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.
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.
| Original language | English |
|---|---|
| Journal | The Lancet Oncology |
| Early online date | 18 Jul 2017 |
| DOIs | |
| Publication status | E-pub ahead of print - 18 Jul 2017 |
