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Annals of Oncology Advance Access published online on January 24, 2005
Annals of Oncology, doi:10.1093/annonc/mdi089
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© 2005 European Society for Medical Oncology
Received August 2, 2004
Revised October 25, 2004
Accepted October 26, 2004

Original article

Avoiding axillary dissection in breast cancer surgery: a randomized trial to assess the role of axillary radiotherapy

U. Veronesi 1*, R. Orecchia 2, S. Zurrida 1, V. Galimberti 1, A. Luini 1, P. Veronesi 1, G. Gatti 1, G. D'Aiuto 3, L. Cataliotti 4, R. Paolucci 5, P. Piccolo 5, N. Massaioli 6, P. Sismondi 6, A. Rulli 7, F. Lo Sardo 8, A. Recalcati 9, D. Terribile 10, A. Acerbi 11, N. Rotmensz 12, P. Maisonneuve 3, and & GrISO (Italian Oncological Senology Group) {dagger}

1 Division of Senology, European Institute of Oncology, Milan, Italy
2 Division of Radiotherapy, European Institute of Oncology, Milan, Italy
3 Division of Surgery, Pascale Institute of Cancer, Naples, Italy
4 Division of Surgery, University of Florence, Florence, Italy
5 Division of Surgery, Ospedale Maggiore, Parma, Italy
6 Division of Surgery, Ospedale Molinette, Turin, Italy
7 Division of Surgery, University of Perugia, Perugia, Italy
8 Division of Surgery, Ospedale Oncologico ‘Maurizio Ascoli’, Palermo, Italy
9 Divison of Surgery II, Ospedale di Lecco, Lecco, Italy
10 Istituto Patologia Chirurgica--Gemelli, and Università Cattolica Sacro Cuore, Rome, Italy
11 Division Surgery C, Policlinico GB Rossi, Verona, Italy
12 Division of Epidemiology and Biostatistics, European Institute of Oncology, Milan, Italy

* To whom correspondence should be addressed.
U. Veronesi, E-mail: umberto.veronesi{at}ieo.it


  Abstract

Background: The need to dissect axillary nodes in patients with early breast cancer and clinically negative axilla remains controversial. The aim of the study was to assess the role of axillary radiotherapy (RT) in reducing axillary metastases in patients with early breast cancer who did not receive axillary dissection.

Patients and methods: From 1995 to 1998, 435 patients over 45 years old with breast cancer up to 1.2 cm and no palpable axillary nodes were randomized 214 to breast conservation without axillary treatment and 221 to breast conservation plus axillary RT.

Results: After a median follow-up of 63 months, overt axillary metastases were fewer than expected: three cases in the no axillary treatment group (1.5%) and one in the RT group (0.5%). Expected cases were 43 in the no axillary treatment group and 10 in the RT group. Rates of distant metastases and local failures were low, and 5-year disease free survival was 96.0% (95% confidence interval, 94.1%-97.9%) without significant differences between the two arms.

Conclusions: This study suggests that occult axillary metastases might never become clinically overt and axillary dissection might be avoided in patients with small carcinomas and a clinically negative axilla. Axillary RT seems to protect the patients from axillary recurrence almost completely.

Keywords: axillary radiotherapy; breast cancer; lymph nodes; metastases; randomized trial.

{dagger} Collaborators actively contributing to this study are listed in the Acknowledgements.


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