Jorge Exhibit Chicago 2009

8/14/2019 Jorge Exhibit Chicago 2009

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BACKGROUNDBACKGROUND

The gold standard for staging of the axilla inThe gold standard for staging of the axilla in

patients with known invasive cancer requirespatients with known invasive cancer requires

axillary lymph node dissectionaxillary lymph node dissection

Sentinel lymph node biopsy is an acceptedSentinel lymph node biopsy is an accepted

alternative, yet carries a false negative ratealternative, yet carries a false negative ratewhich varies between 5-12%which varies between 5-12%


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BACKGROUNDBACKGROUND

Pathologic demonstration of positivePathologic demonstration of positive

adenopathy prior to surgery is desirableadenopathy prior to surgery is desirable

due to its ease of performance, low costdue to its ease of performance, low costas well as beneficial savings by avoidingas well as beneficial savings by avoiding

the time and cost involved in sentinelthe time and cost involved in sentinel

lymph node biopsy procedurelymph node biopsy procedure


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METHODS:METHODS:

We retrospectively reviewed a total of oneWe retrospectively reviewed a total of one

hundred forty four ultrasound guided axillaryhundred forty four ultrasound guided axillary

lymph node core biopsies performed betweenlymph node core biopsies performed between

January 2005 and September 2009 at UniversityJanuary 2005 and September 2009 at Universityof Miami Sylvester Comprehensive Cancer Centerof Miami Sylvester Comprehensive Cancer Center

Fifty nine of these patients had definitive surgicalFifty nine of these patients had definitive surgical

pathology correlation at the time of this studypathology correlation at the time of this study


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METHODS:METHODS:

Four patients found to be positive on core biopsy,Four patients found to be positive on core biopsy,received neoadjuvant chemotherapy and were found toreceived neoadjuvant chemotherapy and were found tobe negative at surgical pathology, presumably related tobe negative at surgical pathology, presumably related toeradication of cancer cells due to therapy, reason foreradication of cancer cells due to therapy, reason for

which they were excluded from the study populationwhich they were excluded from the study population

A total of fifty five patients were included in this study.A total of fifty five patients were included in this study.


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METHODSMETHODS

All biopsies were performed under ultrasoundAll biopsies were performed under ultrasound

guidance with a standard spring loaded 14guidance with a standard spring loaded 14

gauge biopsy or ACHIEVE programmablegauge biopsy or ACHIEVE programmable

automatic biopsy systemautomatic biopsy system

An average of 3 cores were obtained at eachAn average of 3 cores were obtained at each

biopsybiopsy

No complications were reportedNo complications were reported


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US image shows a normal lymph node with a thin cortexUS image shows a normal lymph node with a thin cortex

and a large fatty hilumand a large fatty hilum


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POSITIVE FINDINGS IN METASTATICPOSITIVE FINDINGS IN METASTATIC

LYMPHADENOPATHYLYMPHADENOPATHY

Asymmetric cortical thickening exceeding 3mms, with indentation of the fatty hilum.


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Displaced fatty hilum andDisplaced fatty hilum and

asymmetric cortical thickeningasymmetric cortical thickening


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Symmetric cortical thickening with loss of fatty hilum.Symmetric cortical thickening with loss of fatty hilum.


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Hypoechoic thickened cortex and minimal fatty hilumHypoechoic thickened cortex and minimal fatty hilum


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Color Doppler US image shows abnormal cortical bloodColor Doppler US image shows abnormal cortical blood

flow and absence of normal hilar blood flow in metastaticflow and absence of normal hilar blood flow in metastatic

lobular carcinoma.lobular carcinoma.


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Pathologic small lymph node, withPathologic small lymph node, with

rounded shape and loss of fatty hilumrounded shape and loss of fatty hilum


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Metastatic mucinous adenocarcinomaMetastatic mucinous adenocarcinoma

presenting as an axillary masspresenting as an axillary mass


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Axillary masses consistent withAxillary masses consistent with

abnormal lymph nodesabnormal lymph nodes


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Proven metastatic IMLN. PartiallyProven metastatic IMLN. Partially

thickened cortex and increasedthickened cortex and increasedcortical vascularity is noted.cortical vascularity is noted.


