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This study aims to evaluate the value and safety of sentinel lymph node biopsy (SLND) in breast cancer management in a community hospital in Rome, Italy. The study found that SLND is highly accurate in predicting lymph node status, allowing for the avoidance of unnecessary axillary node dissection in the majority of patients.
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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
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
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)
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)
ResultsFalse 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)
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