Treatment of operable breast cancer in the elderly: a randomised clinical trial EORTC 10851 comparing tamoxifen alone with modified radical mastectomy.
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.
Fentiman
I S
IS
Hedley Atkins Breast Unit, Guy's Hospital, SE1 9RT, London, UK. ian.fentiman@cancer.org.uk
Christiaens
M-R
MR
Paridaens
R
R
Van Geel
A
A
Rutgers
E
E
Berner
J
J
de Keizer
G
G
Wildiers
J
J
Nagadowska
M
M
Legrand
C
C
Therasse
P
P
D000368:Aged; D000369:Aged, 80 and over; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000601:surgery*; D003131:Combined Modality Therapy / Q000379:methods; D018450:Disease Progression; D005260:Female; D006801:Humans; D015409:Mastectomy, Radical; D015999:Multivariate Analysis; D009364:Neoplasm Recurrence, Local / Q000209:etiology; D011446:Prospective Studies; D016879:Salvage Therapy; D016019:Survival Analysis; D013629:Tamoxifen / Q000627:therapeutic use*; D016896:Treatment Outcome
D018931:Antineoplastic Agents, Hormonal; D013629:Tamoxifen