Palpable breast mass evaluation

Palpable breast mass evaluation •

Updated 2012 Nov 16 02:21:00 PM: fine needle aspiration may have high rate of inadequate specimen collection with similar diagnostic accuracy as core needly biopsy (Am J Surg 2012 Aug) view updateShow more updates

Related Summaries: • •

Breast cancer in women Breast cancer screening

•

Breast cancer (list of topics)

Overview: •

most breast masses are benign (most commonly fibroadenoma), but breast mass associated with increased risk of breast cancer in postmenopausal women

•

imaging tests for initial evaluation o

for women ≥ 30 years old - mammography, immediately followed by ultrasound

o

for women < 30 years old - ultrasound of breast, then mammography only if suspicious for malignancy

•

aspiration may be adequate if simple cyst, no residual mass, and no bloody aspirate

•

if suspicious for malignancy on clinical exam or imaging o

core needle biopsy associated with higher diagnostic accuracy for detection of breast cancer than fine needle aspiration cytology in patients with palpable breast masses (level 2 [mid-level] evidence)

o

consider triple test score 

clinical exam, imaging, and tissue sampling each scored 1 for benign, 2 for suspicious, and 3 for malignant



triple test score validated to be accurate for diagnosing breast cancer if score ≥ 6 and rule out breast cancer if score 3-4 (level 1 [likely reliable] evidence)



excisional biopsy recommended if triple test score 5 (inconsistent results)

Clinical Significance • most breast masses are benign(1) •

breast symptoms associated with increased risk of breast cancer in postmenopausal women o

based on study of 57,681 postmenopausal women having diagnostic or screening mammogram

o

13,524 diagnostic and 110,323 screening exams were done and women followed for 1 year after mammogram

o

rates of cancer on diagnostic exam

o

o



in women with no symptoms - 41 per 1,000 women per year



in women with lump - 66 per 1,000 women per year (odds ratio [OR] 2.8, 95% CI 2.3-3.4)



in women with nipple discharge - 53 per 1,000 women per year (OR 1.5, 95% CI 1-2.3)



in women with pain - 52 per 1,000 women per year (OR 1.4, 95% CI 0.9-1.6)

rates of cancer on screening exam 

in women with no symptoms - 6 per 1,000 women per year



in women with lump - 22 per 1,000 women per year (OR 3.6, 95% CI 2.6-5)



in women with nipple discharge - 11 per 1,000 women per year (OR 1.8, 95% CI 1-3.4)



in women with pain - 9 per 1,000 women per year (OR 1.5, 95% CI 0.8-1.9)

Reference - J Am Board Fam Pract 2004 Nov-Dec;17(6):408 full-text

Risk Factors for Breast Cancer • Breast Cancer Risk Assessment Tool (Gail model) can predict risk for breast cancer in most women • genetic risk factors include o

family history of breast cancer

o

BRCA mutation

o •

•

•

rare genetic conditions

for postmenopausal hormone replacement therapy (HRT) o

combination estrogen plus progestin increases risk (level 1 [likely reliable] evidence)

o

estrogen alone may not increase risk for short-term use but may increase risk with use > 5 years (level 2 [mid-level] evidence)

for hormonal contraceptives o

combination oral contraceptive use associated with small increase in risk for breast cancer during use and for up to 10 years after cessation (level 2 [midlevel] evidence)

o

progestin-only contraceptive use not associated with increased risk for breast cancer (level 2 [mid-level] evidence)

breast-related risk factors include o

mammographic density

o

carcinoma in situ and other histologic lesions

•

overweight and weight gain associated with increased risk in postmenopausal women

•

radiation therapy to chest associated with increased risk

•

lifestyle factors affecting breast cancer risk may include

•

•

o

dietary factors (but evidence inconsistent)

o

alcohol use

o

tobacco use

possible risk factors with limited or inconsistent evidence include o

history of childhood cancer

o

gestational diabetes

o

infertility treatment

o

organochlorine compounds

see Risk factors for breast cancer for details

History and Physical

History: History of present illness (HPI): •

•

ask about o duration of mass(1) o

change in mass size(1, 3)

o

changes related to menstrual cycle(1, 2, 3)

ask about related symptoms o

breast tenderness or swelling(1, 2, 3)

o

history of fever(1)

o

nipple discharge(3) 

pathologic cause more likely if patient > 50 years old, or discharge is bloody, blood-containing, watery, unilateral, spontaneous, or involves a single duct



physiologic cause more likely with discharge that is bilateral, multiduct, multicolored or milky, sticky, and occurs with stimulation

