EORTC 1081

  • The EORTC 1081 study:
    • Was a large multicenter clinical trial:
      • Designed to demonstrate the safety of breast conservation therapy (BCT) compared to modified radical mastectomy (MRM):
        • In patients with:
          • Tumors 5 cm or smaller and
          • Axillary node-negative disease
          • Axillary node-positive disease
    • This study was open for accrual:
      • Between 1980 and 1986:
      • In 8 centers in the UK, Netherlands, Belgium, and South Africa
    • Four hundred and forty eight patients (448) were randomized to BCT and 420 to MRM
    • Patients who received BCT:
      • Were treated with lumpectomy and complete axillary clearance:
        • Followed by breast radiotherapy and tumor bed boost
    • The primary endpoint:
      • Was time to distant metastasis
    • Compared to BCT:
      • MRM resulted in better local control:
        • But did not affect overall survival or time to distant metastasis
    • At the 20-year follow-up:
      • No significant difference was noted for long-term OS:
        • 44.5% MRM group vs 39.1% BCT group or time to distant metastasis
    • BCT was noted to have:
      • A higher LRR at 10 years of:
        • 20% versus 12% for MRM
      • Additionally, factors associated with increased LRR included:
        • Larger tumor size
        • Lymph node metastasis
        • Receptor type
  • Interpretation of results from EORTC 10801 trial:
    • Found BCT to be a justifiable form of treatment for patients with small breast cancers:
      • Given that long-term follow-up showed similar OS compared to mastectomy
    • This study contributed to earlier bodies of evidence:
      • Found in the NSABP B-06 and Milan I:
        • Study which evaluated the safety and effectiveness of BCT for women with small breast tumors
    • One of the main differences between the studies was that:
      • The EORTC 10801 trial:
        • Generally had patients with larger tumors (80% had T2 tumors) and 41% had lymph node metastasis
    • Although tumor size > 2 cm and positive lymph node status:
      • Were found to increase risk for distant metastasis and death:
        • This was found to be independent of surgical intervention
    • Thus, the EORTC 10801 trial:
      • Provided valuable data that BCT can safely be performed for patients with larger tumors and positive lymph nodes


  1. Black DM, Hunt KK, Mittendorf EA. Long-term outcomes reporting the safety of breast conserving therapy compared to mastectomy: 20-year results of EORTC 10801. Gland Surgery. 2013;2:120-123
  2. Liliere S, Werutsky G, Fentiman IS, et al. Breast conserving therapy versus mastectomy for stage I-II breast cancer: 20 year follow-up of the EORTC 10801 phase 3 randomized trial. Lancet Oncol. 2012;13:412-419.

#Arrangoiz #Surgeon #BreastSurgeon #CancerSurgeon #BreastCancer #SurgicalOncologist

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