Journal
EUROPEAN JOURNAL OF CANCER
Volume 42, Issue 4, Pages 548-556Publisher
ELSEVIER SCI LTD
DOI: 10.1016/j.ejca.2005.11.014
Keywords
BAY 43-9006; sorafenib; refractory solid tumours; raf kinase inhibition; VEGFR inhibitor; PDGFR inhibitor; pooled analysis; phase I studiesy
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In this analysis of the safety and efficacy of BAY 43-9006 (sorafenib) - a novel, oral multikinase inhibitor with effects on tumour and its vasculature - pooled data were obtained from four phase I dose-escalation trials. Time to progression (TTP) was compared in patients with/without >= grade 2 skin toxicity/diarrhoea. Grade 3 hand-foot skin reactions (HFS; 8%) and diarrhoea (6%) were common. At the recommended 400 mg bid dose for phase II/III trials (RDP), 15% of patients experienced grade 2/3 HFS, and 24% experienced grade 2/3 diarrhoea. Sorafenib induced stable disease for >= 6 months in 12% of patients (6% stabilized for >= 1 year). Patients receiving sorafenib doses at or close to the RDP, who experienced skin toxicity/diarrhoea, had a significantly increased TTP compared with patients without such toxicity (P < 0.05). Sorafenib was well tolerated at the RDP, and induced sustained disease stabilization, particularly in patients with skin toxicity/ diarrhoea. (c) 2005 Elsevier Ltd. All rights reserved.
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