Adjuvant tamoxifen and exemestane in early breast cancer (TEAM): a randomised phase 3 trial

Research output: Contribution to journalArticle

Authors

  • CJH van de Velde
  • C Seynaeve
  • H Putter
  • A Hasenburg
  • JM Vannetzel
  • R Paridaens
  • C Markopoulos
  • Y Hozumi
  • ETM Hille
  • DG Kieback
  • L Asmar
  • J Smeets
  • JWR Nortier
  • P Hadji
  • JMS Burdett
  • SE Jones

Colleges, School and Institutes

Abstract

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 [

Details

Original languageEnglish
Pages (from-to)321-331
Number of pages11
JournalLancet
Volume377
Issue number9762
Publication statusPublished - 1 Jan 2011

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