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Complete Axillary Lymph Node Dissection Versus Clinical Follow-up in Breast Cancer Patients with Sentinel Node Micrometastasis: Final Results from the Multicenter Clinical Trial AATRM 048/13/2000

  • Breast Oncology
  • Published:
Annals of Surgical Oncology Aims and scope Submit manuscript

Abstract

Background

It has been suggested that selective sentinel node (SN) biopsy alone can be used to manage early breast cancer, but definite evidence to support this notion is lacking. The aim of this study was to investigate whether refraining from completion axillary lymph node dissection (ALND) suffices to produce the same prognostic information and disease control as proceeding with completion ALND in early breast cancer patients showing micrometastasis at SN biopsy.

Methods

This prospective, randomized clinical trial included patients with newly diagnosed early-stage breast cancer (T < 3.5 cm, clinical N0, M0) who underwent surgical excision as primary treatment. All had micrometastatic SN. Patients were randomly assigned to one of the two study arms: complete ALND (control arm) or clinical follow-up (experimental arm). Median follow-up was 5 years, recurrence was assessed, and the primary end point was disease-free survival.

Results

From a total sample of 247 patients, 14 withdrew, leaving 112 in the control arm and 121 in the experimental arm. In 15 control subjects (13 %), completion ALND was positive, with a low tumor burden. Four patients experienced disease recurrence: 1 (1 %) of 108 control subjects and 3 (2.5 %) of 119 experimental patients. There were no differences in disease-free survival (p = 0.325) between arms and no cancer-related deaths.

Conclusions

Our results strongly suggest that in early breast cancer patients with SN micrometastasis, selective SN lymphadenectomy suffices to control locoregional and distant disease, with no significant effects on survival.

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Acknowledgment

Supported in part by Grant AATRM 048/13/2000 from the Catalan Agency for Health Information, Assessment and Quality, Barcelona, Spain. We are deeply grateful to all the local researchers and patients who were willing to participate so generously. We especially acknowledge the contribution of Dr. J. M. Gubern (Hospital de Mataró) and Dr. A. Barnadas (Hospital Sant Pau de Barcelona) for their careful review. Our special thanks go to the following investigators, who, together with those cited as authors, also participated in the study: Dr. Jordi Solsona, Hospital del Mar de Barcelona; Dr. Pere Puig, Hospital Sant Jaume de Calella; Dr. Jose L de Pablo, Hospital de Txagorritxu de Vitoria; Dr. Guadalupe Peñalva, Fundació Hospital Assil de Granollers; Dr. Ricardo Rojo, Hospital Ramón y Cajal de Madrid; Dr. Joan Janer, Hospital de l’Esperit Sant de Santa Coloma de Gramenet; Dr. Josep M Gubern, Hospital de Mataró; Dr. Pere Deulofeu, Hospital Municipal de Badalona; Dr. Enrique Veloso, Hospital Mutua de Terrassa; Dr. Constantí Serra, Hospital General de Vic; Dr. Luis Solarnau, ALTHAIA–Xarxa Assistencial de Manresa. This study corresponds to a substantial part of a doctoral thesis that will be presented at Autonomous University of Barcelona.

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Authors and Affiliations

  1. Hospital Universitari Germans Trias i Pujol de Badalona, Barcelona, Spain

    Montserrat Solá MD & Manuel Fraile MD

  2. Instituto Oncológico de San Sebastian, San Sebastian, Spain

    José A. Alberro MD & Pilar Santesteban MD

  3. Hospital Universitario de Salamanca, Salamanca, Spain

    Manuel Ramos MD

  4. Instituto Universitario Dexeus de Barcelona, Barcelona, Spain

    Rafael Fabregas MD

  5. Hospital Sant Pau de Barcelona, Barcelona, Spain

    Antonio Moral MD

  6. Hospital de la Ribera de Alzira, Alzira, Spain

    Blas Ballester MD

  7. Hospital Clínic de Barcelona, Barcelona, Spain

    Sergi Vidal MD

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  1. Montserrat Solá MD
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  2. José A. Alberro MD
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  3. Manuel Fraile MD
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  4. Pilar Santesteban MD
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  5. Manuel Ramos MD
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  7. Antonio Moral MD
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Correspondence to Montserrat Solá MD.

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Solá, M., Alberro, J.A., Fraile, M. et al. Complete Axillary Lymph Node Dissection Versus Clinical Follow-up in Breast Cancer Patients with Sentinel Node Micrometastasis: Final Results from the Multicenter Clinical Trial AATRM 048/13/2000. Ann Surg Oncol 20, 120–127 (2013). https://doi.org/10.1245/s10434-012-2569-y

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  • DOI: https://doi.org/10.1245/s10434-012-2569-y

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