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Sentinel Lymph Node Biopsy in Breast Cancer: Ten-Year Results of a Randomized Controlled Study

Veronesi, Umberto MD*; Viale, Giuseppe MD, FRCPath†‡; Paganelli, Giovanni MD§; Zurrida, Stefano MD*‡¶; Luini, Alberto MD¶; Galimberti, Viviana MD¶; Veronesi, Paolo MD‡¶; Intra, Mattia MD¶; Maisonneuve, Patrick Eng∥; Zucca, Francesca DSc¶; Gatti, Giovanna MD¶; Mazzarol, Giovanni MD†; De Cicco, Concetta MD§; Vezzoli, Dario MD**

doi: 10.1097/SLA.0b013e3181c0e92a

Objective: Sentinel 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.

Methods: From 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).

Results: The 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).

Conclusions: Preservation of healthy lymph nodes may have beneficial consequences. Axillary dissection should not be performed in breast cancer patients without first examining the sentinel node.

In this study, we present 10-year follow-up of our trial to compare no axillary dissection if sentinel node biopsy was negative, with complete axillary dissection, show an exceptionally low rate of axillary metastases, and slightly better survival in the no axillary dissection arm. Sentinel node biopsy is as good as axillary dissection in staging the axilla.

From the *European Institute of Oncology, Milan, Italy; †Department of Pathology and Laboratory Medicine, European Institute of Oncology, Milan, Italy; ‡University of Milan School of Medicine, Milan, Italy; §Division of Nuclear Medicine, European Institute of Oncology, Milan, Italy; ¶Division of Senology, European Institute of Oncology, Milan, Italy; ∥Division of Epidemiology and Biostatistics, European Institute of Oncology, Milan, Italy; and **Division of Anaesthesiology, European Institute of Oncology, Milan, Italy.

Trial Registration number: NCT00970983.

U. Veronesi designed the study and did a large proportion of surgical procedures. G. Paganelli and C. De Cicco did the sentinel node lymphoscintigraphy. G. Viale and G. Mazzarol did pathological assessment of the primary tumors and sentinel nodes. A. Luini, S. Zurrida, V. Galimberti, M. Intra, P. Veronesi, G. Manfredi, and J. Rodriguez Fernandez enrolled, treated, and followed up the patients. G. Gatti supervised data collection. P. Maisonneuve did the statistical analysis. U. Veronesi wrote a draft of the paper which was revised and approved by all authors, who had full access to the data and take full responsibility for the decision to submit for publication.

Reprints: Umberto Veronesi, MD, European Institute of Oncology, Via Ripamonti 435, 20141 Milan, Italy. E-mail:; or

© 2010 Lippincott Williams & Wilkins, Inc.