A Randomized Comparison of Sentinel-Node Biopsy with Routine Axillary Dissection in Breast Cancer

doi:10.1056/NEJMoa012782

Volume 349:546-553		August 7, 2003		Number 6

A Randomized Comparison of Sentinel-Node Biopsy with Routine Axillary Dissection in Breast Cancer

Umberto Veronesi, M.D., Giovanni Paganelli, M.D., Giuseppe Viale, F.R.C.Path., Alberto Luini, M.D., Stefano Zurrida, M.D., Viviana Galimberti, M.D., Mattia Intra, M.D., Paolo Veronesi, M.D., Chris Robertson, Ph.D., Patrick Maisonneuve, Eng., Giuseppe Renne, M.D., Concetta De Cicco, M.D., Francesca De Lucia, M.D., and Roberto Gennari, M.D.

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ABSTRACT

Background Although numerous studies have shown that the statusof the sentinel node is an accurate predictor of the statusof the axillary nodes in breast cancer, the efficacy and safetyof sentinel-node biopsy require validation.

Methods From March 1998 to December 1999, we randomly assigned516 patients with primary breast cancer in whom the tumor wasless than or equal to 2 cm in diameter either to sentinel-nodebiopsy and total axillary dissection (the axillary-dissectiongroup) or to sentinel-node biopsy followed by axillary dissectiononly if the sentinel node contained metastases (the sentinel-nodegroup).

Results The number of sentinel nodes found was the same in thetwo groups. A sentinel node was positive in 83 of the 257 patientsin the axillary-dissection group (32.3 percent), and in 92 ofthe 259 patients in the sentinel-node group (35.5 percent).In the axillary-dissection group, the overall accuracy of thesentinel-node status was 96.9 percent, the sensitivity 91.2percent, and the specificity 100 percent. There was less painand better arm mobility in the patients who underwent sentinel-nodebiopsy only than in those who also underwent axillary dissection.There were 15 events associated with breast cancer in the axillary-dissectiongroup and 10 such events in the sentinel-node group. Among the167 patients who did not undergo axillary dissection, therewere no cases of overt axillary metastasis during follow-up.

Conclusions Sentinel-node biopsy is a safe and accurate methodof screening the axillary nodes for metastasis in women witha small breast cancer.

Source Information

From the Divisions of Senology (U.V., A.L., S.Z., V.G., M.I., P.V., R.G.), Nuclear Medicine (G.P., C.D.), Pathology (G.V., G.R.), Epidemiology (C.R., P.M.), and Anaesthesiology (F.D.), European Institute of Oncology; and the University of Milan School of Medicine (G.V.) — both in Milan, Italy.

Address reprint requests to Dr. Umberto Veronesi at the Istituto Europeo di Oncologia, Via G. Ripamonti 435, 20141 Milan, Italy, or at umberto.veronesi{at}ieo.it.

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Sentinel-Node Biopsy in Breast Cancer
Badwe R. A., Thorat M. A., Parmar V. V., De Salvo G. L., Del Bianco P., Zavagno G., Munster A. M., McMasters K. M., Veronesi U., Maisonneuve P., Krag D., Ashikaga T.
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N Engl J Med 2003; 349:1968-1971, Nov 13, 2003. Correspondence

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