A Phase II Study of Sorafenib in Malignant Mesothelioma: Results of Cancer and Leukemia Group B 30307

作者: Sarita Dubey , Pasi A. Jänne , Lee Krug , Herbert Pang , Xiaofei Wang

DOI: 10.1097/JTO.0B013E3181EC18DB

关键词: Vascular endothelial growth factorInternal medicinePhases of clinical researchMedicineSorafenibMesotheliomaCancerTyrosine-kinase inhibitorPathologyLeukemiaGastroenterologySurvival rate

摘要: Hypothesis: Malignant mesotheliomas (MMs) express vascular endothelial growth factor receptor (VEGFR), platelet-derived receptor, and cKIT. Sorafenib is a potent inhibitor of the ras/raf/MEK pathway also targets VEGFR We evaluated activity sorafenib in patients with unresectable mesothelioma. Methods: MM who had received 0 to 1 prior chemotherapy regimens were treated 400 mg orally twice daily continuously. The primary end point was objective response. ERK1/2 phosphorylation archival tissues correlated response survival. Results: A total 51 enrolled, 50 evaluable included analysis. Three partial (6% [95% confidence interval=1.3–16.6%]), 27 (54% interval=39.3–68.2%]) stable disease. Median progression-free survival median overall (OS) 3.6 9.7 months, respectively. superior epithelioid histology versus other types (10.7 3.7 p = 0.0179). difference OS between pretreated chemonaive not statistically significant (13.2 5 0.3117). Low/negative baseline tumor phospho-ERK1/2 levels associated improved (13.9 5.2 0.0066). Conclusion: has limited advanced patients, similar that seen tyrosine kinase inhibitors. Additional studies are warranted.

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