Reduced cardiotoxicity and comparable efficacy in a phase IIItrial of pegylated liposomal doxorubicin HCl(CAELYX™/Doxil®) versus conventional doxorubicin forfirst-line treatment of metastatic breast cancer
| Autor: | F. Orlandi, L. Mellars, Raphael Catane, Nely Wigler, D. G. Kieback, E. Grischke, Piotr Tomczak, L. Alland, Stephen P. Ackland, Armando Santoro, C. Tendler, R. Rosso, Moshe Inbar, Mary O'Brien |
|---|---|
| Rok vydání: | 2004 |
| Předmět: |
Adult
medicine.medical_specialty Heart Diseases Anthracycline Nausea Urology Breast Neoplasms Neutropenia Pharmacology Polyethylene Glycols medicine Mucositis Humans Doxorubicin Survival rate Aged Aged 80 and over Cardiotoxicity Antibiotics Antineoplastic business.industry Hematology Middle Aged Prognosis medicine.disease Metastatic breast cancer Survival Rate Treatment Outcome Oncology Liposomes Female medicine.symptom business medicine.drug |
| Zdroj: | Annals of Oncology. 15:440-449 |
| ISSN: | 0923-7534 |
| Popis: | Reduced cardiotoxicity and comparable efficacy in a phase III trial of pegylated liposomal doxorubicin HCl (CAELYX (TM)/Doxil (R)) versus conventional doxorubicin for first-line treatment of metastatic breast cancer Background: This study was designed to demonstrate that efficacy [progression-free survival (PFS)] of CAELYX(TM) [pegylated liposomal doxorubicin HCl (PLD)] is non-inferior to doxorubicin with significantly less cardiotoxicity in first- line treatment of women with metastatic breast cancer (MBC). Patients and methods: Women (n = 509) with MBC and normal cardiac function were randomized to receive either PLD 50 mg/m(2) (every 4 weeks) or doxorubicin 60 mg/m(2) (every 3 weeks). Cardiac event rates were based on reductions in left ventricular ejection fraction as a function of cumulative anthracycline dose. Results: PLD and doxorubicin were comparable with respect to PFS [6.9 versus 7.8 months, respectively; hazard ratio (HR) = 1.00; 95% confidence interval (CI) 0.82-1.22]. Subgroup results were consistent. Overall risk of cardiotoxicity was significantly higher with doxorubicin than PLD (HR = 3.16; 95%CI 1.58-6.31; P |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|