Annals of Oncology Advance Access originally published online on January 27, 2009
Annals of Oncology 2009 20(6):1001-1007; doi:10.1093/annonc/mdn746
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breast cancer |
Sentinel node biopsy compared with complete axillary dissection for staging early breast cancer with clinically negative lymph nodes: results of randomized trial
1 Surgical Senology Unit, National Cancer Research Institute
2 Department of General Surgery
3 Department of Nuclear Medicine, A.O.U San Martino
4 Department of Anatomy and Cytohistology Unit
5 Department of Clinical Epidemiology Unit, National Cancer Research Institute, Genoa, Italy
* Correspondence to: Dr B. Dozin, Clinical Epidemiology Unit, National Cancer Research Institute, Largo Rosanna Bensi 10, 16132 Genoa, Italy. Tel: +39-010-5737492; Fax: +39-010-354103; E-mail: beatrice.dozin{at}istge.it
Background: Sentinel lymph node (SLN) staging is currently used to avoid complete axillary dissection in breast cancer patients with negative SLNs. Evidence of a similar efficacy, in terms of survival and regional control, of this strategy as compared with axillary resection is based on few clinical trials. In 1998, we started a randomized study comparing the two strategies, and we present here its results.
Materials and methods: Patients were randomly assigned to sentinel lymph node biopsy (SLNB) and axillary dissection [axillary lymph node dissection (ALND arm)] or to SLNB plus axillary resection if SLNs contained metastases (SLNB arm). Main end points were overall survival (OS) and axillary recurrence.
Results: One hundred and fifteen patients were assigned to the ALND arm and 110 to the SLNB arm. A positive SLN was found in 27 patients in the ALND arm and in 31 in the SLNB arm. Overall accuracy of SLNB was 93.0%. Sensitivity and negative predictive values were 77.1% and 91.1%, respectively. At a median follow-up of 5.5 years, no axillary recurrence was observed in the SLNB arm. OS and event-free survival were not statistically different between the two arms.
Conclusions: The SLNB procedure does not appear inferior to conventional ALND for the subset of patients here considered.
Key words: axillary lymph node dissection, breast cancer, overall survival, randomized clinical trial, regional node recurrence, sentinel lymph node biopsy
Received for publication August 4, 2008. Revision received November 5, 2008. Accepted for publication November 6, 2008.
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