•

ask about history of breastfeeding and current lactation status(1, 2)

•

ask about hormonal medication use o

prior or current use of oral contraceptives(1, 3)

o

estrogen or hormone replacement therapy(1, 3)

Past medical history (PMH): •

findings that may be associated with higher risk for breast cancer include o family history of breast cancer o

postmenopausal hormone replacement therapy (HRT)

o

contralateral breast cancer

o

cancer of uterus or ovary

o

atypical hyperplasia

o

breast carcinoma in situ

o

radiation therapy to chest

o

see Risk factors for breast cancer for details

•

ask about o

prior breast mass or biopsy(1, 2, 3)

o

recent breast trauma or surgery(1, 2)

Family history (FH): •

ask about(3) o breast cancer in first-degree relatives o

mother, sister, or daughter with history of breast or ovarian cancer before age 50 years or positive test for mutated breast cancer genes (if so, consider BRCA mutation testing)

Physical: General physical: •

fever and chills may be indicative of infection (such as mastitis)(1, 3)

Breast exam: • •

look for signs of infection (skin may be red, tender, and warm)(1, 2, 3) inspect for ulceration, contour changes, skin changes(3)

•

examine nipple for evidence of disease (including Paget disease), infection, spontaneous discharge, retraction, and nipple inversion(3)

•

palpate for nodules or mass in upright and supine positions(3)

•

clinical breast exam (CBE) - technique based on evidence-based review o

preferred technique includes proper positioning of patient, thorough search, use of vertical-strip search pattern, varying palpation pressure, use of 3 finger pads, circular motion, and CBE duration at least 3 minutes per breast

o

value of inspection unproven

o

patient position 

supine



to flatten lateral part of breast, have patient roll onto contralateral hip, rotate shoulders into supine position, and place ipsilateral hand on forehead



to flatten medial part of breast, have patient lie flat on back and move elbow to shoulder level

o

o

•

thoroughness of search 

cover area from clavicle to bra line



cover area from midsternum to midaxillary line



vertical strip pattern (lawnmower technique) with overlapping vertical rows found to be more thorough than concentric circles or radial spoke pattern

finger motion 

3 middle fingers held together



finger pads used for exam



palpation done with dime-sized circular motion



light, medium, and deep pressure used for each spot

o

longer duration of breast exam associated with higher sensitivity, article states at least 3 minutes necessary for careful exam of average-sized breast but no clear evidence

o

palpation of axillary and supraclavicular areas for adenopathy recommended but not proven

o

palpation of nipple area recommended to be done similar to rest of breast, expression of nipple discharge on exam not shown to increase cancer detection rates

o

Reference - JAMA 1999 Oct 6;282(13):1270, commentary can be found in JAMA 2000 Apr 5;283(13):1687, J Am Geriatr Soc 2001 Jul;49(7):991

assessment for nipple discharge(1, 2, 3) o

pathologic discharge usually spontaneous, unilateral, involving single duct, bloody, or occasionally watery and clear

o

physiologic discharge usually responds to stimulus (not spontaneous), bilateral, involving multiple ducts, multicolored, or milky and sticky

Chest: •

palpation of lymph draining regions of axillae, supraclavicular and infraclavicular fossae for adenopathy recommended as part of clinical breast exam (Breast J 2003 May-Jun;9 Suppl 2:S90)

Differential Diagnosis

Benign causes of breast mass: •

•

•

infection and inflammation(1, 2) o mastitis o

cellulitis

o

abscess

o

chronic infections from mycobacteria or parasites (such as filariasis)

o

mammillary duct fistula

o

sarcoidosis

o

foreign bodies

solid, non-inflammatory lump o

fibroadenoma of breast (most common)(1, 2, 3)

o

benign cyst(1, 2, 3)

case series and case reports of other breast conditions o

lipoma presenting as lump in breast of woman aged 64 years (Breast J 2009 Jan-Feb;15(1):107)

o

fat necrosis presenting as axillary lump in breast of woman aged 80 years (Australas Radiol 2007 Oct;51 Spec No.:B40)

o

galactocele presenting as lump in axillary accessory breast tissue of pregnant woman (Arch Gynecol Obstet 2007 Oct;276(4):379)

o

diabetic fibrous breast disease (Lancet 2001 May 26;357(9269):1670)

o

cavernous lymphangioma of breast (World J Surg Oncol 2007 Jun 20;5:69 full-text)

o

mammary tuberculosis in 3 cases (World J Surg Oncol 2007 Jun 18;5:67 full-text, J Med Case Reports 2008 Feb 1;2:34 full-text)

o

postsurgical changes in 6 cases (Mayo Clin Proc 1996 Jun;71(6):552)

o

idiopathic granulomatous mastitis (CMAJ 2007 Jun 19;176(13):1822 fulltext)

