A nonrandomized follow-up comparison between standard axillary node dissection and sentinel node biopsy in breast cancer

Introduction: In many countries sentinel node biopsy (SNB) has become the standard of care in breast cancer based on a large number of observational studies but without results from prospective randomized trials. The goat of our study was to evaluate the oncological safety of the SNB in breast cancer in a multicenter, norrandomized setting with comparable groups. Patients and methods: Between 1996/05 and 2004/11, 2942 patients from 14 departments in Austria with unicentric, unilateral, invasive disease without neoadjuvant therapy were collected in a database. The recommendations of the Austrian Sentinel Node Study Group were to complete a training period (phase 1) with 50 cases of SNB followed by axillary lymph node dissection (ALND) to prove a detection rate of >= 90% and a fatse-negative rate of <= 5%. In the executing period (phase 11), SNB was followed by ALND only if the sentinel node (SN) contained metastases. We compared the results on disease-free survival, local recurrence rates, distant recurrence rates and overall survival of both groups. Cases from phases I and II generated groups 1 (n = 671) and 2 (n = 2271 cases), respectively. Results: Overall mean follow-up time: 34.41 months [GRAPHICS] Conclusion: SNB followed by ALND only in cases with metastases in the SN is a safe procedure and at least equal to ALND in all cases. (c) 2007 Elsevier Ltd. All rights reserved.