Document Detail


A phase II study of sorafenib in malignant mesothelioma: results of Cancer and Leukemia Group B 30307.
MedLine Citation:
PMID:  20736856     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
HYPOTHESIS: Malignant mesotheliomas (MMs) express vascular endothelial growth factor receptor (VEGFR), platelet-derived growth factor receptor, and cKIT. Sorafenib is a potent inhibitor of the ras/raf/MEK pathway and also targets VEGFR and cKIT. We evaluated the activity of sorafenib in patients with unresectable mesothelioma.
METHODS: MM patients who had received 0 to 1 prior chemotherapy regimens were treated with sorafenib 400 mg orally twice daily continuously. The primary end point was objective response. ERK1/2 phosphorylation in archival tissues was correlated with response and survival.
RESULTS: A total of 51 patients were enrolled, 50 were evaluable and included in the analysis. Three patients had a partial response (6% [95% confidence interval = 1.3-16.6%]), and 27 (54% [95% confidence interval = 39.3-68.2%]) had stable disease. Median progression-free survival and median overall survival (OS) were 3.6 and 9.7 months, respectively. Median survival was superior in epithelioid histology versus other types (10.7 versus 3.7 months, p = 0.0179). The difference in median OS between pretreated and chemonaive patients was not statistically significant (13.2 versus 5 months, p = 0.3117). Low/negative baseline tumor phospho-ERK1/2 levels were associated with improved OS (13.9 versus 5.2 months, p = 0.0066).
CONCLUSION: Sorafenib has limited activity in advanced MM patients, similar to that seen with other VEGFR tyrosine kinase inhibitors. Additional studies of sorafenib in MM are not warranted.
Authors:
Sarita Dubey; Pasi A Jänne; Lee Krug; Herbert Pang; Xiaofei Wang; Robin Heinze; Colleen Watt; Jeff Crawford; Robert Kratzke; Everett Vokes; Hedy Lee Kindler
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Publication Detail:
Type:  Clinical Trial, Phase II; Journal Article; Multicenter Study; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer     Volume:  5     ISSN:  1556-1380     ISO Abbreviation:  J Thorac Oncol     Publication Date:  2010 Oct 
Date Detail:
Created Date:  2010-09-27     Completed Date:  2011-02-03     Revised Date:  2013-12-19    
Medline Journal Info:
Nlm Unique ID:  101274235     Medline TA:  J Thorac Oncol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1655-61     Citation Subset:  IM    
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MeSH Terms
Descriptor/Qualifier:
Aged
Antineoplastic Agents / therapeutic use*
Benzenesulfonates / therapeutic use*
Extracellular Signal-Regulated MAP Kinases / antagonists & inhibitors
Female
Humans
Male
Mesothelioma / drug therapy*,  pathology
Middle Aged
Neoplasm Staging
Niacinamide / analogs & derivatives
Peritoneal Neoplasms / drug therapy*,  pathology
Phenylurea Compounds
Phosphorylation
Pleural Neoplasms / drug therapy*,  pathology
Pyridines / therapeutic use*
Survival Rate
Treatment Outcome
Grant Support
ID/Acronym/Agency:
CA31946/CA/NCI NIH HHS; CA33601/CA/NCI NIH HHS; R01 CA135257/CA/NCI NIH HHS; U10 CA031946/CA/NCI NIH HHS; U10 CA033601/CA/NCI NIH HHS
Chemical
Reg. No./Substance:
0/Antineoplastic Agents; 0/Benzenesulfonates; 0/Phenylurea Compounds; 0/Pyridines; 0/sorafenib; 25X51I8RD4/Niacinamide; EC 2.7.11.24/Extracellular Signal-Regulated MAP Kinases
Comments/Corrections

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