Abstract
Objective
The Hungarian National Institute of Oncology has just closed a single-center randomized
clinical study. The Optimal Treatment of the Axilla–Surgery or Radiotherapy (OTOASOR)
trial compares completion axillary lymph node dissection (cALND) with 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 cALND. In these patients we had information only about the sentinel lymph node
(SLN) status, but the further axillary nodal involvement remained unknown. The aim
of this study was to investigate whether the result of cALND influenced the recommendation
for adjuvant treatment in patients with SLN+ breast cancer.
Patients and Methods
Patients with SLN+ primary breast cancer were randomized for cALND (arm A, standard
treatment) or RNI (arm B, investigational treatment). Adjuvant systemic treatments
were 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 cALND (arm
A, standard treatment = 244 patients) or RNI (arm B, investigational treatment = 230
patients). The 2 arms were well balanced according to the majority of main prognostic
factors. However, more patients were premenopausal (34% vs. 27%; P = .095) and had pT2-3 tumors (57% vs. 40%; P = .003) in the completion axillary lymph node dissection (ALND) arm. On the other
hand, there were more patients with known human epidermal growth factor receptor type
2 positive tumor (12% vs. 17%, P = .066) in the RNI arm. In the ALND and RNI arms, 78% (190/244) and 69% (159/230),
respectively, received chemotherapy (P = .020). Endocrine therapy was administered in 87% (213/244) of the patients in the
ALND arm and 89% (204/230) of the patients in the RNI arm (P = .372). Six patients (2.5%) on arm A and 13 patients (5.7%) on arm B received adjuvant
trastuzumab treatment (P = not significant). Subgroup analyses explored that more frequent administration
of adjuvant chemotherapy in arm A was associated with the higher percentage of premenopausal
patients and patients with larger (pT2-3) tumors.
Conclusions
The result of cALND after positive SLN biopsy seems to have no major impact on the
administration of adjuvant systemic therapy.
Keywords
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Article info
Publication history
Published online: June 17, 2013
Accepted:
April 29,
2013
Received in revised form:
April 24,
2013
Received:
September 17,
2012
Identification
Copyright
© 2013 Elsevier Inc. Published by Elsevier Inc. All rights reserved.
