1. 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

2. 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

3. 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)

4. 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

5. 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)

6. 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

7. Tumor histology

8. 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

9. Localization technique

10. Lymphoscintigraphy

11. 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)

12. Sentinel Lymph Node Findings in the operating room PERCENT

13. 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

14. 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)

15. 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.

16. Results Correlation between SLND and Positive axillary status (N=20)

17. 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