Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
Gewählte Publikation:
Schmid, M; Jakesz, R; Samonigg, H; Kubista, E; Gnant, M; Menzel, C; Seifert, M; Haider, K; Taucher, S; Mlineritsch, B; Steindorfer, P; Kwasny, W; Stierer, M; Tausch, C; Fridrik, M; Wette, V; Steger, G; Hausmaninger, H.
Randomized trial of tamoxifen versus tamoxifen plus aminoglutethimide as adjuvant treatment in postmenopausal breast cancer patients with hormone receptor-positive disease: Austrian breast and colorectal cancer study group trial 6.
J Clin Oncol. 2003; 21(6):984-990
Doi: 10.1200/JCO.2003.01.138
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- Führende Autor*innen der Med Uni Graz
- Schmid Marianne
- Co-Autor*innen der Med Uni Graz
- Samonigg Hellmut
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- Abstract:
- PURPOSE: To determine whether the addition of aminoglutethimide to tamoxifen is able to improve the outcome in postmenopausal patients with hormone receptor-positive, early-stage breast cancer. PATIENTS AND METHODS: A total of 2,021 postmenopausal women were randomly assigned to receive either tamoxifen for 5 years alone or tamoxifen in combination with aminoglutethimide (500 mg/d) for the first 2 years of treatment. Tamoxifen was administered at 40 mg/d for the first 2 years and at 20 mg/d for 3 years. RESULTS: All randomized and eligible patients were included in the analysis according to the intention-to-treat principle. After a median follow-up of 5.3 years, the 5-year disease-free survival in the aminoglutethimide plus tamoxifen group was 83.6% versus 83.7% in the monotherapy group (P =.89). The corresponding data for overall survival at 5 years were 91.4% and 91.2%, respectively (P =.74). More patients failed to complete combination treatment (13.7%) because of side effects as compared to tamoxifen alone (5.2%; P =.0001). CONCLUSION: Aminoglutethimide given for 2 years in addition to tamoxifen for 5 years does not improve the prognosis of postmenopausal patients with receptor-positive, lymph node-negative or lymph node-positive breast cancer.
- Find related publications in this database (using NLM MeSH Indexing)
- Aged -
- Aminoglutethimide - administration and dosage
- Antineoplastic Agents, Hormonal - administration and dosage
- Antineoplastic Combined Chemotherapy Protocols - administration and dosage
- Austria - administration and dosage
- Breast Neoplasms - chemistry
- Chemotherapy, Adjuvant - chemistry
- Disease Progression - chemistry
- Drug Administration Schedule - chemistry
- Estrogen Receptor Modulators - administration and dosage
- Female - administration and dosage
- Humans - administration and dosage
- Middle Aged - administration and dosage
- Neoplasm Recurrence, Local - administration and dosage
- Neoplasm Staging - administration and dosage
- Neoplasms, Second Primary - etiology
- Postmenopause - etiology
- Receptors, Estrogen - analysis
- Receptors, Progesterone - analysis
- Survival Analysis - analysis
- Tamoxifen - administration and dosage
- Treatment Outcome - administration and dosage