1. AUTHOR:1.DR RAVICHANDRA MATCHA,M.S(G.S),
ASSISTANT PROFESSOR OF SURGERY,RANGARAYA MEDICAL
COLLEGE,KAKINADA
2.DR MADHURI DEVI KUNA,M.S(G.S)
ASSISTANT PROFESSOR OF SURGERY ,ANDHRA MEDICAL
COLLEGE.VISAKHAPATNAM
MORBIDITY OF SENTINEL LYMPH NODE
BIOPSY(SLNB)ALONE VERSUS SLNB AND
COMPLETION AXILLARY LYMPH NODE
DISSECTION AFTER BREAST CANCER SURGERY

2. INTRODUCTION
 THIS STUDY IS A PROSPECTIVE SINGLE CENTER STUDY TO
ASSESS THE MORBIDITY AFTER SENTINEL LYMPH NODE
BIOPSY COMPARED WITH SLNB AND COMPLETION AXILLARY
LYMPH NODE DISSECTION (ALND).
 ALND AFTER BREAST CANCER SURGERY IS ASSOCIATED WITH
CONSIDERABLE MOEBIDITY.
 WE HYPOTHESIZED THAT 1.THE MORBITY IN SLNB ONLY
PATIENTS IS SIGNIFICANTLY LOWER COMPARED WITH THOSE
AFTER SLNB AND COMPLETION ALND.2.THE INTERMEDIATE
SURVIVAL RATES AND LOCAL & BREAST RECURRENCE RATES
WERE EQUIVALENT IN BOTH THE GROUPS.

3. OBJECTIVES:
 TO PROVE THE HYPOTHESES THAT WE SET OUT AT THE
BEGINNING OF THIS STUDY.
 1.THE MORBIDITY IN SLNB ALONE PATIENTS IS
SIGNIFICANTLY LOWER COMPARED TO SLNB AND
COMPLETION ALND PATIENTS
 2.THE INTERMEDIATE SURVIVAL RATES & LOCAL AND
AXILLARY RECURRENCES RATES WERE SIGNIFICANTLY
EQUIVALENT IN BOTH THE GROUPS.

4. PATIENTS & METHODS
 PATIENTS WITH EARLY STAGE BREAST CANCER (T1 & T2
</EQUAL TO 3cm N0) WERE INCLUDED BETWEEN DECEMBER
2006 & DECEMBER 2010 IN THIS PROSPECTIVE SINGLE CENTER
STUDY.
 ALL PATIENTS UNDERWENT SLNB. IN ALL PATIENTS WITH
POSITIVE SLN METASTASIS A COMPLETION ALND WAS
PERFORMED.
 POST OPERATIVE MORBIDITY & LOCAL AND AXILLARY
RECURRENCES WERE ASSESSED BASED ON A STANDARDIZED
PROTOCOL.

5. PATIENTS & METHODS CONTD……
 INCLUSION CRITERIA FOR THE STUDY WERE
 1.PRESENCE OF PALPABLE BREAST CANCER
 2.TUMOUR SIZE EQUAL TO OR LESS THAN 3cms.
 3.CLINICALLY NEGATIVE AXILLARY LYMPH NODES
 4.NO H/O BREAST CANCER /OTHER MALIGNANCIES
 5.NO NEOADJUVANT THERAPY.
 6.NO PREGNANCY.
 A TOTAL OF 690 PATIENTS WITH EARLY STAGE BREAST
CANCER WERE ENROLLED .
 30 PATIENTS DID NOT MATCH INCLUSION CRITERIA AND
WERE EXCLUDED.
 WRITTEN INFORMED CONSENT WAS OBTAINED FROM ALL THE
PATIENTS.
 THE STUDY WAS APPROVED BY ALL INVOLVED LOCAL ETHIC
COMMITTEES.

6. PATIENTS&METHODS CONTD…….
 OPERATIVE TECHNIQUE:SLN MAPPING WAS PERFORMED BY
USING A COMBINATION OF RADIOLABELLED COLLOID & A VITAL
BLUE DYE.
 99m TECHNITIUM LABELLED COLLOID AT A DOSE OF 70MBq WAS
INJECTED ,PERITUMOURALLY AT 4 PLACES, WHERE AS AT THE
INJECTION SITE CLOSEST TO AXILLA HALF OF THE DOSE WAS
INJECTED PERITUMOURALLY AND SUBDERMALLY.
 THE SLN WERE FIRST IDENTIFIED USING A HAND HELD GAMMA
PROBE.
 UPTO 5 ml OF ISOSULPHAN BLUE WAS INJECTED IN THE SAME
FASHION AS RADIOACTIVE TRACER 5 TO 10 MINUTES PRIOR TO
SURGERY.
 PRIOR TO PARTICIPATION IN THE STUDY THE SLNB PROCEDURE
WAS VALIDATED BASED ON AT LEAST 20 BREAST CANCER PATIENTS
IN WHOM BOTH SLNB & COMPLETION ALND WERE PERFORMED.
 A SLN IDENTIFICATION RATE AND SENSITIVITY OF AT LEAST 95%
WERE REQUIRED FOR INCLUSION IN THIS TRIAL.

