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Type: Journal article
Title: Phase I dose intensification study of 2-weekly epirubicin with GM-CSF in advanced cancer
Author: Michael, M.
Toner, G. C.
Olver, Ian N.
Fennesy, A.
Bishop, James F.
Citation: American Journal of Clinical Oncology, 1997; 20(3):259-262
Issue Date: 1997
ISSN: 0277-3732
Abstract: This study investigated dose intensification of epirubicin administered as a 2-weekly regimen with granulocyte-macrophage colony-stimulating factor (GM-CSF) support. The aim was to define the maximally tolerated dose of epirubicin and to assess the efficacy of GM-CSF to ameliorate its toxicity. Patients with anthracycline-responsive advanced malignancies were eligible. Six dose levels, commencing at 90 mg/m2, of epirubicin administered every 2 weeks for four courses were planned with GM-CSF 10 µg/kg/day administered for 10 days from the second day of each course. Six patients were to be entered at each dose level, and escalation to the next level was based upon toxicity criteria. Twelve patients were entered, six at dose level 1 (90 mg/m2) and six at dose level 2 (120 mg/m2). Prospectively defined haematological dose-limiting toxicities were noted in one patient at dose level 1 and in five patients at dose level 2. Further dose escalation was not attempted. Significant nonhaematological toxicities included febrile neutropenia in two and four patients at dose levels 1 and 2, respectively. This study has demonstrated that epirubicin can be safely administered at 2 week intervals with GM-CSF at a dose of 90 mg/m2, equivalent to the previously reported maximum tolerated dose intensity of 45 mg/m2/week. Neutropenia was dose-limiting despite the use of GM-CSF.
Keywords: Epirubicin, Dose intensification, GM-CSF
Rights: © Lippincott-Raven Publishers
Appears in Collections:Medicine publications

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