Adjuvant tamoxifen and exemestane in early breast cancer (TEAM): A randomised phase 3 trial
Aromatase inhibitors improved disease-free survival compared with tamoxifen when given as an initial adjuvant treatment or after 2-3 years of tamoxifen 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). 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 Commission Trial 27/2001; and UMIN, C000000057. 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  of 4814 vs 523  of 4852), venous thrombosis (99  vs 47 ), and endometrial abnormalities (191  vs 19 [<1]) than was exemestane alone. Musculoskeletal adverse events (2448  vs 2133 ), hypertension (303  vs 219 ), and hyperlipidaemia (230  vs 136 ) were reported more frequently with exemestane alone. 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. Pfizer.
|Keywords||adult, aged, arthropathy, article, brain infarction, breast cancer, breast disease, cancer adjuvant therapy, cerebrovascular accident, depression, disease free survival, dizziness, drug safety, early cancer, embolism, endocrine disease, endometrial disease, exemestane, female, flushing, fracture, gynecologic disease, heart arrhythmia, heart disease, heart failure, heart infarction, heart muscle ischemia, human, hyperlipidemia, hypertension, insomnia, kidney disease, libido disorder, liver function test, major clinical study, mental disease, metabolic disorder, monotherapy, multicenter study, muscle disease, musculoskeletal disease, nerve compression, neurologic disease, osteoporosis, peripheral occlusive artery disease, phase 3 clinical trial, postmenopause, priority journal, randomized controlled trial, side effect, sleep disorder, sweat, tamoxifen, thrombosis, vagina discharge, vascular disease, vein thrombosis, vulvovaginal disease, weight gain|
|Persistent URL||dx.doi.org/10.1016/S0140-6736(10)62312-4, hdl.handle.net/1765/23593|
van de Velde, C.J.H, Rea, D, Seynaeve, C.M, Putter, H, Hasenburg, A, Vannetzel, J.M, … Jones, S.E. (2011). Adjuvant tamoxifen and exemestane in early breast cancer (TEAM): A randomised phase 3 trial. The Lancet, 377(9762), 321–331. doi:10.1016/S0140-6736(10)62312-4