Abstract

792 Background: Although numerous studies have demonstrated the feasibility and accuracy of the sentinel lymph node (SLN) procedure for axillary staging of breast cancer, most have limited follow-up data and relatively small numbers. Establishing SLN biopsy as the standard of care requires examining those factors affecting patient outcome, including recurrence of disease, time to disease, and overall survival. Methods: Since February 1997, 1486 patients were enrolled in an IRB-approved, multi-center study designed to systematically determine factors affecting patients undergoing sentinel lymph node procedure. Data was reviewed for patient’s age, tumor size, number of positive SLN and nonsentinel lymph nodes (NSLN), false negative rate, recurrent disease (local, axillary or distant), and time to death or recurrence. Results: The average age was 57.5 years (range 24–98), tumor size 1.83 cm (0.03–10.5 cm), total number of nodes examined 9.2 (0–40), and mean follow-up time was 39.4 months (7 days - 95 months). In this study, 818 patients underwent completion axillary nodal dissection (AND) at the time of the SLN procedure. Thirty-one patients were found to have positive NSLN with negative SLN for a false negative rate of 3.8%. Recurrent disease developed in 105 (7.1%) patients, including 1 (0.06%) axillary alone, 22 (1.5%) local in breast (LIB) alone, 67 (4.5%) distant alone, 12 (0.8%) LIB and distant, 2 (0.13%) axillary and distant, and 1 (0.06%) LIB, axillary, and distant. Fifty-two (49.5%) patients died who developed recurrent disease with a mean time of 35.3 months (10.4–84.5 months) from date of diagnosis. Of the 4 patients who developed axillary recurrence, all four patients had undergone an AND after SLN procedure. Twenty-two (4.6%) out of 481 patients who had negative SLN without AND developed LIB and/or distant recurrent disease only versus 76 (8.5%) out of 895 patients who had complete AND (ns). Conclusions: Sentinel lymph node biopsy is a safe, accurate procedure. We are able to spare patients most of the morbidity of an AND without compromising risk of recurrent disease. The SLN procedure should be the standard of care for the breast cancer patient who does not have biopsy proven axillary disease. No significant financial relationships to disclose.

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