Sentinel-node biopsy for axillary staging in breast cancer: results from a large prospective German multi-institutional trial

Purpose. To analyse the reliability of sentinel-node biopsy (SNB) in a multicentre setting and define conditions for the routine use of the procedure. Material and methods. SNB with consecutive axillary clearing was performed in 1124 breast cancer patients. The detection rate of a sentinel lymph node and its dependence on the choice of lymphography technique, patient selection, and technical procedure were analysed. The diagnostic performance of the sentinel-node method was compared to clinical, ultrasound-guided and histological staging. In order to study training effects all learning periods were included. Results. Twenty-two institutions with a total of 89 surgeons participated in the trial. The detection rate (overall: 85.2%) was found to be related to the applied lymphography technique, the experience of the institution and various technical factors of the procedure itself. The false-negative rate (FNR, overall: 8.2%) was independent of patient selection and technical features. The FNR did not depend on experience in the application of the method, but seemed related to surgical accuracy to detect sentinel nodes. Compared to conventional staging procedures (palpation, ultrasound) SNB yielded highly reproducible results for the prediction of the axillary status even in a multicentre setting involving surgeons with different training status. Conclusion. SNB is suited as standard of care procedure. Measures of quality control appear more important than learning periods to minimize the FNR.