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
- 7 September 2012
- journal article
- research article
- Published by Springer Science and Business Media LLC in Annals of Surgical Oncology
- Vol. 20 (1), 120-127
- https://doi.org/10.1245/s10434-012-2569-y
Abstract
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. 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. 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. 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.Keywords
This publication has 29 references indexed in Scilit:
- Can we avoid axillary dissection in the micrometastatic sentinel node in breast cancer?Breast Cancer Research and Treatment, 2011
- Axillary Dissection vs No Axillary Dissection in Women With Invasive Breast Cancer and Sentinel Node MetastasisJAMA, 2011
- Prognostic Value of Lymph Node Micrometastases in Breast Cancer: A Multicenter Cohort StudyAnnals of Surgical Oncology, 2010
- Sentinel node micrometastases in breast cancer do not affect prognosis: a population-based studyBreast Cancer Research and Treatment, 2010
- Low locoregional failure rates in selected breast cancer patients with tumor‐positive sentinel lymph nodes who do not undergo completion axillary dissectionCancer, 2007
- Recent trends in breast cancer incidence rates by age and tumor characteristics among U.S. womenBreast Cancer Research, 2007
- The prevalence of non-sentinel node metastases in breast cancer patients with sentinel node micrometastasesEuropean Journal of Surgical Oncology, 2005
- Predicting the status of axillary sentinel lymph nodes in 4351 patients with invasive breast carcinoma treated in a single institutionCancer, 2005
- The Risk of Axillary Relapse After Sentinel Lymph Node Biopsy for Breast Cancer Is Comparable With That of Axillary Lymph Node DissectionAnnals of Surgery, 2004
- Meeting Highlights: Updated International Expert Consensus on the Primary Therapy of Early Breast CancerJournal of Clinical Oncology, 2003