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  • Coombes, R C (author)

Survival and safety of exemestane versus tamoxifen after 2-3 years' tamoxifen treatment (Intergroup Exemestane Study): a randomised controlled trial.

  • Article/chapterEnglish2007

Publisher, publication year, extent ...

  • 2007

Numbers

  • LIBRIS-ID:oai:gup.ub.gu.se/59709
  • https://gup.ub.gu.se/publication/59709URI
  • https://doi.org/10.1016/S0140-6736(07)60200-1DOI

Supplementary language notes

  • Language:English

Part of subdatabase

Classification

  • Subject category:ref swepub-contenttype
  • Subject category:art swepub-publicationtype

Notes

  • 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

  • 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

Added entries (persons, corporate bodies, meetings, titles ...)

  • Kilburn, L S (author)
  • Snowdon, C F (author)
  • 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)
  • Holmberg, Stig B,1946Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper,Institute of Clinical Sciences (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)
  • Göteborgs universitetInstitutionen för kliniska vetenskaper (creator_code:org_t)

Related titles

  • In:Lancet369:9561, s. 559-701474-547X

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