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See Latest ArticlesPhase II, multicenter, uncontrolled trial of single-agent sorafenib in patients with relapsed or refractory, advanced non–small-cell lung cancer
Journal of Clinical Oncology, 09/10/09
Blumenschein GR et al. – Continuous treatment with sorafenib 400 mg twice daily was associated with disease stabilization in patients with advanced NSCLC.
Methods- Phase II, single-arm, multicenter study
- Patients with relapsed or refractory advanced NSCLC received sorafenib 400 mg orally twice daily until tumor progression or an unacceptable drug-related toxicity occurred
- Of 54 patients enrolled, 52 received sorafenib
- The predominant histologies were adenocarcinoma (54%) and squamous cell carcinoma (31%)
- No complete or partial responses were observed
- SD was achieved in 30 (59%) of the 51 patients who were evaluable for efficacy
- 4patients with SD developed tumor cavitation
- Median progression-free survival (PFS) was 2.7 months, and median overall survival was 6.7 months
- Patients with SD had a median PFS of 5.5 months
- Major grades 3-4, treatment-related toxicities included hand-foot skin reaction (10%), hypertension (4%), fatigue (2%), and diarrhea (2%)
- 9patients died within a 30-day period after discontinuing sorafenib, and one patient experienced pulmonary hemorrhage that was considered drug related
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