Trial reportEuropean journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology2017
Eight-year follow up result of the OTOASOR trial: The Optimal Treatment Of the Axilla - Surgery Or Radiotherapy after positive sentinel lymph node biopsy in early-stage breast cancer: A randomized, single centre, phase III, non-inferiority trial.
Trial report in European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 139 papers, 10 of them syntheses that pooled it.
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Who cites it
139 citing papers in PubMed, 10 syntheses or guidelines pooled it, 313 citations in OpenAlex.
- DEGRO practical guidelines: radiotherapy of breast cancer-regional nodal irradiation.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2026Guideline
- Can axillary lymph node dissection be omitted in breast cancer patients with 1-2 positive sentinel nodes? A systematic review and meta-analysis.The oncologist · 2025Pooled it
- Safety analysis of omitting axillary lymph node dissection in early-stage breast cancer with 1-2 sentinel lymph nodes macro-metastases: a meta-analysis.Frontiers in oncology · 2025Pooled it
- Pan-Asian adapted ESMO Clinical Practice Guidelines for the diagnosis, treatment and follow-up of patients with early breast cancer.ESMO open · 2024Guideline
- The Japanese Breast Cancer Society Clinical Practice Guidelines for surgical treatment of breast cancer, 2022 edition.Breast cancer (Tokyo, Japan) · 2024Guideline
- Can Axillary Lymph Node Dissection be Omitted in Breast Cancer Patients with Metastatic Sentinel Lymph Nodes Undergoing Mastectomy? A Systematic Review and Meta-Analysis of Real-World Evidence.World journal of surgery · 2023Pooled it
- Uncertainties and controversies in axillary management of patients with breast cancer.Cancer treatment reviews · 2023Pooled it
- Axillary management in patients with clinical node-negative early breast cancer and positive sentinel lymph node: a systematic review and meta-analysis.Frontiers in oncology · 2023Pooled it
- Comparing Early-Stage Breast Cancer Patients with Sentinel Lymph Node Metastasis with and without Completion Axillary Lymph Node Dissection: A Systematic Review and Meta-Analysis.Asian Pacific journal of cancer prevention : APJCP · 2022Pooled it
- Radiotherapy of Breast Cancer-Professional Guideline 1st Central-Eastern European Professional Consensus Statement on Breast Cancer.Pathology oncology research : POR · 2022Pooled it
- Use of indocyanine green fluorescence versus patent blue V dye for sentinel lymph node biopsy in early breast cancer, a randomized controlled trial.Journal of the Egyptian National Cancer Institute · 2026Trial
- Trial
- Tailored axillary surgery in patients with clinically node-positive breast cancer: Pre-planned feasibility substudy of TAXIS (OPBC-03, SAKK 23/16, IBCSG 57-18, ABCSG-53, GBG 101).Breast (Edinburgh, Scotland) · 2021Trial
- Association between sentinel lymph node number and prognosis in cT1-2N0M0 early breast cancer patients with negative sentinel lymph nodes: a single‑center retrospective cohort study.Annals of medicine · 2026Article
- De-escalation of breast surgery for early stage breast cancer.Japanese journal of clinical oncology · 2026Review
- [The evolution of surgical management for early-stage breast cancer at a university breast centre in Hungary].Magyar onkologia · 2026Article
- Oncological outcomes of omitting axillary lymph node dissection in breast cancer patients with sentinel lymph node micrometastasis undergoing mastectomy without radiotherapy.Surgery today · 2026Article
- The Past, Present, and Future of Sentinel Lymph Node Biopsy in Breast Cancer.Annals of surgical oncology · 2026Review
- Five Decades of Innovation-Tailored Breast Cancer Treatment: 1976-2026.World journal of surgery · 2026Review
- Retrospective study on regional nodal irradiation after omission of axillary lymph node dissection in sentinel lymph node-positive breast cancer: a propensity score matching analysis.Breast cancer research and treatment · 2026Article
79 more citing papers are in PubMed but not listed here.
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Authors and funding
9 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionThe 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
methodsPatients 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).
resultsMean 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.
conclusionsThe 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.
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