple test score is the easiest. They simply
read the x-ray as they normally would, and if the x-ray is given a BIRADS score
of 1 or 2, then it receives a triple test score of 1. If they read a BIRADS
score of 3 or 4, it receives a triple test score of 2, and if they read it as
BIRADS 5, it receives a score of 3.
Are our evaluators blinded? Actually, they are.
There is some communication that occurs during our multidisciplinary conference
every week, but that is a minority of cases. The data that Dr Morris showed you
was read mostly off of reports. So, yes, the test does work if the results are
blinded. In fact, one of my favorite things to read in the report is "In
the absence of clinical history, this radiographic (or this pathologic)
impression is based on radiographic (or pathologic) grounds only."
Independent scoring is the idea of the test.
In terms of the miscellaneous questions, who
needs an FNA if both scores are benign? I would like to pause for a second and
talk about that. If the patient comes to the clinic and is reported to have a
palpable mass but no mass is found and the mammogram is normal, we document
that "the patient has a negative doublet with no target for triple
testing." If the patient has a lump that is present but it is felt to be
benign and the imaging is negative, we offer the patient FNA, but we do not
hard sell it if the patient is not interested. We simply document their
decision. If the patient has either a suspicious examination or a suspicious
imaging, we do recommend strongly to the patient that they proceed with the
completion of the triplet and the triple test score because if the FNA is then
at least suspicious, they will have a score of 5 and a subsequent 50% chance of
malignancy.
Do we do core-needle biopsy? As originally
described, the triple test includes either FNA or core biopsy. We like FNA because
in our hands it actually is more accurate, allowing one to sample the entire
lesion and not resulting in the sampling error that core can be associated
with. It produces less bleeding. It can be read on site. It does not require a
local anesthetic, and we in general favor cytopathology. In terms of
transferability of the triple test score to the community, I think that this
system is easily transferable to any multidisciplinary clinic in either a
private or university setting. We would highly recommend it for those settings.
If the setting is a multisurgeon private practice not associated with a large
preexisting breast clinic, we would highly recommend obtaining the services of
a skilled cytopathologist.
The clinical practice setting that I see most
difficult for this is the solo practitioner, especially in a rural setting. I
am of the opinion that those providers should consider referral of patients to
multidisciplinary centers; certainly patient pressure leans in that direction.
If the provider wishes to perform a triple test score, that is possible by
performing one's own cytopathology and sending it off. That will, however,
negate the benefit of same-day cytopathology. In fact nowadays a surgeon can
even do their own radiographic interpretation, thanks to the American College
of Surgeons Statement No. 29.
Finally, I would like to close with Dr Bold's
question because it gets to our future plans. What about women younger than 40?
We have previously published a modified triple test in which women of younger
than screening age have a mass evaluated with ultrasound instead of with
mammography. Dr Morris is in the process of culling the data on a modified
triple test score for these women, and we hope to present that data in the
future.
Edward E.
Rylander, M.D.
Diplomat American
Board of Family Practice.
Diplomat American
Board of Palliative Medicine.