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Pooled safety analysis of BAY 43-9006 (sorafenib) monotherapy in patients with advanced solid tumours: Is rash associated with treatment outcome?

In this analysis of the safety and efficacy of BAY 43-9006 (sorafenib) – a novel, oral multi-kinase 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...

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Bibliographic Details
Published in:European journal of cancer (1990) 2006-03, Vol.42 (4), p.548-556
Main Authors: Strumberg, D., Awada, A., Hirte, H., Clark, J.W., Seeber, S., Piccart, P., Hofstra, E., Voliotis, D., Christensen, O., Brueckner, A., Schwartz, B.
Format: Article
Language:English
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Summary:In this analysis of the safety and efficacy of BAY 43-9006 (sorafenib) – a novel, oral multi-kinase 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.
ISSN:0959-8049
1879-0852
DOI:10.1016/j.ejca.2005.11.014