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Randomized Controlled Trial
Sentinel lymph node biopsy in breast cancer: ten-year results of a randomized controlled study.
- Umberto Veronesi, Giuseppe Viale, Giovanni Paganelli, Stefano Zurrida, Alberto Luini, Viviana Galimberti, Paolo Veronesi, Mattia Intra, Patrick Maisonneuve, Francesca Zucca, Giovanna Gatti, Giovanni Mazzarol, Concetta De Cicco, and Dario Vezzoli.
- European Institute of Oncology, Milan, Italy. umberto.veronesi@ieo.it
- Ann. Surg. 2010 Apr 1;251(4):595-600.
ObjectiveSentinel node biopsy (SNB) is widely used to stage the axilla in breast cancer. We present 10-year follow-up of our single-institute trial designed to compare outcomes in patients who received no axillary dissection if the sentinel node was negative, with patients who received complete axillary dissection.MethodsFrom March 1998 to December 1999, 516 patients with primary breast cancer up to 2 cm in pathologic diameter were randomized either to SNB plus complete axillary dissection (AD arm) or to SNB with axillary dissection only if the sentinel node contained metastases (SN arm).ResultsThe 2 arms were well-balanced for number of sentinel nodes found, proportion of positive sentinel nodes, and all other tumor and patient characteristics. About 8 patients in the AD arm had false-negative SNs on histologic analysis: a similar number (8, 95% CI: 3-15) of patients with axillary involvement was expected in SN arm patients who did not receive axillary dissection; but only 2 cases of overt axillary metastasis occurred. There were 23 breast cancer-related events in the SN arm and 26 in the AD arm (log-rank, P = 0.52), while overall survival was greater in the SN arm (log-rank, P = 0.15).ConclusionsPreservation of healthy lymph nodes may have beneficial consequences. Axillary dissection should not be performed in breast cancer patients without first examining the sentinel node.
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