WFRF:(Jassem E)
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Survival and safety of exemestane versus tamoxifen after 2-3 years' tamoxifen treatment (Intergroup Exemestane Study): a randomised controlled trial.
- Coombes, R C (author)
- Kilburn, L S (author)
- Snowdon, C F (author)
- show more...
- Paridaens, R (author)
- Coleman, R E (author)
- Jones, S E (author)
- Jassem, J (author)
- Van de Velde, C J H (author)
- Delozier, T (author)
- Alvarez, I (author)
- Del Mastro, L (author)
- Ortmann, O (author)
- Diedrich, K (author)
- Coates, A S (author)
- Bajetta, E (author)
- Dodwell, D (author)
- Mickiewicz, E (author)
- Andersen, J (author)
- Lønning, P E (author)
- Cocconi, G (author)
- Forbes, J (author)
- Castiglione, M (author)
- Stuart, N (author)
- Stewart, A (author)
- Fallowfield, L J (author)
- Bertelli, G (author)
- Hall, E (author)
- Bogle, R G (author)
- Carpentieri, M (author)
- Colajori, E (author)
- Subar, M (author)
- Ireland, E (author)
- Bliss, J M (author)
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- (creator_code:org_t)
- 2007
- 2007
- English.
- In: Lancet. - 1474-547X. ; 369:9561, s. 559-70
- Journal article (peer-reviewed)
Abstract
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- BACKGROUND: Early improvements in disease-free survival have been noted when an aromatase inhibitor is given either instead of or sequentially after tamoxifen in postmenopausal women with oestrogen-receptor-positive early breast cancer. However, little information exists on the long-term effects of aromatase inhibitors after treatment, and whether these early improvements lead to real gains in survival. METHODS: 4724 postmenopausal patients with unilateral invasive, oestrogen-receptor-positive or oestrogen-receptor-unknown breast cancer who were disease-free on 2-3 years of tamoxifen, were randomly assigned to switch to exemestane (n=2352) or to continue tamoxifen (n=2372) for the remainder of a 5-year endocrine treatment period. The primary endpoint was disease-free survival; overall survival was a secondary endpoint. Efficacy analyses were intention-to-treat. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN11883920. RESULTS: After a median follow-up of 55.7 months (range 0-89.7), 809 events contributing to the analysis of disease-free survival had been reported (354 exemestane, 455 tamoxifen); unadjusted hazard ratio 0.76 (95% CI 0.66-0.88, p=0.0001) in favour of exemestane, absolute benefit 3.3% (95% CI 1.6-4.9) by end of treatment (ie, 2.5 years after randomisation). 222 deaths occurred in the exemestane group compared with 261 deaths in the tamoxifen group; unadjusted hazard ratio 0.85 (95% CI 0.71-1.02, p=0.08), 0.83 (0.69-1.00, p=0.05) when 122 patients with oestrogen-receptor-negative disease were excluded. CONCLUSIONS: Our results suggest that early improvements in disease-free survival noted in patients who switch to exemestane after 2-3 years on tamoxifen persist after treatment, and translate into a modest improvement in overall survival.
Keyword
- Aged
- Androstadienes
- adverse effects
- therapeutic use
- Aromatase Inhibitors
- adverse effects
- therapeutic use
- Breast Neoplasms
- drug therapy
- mortality
- pathology
- Disease-Free Survival
- Drug Administration Schedule
- Female
- Follow-Up Studies
- Humans
- Middle Aged
- Neoplasm Recurrence
- Local
- Postmenopause
- Selective Estrogen Receptor Modulators
- adverse effects
- therapeutic use
- Survival Analysis
- Tamoxifen
- adverse effects
- therapeutic use
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- ref (subject category)
- art (subject category)
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- By the author/editor
- Coombes, R C
- Kilburn, L S
- Snowdon, C F
- Paridaens, R
- Coleman, R E
- Jones, S E
- show more...
- Jassem, J
- Van de Velde, C ...
- Delozier, T
- Alvarez, I
- Del Mastro, L
- Ortmann, O
- Diedrich, K
- Coates, A S
- Bajetta, E
- Holmberg, Stig B ...
- Dodwell, D
- Mickiewicz, E
- Andersen, J
- Lønning, P E
- Cocconi, G
- Forbes, J
- Castiglione, M
- Stuart, N
- Stewart, A
- Fallowfield, L J
- Bertelli, G
- Hall, E
- Bogle, R G
- Carpentieri, M
- Colajori, E
- Subar, M
- Ireland, E
- Bliss, J M
- show less...
- Articles in the publication
- Lancet
- By the university
- University of Gothenburg
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