Malignant and premalignant causes of breast mass: • •

breast cancer in women breast cancer in men

•

ductal carcinoma in situ (DCIS)

•

lobular carcinoma in situ

•

case reports of other malignant causes of breast mass o

small bowel carcinoid metastatic to breast (World J Surg Oncol 2006 Mar 27;4:15 full-text)

o

breast lymphoma (Radiology 2007 Dec;245(3):692 full-text)

o

mammary angiosarcoma (Radiology 2007 Mar;242(3):725)

Diagnostic Algorithms • American College of Radiology (ACR) Appropriateness Criteria for palpable breast mass(4) o for women ≥ 30 years old 

initial evaluation is mammography, immediately followed by ultrasound of breast



if mammographic findings suspicious for malignancy





o



ultrasound critical to ensure palpable finding corresponds with mammogram finding



core biopsy should be performed

if mammographic findings probably benign 

ultrasound critical to ensure palpable finding corresponds with mammogram finding



follow-up with mammogram after short interval may be appropriate



core biopsy of breast may be appropriate, depending on suspicion of clinical findings and ultrasound

if mammographic findings benign (like lipoma) or negative, ultrasound of breast is usually appropriate

for women < 30 years old 

ultrasound of breast usually appropriate as first study



mammography not usually appropriate, but may be initial test in high-risk patients < 30 years old



if ultrasound findings suspicious for malignancy



o

o

•



bilateral diagnostic mammography should be performed immediately after ultrasound to help characterize mass and evaluate for additional lesions that may not be seen by ultrasound



core biopsy of malignant palpable mass should be done only after bilateral mammography completed

if ultrasound findings probably benign 

follow-up with ultrasound after short interval usually appropriate



diagnostic mammography may be appropriate, but evidence lacking and clinical practice varies



fine needle aspiration or core biopsy usually not appropriate, but may be done to alleviate patient anxiety



if ultrasound findings benign (like simple cyst), no further testing is usually appropriate



if ultrasound findings negative, mammography may be appropriate if clinically suspicious

supplemental mammographic views (to clarify features, location or presence of mammographic lesion) may include 

small metal marker placed on skin over mass to identify location



spot compression



magnification



exaggerated craniocaudal to medial or lateral side



tangential



change of angle



cleavage



cleopatra



90-degree lateral

ultrasound is preferred initial test in women who are pregnant (due to lack of ionizing radiation) or lactating (because tissue density limits mammographic evaluation)

Institute for Clinical Systems Improvement (ICSI) algorithm for evaluation of breast mass(3)

o

o

o

determine if dominant mass 

if dominant mass (discrete, solid, clearly different from surrounding parenchyma) - proceed immediately with testing



if indeterminate mass 

size, location, character should be documented for follow-up examination



proceed with imaging evaluation

imaging evaluation (ICSI Strong recommendation, Low quality evidence) 

for women ≥ 30 years old - initial evaluation is mammogram followed by ultrasound of breast



for women < 30 years old - initial evaluation is ultrasound

follow-up based on imaging findings 

if imaging findings suggest solid lesion or complex cyst, core biopsy should be performed



if imaging findings suggest uncomplicated (simple) cyst and patient is symptomatic, aspiration of cyst should be performed





if residual mass or bloody aspirate, biopsy or surgical excision should be performed (ICSI Strong recommendation, Low quality evidence)



if no residual mass or bloody aspirate, consider repeat exam in 4-6 weeks, ideally after 1 menstrual cycle

if imaging findings negative 

if dominant mass - refer to surgeon



if indeterminate mass - follow-up clinical breast exam in 2-3 months

Imaging Mammography: •

Breast Imaging Reporting and Data System (BI-RADS) classification for management of abnormal mammograms o BI-RADS 0 assessment incomplete - need to review prior studies and/or complete additional imaging o

