Sentinel-node-biopsy in breast cancer - Results from a multicenter trial

Purpose: To analyse the reliability of sentinel-node biopsy (SNB) in a mult icenter setting and to analyse factors potentially influencing the success rates. Material and Methods: SNB with consecutive axillary clearance was performed in 814 breast cancer patients. The detection rate and the sensitivity as w ell as the impact of the lymphography technique, patient selection, technic al procedure and learning curves were analysed. Results: 21 centers and 80 surgeons were involved in the trial. The detecti on rate for the sentinel node was 84.0% for the entire group and showed a s ignificant dependence on the lymphography technique (blue dye, 71.6%; radio labelled tracer, 78.8%; combined technique, 89.6%) as well as the number of interventions performed. The sensitivity was 91.8% for the entire collecti ve. Little variation for the false negative rate was observed when comparin g the lymphography techniques, technical procedures, different centers or l earning curves. Compared to conventional staging procedures (palpation, ult rasound), SNB showed only minor variation in the success rate even in a mul ticenter setting. Conclusion: SNB is a promising staging procedure for axillary involvement i n breast cancer patients. Although the detection rate depends strongly on t he technical procedure, the false-negative rate remains largely unaffected by potential influencing factors. Therefore, this procedure provides reliab le results and appears suitable for general application. Although the impac t of influencing factors on the success rates require further examination a nd although the oncologic role of lymphatic mapping can only be studied in prospective randomized trials, the data of this study may provide the ethic al basis to initiate an observational trial following the randomization pha se.