7. PATIENTS & METHODS CONTD……
 PATHOLOGIC EXAMINATION OF LYMPH NODES: FROZEN SECTIONS
WERE PERFORMED ROUTINELY INTRAOPERATIVELY.
 THE SLN WERE EXAMINED AT 3 LEVELS
 1. WITH HEMOTOXYLON &EOSIN STAINED SECTIONS AT A CUTTING
INTERVAL OF 150milli microns.
 2.THE REMAINING TISSUE WAS FORMALIN FIXED & EMBEDDED IN
PARAFFIN FOR HISTOLOGICALANALYSIS.
 3.THE RESIDUAL TISSUE WAS EXAMINED USING STEP SECTIONING
AT A CUTTING INTERVAL OF 250 milli microns
 IF NO CARCINOMA CELLS WERE DETECTED ,
IMMUNOHISTOCHEMISTRY WITH CYTO KERATIN METHOD WAS
PERFORMED.
 ALL PATIENTS WITH SLN MACROMETASTASIS(>2MM)IN FROZEN
SECTION BIOPSY UNDERWENT IMMEDIATE COMPLETION ALND.
 IF MACROMETASTASIS WERE FOUND AT FINAL HISTOPATHOLOGY
,PATIENTS UNDERWENT DELAYED COMPLETION ALND.

8. CONCLUSION
 POST OPERATIVE FOLLOW-UP:THE FOLLOW UP DIAGNOSTICS
INCLUDED CLINICAL EXAMINATION OF BREAST & AXILLA EVERY 3
MONTHS AS WELLAS ANNUAL MAMMOGRAPHY TO DETECT LOCAL &
AXILLARY RECURRENCES.
 ADDITIONAL U/S EXAMINATION WAS CARRIED OUT TO CLARIFY
SUSPICIOUS MAMMOGRAPHIC FINDINGS.
 A STANDARDIZED STUDY FORM WAS FILLED OUT 1.BEFORE
SURGERY2.ON DAY 3 POSTOPERATIVELY3.DURING EVERY FOLLOW UP
IN THE O.P. CLINIC.
 SUBJECTIVE CRITERIA SUCH AS PAIN (ARM,SHOULDER,BREAST &
THORAX),NUMBNESS,AND RESTRICTION IN DAILYACTIVITIES WERE
ASSESSED AS BEING PRESENT OR NOT.
 OBJECTIVE CRITERIA: THE PREOPERATIVE & POSTOPERATIVE
MEASUREMENTS OF1.RANGE OF MOVEMENT IN ALL DIRECTIONS OF
THE SHOULDER ACCORDING TO1. NEUTRAL ZERO CROSSING
METHOD2.THE MEASUREMENTS OF BOTH UPPER & FORE ARM 15 cm
ABOVE & BELOW OLECRANON PROCESS.

9. CONLUSION CONTD…….
 A DEFICIT OF RANGE OF MOTION 20 DEGREES OVER STANDARD
VALUE WAS CONSIDERED AS ABNORMAL.
 THE DIAGNOSIS OF LYMPHEDEMA WAS BASED ON EITHER
SUBJECTIVE SYMPTOMS OR OBJECTIVE FINDINGS &
MEASUREMENTS.
 SYMPTOMS LIKE SWELLING & HEAVINESS AS WELL AS CLINICAL
FINDINGS SUCH AS INDENTATION OF SKIN IMPRESSION OR LOSS
OF SKIN FOLDS.
 A 2 cm OF INCREASEOF THE ARM CIRCUMFERENCE WAS
CONSIDERED ABNORMAL.DIFFERENCE IN CIRCUMFERENCE OF
MORE THAN 2cms TO THE MEASUREMENT OF CONTRALATERAL
ARM WERE ALSO REGARDED AS ABNORMAL.

10. CONCLUSION CONTD……
 RESULTS:BETWEEN DECEMBER 2006 & DECEMBER 2010 SLNB WERE
PERFORMED ON 641 PATIENTS MEETING THE INCLUSION CRITERIA.
 THE OVERALL IDENTIFICATION RATE WAS 97.1%(641OF 660)
 A MEDIAN NUMBER OF 2 SLN WERE HARVESTED IN BOTH GROUPS.
 THE SLNBs WERE NEGATIVE IN 416 PATIENTS(416OF 641)
64.8%),MACROMETASTASIS WERE IN 145 PATIENTS (145OF 641
22.6%),MICROMETASTASIS IN 61 PATIENTS(61 OF 641 10.3%) &
ISOLATED TUMOUR CELLS IN 19 PATIENTS(19 OF 641 13.26%).
 ALL PATIENTS WITH SLN MACROMETASTASIS .MICROMETASTASIS
AND ISOLATED TUMOUR CELLS UNDERWENT COMLETION ALND.
 SLNB & COMPLETION ALND WERE PERFORMED IN 225 PATIENTS.(225
OF 641 35.1%)IN THE REMAINING 416 WOMEN (416 OF 641 64.89%)NO
FURTHER AXILLARY SURGERY WAS PERFORMED.BASED ON FROZEN
SECTION SHOWING MACROMETASTASIS (145 PATIENTS),
MICROMETASTASIS (61 PATIENTS)AND IN CASE OF SLN
IDENTIFICATION FAILURE(11 PATIENTS)AN IMMEDIATE COMPLETION
ALND WAS PERFORMED. IN 160 PATIENTS A DELAYED ALND WAS
PERFORMED. IN 50 PATIENTS(50 OF 235 21.27%)THEREFORE 7.6% (50
OF 641) PATIENTS UNDERWENT DELAYED COMPLETION ALND).

