Background

• Sentinel lymph node biopsy has been recently introduced in the clinical setting because it is highly accurate in predicting the lymph node status

• Therefore, axillary node dissection could be avoided in the majority of women with breast cancer

Purpose of the study

• To evaluate in a prospective manner the value of sentinel lymph node biopsy (SLND) in the management of patients with breast cancer

• To evaluate if the technique can be applied safely and proficiently in a Cancer Unit of a Community Hospital in Rome, Italy

Methods• All patients were entered onto a prospective

data base• All patients signed an informed consent• Patients were injected with Tecnectium-99

around the breast tumor area and/or Patent Blu dye to identify the SLND

• The biopsy was directioned by a hand-held gamma probe in the operating room (Scintiprobe MR100 - Pol.hi.tech, ITALY)

Methods

• The first 15 patients underwent routine axillary node dissection to validate the technique

• Thereafter, only patients with positive SLND, suspicious findings, or personal preference underwent partial or total axillary node dissection

Patients

• 68 consecutive patients from January 1999 to January 2000 with unicentric breast cancer less than 3 cm in diameter

• 67 women, 1 man• Median age 62 years (range 37-85)• 52 post-menopausal, 15 pre-menopausal• Median tumor diameter 1.5 cm (range 0.4-3

cm)

Technique

• Intradermal or subdermal injection of 0.6-1 mCi of Tc-99 filtered nanocolloid (6-20 hours before surgery)

• Lymphoscintigraphy• Intradermal injection of 1-3 cc of Patent Blue

at the biopsy site 5-10 minutes before the axillary biopsy

• Hand-held gamma probe in the OR

Tumor histology

0

10

20

30

40

50

60

InfiltratingDuctal

Mucinous Lobular DCIS

Type of Operation

• 17/68 patients (25%) underwent mastectomy at the time of SLND biopsy

• 4 additional patients (6%) underwent mastectomy after initial biopsy and SLND due to unfavorable characteristics of the primary tumor

• 45 patients (66%) underwent SLND biopsy synchronous to primary treatment of the breast tumor

Localization technique

0

10

20

30

40

50

60

Tc-99 & Blu Dye Blu Dye only Tc-99 only

Lymphoscintigraphy

MEDIAN RANGE

Dose Tc-99(mCi)

0.8 0.6-1.2

Number of SLNDvisualized/case

1 0-4

Time tovisualization (min)

20 5-105

Results

• A SLND was identified in in the OR in 64/68 cases (94%)

• 122 sentinel lymph nodes were identified in 64 patients (median = 2; range 1-4)

• 490 additional lymph nodes were removed in 68 patients (median 6 nodes/patient)

Sentinel Lymph NodeFindings in the operating room

01020

3040

5060

708090

100

HOT & BLU HOT ONLY BLU ONLY

PERCENT

Results

• Correlation between SLND and final lymph node status was in 62/64 patients (97%)

• In 11/20 positive cases the only metastatic lymph nodes were the sentinel nodes

• In these 11 patients 134 additional lymph nodes were removed and resulted negative

Results

• There were 20/68 patients (29%) with axillary metastasis (1-8 positive lymph nodes)

• 2/20 patients had only microscopic foci of cancer in the SLN’s, diagnosed after multiple H/E sections (n=1) or immunohistochemistry (n=1)

Results False negative Cases

• There were two false negative cases (3%)

• The first case in the series, likely due to technical error, was performed only with the Blue dye

• The 18th case, at SLND biopsy, multiple enlarged lymph nodes were encountered.

ResultsCorrelation between SLND and Positive axillary status (N=20)

17

21

0

2

4

6

8

10

12

14

16

18

TRUE POSITIVE FALSENEGATIVE

SLND NOTIDENTIFIED

Conclusions

• In this series, 42/68 patients (67%) with breast cancer could have spared unnecessary axillary lymph node dissection

• SLND can be performed safely and accurately in the community setting

• SLND is rapidly changing the breast cancer management paradigm