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Survival and safety...
Survival and safety of exemestane versus tamoxifen after 2-3 years' tamoxifen treatment (Intergroup Exemestane Study): a randomised controlled trial.
- Article/chapterEnglish2007
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LIBRIS-ID:oai:gup.ub.gu.se/59709
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https://gup.ub.gu.se/publication/59709URI
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https://doi.org/10.1016/S0140-6736(07)60200-1DOI
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Subject category:ref swepub-contenttype
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Subject category:art swepub-publicationtype
Notes
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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.
Subject headings and genre
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Aged
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Androstadienes
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adverse effects
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therapeutic use
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Aromatase Inhibitors
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adverse effects
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therapeutic use
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Breast Neoplasms
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drug therapy
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mortality
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pathology
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Disease-Free Survival
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Drug Administration Schedule
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Female
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Follow-Up Studies
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Humans
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Middle Aged
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Neoplasm Recurrence
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Local
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Postmenopause
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Selective Estrogen Receptor Modulators
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adverse effects
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therapeutic use
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Survival Analysis
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Tamoxifen
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adverse effects
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therapeutic use
Added entries (persons, corporate bodies, meetings, titles ...)
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Kilburn, L S
(author)
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Snowdon, C F
(author)
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Paridaens, R
(author)
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Coleman, R E
(author)
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Jones, S E
(author)
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Jassem, J
(author)
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Van de Velde, C J H
(author)
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Delozier, T
(author)
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Alvarez, I
(author)
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Del Mastro, L
(author)
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Ortmann, O
(author)
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Diedrich, K
(author)
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Coates, A S
(author)
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Bajetta, E
(author)
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Holmberg, Stig B,1946Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper,Institute of Clinical Sciences
(author)
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Dodwell, D
(author)
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Mickiewicz, E
(author)
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Andersen, J
(author)
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Lønning, P E
(author)
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Cocconi, G
(author)
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Forbes, J
(author)
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Castiglione, M
(author)
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Stuart, N
(author)
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Stewart, A
(author)
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Fallowfield, L J
(author)
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Bertelli, G
(author)
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Hall, E
(author)
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Bogle, R G
(author)
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Carpentieri, M
(author)
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Colajori, E
(author)
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Subar, M
(author)
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Ireland, E
(author)
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Bliss, J M
(author)
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Göteborgs universitetInstitutionen för kliniska vetenskaper
(creator_code:org_t)
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In:Lancet369:9561, s. 559-701474-547X
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Coombes, R C
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Kilburn, L S
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Snowdon, C F
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Paridaens, R
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Coleman, R E
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Jones, S E
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Jassem, J
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Van de Velde, C ...
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Delozier, T
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Alvarez, I
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Del Mastro, L
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Ortmann, O
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Diedrich, K
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Coates, A S
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Bajetta, E
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Holmberg, Stig B ...
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Dodwell, D
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Mickiewicz, E
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Andersen, J
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Lønning, P E
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Cocconi, G
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Forbes, J
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Castiglione, M
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Stuart, N
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Stewart, A
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Fallowfield, L J
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Bertelli, G
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Hall, E
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Bogle, R G
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Carpentieri, M
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Colajori, E
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Subar, M
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Ireland, E
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Bliss, J M
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University of Gothenburg