BI-RADS 1 negative - continue routine screening

•

o

BI-RADS 2 benign finding - continued routine screening

o

BI-RADS 3 probably benign finding - follow-up mammogram at 6 months, then every 6-12 months for 1-2 years

o

BI-RADS 4 suspicious abnormality - perform biopsy, preferably needle biopsy

o

BI-RADS 5 highly suspicious of malignancy; appropriate action should be taken - biopsy and treatment as necessary

o

BI-RADS 6 known biopsy-proven malignancy, treatment pending - assure that treatment is completed

o

Reference - J Am Board Fam Med 2006 Mar-Apr;19(2):161 full-text

American College of Radiology (ACR) Appropriateness Criteria for palpable breast mass(4) o

mammography is initial test of choice for women ≥ 30 years old

o

for women < 30 years old

o



mammography not usually appropriate, but may be initial test in high-risk patients < 30 years old



if ultrasound findings suspicious for malignancy, bilateral diagnostic mammography should be performed immediately after ultrasound to help characterize mass and evaluate for additional lesions that may not be seen by ultrasound

supplemental mammographic views (to clarify features, location or presence of mammographic lesion) may include 

small metal marker placed on skin over mass to identify location



spot compression



magnification



exaggerated craniocaudal to medial or lateral side



tangential



change of angle



cleavage



cleopatra



90-degree lateral

o •

digital mammography o

o

•

ultrasound is preferred initial test in women who are pregnant or lactating

digital mammography may be more sensitive but less specific than filmscreen mammography in women aged 40-49 years (level 3 [lacking direct] evidence) 

based on extrapolation from evidence in screening mammography



digital mammography and film-screen mammography may have similar overall performance for breast cancer screening, but digital mammography may have higher sensitivity and lower specificity in women aged 40-49 years (level 2 [mid-level] evidence)



see Mammography for breast cancer screening for details

digital mammogram considered preferable for women < 50 years old with dense breast tissue(3)

diagnostic mammogram has modest positive predictive value and high negative predictive value for breast cancer in women with palpable mass or other breast symptoms (level 1 [likely reliable] evidence) o

based on diagnostic cohort study

o

41,427 diagnostic mammograms performed on symptomatic women aged 25-89 years with no history of breast cancer

o

reference standard was histologically confirmed breast cancer (invasive and ductal carcinoma in situ)

Performance of Diagnostic Mammography: Entire Women with Self- Women without SelfCohort reported Lump reported Lump Number evaluated 41,427 15,853 16,895 Prevalence of 3.9% 6.1% 2.2% breast cancer Sensitivity 85.8% 87.3% 82.3% Specificity 87.7% 84.5% 91.2% Positive predictive 21.8% 26.8% 17.5% value Negative 99.4% 99% 99.6% predictive value o Reference - J Natl Cancer Inst 2002 Aug 7;94(15):1151 full-text Ultrasound:

•

•

American College of Radiology (ACR) Appropriateness Criteria for palpable breast mass(4) o for women < 30 years old - ultrasound of breast usually appropriate as first study o

for women ≥ 30 years old - ultrasound of breast should be done immediately after mammography for initial evaluation

o

ultrasound is preferred initial test in women who are pregnant (due to lack of ionizing radiation) or lactating (because tissue density limits mammographic evaluation)

addition of ultrasound to clinical exam and mammogram may help diagnose or rule out breast cancer in patients with palpable breast masses or abnormal screening mammography (level 2 [mid-level] evidence) o

based on diagnostic cohort study with unclear blinding of reference standard or test under investigation

o

2,020 consecutive patients (3,835 breasts) had mammogram plus clinical exam followed by ultrasound

o

indication for exam included 

referral for clinical or mammographic abnormalities in 2,812 breasts



screening contralateral side or patient reassurance in 1,023 breasts

o

reference standard was pathologic results of core needle biopsies, open biopsies, and other surgical interventions within 12-month follow-up

o

prevalence of breast cancer was 6.3% by reference standard in total cohort

o

diagnostic performance for detection of breast cancer comparing ultrasound plus clinical exam and mammogram vs. clinical exam and mammogram alone 

sensitivity 96.9% vs. 91.5% (with ultrasound detecting 8 additional malignancies)



specificity 94.8% vs. 87% (with ultrasound appropriately downgrading 332 cases from suggested malignancy to no malignancy, but providing false-positive results for 46 additional cases)



positive predictive value 39.2% vs. 19.7%



negative predictive value 99.9% vs. 99.7%

•

o

ultrasound increased diagnostic yield in patients with palpable breast lumps (p = 0.004) and patients referred for abnormal screening mammogram results (p = 0.05)

o

Reference - Arch Intern Med 2003 May 26;163(10):1194 full-text

sonoelastography o

addition of sonoelastography to B-mode ultrasound may increase sensitivity but decrease specificity for detection of breast cancer in patients with palpable or nonpalpable masses (level 2 [mid-level] evidence) 

based on diagnostic case-control study



97 palpable or nonpalpable breast lesions (31 malignant, 66 benign) were evaluated by sonoelastography, B-mode ultrasound, and mammogram Diagnostic Performance: Sonography Mammograp Sonograp Sonoelastograp plus hy hy hy Sonoelastograp hy

