Phase 2 study of sorafenib in malignant mesothelioma previously treated with platinum-containing chemotherapy

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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.

Original languageEnglish
Pages (from-to)783-7
Number of pages5
JournalJournal of Thoracic Oncology
Issue number6
Publication statusPublished - Jun 2013


  • Aged
  • Aged, 80 and over
  • Antineoplastic Combined Chemotherapy Protocols
  • Drug Resistance, Neoplasm
  • Female
  • Follow-Up Studies
  • Glutamates
  • Guanine
  • Humans
  • Male
  • Mesothelioma
  • Middle Aged
  • Neoplasm Staging
  • Niacinamide
  • Pemetrexed
  • Phenylurea Compounds
  • Platinum
  • Pleural Neoplasms
  • Prognosis
  • Protein Kinase Inhibitors
  • Salvage Therapy
  • Survival Rate


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