Abstract
Introduction
The National Institute of Oncology, Budapest conducted a single centre randomized
clinical study. The OTOASOR (Optimal Treatment Of the Axilla – Surgery Or Radiotherapy)
trial compares completion of axillary lymph node dissection (cALND) to regional nodal
irradiation (RNI) in patients with sentinel lymph node metastasis (pN1sn) in stage
I–II breast cancer.
Patients and methods
Patients with primary invasive breast cancer (cN0 and cT ≤ 3 cm) were randomized before
surgery for cALND (standard treatment) or RNI (investigational treatment). Sentinel
lymph nodes (SN) were investigated with serial sectioning at 0.5 mm levels by hematoxylin–eosin
staining. Investigational treatment arm patients received 50 Gy RNI instead of cALND.
Adjuvant treatment and follow up were performed according to the actual guidelines.
Between August 2002 and June 2009, 1054 patients were randomized for cALND and 1052
patients for RNI. SN was evaluated in 2073 patients and was positive in 526 patients
(25.4%). 474 cases were evaluable (244 in the cALND and 230 in the RNI arm), and in
the cALND group 94 of 244 patients (38.5%) who underwent completion axillary surgery
has additional positive nodes. The two arms were well balanced according to the majority
of main prognostic factors. Primary endpoint was axillary recurrence and secondary
endpoints were overall survival (OS) and disease-free survival (DFS).
Results
Mean follow-up was 97 months (Q1–Q3: 80–120). Axillary recurrence was 2.0% in cALND
arm vs. 1.7% in RNI arm (p = 1.00). OS at 8 years was 77.9% vs. 84.8% (p = 0.060),
and DFS was 72.1% in cALND arm and 77.4% after RNI (p = 0.51). The results show that
RNI is statistically not inferior to cALND treatment.
Conclusions
The long term follow-up results of this prospective-randomized trial suggest that
RNI without cALND does not increase the risk of axillary failure in selected patients
with early-stage invasive breast cancer (cT ≤ 3 cm, cN0) and pN1(sn). Axillary radiotherapy
should be an alternative treatment for selected patients with sentinel lymph node
metastases.
Keywords
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References
- Relation of tumor size, lymph node status, and survival in 124,740 breast cancer cases.Cancer. 1989; 63: 181-187
- Sentinel lymph node biopsy and axillary dissection in breast cancer: results in a large series.J Natl Cancer Inst. 1999; 91: 368-373
- A randomized comparison of sentinel node biopsy with routine axillary dissection in breast cancer.N Engl J Med. 2003; 349: 546-553
- Prospective observational study of sentinel lymphadenectomy without further axillary dissection in patients with sentinel node-negative breast cancer.J Clin Oncol. 2000; 18: 2553-2559
- Axillary dissection is not required for all patients with breast cancer and positive sentinel nodes.Arch Surg. 2003; 138: 52-56
- Preliminary outcome analysis in patients with breast cancer and a positive sentinel lymph node who declined axillary dissection.Ann Surg Oncol. 2003; 10: 126-130
- Avoidance of axillary lymph node dissection in selected patients with node-positive breast cancer.Eur J Surg Oncol. 2008; 34: 129-134
- Sentinel-lymph-node resection compared with conventional axillary-lymph-node dissection in clinically node-negative patients with breast cancer: overall survival findings from the NSABP B-32 randomised phase 3 trial.Lancet Oncol. 2010; 11: 927-933
- Positive sentinel nodes without axillary dissection: implications for the radiation oncologist.J Clin Oncol. 2011; 29: 4479-4488
- Power calculator for binary outcome non-inferiority trial.2012 ([Online] Available from:) ([Accessed 26 December 2015])
- Trends in and outcomes from sentinel lymph node biopsy (SLNB) alone vs. SLNB with axillary lymph node dissection for node-positive breast cancer patients: experience from the SEER database.Ann Surg Oncol. 2010; 17: S343-S351
- Axillary lymph node dissection for sentinel lymph node micrometastases may be safely omitted in early-stage breast cancer patients: long-term outcomes of a prospective study.Ann Surg Oncol. 2009; 16: 3366-3374
- Low locoregional failure rates in selected breast cancer patients with tumor-positive sentinel lymph nodes who do not undergo completion axillary dissection.Cancer. 2007; 110: 723-730
- Axillary dissection vs no axillary dissection in women with invasive breast cancer and sentinel node metastasis. A randomized clinical trial.JAMA. 2011; 305: 569-575
- To cut is to cure: can we really apply Z0011 in practice?.Ann Surg Oncol. 2011; 18: 2413-2415
- Axillary dissection versus no axillary dissection in patients with sentinel-node micrometastases (IBCSG 23–01): a phase 3 randomised controlled trial.Lancet Oncol. 2013; 14.4: 297-305
- Radiotherapy or surgery of the axilla after a positive sentinel node in breast cancer (EORTC 10981-22023 AMAROS): a randomised, multicentre, open-label, phase 3 non-inferiority trial.Lancet Oncol. 2014; 15: 1303-1310
- Axillary treatment in conservative management of operable breast cancer: dissection or radiotherapy? Results of a randomized study with 15 years of follow-up.J Clin Oncol. 2004; 22: 97-101
- Primary axillary radiotherapy as axillary treatment in breast-conserving therapy for patients with breast carcinoma and clinically negative axillary lymph nodes.Cancer. 2000; 88: 1633-1642
- Optimal treatment of the axilla after positive sentinel lymph node biopsy in early invasive breast cancer. Early results of the OTOASOR trial.Orvosi Hetilap. 2013; 154: 1934-1942
- Does the result of completion axillary lymph node dissection influence the recommendation for adjuvant treatment in sentinel lymph node-positive patients?.Clin Breast Cancer. 2013; 13: 364-370
- Regional nodal irradiation in early-stage breast cancer.N Engl J Med. 2015; 373: 307-316
- Axillary dissection can be avoided in the majority of clinically node-negative patients undergoing breast-conserving therapy.Ann Surg Oncol. 2014; 21: 22-27
- Sentinel lymph node biopsy for patients with early-stage breast cancer: American Society of Clinical Oncology clinical practice guideline update.J Clin Oncol. 2014; 32: 1365-1383
- Size of breast cancer metastases in axillary lymph nodes: clinical relevance of minimal lymph node involvement.J Clin Oncol. 2005; 23: 1379-1389
- Tailoring therapies—improving the management of early breast cancer: St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2015.Ann Oncol. 2015; 26: 1533-1546
Article info
Publication history
Published online: January 16, 2017
Accepted:
December 5,
2016
Identification
Copyright
© 2017 Elsevier Ltd, BASO ~ The Association for Cancer Surgery, and the European Society of Surgical Oncology. All rights reserved.