Sensitivit 84% 97% 71% 100% y Specificit 89% 82% 48% 38% y Positive predictiv 79% 71% 39% 43% e value Negative predictiv 92% 98% 78% 100% e value  diagnostic performance results were similar for palpable and nonpalpable masses  o

Reference - Ultraschall Med 2010 Dec;31(6):596

sonoelastography may have higher specificity and lower sensitivity than B-mode sonography in evaluation of breast lesions 

based on cohort of 300 patients with histologically confirmed breast lesions (168 benign, 132 malignant)



mammography had 87% sensitivity and 85% specificity



B-mode ultrasound had 94% sensitivity and 83% specificity



elastography had 82% sensitivity and 87% specificity



Reference - Acad Radiol 2006 Dec;13(12):1496

Magnetic resonance imaging: •

•

magnetic resonance imaging (MRI) may be useful for detection of breast lesions in high risk patients, including those with(1, 2, 3) o silicone breast implants o

prior breast conserving surgery

o

known carcinoma

o

axillary metastasis and unknown primary site

o

extra dense breast tissue

magnetic resonance imaging plus clinical exam and mammogram may be more sensitive than ultrasound plus clinical exam and mammogram to rule out malignancy in women with suspected invasive breast cancer (level 2 [mid-level] evidence) o

based on diagnostic cohort study without blinding of reference standard or tests under investigation

o

111 women (121 breasts) with known or suspected invasive breast cancer had clinical exam, mammogram, ultrasound, and contrast-enhanced magnetic resonance imaging (MRI)

o

258 lesions (177 [68.6%] malignant, 81 benign) were identified by biopsy with histopathologic exam as reference standard

o

diagnostic performance for detection of malignant tumors comparing MRI plus clinical exam and mammogram vs. ultrasound plus clinical exam and mammogram 

sensitivity 99.4% vs. 93.2% (p < 0.001)



specificity 7% vs. 22%



positive predictive value 70.1% vs. 72.4%



negative predictive value 85.7% vs. 60%

o

ultrasound after MRI not associated with additional detection benefit

o

Reference - Radiology 2004 Dec;233(3):830 full-text

Tissue Sampling

Core needle biopsy: •

core needle biopsy associated with higher diagnostic accuracy for detection of breast cancer than fine needle aspiration cytology in patients with palpable breast masses (level 2 [mid-level] evidence) o based on 1 randomized trial (indirect comparisons) and 1 prospective cohort study (without independent reference standard) o

296 women aged 15-74 years with palpable breast masses randomized to core needle biopsy vs. fine needle aspiration cytology 

results compared to final diagnosis by histopathology



comparing core needle biopsy vs. fine needle aspiration cytology

 o



sensitivity 92.3% vs. 66.7%



specificity 94.8% vs. 81.8%

Reference - Saudi Med J 2005 Jan;26(1):42

330 consecutive patients with 344 palpable breast masses were evaluated for malignancy in prospective cohort study 

patients had physical exam, ultrasound, and (if > 35 years old or solid mass) mammogram



patients with solid mass had fine needle aspiration (with or without ultrasound guidance) and core needle biopsy with histology



fine needle aspiration cytology (FNAC) findings





31.7% inadequate (C1)



41.9% sufficient, benign (C2)



1.7% sufficient, atypia, probably benign (C3)



4.9% sufficient, suspicious of malignancy (C4)



19.8% sufficient, malignant (C5)

core needle biopsy (CNB) findings 

28.2% non-breast tissue or normal breast epithelium (B1)



43.6% benign breast pathology (B2)



2% uncertain, probably benign breast pathology (B3)



0.9% suspicious, probably malignant breast pathology (B4)

 

benign lesions in 74.4% based on results of all tests



comparing core needle biopsy vs. fine needle aspiration cytology



 o

25.3% carcinoma-in-situ or invasive carcinoma (B5)



malignancy in 25.3% vs. 19.8%



inadequate epithelial cells for diagnosis in 16.3% vs. 31.7%

CNB diagnosed malignancy in 19 specimens (21.8%) not diagnosed

by FNAC 

12 sufficient, suspicious of malignancy by FNAC (C4)



2 sufficient, benign by FNAC (C2)



5 inadequate by FNAC (C1)

