TY - JOUR
T1 - Adjuvant tamoxifen and exemestane in early breast cancer (TEAM): a randomised phase 3 trial
AU - van de Velde, CJH
AU - Rea, Daniel
AU - Seynaeve, C
AU - Putter, H
AU - Hasenburg, A
AU - Vannetzel, JM
AU - Paridaens, R
AU - Markopoulos, C
AU - Hozumi, Y
AU - Hille, ETM
AU - Kieback, DG
AU - Asmar, L
AU - Smeets, J
AU - Nortier, JWR
AU - Hadji, P
AU - Burdett, JMS
AU - Jones, SE
PY - 2011/1/1
Y1 - 2011/1/1
N2 - 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 [
AB - 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 [
U2 - 10.1016/S0140-6736(10)62312-4
DO - 10.1016/S0140-6736(10)62312-4
M3 - Article
SN - 0140-6736
VL - 377
SP - 321
EP - 331
JO - The Lancet
JF - The Lancet
IS - 9762
ER -
