Does the Result of Completion Axillary Lymph Node Dissection Influence the Recommendation for Adjuvant Treatment in Sentinel Lymph Node Positive Patients?

Sávolt Á¹, Mátrai Z¹, Tóth L¹, Polgár C², Musonda P³, Szabó É⁴, Horváth Z⁵, Kásler M⁶, Péley G⁷

1 Department of General and Thoracic Surgical Oncology, National Institute of Oncology, Budapest, Hungary
2 Department of Radiotherapy, National Institute of Oncology, Budapest, Hungary
3 School of Medicine, Health Policy and Practice, University of East Anglia, Norwich, UK
4 Department of Diagnostic Radiology , National Institute of Oncology, Budapest, Hungary
5 Department of Medical Oncology, National Institute of Oncology, Budapest, Hungary
6 National Institute of Oncology, Budapest, Hungary
7 Department of General Surgery, Norfolk and Norwich University Hospital, Norwich, UK

Aims: The Hungarian National Institute of Oncology has just closed a single-centre randomized clinical study. The OTOASOR (Optimal Treatment of the Axilla – Surgery or Radiotherapy) trial compares completion axillary lymph node dissection (ALND) to regional nodal irradiation (RNI) in patients with sentinel lymph node-positive (SLN+) primary invasive breast cancer. In the investigational treatment arm patients received 50 Gy RNI instead of completion ALND. In these patients we had information only about the SLN status, but the further axillary nodal involvement remained unknown. The aim of this study was to investigate whether the result of completion ALND influenced the recommendation for adjuvant treatment in SLN+ breast cancer patients.
Patients and methods: Patients with SLN+ primary breast cancer were randomized for completion ALND (arm A-standard treatment) or RNI (arm B-investigational treatment). Adjuvant systemic treatments was given according to the standard institutional protocol and patients were followed according to the actual institutional guidelines.
Results: Between August 2002 and June 2009, 474 SLN+ patients were randomized to completion ALND (arm A-standard treatment, 244 patients) or RNI (arm B-investigational treatment, 230 patients). There were no significant differences in terms of major prognostic factors between the two arms. Two-hundred and fourty-two patients (99.6%) on arm A and 229 patients (99.6%) on arm B received adjuvant systemic treatments including chemotherapy and/or endocrine treatment (p=NS). One-hundred and ninety-four patients (79.5%) received adjuvant chemotherapy on arm A and 159 patients (69.1%) on arm B (p=0.031). Two-hundred and four patients (83.6%) received adjuvant endocrine treatment on arm A and 196 patients (85.2%) on arm B (p=NS). Six patients (2.5%) received adjuvant trastuzumab treatment on arm A and 13 patients (5.7%) on arm B (p=NS).
Conclusions: The result of completion ALND after positive SLNB appears to have no major impact on the administration of adjuvant systemic therapy.