Τίτλος:
Adjuvant tamoxifen and exemestane in early breast cancer (TEAM): a
randomised phase 3 trial
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
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.
Συγγραφείς:
van de Velde, Cornelis J. H.
Rea, Daniel
Seynaeve, Caroline and
Putter, Hein
Hasenburg, Annette
Vannetzel, Jean-Michel and
Paridaens, Robert
Markopoulos, Christos
Hozumi, Yasuo
Hille,
Elysee T. M.
Kieback, Dirk G.
Asmar, Lina
Smeets, Jan and
Nortier, Johan W. R.
Hadji, Peyman
Bartlett, John M. S. and
Jones, Stephen E.
Περιοδικό:
The Lancet Neurology
Εκδότης:
EXCERPTA MEDICA INC-ELSEVIER SCIENCE INC
DOI:
10.1016/S0140-6736(10)62312-4
