30. Sentinel Node Skills Verification and Surgeon Performance: Data From A Multicenter Clinical Trial For Early Stage Breast Cancer
Katherine E. Posther, MD*1, Linda M. McCall, MS*1, Peter W. Blumencranz, MD*2, William E. Burak, Jr., MD*3, Peter D. Beitsch, MD*4, Nora M. Hansen, MD*5, Monica Morrow, MD6, James E. Herndon, PhD*1, Kelly K. Hunt, MD6, Armando E. Giuliano, MD5
1American College of Surgeons Oncology Group, Durham, NC; 2Morton Plant Mease Health Care, Clearwater, FL; 3Arthur G. James Cancer Hospital and Solove Institute, Ohio State University, Columbus, OH; 4Dallas Surgical Group, Dallas, TX; 5John Wayne Cancer Institute, Santa Monica, CA; 6Fox Chase Cancer Center, Philadelphia, PA; 7University of Texas M.D. Anderson Cancer Center, Houston, TX
OBJECTIVE(S): A prospective multicenter trial was initiated in 1999 to evaluate the prognostic significance of sentinel lymph node (SLN) micrometastases in early-stage breast cancer. Marked variations in SLN dissection (SLND) techniques and failure rates, documented in previous studies, emphasize the need for procedural performance standards. METHODS: Participating surgeons were required to document at least 20 cases of SLND followed by completion lymph node dissection (CLND) with failure rates less than 15%. Surgeons reporting 20+ training cases during surgical residency or fellowship were exempt from skill requirements. Data from 5327 subjects and 198 surgeons are presented. RESULTS: Participating surgeons from academic (50%), community (26%), or teaching-affiliated (23%) institutions qualified with 20+ SLND/CLND cases (86.8%) or exemption (13.2%). Surgeons used radiocolloid alone, blue dye alone, or both in 5.7%, 14.8% and 79.4% of cases, respectively, identifying the SLN(s) in 98.6% of cases. Using chi-square analysis, patient factors associated with increased SLND failure were increased body mass index and age (p≤ 0.0001). Subjects registered by surgeons with lower study accrual (< 50 subjects), compared to higher accrual (≥ 50 subjects), were also at higher risk for failed SLND (p≤ 0.0001). Factors that were not associated with technical failure included presence of nodal metastases, number of positive nodes, tumor stage, SLND technique, number of qualifying cases or exemption status, and institution type. CONCLUSIONS: Using standardized skill requirements, surgeons from a variety of institutions achieved an acceptably low SLND failure rate within a large multicenter trial, validating the incorporation of this procedure into clinical practice.