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Calcified lymphadenopathy provenCalcified lymphadenopathy proven

to be metastatic IDCto be metastatic IDC


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BIOPSY TECHNIQUEBIOPSY TECHNIQUE

After explaining risks and benefits of the procedure informedAfter explaining risks and benefits of the procedure informedconsent is obtainedconsent is obtained

The patient is placed in an oblique position using a wedgeThe patient is placed in an oblique position using a wedge

pillow to rotate the patients body and elevate the targetedpillow to rotate the patients body and elevate the targetedareaarea

Color doppler is used to determine the presence and locationColor doppler is used to determine the presence and locationof adjacent vesselsof adjacent vessels

A lateral or inferior approach is preferred to avoid adjacentA lateral or inferior approach is preferred to avoid adjacentvesselsvessels


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BIOPSY TECHNIQUEBIOPSY TECHNIQUE

Under sterile technique, the area of concern isUnder sterile technique, the area of concern isanesthetized, a small skin incision is made with a #11anesthetized, a small skin incision is made with a #11scalpel blade through which the biopsy needle isscalpel blade through which the biopsy needle isintroducedintroduced

Occasionally a fibrous facial layer requires deeperOccasionally a fibrous facial layer requires deeperincision or the use of a coaxial techniqueincision or the use of a coaxial technique

Standard spring loaded 14 gauge automated gun or anStandard spring loaded 14 gauge automated gun or an

ACHIEVE technique may be used. The latter allowsACHIEVE technique may be used. The latter allowsadvancement of the needle with open aperture in orderadvancement of the needle with open aperture in orderto avoid injury to adjacent vessels, and thereforeto avoid injury to adjacent vessels, and thereforerecommended when vessels are identified in proximity torecommended when vessels are identified in proximity tothe abnormal lymph nodethe abnormal lymph node


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Standard spring loaded 14Standard spring loaded 14

gauge biopsygauge biopsy

Prefire image in which the cocked

needle is introduced and placed 1 cm

proximal from the lesion

Postfire image in which the sample is

retrieved by firing a stylet and then a

cutting cannula at high speed in rapid

sequence to capture the sample with

the push of a button.


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Target lesions are frequently located near vessels. TheTarget lesions are frequently located near vessels. The

ACHIEVE programmable automatic biopsy system isACHIEVE programmable automatic biopsy system is

preferred in these casespreferred in these cases


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ACHIEVE needle with open aperture


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ACHIEVE ProgrammableACHIEVE Programmable

Automatic Biopsy System.Automatic Biopsy System.


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TECHNIQUETECHNIQUE

After sampling and documentation, the needle isAfter sampling and documentation, the needle is

withdrawn, and pressure applied to the biopsy site towithdrawn, and pressure applied to the biopsy site to

minimize bleeding.minimize bleeding.

The sample is placed in a 10% formalin solution. TheThe sample is placed in a 10% formalin solution. Thespecimen should have a white or brown tan componentspecimen should have a white or brown tan component

and should sink to the bottom of the container.and should sink to the bottom of the container.


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The cortical component of the lymph node (arrow) sinks in the formalin solution,

whereas the fatty tissue (arrowheads) floats. Because the aperture of the needle

is often longer than the lymph node, adjacent fatty tissue is usually sampled

together with the target cortex.


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COMPLICATIONSCOMPLICATIONS

No major complications are usually encounteredNo major complications are usually encountered

Sharp pain indicates possible contact with a nerve. ASharp pain indicates possible contact with a nerve. Achange in direction of the needle is advisedchange in direction of the needle is advised

Bleeding is usually minor and easy to control. Use of theBleeding is usually minor and easy to control. Use of theinferolateral to superomedial approach with the patientsinferolateral to superomedial approach with the patientsipsilateral arm raised but not fully extended allows mostipsilateral arm raised but not fully extended allows mostsampling to be performed in a direction parallel to majorsampling to be performed in a direction parallel to major

vesselsvessels

Infection is highly unusual if sterile technique is used.Infection is highly unusual if sterile technique is used.


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RESULTS:RESULTS:

Twenty nine biopsies yielded positive results andTwenty nine biopsies yielded positive results and

were corroborated after axillary node dissection orwere corroborated after axillary node dissection or

surgical excisionsurgical excision

Twenty seven of these biopsies were positive forTwenty seven of these biopsies were positive for

metastatic breast malignancymetastatic breast malignancy

One was positive for lymphomaOne was positive for lymphoma

One was positive for toxoplasmosisOne was positive for toxoplasmosis


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TRUE POSITIVE BIOPSIESTRUE POSITIVE BIOPSIES

0

5

10

15

20

25

IDC

ILC

Mucinous

Medullary

Toxoplasmosis

Lymphoma

21 3 2 1 1 1


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RESULTS:RESULTS:

The remaining twenty six biopsies were reported asThe remaining twenty six biopsies were reported asnormal lymph nodes on US guided core biopsy.normal lymph nodes on US guided core biopsy.Nineteen (%) of these cases were confirmed negative atNineteen (%) of these cases were confirmed negative at

surgery.surgery.