Reference - Eur J Surg Oncol 2003 May;29(4):374

fine needle aspiration may have high rate of inadequate specimen collection with similar diagnostic accuracy as core needly biopsy (level 2 [mid-level] evidence) 

based on retrospective diagnostic cohort study with unclear blinding of reference standard



patients with palpable breast lesions were evaluated with core needle biopsy (94 patients) or fine needle aspiration (68 patients)



reference standard was histologic confirmation with surgical biopsy or clinical follow-up



inadequate specimen in 0% with core needle biopsy and 21% (14 patients) with fine needle aspiration



no false positives or false negatives in either group



for detection of malignancy 



core needle biopsy had 

sensitivity 100%



specificity 90%



positive predictive value 93%



negative predictive value 100%

fine needle aspiration had

 •

sensitivity 89%



specificity 98%



positive predictive value 94%



negative predictive value 96%

Reference - Am J Surg 2012 Aug;204(2):193

automated core biopsy appears more sensitive for breast cancer than fine needle aspiration cytology in women with palpable breast masses (level 2 [midlevel] evidence) o

based on small diagnostic cohort study

o

52 patients with symptomatic breast masses had standard triple test (clinical exam, mammogram, and fine needle aspiration) plus automated core biopsy

o

reference standard was histologic assessment

o

50 patients had breast cancer by reference standard

o

comparing automated core biopsy vs. fine needle aspiration cytology

o •





sensitivity 96% vs. 60%



sufficient information to guide treatment based on triple test results in 96% vs. 37%

Reference - Ann R Coll Surg Engl 2001 Mar;83(2):110 PDF

4 core biopsies plus fine needle aspiration cytology may have 100% sensitivity for breast cancer in patients with palpable breast masses ≥ 2 cm (level 2 [midlevel] evidence) o

based on diagnostic cohort study without independent validation

o

143 patients with palpable breast masses ≥ 2 cm had fine needle aspiration cytology and 4 core biopsies

o

105 patients had malignant breast cancer confirmed by fine needle aspiration cytology plus core biopsy as reference standard

o

sensitivity for breast cancer 

76.2% with 1 core biopsy



80.9% with 2 core biopsies



89.2% with 3 core biopsies

o •



95.2% with 4 core biopsies



100% with 4 core biopsies plus fine needle aspiration cytology

Reference - Breast J 2003 Nov-Dec;9(6):491

during biopsy of cyst suspicious for malignancy, placement of clip or embolization coil marker at time of sonographic biopsy can facilitate subsequent identification if excision needed (Radiology 2003 Apr;227(1):183 full-text)

Fine needle aspiration: •

fine needle aspiration biopsy may help diagnose or rule out breast cancer in patients with palpable breast masses (level 2 [mid-level] evidence) o based on 2 diagnostic cohort studies with reference test not applied to all patients o

o

retrospective study of 1,401 patients with palpable breast lesions from 19962005 in Nigeria who had fine needle aspiration biopsy with cytology 

histological analysis from biopsy (reference standard) applied to 250 patients (17.8%)



of patients who had biopsy, 124 patients (49.6%) had malignancy



diagnostic performance of fine needle aspiration biopsy for detection of breast cancer (in analysis limited to patients who had biopsy) 

sensitivity 91.1%



specificity 93.7%



positive predictive value 93.4%



negative predictive value 91.5%



of 1,151 patients who did not have biopsy, cytology results on fine needle aspiration were malignant in 351 and suspicious of malignancy in 82



Reference - J Cytol 2011 Jul;28(3):111 full-text

222 women with palpable breast mass had fine needle aspiration cytology 

112 patients also had mammography



89 cases has histopathologic analysis (reference standard)



36 cases (40%) were malignant by reference standard



 •

diagnostic performance for detection of breast cancer comparing of fine needle aspiration cytology vs. mammogram 

sensitivity 97.2% vs. 82.8%



specificity 99.5% vs. 90.4%



positive predictive value 97.2% vs. 75%



negative predictive value 99.5% vs. 93.8%

Reference - Mymensingh Med J 2011 Oct;20(4):658

during aspiration of cyst suspicious for malignancy, placement of clip or embolization coil marker at time of sonographic biopsy can facilitate subsequent identification if excision needed (Radiology 2003 Apr;227(1):183 full-text)

Excisional biopsy: •

excisional (open) biopsy considered "gold standard" for histologic evaluation of breast masses(1, 3) o may be useful in patients with clinically suspicious masses and/or unclear results from imaging and tissue sampling o

•

may not be necessary in patients with definitive results from less invasive core needle biopsy

excisional biopsy reported to be both diagnostic and therapeutic when mass can be completely removed and additional surgery not required(1)

