期刊
BRITISH JOURNAL OF CANCER
卷 105, 期 3, 页码 353-359出版社
NATURE PUBLISHING GROUP
DOI: 10.1038/bjc.2011.257
关键词
melanoma; sorafenib; dacarbazine; combination therapy; biomarker
类别
资金
- Bayer
- Bayer Healthcare Pharmaceuticals
- Bayer Healthcare
- National Institute for Health Research, UK
METHOD: The safety of oral sorafenib up to a maximum protocol-specified dose combined with dacarbazine in patients with metastatic, histologically confirmed melanoma was investigated in a phase I dose-escalation study and the activity of the combination was explored in an open-label phase II study. RESULTS: In the phase I study, three patients were treated with sorafenib 200 mg twice daily (b.i.d.) plus 1000 mg m(-2) dacarbazine on day 1 of a 21-day cycle and 15 patients had the sorafenib dose escalated to 400 mg b.i.d. without reaching the maximum tolerated dose of the combination. In the phase II study (n = 83), the overall response rate was 12% (95% CI: 6, 21): one complete and nine partial, with median response duration of 46.7 weeks. Stable disease was the best response in 37%; median duration was 13.3 weeks. Median overall survival (OS) was 37.0 weeks (95% CI: 33.9, 46.0). CONCLUSION: Oral sorafenib combined with dacarbazine had acceptable toxicity and some antineoplastic activity against metastatic melanoma. British Journal of Cancer (2011) 105, 353-359. doi:10.1038/bjc.2011.257 www.bjcancer.com Published online 12 July 2011 (C) 2011 Cancer Research UK
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