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 goal of our study was to evaluate the oncological safety of the SNB in breast cancer in a multicenter, nonrandomized 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 I) with 50 cases of SNB followed by axillary lymph node dissection (ALND) to prove a detection rate of > or = 90% and a false-negative rate of < or = 5%. In the executing period (phase II), 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 I (n=671) and 2 (n=2271 cases), respectively.
Results: Overall mean follow-up time: 34.41 months.
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.