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Original Article
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Volume 349:546-553 August 7, 2003 Number 6
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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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 by Krag, D.
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ABSTRACT

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

Methods From March 1998 to December 1999, we randomly assigned 516 patients with primary breast cancer in whom the tumor was less than or equal to 2 cm in diameter either to sentinel-node biopsy and total axillary dissection (the axillary-dissection group) or to sentinel-node biopsy followed by axillary dissection only if the sentinel node contained metastases (the sentinel-node group).

Results The number of sentinel nodes found was the same in the two groups. A sentinel node was positive in 83 of the 257 patients in the axillary-dissection group (32.3 percent), and in 92 of the 259 patients in the sentinel-node group (35.5 percent). In the axillary-dissection group, the overall accuracy of the sentinel-node status was 96.9 percent, the sensitivity 91.2 percent, and the specificity 100 percent. There was less pain and better arm mobility in the patients who underwent sentinel-node biopsy only than in those who also underwent axillary dissection. There were 15 events associated with breast cancer in the axillary-dissection group and 10 such events in the sentinel-node group. Among the 167 patients who did not undergo axillary dissection, there were no cases of overt axillary metastasis during follow-up.

Conclusions Sentinel-node biopsy is a safe and accurate method of screening the axillary nodes for metastasis in women with a 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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Related Letters:

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.
Extract | Full Text | PDF  
N Engl J Med 2003; 349:1968-1971, Nov 13, 2003. Correspondence



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