| Literature DB >> 16426838 |
D Strumberg1, A Awada, H Hirte, J W Clark, S Seeber, P Piccart, E Hofstra, D Voliotis, O Christensen, A Brueckner, B Schwartz.
Abstract
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 400mg 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.Entities:
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Year: 2006 PMID： 16426838 DOI： 10.1016/j.ejca.2005.11.014
Source DB: PubMed Journal: Eur J Cancer ISSN： 0959-8049 Impact factor: 9.162