TY - JOUR
TI - Adjuvant tamoxifen and exemestane in early breast cancer (TEAM): a
randomised phase 3 trial
AU - van de Velde, Cornelis J. H.
AU - Rea, Daniel
AU - Seynaeve, Caroline and
AU - Putter, Hein
AU - Hasenburg, Annette
AU - Vannetzel, Jean-Michel and
AU - Paridaens, Robert
AU - Markopoulos, Christos
AU - Hozumi, Yasuo
AU - Hille,
AU - Elysee T. M.
AU - Kieback, Dirk G.
AU - Asmar, Lina
AU - Smeets, Jan and
AU - Nortier, Johan W. R.
AU - Hadji, Peyman
AU - Bartlett, John M. S. and
AU - Jones, Stephen E.
JO - The Lancet Neurology
PY - 2011
VL - 377
TODO - 9762
SP - 321-331
PB - EXCERPTA MEDICA INC-ELSEVIER SCIENCE INC
SN - null
TODO - 10.1016/S0140-6736(10)62312-4
TODO - null
TODO - Background Aromatase inhibitors improved disease-free survival compared
with tamoxifen when given as an initial adjuvant treatment or after 2-3
years of tamcodfen to postmenopausal women with
hormone-receptor-positive breast cancer. We therefore compared the
long-term effects of exemestane monotherapy with sequential treatment
(tamoxifen followed by exemestane).
Methods The Tamoxifen Exemestane Adjuvant Multinational (TEAM) phase 3
trial was conducted in hospitals in nine countries. Postmenopausal women
(median age 64 years, range 35-96) with hormone-receptor-positive breast
cancer were randomly assigned in a 1:1 ratio to open-label exemestane
(25 mg once a day, orally) alone or following tamoxifen (20 mg once a
day, orally) for 5 years. Randomisation was by use of a
computer-generated random permuted block method. The primary endpoint
was disease-free survival (DFS) at 5 years. Main analyses were by
intention to treat. The trial is registered with ClinicalTrials.gov,
NCT00279448, NCT00032136, and NCT00036270; NTR 267; Ethics Commis;ion
Trial 27/2001; and UMIN, C000000057.
Findings 9779 patients were assigned to sequential treatment (n=4875) or
exemestane alone (n=4904), and 4868 and 4898 were analysed by intention
to treat, respectively. 4154 (85%) patients in the sequential group and
4186 (86%) in the exemestane alone group were disease free at 5 years
(hazard ratio 0.97, 95% CI 0.88-1.08; p=0.60). In the safety analysis,
sequential treatment was associated with a higher incidence of
gynaecological symptoms (942[20%] of 4814 vs 523 [11%] of 4852),
venous thrombosis (99 [2%] vs 47 [1%]), and endometrial
abnormalities (191 [4%] vs 19 [<1%]) than was exemestane alone.
Musculoskeletal adverse events (2448 [50%] vs 2133 [44%]),
hypertension (303 [6%] vs 219 [5%]), and hyperlipidaemia (230
[5%] vs 136 [3%]) were reported more frequently with exemestane
alone.
Interpretation Treatment regimens of exemestane alone or after tamoxifen
might be judged to be appropriate options for postmenopausal women with
hormone-receptor-positive early breast cancer.
ER -