Adjuvant tamoxifen and exemestane in early breast cancer (TEAM): A randomised phase III trial
The Lancet, 01/25/2011
Clinical Article
van de Velde CJH et al. – 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.
Methods- Tamoxifen Exemestane Adjuvant Multinational (TEAM) phase 3 trial conducted in hospitals in 9 countries
- Postmenopausal women (median age 64 years, range 35—96) with hormone-receptor-positive breast cancer randomly assigned in 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
- Primary endpoint DFS at 5 years
- Main analyses by intention to treat
- 9779 patients assigned to sequential treatment (n=4875) or exemestane alone (n=4904), and 4868 and 4898 analysed by intention to treat
- 4154 (85%) patients in sequential group and 4186 (86%) in exemestane alone group were disease free at 5 years (HR 0·97, 95% CI 0·88—1·08; p=0·60)
- In safety analysis, sequential treatment associated with higher incidence of gynecological 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 exemestane alone
- Musculoskeletal adverse events (2448 [50%] vs 2133 [44%]), hypertension (303 [6%] vs 219 [5%]), and hyperlipidaemia (230 [5%] vs 136 [3%]) reported more frequently with exemestane alone
