Breast conserving therapy versus mastectomy for stage I−II breast cancer: 20 year follow-up of the EORTC 10801 phase 3 randomized trial
The Lancet Oncology, 02/28/2012
Clinical Article
Litière S et al. – Litière S
Methods- EORTC 10801 trial was open for accrual between 1980 and 1986 in 8 centres in the UK, the Netherlands, Belgium, and South Africa
- 448 patients were randomized to BCT and 420 to MRM
- Randomization was done centrally, stratifying patients by institute, carcinoma stage (I or II), and menopausal status
- BCT comprised of lumpectomy and complete axillary clearance, followed by breast radiotherapy and a tumor-bed boost
- Primary endpoint was time to distant metastasis
- Analysis was done on all eligible patients, as they were randomized
- After median follow-up of 22·1 years (IQR 18·5—23·8), 175 patients (42%) had distant metastases in MRM group versus 207 (46%) in BCT group
- 506 patients (58%) died (232 [55%] in MRM group and 274 [61%] in the BCT group)
- No significant difference was observed between BCT and MRM for time to distant metastases (HR 1·13, 95% CI 0·92—1·38; p=0·23) or for time to death (1·11, 0·94—1·33; 0·23)
- Cumulative incidence of distant metastases at 20 years was 42·6% (95% CI 37·8—47·5) in the MRM group and 46·9% (42·2—51·6) in the BCT group
- 20-year OS was estimated to be 44·5% (95% CI 39·3—49·5) in the MRM group and 39·1% (34·4—43·9) in the BCT group
- No difference between groups in time to distant metastases or OS by age (time to distant metastases: <50 years 1·09 [95% CI 0·79—1·51] vs ≥50 years 1·16 [0·90—1·50]; OS <50 years 1·17 [0·86—1·59] vs ≥50 years 1·10 [0·89—1·37])
