Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
Gewählte Publikation:
SHR Neuro Krebs Kardio Lipid Stoffw Microb
Jakesz, R; Jonat, W; Gnant, M; Mittlboeck, M; Greil, R; Tausch, C; Hilfrich, J; Kwasny, W; Menzel, C; Samonigg, H; Seifert, M; Gademann, G; Kaufmann, M.
Switching of postmenopausal women with endocrine-responsive early breast cancer to anastrozole after 2 years' adjuvant tamoxifen: combined results of ABCSG trial 8 and ARNO 95 trial.
Lancet. 2005; 366(9484):455-462
Doi: 10.1016/S0140-6736(05)67059-6
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- Co-Autor*innen der Med Uni Graz
- Samonigg Hellmut
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- Abstract:
- BACKGROUND: Tamoxifen has been the standard adjuvant treatment for postmenopausal women with hormone-responsive early breast cancer for more than 20 years. However, the third-generation aromatase inhibitor anastrozole has proven efficacy and tolerability benefits compared with tamoxifen when used as initial adjuvant therapy. We investigate whether women who have received a period of adjuvant tamoxifen would benefit from being switched to anastrozole. METHODS: We present a combined analysis of data from two prospective, multicentre, randomised, open-label trials with nearly identical inclusion criteria. Postmenopausal women with hormone-sensitive early breast cancer who had completed 2 years' adjuvant oral tamoxifen (20 or 30 mg daily) were randomised to receive 1 mg oral anastrozole (n=1618) or 20 or 30 mg tamoxifen (n=1606) daily for the remainder of their adjuvant therapy. The primary endpoint was event-free survival, with an event defined as local or distant metastasis, or contralateral breast cancer. Analysis was by intention to treat. FINDINGS: 3224 patients were included in analyses. At a median follow-up of 28 months, we noted a 40% decrease in the risk for an event in the anastrozole group as compared with the tamoxifen group (67 events with anastrozole vs 110 with tamoxifen, hazard ratio 0.60, 95% CI 0.44-0.81, p=0.0009). Both study treatments were well tolerated. There were significantly more fractures (p=0.015) and significantly fewer thromboses (p=0.034) in patients treated with anastrozole than in those on tamoxifen. INTERPRETATION: These data lend support to a switch from tamoxifen to anastrozole in patients who have completed 2 years' adjuvant tamoxifen.
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- Aged -
- Antineoplastic Agents, Hormonal - adverse effects
- Aromatase Inhibitors - adverse effects
- Breast Neoplasms - drug therapy
- Disease Progression - drug therapy
- Disease-Free Survival - drug therapy
- Female - drug therapy
- Humans - drug therapy
- Nitriles - adverse effects
- Postmenopause - adverse effects
- Prospective Studies - adverse effects
- Randomized Controlled Trials as Topic - adverse effects
- Receptors, Estrogen - analysis
- Tamoxifen - adverse effects
- Triazoles - adverse effects