Journal
JOURNAL OF THORACIC ONCOLOGY
Volume 8, Issue 6, Pages 783-787Publisher
ELSEVIER SCIENCE INC
DOI: 10.1097/JTO.0b013e31828c2b26
Keywords
Mesothelioma; Sorafenib
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Funding
- NIHR Academic Clinical Lecturer award
- higher education funding council for England
- U.K. National Institute for Health Research (NIHR) Biomedical Research Centres
- Bayer Healthcare
- Academy of Medical Sciences (AMS) [AMS-SGCL6-Papa] Funding Source: researchfish
- National Institute for Health Research [CL-2011-17-007] Funding Source: researchfish
- Prostate Cancer UK [PA12-06] Funding Source: researchfish
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Introduction: The incidence of mesothelioma is rising. First-line cisplatin and pemetrexed confers a survival benefit, with a median progression-free survival (PFS) of 5.7 months. Sorafenib inhibits tyrosine kinases, including receptors for vascular endothelial growth factor, which are implicated in mesothelioma pathogenesis by preclinical and clinical data. Methods: Sorafenib, at 400 mg twice daily, was assessed in a single-arm multicenter phase 2 study, using Simon's two-stage design. Eligible patients had received platinum combination chemotherapy earlier. The primary endpoint was PFS at 6 months, with secondary endpoints, including response rate and metabolic response, assessed using fluorodeoxyglucose positron emission tomography. Published reference values for PFS in mesothelioma provide a benchmark for the null hypothesis of 28% progression-free at 6 months, and for moderate or significant clinical activity of 35% or 43% progression-free at 6 months, respectively. Results: Fifty-three patients (72%) were treated. Most had epithelioid histology. Ninety-three percent of patients had a performance status 0 or 1. Treatment was well tolerated with few grade 3 or 4 toxicities. Median PFS was 5.1 months, with 36% of patients being progression-free at 6 months. Nine percent of patients remained on study beyond 1 year. Changes in fluorodeoxyglucose positron emission tomography parameters did not predict clinical outcome. Conclusions: Sorafenib is well tolerated in patients with mesothelioma after completion of platinum-containing chemotherapy. PFS of sorafenib compares favorably with that reported for other targeted agents, and suggests moderate activity in this disease.
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