11. CONCLUSION CONTD……..
 IN HOSPITAL MORBIDITY AND MORTALITY:A TOTAL OF 641 (641 OF
660 97.12%)PATIENTS WERE EVALUATED.9 PATIENTS WERE
EXCLUDED BECAUSE OF INCOMPLETE DATA SHEETS.
 THERE WAS NO REPORTED MORBIDITY IN 35.8% AND 66.2% IN THE
SLN GROUP & SLNB PLUS ALND GROUP.RESPECTIVELY(P<0.0001)
 THE FOLLOWING POSTOPERATIVE SEQUELAE WERE
SIGNIFICANTLY LOWER IN SLNB GROUP COMPARED WITH THE
GROUP HAVING SLNB PLUS ALND.
 1.SHOULDER RANGE MOTION: 26.8% Vs 50.0%
 2.SHOULDER/ARM PAIN: 9.3% Vs 22.9%
 3.NUMBNESS: 6.6% Vs 22.9%
 4.AXILLARY PAIN : 8.2%Vs 17.1%
 5.SEROMA FORMATION:ALL P VALUES LESS THAN 0.001%
 6.THE WOUND INFECTION RATES WERE LOW IN BOTH THE GROUPS 0.9%Vs 2.9%
 ONE PATIENT DIED ON 3RD DAY DUE TO MI

12. CONCLUSION CONTD…..
 INTERMEDIATE TERM MORBIDITY & MORTALITY:INTERMEDIATE
TERM FOLLOW UP INFORMATION WERE COLLECTED IN 630 OF 641
PATIENTS 98.28%.
 THE MEDIAN FOLLOW UP FOR BOTH GROUPS OF PATIENTS WERE 31
& 29.5 MONTHS RESPECTIVELY.
 A TOTAL OF 168 OF 416 (39.0%) & 140 OF 225 PATIENTS (62.2%%)IN
THE SLNB & SLNB PLUS ALND GROUP,RESPECTIVELY, SUFFERED
FROM AT LEAST 1 COMPLICATION.
COMPLICATION SLNB GROUP SLNB+ALND
1.SHOULDER
MOTION
3.5% 11.3%
2.SHOULDER/
ARM PAIN
8.1% 21.1%
3.PAINFUL
SCARS
3.7% 13.7%
4.NUMBNESS 10.9% 37.7%
5.LYMPHEDEMA 3.5% 19.1%
THE COMPLICATIONS WERE SIGNIFICANTLY LESS IN SLNB GROUPTHAN SLNB
PLUS ALND

13. CONCLUSION CONTD…….
 TUMOUR RECURRENCE:AFTER MEDIAN RANGE FOLLOW UP
,THERE WAS NO STATISTICAL DIFFERENCE REGARDING BREAST
OR AXILLARY TUMOUR RECURRENCE BETWEEN BOTH THE
GROUPS.
COMPLICATIO
N
SLNB GROUP SLNB+ALND
BREAST
RECURRENCE
0.9% 2.5%
AXILLARY
RECURRENCE
1.2% 1.5%
DISTANT METASTASIS OCCURRED MORE FREQUENTLY IN SLNB & ALND
GROUP COMPAREDWITH SLNBALONE GROUP.THISCAN BE EXPLAINED BYTHE
FACTTHAT INTHE SLNB&ALND GROUPTHE PATIENTSWERE MOSTLY NODE
POSITIVE

14. CONCLUSION CONTD……..
 THE PRESENT PROSPECTIVE STUDY BASED ON A LARGE SAMPLE
OF BREAST CANCER PATIENTS PROVIDES COMPELLING
EVIDENCE THAT POSTOPERATIVE MORBIDITY IS SIGNIFICANTLY
LOWER IN SLNB PATIENTS COMPARED WITH SLNB PLUS ALND
PATIENTS.
 HOWEVER THE MORBIDITY AFTER SLNB ALONE IS NOT
NEGLIGIBLE.
 ALND IS ASSOCIATED WITH SIGNIFICANT MORBIDITY THAT
NEGATIVELY EFFECTS QUALITY OF LIFE.
 THE OCCURRENCE OF LYMPHEDEMA IS BETWEEN 5% & 25%
AFTER SLNB + ALND.
 OUR RESULTS ARE IN LINE WITH AND CONFIRM THE PREVALENT
OCCURRENCE OF MORBIDITY AFTER SLNB PLUS COMPLETION
ALND.

15. HAVE A NICE DAY