First-line gemcitabine versus epirubicin in postmenopausal women aged 60 or older with metastatic breast cancer: a multicenter, randomized, phase III study
| Autor: | Debasish Roychowdhury, M. A. Miller, Suresh H. Advani, D. C. Doval, K. S. Khoo, S. Ermisch, Jacek Jassem, G. Morack, O. Feher, G. von Minckwitz, P. Vodvarka |
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| Rok vydání: | 2005 |
| Předmět: |
Oncology
medicine.medical_specialty medicine.drug_class medicine.medical_treatment Breast Neoplasms Antimetabolite Deoxycytidine chemistry.chemical_compound Breast cancer Internal medicine polycyclic compounds medicine Humans Neoplasm Metastasis skin and connective tissue diseases Aged Epirubicin Gynecology Chemotherapy business.industry Hematology Middle Aged medicine.disease Metastatic breast cancer Gemcitabine Postmenopause chemistry Female business Progressive disease medicine.drug |
| Zdroj: | Annals of oncology : official journal of the European Society for Medical Oncology. 16(6) |
| ISSN: | 0923-7534 |
| Popis: | This randomized, phase III study compared the efficacy and safety of first-line gemcitabine versus epirubicin in the treatment of postmenopausal women with metastatic breast cancer (MBC).Patients agedor = 60 years (median 68 years) with clinically measurable MBC received either gemcitabine 1200 mg/m(2) or epirubicin 35 mg/m(2) on days 1, 8, and 15 of a 28-day cycle.Of 410 patients entered, 397 (198 gemcitabine and 199 epirubicin) were randomized and qualified for the time to progressive disease (TTP) and survival analyses. Total cycles administered in 185 gemcitabine and 192 epirubicin patients, respectively, were 699 (mean 3.5, range 0-12) and 917 (mean 4.6, range 0-10). Epirubicin demonstrated statistically significant superiority in TTP (6.1 and 3.4 months, P=0.0001), overall survival (19.1 and 11.8 months, P=0.0004), and independently assessed response rate (40.3% and 16.4% in 186 and 183 evaluable patients, P0.001). For gemcitabine (n=190) and epirubicin (n=192), respectively, common WHO grade 3/4 toxicities were neutropenia (25.3% and 17.9%) and leukopenia (14.3% and 19.3%). Of the 28 on-study deaths (17 gemcitabine, 11 epirubicin), three were considered possibly or probably related to treatment (gemcitabine).Postmenopausal womenor =60 years of age with MBC tolerate chemotherapy well. In this study, epirubicin was superior to gemcitabine in the treatment of MBC in women ageor =60, confirming that anthracyclines remain important drugs for first-line treatment of MBC. |
| Databáze: | OpenAIRE |
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