Phase III Study Comparing Exemestane With Tamoxifen As First-Line Hormonal Treatment of Metastatic Breast Cancer in Postmenopausal Women: The European Organisation for Research and Treatment of Cancer Breast Cancer Cooperative Group
| Autor: | Martine Piccart, Robert Paridaens, Patrick Therasse, Jan Bogaerts, David Cameron, M. Nooij, Luc Dirix, Tanja Cufer, Louk V.A.M. Beex |
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| Rok vydání: | 2008 |
| Předmět: |
Adult
Oncology Cancer Research medicine.medical_specialty medicine.drug_class Antineoplastic Agents Bone Neoplasms Breast Neoplasms Soft Tissue Neoplasms Disease-Free Survival chemistry.chemical_compound Breast cancer Exemestane Interventional oncology [UMCN 1.5] Internal medicine Breast Cancer medicine Humans skin and connective tissue diseases Aged Aged 80 and over Gynecology Aromatase inhibitor Aromatase Inhibitors business.industry Estrogen Antagonists Cancer Middle Aged Antiestrogen medicine.disease Metastatic breast cancer Androstadienes Postmenopause Tamoxifen Treatment Outcome chemistry Drug Resistance Neoplasm Lymphatic Metastasis Female Breast disease business medicine.drug |
| Zdroj: | Journal of Clinical Oncology, 26, 30, pp. 4883-90 Journal of Clinical Oncology, 26, 4883-90 Paridaens, R J, Dirix, L Y, Beex, L V, Nooij, M, Cameron, D A, Cufer, T, Piccart, M J, Bogaerts, J & Therasse, P 2008, ' Phase III study comparing exemestane with tamoxifen as first-line hormonal treatment of metastatic breast cancer in postmenopausal women: the European Organisation for Research and Treatment of Cancer Breast Cancer Cooperative Group ', Journal of Clinical Oncology, vol. 26, no. 30, pp. 4883-90 . https://doi.org/10.1200/JCO.2007.14.4659 |
| ISSN: | 1527-7755 0732-183X |
| DOI: | 10.1200/jco.2007.14.4659 |
| Popis: | Purpose This phase III randomized open-label clinical trial was designed to evaluate the efficacy and safety of the steroidal aromatase inactivator exemestane versus the antiestrogen tamoxifen as first-line treatment for metastatic breast cancer (MBC) in postmenopausal women. Patients and Methods The study was conducted at 81 centers and enrolled postmenopausal patients with measurable hormone-sensitive metastatic or locally advanced breast cancer. Prior adjuvant chemotherapy and/or tamoxifen were allowed. One previous chemotherapy regimen and no prior hormone therapy for advanced disease were permitted. Patients were randomly assigned to receive exemestane 25 mg or tamoxifen 20 mg orally once daily until disease progression or unacceptable toxicity occurred. Results A total of 371 patients enrolled at 79 sites (182 exemestane, 189 tamoxifen) were included in the analysis. Both treatments were generally well tolerated without major toxicity. Overall response rate was greater for exemestane than for tamoxifen treatment (46% v 31%; odds ratio = 1.85; 95% CI, 1.21 to 2.82; P = .005). Median progression-free survival (PFS) was longer with exemestane (9.9 months; 95% CI, 8.7 to 11.8 months) than with tamoxifen (5.8 months; 95% CI, 5.3 to 8.1 months). However, these early differences (Wilcoxon P = .028) did not translate to a longer-term benefit in PFS, the primary study end point (log-rank P = .121). There was also no difference in survival between both study arms. Conclusion Exemestane is an effective and well-tolerated first-line hormonal treatment for postmenopausal women with MBC and offers significant early improvement in time to tumor progression when compared with tamoxifen. |
| Databáze: | OpenAIRE |
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