Triple Test Score • triple test score is combination of physical exam, imaging, and tissue sampling • original description of triple test score o

o

score assigned to each of physical exam, mammography, and fine needle aspiration, and combined for final triple test score 

1 point = benign



2 points = suspicious



3 points = malignant

interpretation of combined score 

3 or 4 points = benign mass



5 points = excisional biopsy recommended for definitive diagnosis



≥ 6 points = malignancy, definitive therapy recommended

o

o •

performance of triple test score in original description (derivation cohort with 259 patients with 261 palpable breast masses 1991 to 1997) 

score 3-4 in 152 (58%) masses - 100% were benign



score 5 in 21 (8%) masses - 38% were malignant



score 6-9 in 88 (34%) masses - 100% were malignant

Reference - Arch Surg 1998 Sep;133(9):930 full-text

triple test score validated to be accurate for diagnosing breast cancer if score ≥ 6 and rule out breast cancer if score 3-4 (level 1 [likely reliable] evidence) o

based on multiple cohort studies

o

479 women > 40 years old with 484 palpable breast masses in Oregon, United States 1991 to 2000 

triple test evaluated was physical exam, mammogram, and fine needle aspiration



149 cases confirmed malignant by biopsy with histology (reference standard)



Diagnostic Performance of Triple Test Elements: Sensitivity Specificity Physical exam 87% 80% Mammography 91% 78% Fine needle aspiration 92% 96%  outcomes based on triple test score

 o



315 (65%) had triple test score 3-4 - malignancy in none (specificity 100%)



39 (8%) had triple test score 5 - malignancy in 19 (49%)



130 (27%) had triple test score 6-9 - malignancy in 100% (sensitivity 100%)

Reference - Arch Surg 2001 Sep;136(9):1008 full-text

140 women with palpable breast masses in Saudi Arabia 1998 to 1999 

triple test evaluated was physical exam, mammogram, and fine needle aspiration cytology



histologic confirmation by open biopsy was reference standard



Diagnostic Performance of Test Components: Physical Fine Needle Mammogram Exam Aspiration Cytology Sensitivity 82.6% 87.5% 91.7% Specificity 97.3% 97.3% 100% Positive 86.4% 87.5% 100% predictive value Negative 96.5% 97.3% 98.3% predictive value  triple test associated with 100% accuracy when all 3 tests had consistent results (all malignant or all benign)  o

o

•

Reference - Ann Saudi Med 2003 May-Jul;23(3-4):158

100 women > 40 years old referred to breast clinic in Iran 1998 to 2003 

triple test evaluated was physical exam, mammogram, and fine needle aspiration cytology



31 had triple test score 3-4 - 100% were benign



23 had triple test score 5 - 16% were malignant



46 had triple test score 6-9 - 100% were malignant



Reference - Iranian Journal of Cancer Prevention 2008 Jan;1(1):23 PDF

50 women with palpable breast lump in Nepal 

triple test evaluated was physical exam, mammogram, and fine needle aspiration cytology



19 classified as benign - 100% were benign



31 classified as malignant - 30 (97%) were malignant



Reference - JNMA J Nepal Med Assoc 2008 Oct-Dec;47(172):189

modified triple test score (substituting ultrasound for mammogram) ≥ 6 appears diagnostic for malignancy and modified triple test score 3-4 appears to rule out breast cancer in women < 40 years old with palpable breast masses (level 2 [mid-level] evidence) o

based on diagnostic cohort study without independent validation

o

108 women < 40 years old with 113 palpable breast masses had modified triple test (physical exam, ultrasound, and fine needle aspiration biopsy)

followed by clinical follow-up or histologic confirmation by open biopsy as reference standard o

malignancy in 3 (3%) by reference standard

o

outcomes based on modified triple test score

o



108 (96%) had score 3-4 - malignancy in none (specificity 100%)



3 (3%) had score 5 - malignancy in 1 (33%)



2 (2%) had score 6-9 - malignancy in 100% (sensitivity 100%)

Reference - Am J Surg 2002 Oct;184(4):346

Guidelines and Resources Guidelines: United States guidelines: •

National Comprehensive Cancer Network (NCCN) guidelines can be found at NCCN website (free registration required), guidelines include o breast cancer o

breast cancer risk reduction

o

breast cancer screening and diagnosis

o

genetic/familial high-risk assessment of breast and ovarian cancer

o

invasive breast cancer

•

American College of Radiology (ACR) Appropriateness Criteria for palpable breast masses can be found at ACR 2009 PDF or at National Guideline Clearinghouse 2010 May 24:15723

•

ACR practice guideline on performance of breast ultrasound examination can be found at ACR 2011 PDF

