Sorafenib and Dacarbazine for Advanced Melanoma
Author Information
Author(s): T. Eisen, R. Marais, A. Affolter, P. Lorigan, C. Robert, P. Corrie, C. Ottensmeier, C. Chevreau, D. Chao, P. D. Nathan, T. Jouary, M. Harries, S. Negrier, E. Montegriffo, T. Ahmad, I. Gibbens, M. G. James, U. P. Strauss, S. Prendergast, M. E. Gore
Hypothesis
Can sorafenib combined with dacarbazine improve outcomes in patients with advanced melanoma?
Conclusion
The combination of oral sorafenib and dacarbazine showed acceptable toxicity and some antitumor activity against metastatic melanoma.
Supporting Evidence
- The overall response rate in the phase II study was 12%, with one complete response and nine partial responses.
- The median overall survival for patients was 37 weeks.
- Stable disease was observed in 37% of patients with a median duration of 13.3 weeks.
Takeaway
This study tested a new medicine called sorafenib with another medicine called dacarbazine to see if they could help people with a serious skin cancer called melanoma. They found that the combination was safe and helped some people.
Methodology
The study included a phase I dose-escalation study to assess safety and a phase II study to evaluate efficacy in patients with metastatic melanoma.
Potential Biases
Potential bias due to the small sample size for mutation analysis and the open-label design of the study.
Limitations
The study did not meet its predefined primary endpoint of overall response rate, and the sample size for biomarker analysis was small.
Participant Demographics
{"male":50,"female":33,"median_age":56,"race":{"white":82,"asian":1}}
Statistical Information
Confidence Interval
{"overall_response_rate":"95% CI: 6, 21","median_overall_survival":"95% CI: 33.9, 46.0"}
Statistical Significance
p<0.05
Digital Object Identifier (DOI)
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