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Does the result of completion axillary lymph node dissection influence the recommendation for adjuvant treatment in sentinel lymph node-positive patients ? 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 .
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Intervention_Surgical
completion axillary lymph node dissection
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Intervention_Pharmacological
adjuvant treatment
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Intervention_Physical
completion axillary lymph node dissection ( cALND )
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Intervention_Physical
regional nodal irradiation ( RNI )
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Intervention_Physical
RNI
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Intervention_Physical
cALND
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Intervention_Surgical
.
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Intervention_Physical
cALND
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Intervention_Physical
cALND
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Intervention_Surgical
cALND
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Intervention_Physical
RNI
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Intervention_Physical
ALND
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Intervention_Pharmacological
RNI
60001
Intervention_Physical
chemotherapy
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Intervention_Physical
Endocrine therapy
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Intervention_Physical
adjuvant chemotherapy
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Intervention_Surgical
cALND
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Intervention_Physical
adjuvant systemic therapy
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Intervention_Pharmacological
.
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Participant_Condition
sentinel lymph node-positive
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Participant_Condition
sentinel lymph node-positive ( SLN+ ) primary invasive breast cancer .
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Participant_Condition
SLN+ breast cancer
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Participant_Condition
SLN+ primary breast cancer
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Participant_Sample-size
474
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Participant_Condition
SLN+ patients
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Participant_Condition
premenopausal
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Participant_Condition
type 2 positive tumor
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Participant_Condition
premenopausal
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Participant_Condition
larger ( pT2-3 ) tumors