The 13th St Gallen International Breast Cancer Conference (2013) Expert Panel reviewed and endorsed substantial new evidence on aspects of the local and regional therapies for early breast cancer, supporting less extensive surgery to the axilla and shorter durations of radiation therapy. It refined its earlier approach to the classification and management of luminal disease in the absence of amplification or overexpression of the Human Epidermal growth factor Receptor 2 (HER2) oncogene, while retaining essentially unchanged recommendations for the systemic adjuvant therapy of HER2-positive and ‘triple-negative’ disease. The Panel again accepted that conventional clinico-pathological factors provided a surrogate subtype classification, while noting that in those areas of the world where multi-gene molecular assays are readily available many clinicians prefer to base chemotherapy decisions for patients with luminal disease on these genomic results rather than the surrogate subtype definitions. Several multi-gene molecular assays were recognized as providing accurate and reproducible prognostic information, and in some cases prediction of response to chemotherapy. Cost and availability preclude their application in many environments at the present time. Broad treatment recommendations are presented. Such recommendations do not imply that each Panel member agrees: indeed, among more than 100 questions, only one (trastuzumab duration) commanded 100% agreement. The various recommendations in fact carried differing degrees of support, as reflected in the nuanced wording of the text below and in the votes recorded in supplementary Appendix S1, available at Annals of Oncology online. Detailed decisions on treatment will as always involve clinical consideration of disease extent, host factors, patient preferences and social and economic constraints.
Context
Sentinel lymph node dissection (SLND) accurately identifies nodal metastasis of early breast cancer.
Objective
To determine the impact of complete axillary lymph node dissection (ALND) on survival of patients with sentinel lymph node (SLN) metastasis of breast cancer.
Design and Setting
The 115 sites participating in the American College of Surgeons Oncology Group Z0011 trial enrolled patients from May 1999 to December 2004. In this phase III noninferiority trial, patients with SLN metastasis were randomized to ALND or no further axillary treatment. Targeted enrollment was 1900 women, with final analysis after 500 deaths, but the trial closed early because mortality rate was lower than expected.
Patients
Women with clinical T1–T2 invasive breast cancer, no palpable adenopathy, and 1–2 SLNs containing metastases identified by frozen section, touch preparation, or hematoxylin and eosin staining on permanent section.
Interventions
All patients underwent lumpectomy and tangential whole-breast irradiation. Those randomized to ALND underwent dissection of ≥10 nodes. Systemic therapy was at the discretion of the treating physician.
Main Outcome Measures
Overall survival (OS) was the primary endpoint, with a noninferiority margin of a one-sided hazard ratio of 1.3 or less favoring ALND. Disease-free survival (DFS) was a secondary endpoint.
Results
Clinical and tumor characteristics were similar between 445 patients randomized to ALND and 446 randomized to SLND alone. However, the median number of nodes removed was 17 with ALND and 2 with SLND alone. At a median follow-up of 6.3 years (last follow-up date 03/04/2010), 5-year OS was 91.8% (95% CI: 89.1 to 94.5) with ALND and 92.5% (95% CI: 90.0 to 95.1) with SLND alone; 5-year DFS was 82.2% (95% CI: 78.3 to 86.3) with ALND and 83.9% (95% CI: 80.2 to 87.9) with SLND alone. Hazard ratio for treatment-related OS was 0.79 (90% CI: 0.56 to 1.11) without adjustment and 0.87 (90% CI: 0.62 to 1.23) after adjusting for age and adjuvant therapy.
Conclusions
Among patients with limited SLN metastatic breast cancer treated with breast conservation and systemic therapy, the use of SLND compared with ALND did not result in inferior survival.
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