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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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Published in: | European journal of cancer (1990) 2006-03, Vol.42 (4), p.548-556 |
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Main Authors: | , , , , , , , , , , |
Format: | Article |
Language: | English |
Subjects: | |
Citations: | Items that this one cites Items that cite this one |
Online Access: | Get full text |
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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. |
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ISSN: | 0959-8049 1879-0852 |
DOI: | 10.1016/j.ejca.2005.11.014 |