Adjuvant tamoxifen and exemestane in postmenopausal early breast cancer: ten-year analysis of the randomised phase III TEAM trial

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Authors

  • Marloes GM Derks
  • Erik J. Blok
  • Caroline Seynaeve
  • JWR Nortier
  • E. M K Kranenbarg
  • GJ Liefers
  • Hein Putter
  • Judith R Kroep
  • Annette Hasenburg
  • Christos Markopoulos
  • R Paridaens
  • J Smeets
  • Luc Y. Dirix
  • Cornelis J H van de Velde

Colleges, School and Institutes

Abstract

Background: After five years of median follow-up, the Tamoxifen Exemestane Adjuvant Multinational (TEAM) trial observed no difference in disease free survival between exemestane monotherapy and a sequential scheme of tamoxifen followed by exemestane in postmenopausal patients with early-stage, hormone receptor positive (HR+) breast cancer. As recurrence risk in HR+ breast cancer remains linear beyond five years after diagnosis, long-term follow-up outcomes of this trial were analysed.

Methods: The TEAM trial, a multicenter open-label phase III randomised controlled trial, included postmenopausal patients with early stage HR+ positive breast cancer from nine countries between 2001 and 2006. Patients were randomly allocated in a 1:1 ratio by a computer-generated random permuted block method to either five years of open-label exemestane monotherapy (25 mg daily) or a sequential scheme of tamoxifen (20 mg daily) followed by exemestane for a total duration of five years. Randomisation was performed centrally in each country. Long-term follow-up data for disease recurrence and survival was collected in six participating countries and analyzed by intention-totreat.
The primary endpoint was disease free survival (DFS) at ten years of follow-up. The trial is registered with ClinicalTrials.gov, NCT00279448, NCT00032136; NTR 267; Ethics Commission Trial 27/2001.

Findings: 6120 patients were included in the current intention-to-treat analysis. Median follow-up was 9·8 years (interquartile range 8·0-10·3). During follow-up, 921 (30%) of 3075 patients in the exemestane arm and 929 (31%) of 3045 patients in the sequential arm experienced a DFS event. DFS at ten years was 67% (95% CI 65-69) for the exemestane arm and 67% (95% CI 65-69) for the
sequential arm (hazard ratio (HR) 0·96, 95% CI 0·88-1·05, p=0·39).

Interpretation: The long-term findings of the TEAM trial confirm that both exemestane alone and sequential therapy with upfront tamoxifen are equally effective as adjuvant endocrine therapy in postmenopausal HR+ early breast cancer patients. These results validate the opportunity to individualize adjuvant endocrine strategy accordingly, based on patient preferences, comorbidities
and tolerability.

Details

Original languageEnglish
JournalThe Lancet Oncology
Early online date18 Jul 2017
Publication statusE-pub ahead of print - 18 Jul 2017