•

American College of Radiology (ACR) practice guideline on performance of magnetic resonance imaging-guided breast interventional procedures can be found at ACR 2011 PDF

•

Institute for Clinical Systems Improvement (ICSI) guideline on diagnosis of breast disease can be found at ICSI 2012 Jan PDF or at National Guideline Clearinghouse 2012 Jul 30:36057

United Kingdom guidelines:

•

National Institute of Health and Clinical Excellence (NICE) guideline on diagnosis and treatment of early and locally advanced breast cancer can be found at NICE 2009 Feb:CG80 PDF

Canadian guidelines: •

•

Alberta Health Services (AHS) clinical practice guideline on magnetic resonance imaging for breast cancer screening, pre-operative assessment, and follow-up can be found at AHS 2012 Jan PDF or at National Guideline Clearinghouse 2012 May 7:34595 Canadian evidence-based consensus guidelines on diagnosis of breast cancer (published as CMAJ special supplement) o

lesions detected by mammography can be found at 1998 Feb 10 PDF

o

palpable breast lump can be found at 1998 Feb 10 PDF

European guidelines: •

expert recommendations for pathological examination and histological report for breast cancer specimens in Marche Region can be found in Pathologica 2011 Oct;103(5):294

Review articles: • •

review of common breast problems can be found in Am Fam Physician 2012 Aug 15;86(4):343 review of radiological workup of palpable breast mass can be found in Cleve Clin J Med 2009 Mar;76(3):175 full-text

•

review of core needle biopsy as a diagnostic method for breast lesions can be found in Breast Cancer 2004;11(4):339

•

review of breast cyst aspiration can be found in Am Fam Physician 2003 Nov 15;68(10):1983 full-text, commentary can be found in Am Fam Physician 2004 Oct 15;70(8):1451

•

review of imaging of breast mass can be found in Radiol Clin North Am 2000 Jul;38(4):669

•

review of benign breast disease can be found in Obstet Gynecol Clin North Am 2008 Jun;35(2):285

•

review of clinical approach to breast disorders can be found in J Assoc Physicians India 2006 May;54:389

•

review of abnormal mammography results and palpable breast abnormalities can be found in Ann Intern Med 2003 Aug 19;139(4):274, commentary can be found in Ann Intern Med 2004 May 4;140(9):764

Patient Information: • •

information from TransMed technical information from PatientPlus

References General references used: •

•

1. Klein S. Evaluation of palpable breast masses. Am Fam Physician. 2005 May 1;71(9):1731-8 full-text, correction can be found in Am Fam Physician 2005 Sep 1;72(5):761 2. Cheung KL, Lam TP. Approach to a lump in the breast: a regional perspective.

Asian J Surg. 2005 Jan;28(1):65-70

•

3. Institute for Clinical Systems Improvement (ICSI). Diagnosis of breast disease.

Bloomington (MN): Institute for Clinical Systems Improvement (ICSI); 2012 Jan. 45 pages. ICSI. 2012 Jan PDF or at National Guideline Clearinghouse 2012 May 25:36057

•

4. Parikh JR, Bassett LW, Mahoney MC, et al; American College of Radiology (ACR) Expert Panel on Breast Imaging. ACR Appropriateness Criteria® palpable breast masses. Reston (VA): American College of Radiology (ACR); 2009. 10 pages. ACR. 2009 PDF or at National Guideline Clearinghouse 2010 May 24:15723

Recommendation grading systems used: •

Institute for Clinical Systems Improvement (ICSI) grading system for recommendations o strength of recommendation

o



Strong recommendation - benefits outweigh risks or harms, recommendation applies to most patients



Weak recommendation - benefits and harms are balanced or uncertainty exists about best estimates of benefits and harms; recommendation may depend on local circumstances, patient values, or preferences

quality of evidence 

High-quality evidence - further research unlikely to change confidence in estimate of effect



Moderate-quality evidence - further research may impact recommendation and confidence in estimate of effect



o

Low-quality evidence - further research very likely to have important impact on confidence in estimate of effect and likely to change, so any estimate of effect is very uncertain

Reference - ICSI guideline on diagnosis of breast disease (ICSI 2012 Jan PDF) or at National Guideline Clearinghouse 2012 Jul 30:36057

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Special acknowledgements: •

Jeffrey L. Chamberlain, MD (Core Faculty and Clinical Instructor, Michigan State University Department of Family Medicine; Family Practice Doctor, Advantage Health; Urgent Care Provider, St. Mary's Health South West Urgent Care; Michigan, United States) provides peer review.

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