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

REFERENCES

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