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Pooled safety analysis of BAY 43-9006 (sorafenib) monotherapy in patients with advanced solid tumours: Is rash
D Strumberg1, A Awada, H Hirte
1Department of Internal Medicine and Medical Oncology, West German Cancer Center, University Medical School of Essen, Essen, Germany. dirk.strumberg@marienhospital-herne.de
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.
Insights
Sorafenib, an oral multi-kinase inhibitor, demonstrated safety and efficacy in clinical trials. Patients experiencing skin toxicity or diarrhea with sorafenib showed significantly longer time to progression.
Area of Science:
- Oncology
- Pharmacology
Background:
- BAY 43-9006 (sorafenib) is a novel oral multi-kinase inhibitor targeting tumor and vasculature.
- Understanding its safety and efficacy profile is crucial for clinical application.
Purpose of the Study:
- To analyze the safety and efficacy of sorafenib.
- To evaluate the impact of specific toxicities on treatment outcomes.
Main Methods:
- Pooled data from four Phase I dose-escalation trials were analyzed.
- Time to progression (TTP) was compared between patients with and without grade 2 skin toxicity/diarrhea.
- Safety data, including hand-foot skin reactions (HFS) and diarrhea, were assessed.
Main Results:
- Grade 3 HFS (8%) and diarrhea (6%) were observed. At the recommended Phase II/III dose (RDP), 15% experienced grade 2/3 HFS and 24% experienced grade 2/3 diarrhea.
- Sorafenib induced stable disease for at least 6 months in 12% of patients.
- Patients receiving sorafenib at or near the RDP who experienced skin toxicity/diarrhea showed significantly increased TTP (P < 0.05) compared to those without.
Conclusions:
- Sorafenib is well-tolerated at the RDP.
- The drug induces sustained disease stabilization.
- Skin toxicity and diarrhea associated with sorafenib correlate with improved TTP, suggesting a potential predictive biomarker.
