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Mlineritsch, B; Schabel-Moser, R; Andel, J; Fridrik, M; Moik, M; Mayer, P; Russ, G; Rass, C; Greil, R; Arbeitsgemeinschaft medikamentöse Tumortherapie Study Group.
Multicenter phase II study of pegylated liposomal doxorubicin in combination with vinorelbine as first-line treatment in elderly patients with metastatic breast cancer.
Onkologie. 2009; 32(1-2):18-24
Doi: 10.1159/000180915
Web of Science
PubMed
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FullText_MUG
- Co-authors Med Uni Graz
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Schaberl-Moser Renate
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- Abstract:
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This multicenter phase II trial was conducted to analyze the clinical activity and toxicity of the combination of pegylated liposomal doxorubicin and vinorelbine as first-line treatment in elderly patients with metastatic breast cancer.
From August 2002 to August 2004, 42 patients with metastatic breast cancer were recruited for treatment with pegylated liposomal doxorubicin 40 mg/m(2) intravenously (i.v.) on day 1 and vinorelbine 30 mg/m(2) i.v. on days 1 and 15 every 4 weeks.
The median age of the patients in this trial was 68 years (range 60-82). 40% of patients had 2 or more sites of metastasis, 33 (78%) had predominantly visceral metastasis, and 7 (16%) mostly bone metastasis. Just 2 (5%) patients had only lymphogenous or soft tissue metastasis. All patients had an ECOG performance status of 0-1, but 70% of the patients had relevant comorbidities. In an intention-to-treat analysis, the overall clinical response rate was 36%, the complete response rate was 2%, and the rate of partial remissions was 34%; stable disease occurred in 30%, and progressive disease was observed in 36%. Median duration of response was 10 months. Median time to progression was 4 months, and median overall survival time was 24 months.
The combination of pegylated liposomal doxorubicin and vinorelbine is an active and well tolerated regimen in elderly patients with metastatic breast cancer in first-line treatment.
Copyright (c) 2009 S. Karger AG, Basel.
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Aged -
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Antineoplastic Agents - administration & dosage
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Antineoplastic Agents - adverse effects
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Antineoplastic Combined Chemotherapy Protocols - administration & dosage
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Antineoplastic Combined Chemotherapy Protocols - adverse effects
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Bone Neoplasms - drug therapy
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Metastatic breast cancer
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Elderly patients
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Pegylated liposomal doxorubicin
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Vinorelbine