The remaining seven cases (%) were discordant withThe remaining seven cases (%) were discordant withsurgical findings, and reported as metastatic diseasesurgical findings, and reported as metastatic diseaseafter axillary node dissection .after axillary node dissection .


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RESULTS:RESULTS:

The remaining twenty six biopsies were reported as normalThe remaining twenty six biopsies were reported as normallymph nodes on US guided core biopsy. Nineteen (%) oflymph nodes on US guided core biopsy. Nineteen (%) ofthese cases were confirmed negative at surgerythese cases were confirmed negative at surgery

The remaining seven cases (%) were discordant withThe remaining seven cases (%) were discordant withsurgical findings, and reported as metastatic disease aftersurgical findings, and reported as metastatic disease afteraxillary node dissectionaxillary node dissection

Unfortunately, we could not unequivocally prove that theUnfortunately, we could not unequivocally prove that thelymph node targeted for US guided biopsy corresponded tolymph node targeted for US guided biopsy corresponded tothe positive lymph node at dissectionthe positive lymph node at dissection


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DISCORDANT CASESDISCORDANT CASES

One was found to have a single focus of microscopicOne was found to have a single focus of microscopicmetastatic carcinoma in the affected lymph node of lessmetastatic carcinoma in the affected lymph node of lessthan 0.2 mmthan 0.2 mm

Two demonstrated involvement of less than 3 mm inTwo demonstrated involvement of less than 3 mm inonly one lymph nodeonly one lymph node

Three cases had only one affected lymph node out of 15,Three cases had only one affected lymph node out of 15,

22 and 32 lymph nodes respectively at dissection22 and 32 lymph nodes respectively at dissection

One reported error sampling with only fatty tissueOne reported error sampling with only fatty tissueretrieved and no evidence of lymph node tissueretrieved and no evidence of lymph node tissue


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RESULTSRESULTS

N=55 TEST + TEST -

DISEASE 29

True positives

7

False negatives

NO DISEASE 0

False positives

19

True negatives

Sensitivity: 81%

Specificity: 100%

PPV: 100%

NPV 73%

Accuracy is 87%.

These results are statistically significant p < 0.01


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Negative cases with positiveNegative cases with positive

findings at surgeryfindings at surgery


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Proven Toxoplasmosis in patient withProven Toxoplasmosis in patient with

bilateral axillary lymphadenopathy.bilateral axillary lymphadenopathy.


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CONCLUSIONSCONCLUSIONS

Ultrasound guided core biopsy is an effectiveUltrasound guided core biopsy is an effective

method to evaluate pathology in suspicious axillarymethod to evaluate pathology in suspicious axillary

lymphadenopathylymphadenopathy

Thickened cortex, increased cortical vascularity,Thickened cortex, increased cortical vascularity,

diminished or absent hilum and mass appearancediminished or absent hilum and mass appearance

with lack of normal lymph node morphology arewith lack of normal lymph node morphology are

good predictors of tumoral involvementgood predictors of tumoral involvement


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CONCLUSIONSCONCLUSIONS

With a specificity of 100%, a positive result warrantsWith a specificity of 100%, a positive result warrantsaxillary lymph node dissectionaxillary lymph node dissection

A negative biopsy result does not rule out positiveA negative biopsy result does not rule out positivelymphadenopathy in the targeted lymph node or in otherlymphadenopathy in the targeted lymph node or in otherlymph nodes within the axilla, and therefore requireslymph nodes within the axilla, and therefore requiresfurther evaluation with sentinel lymph node biopsy orfurther evaluation with sentinel lymph node biopsy oraxillary node dissectionaxillary node dissection

Us core biopsy of abnormal adenopathy can effectivelyUs core biopsy of abnormal adenopathy can effectivelystage the axilla prior to administration of neoadjuvantstage the axilla prior to administration of neoadjuvantchemotherapy, as some of the positive lymph nodes maychemotherapy, as some of the positive lymph nodes mayshow no evidence of disease after treatmentshow no evidence of disease after treatment


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CONCLUSIONCONCLUSION

ACHIEVE programmable automatic biopsyACHIEVE programmable automatic biopsy

system is a good option to avoid injury tosystem is a good option to avoid injury to

adjacent vessels or other structuresadjacent vessels or other structures

US guided core biopsy is a safe method with noUS guided core biopsy is a safe method with nomajor complicationsmajor complications


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BIBLIOGRAPHYBIBLIOGRAPHY

PendingPending

Jorge Exhibit Chicago 2009

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