Treatment of operable breast cancer in the elderly: a randomised clinical trial EORTC 10851 comparing tamoxifen alone with modified radical mastectomy

Fentiman, I.S; Christiaens, M.-R; Paridaens, R; Van Geel, A; Rutgers, E; Berner, J; de Keizer, G; Wildiers, J; Nagadowska, M; Legrand, C; Therasse, P

« Previous Next »European Journal of Cancer
Volume 39, Issue 3 , Pages 309-316, February 2003

Treatment of operable breast cancer in the elderly:

a randomised clinical trial EORTC 10851 comparing tamoxifen alone with modified radical mastectomy

I.S Fentiman
- Hedley Atkins Breast Unit, Guy's Hospital, London SE1 9RT, UK
- Corresponding author
M.-R Christiaens
- University Hospital Gasthuisberg, K.U. Leuven, Belgium
R Paridaens
- University Hospital Gasthuisberg, K.U. Leuven, Belgium
A Van Geel
- Daniel Den Hoed, Rotterdam, The Netherlands
E Rutgers
- Antoni van Leeuwenhoek Ziekenhuis/Netherlands Cancer Institute, Amsterdam, The Netherlands
J Berner
- Inst Oncology, Lodz, Poland
G de Keizer
- Twee Steden Ziekenhuis, Tilburg, The Netherlands
J Wildiers
- University Hospital Gasthuisberg, K.U. Leuven, Belgium
M Nagadowska
- Inst Oncology, Warsaw, Poland
C Legrand
- EORTC Data Centre, 83 Avenue E Mounier, B-1200, Brussels, Belgium
P Therasse
- EORTC Data Centre, 83 Avenue E Mounier, B-1200, Brussels, Belgium

Received 16 August 2002; accepted 30 August 2002.

Abstract

For treatment of early breast cancer in older women, little evidence is available from randomised trials. We conducted a randomised trial comparing modified radical mastectomy (MRM) with tamoxifen (TAM) as the sole initial therapy in 164 patients aged ⩾70 years with operable breast cancer. 82 were treated by MRM and 82 with TAM. Survival curves were estimated using the Kaplan–Meier method: multivariate analyses were performed using the Cox's proportional hazards model. Endpoints included survival, time to first relapse or progression, loco-regional progression, time to distant progression and progression-free survival. After a median follow-up of approximately 10 years, there was a significantly decreased time to progression in the TAM only group (logrank P<0.0001) and significantly shorter time to local progression within the TAM group (logrank P<0.0001). Overall survival of the two groups was similar. The results indicate that tamoxifen alone leads to an unacceptably high rate of local progression or relapse.

Keywords: Breast cancer, Randomised trial, Elderly, Mastectomy, Tamoxifen