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

Summary 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 ⩾90% and a false-negative rate of ⩽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 Group I Group II p -value Local recurrences 18 18 0.132 Axillary recurrences 7 8 0.073 Distant metastases 39 64 0.185 Disease events 71 115 0.17 Deaths 35 64 0.82 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.