An open-label, randomised phase 3 trialshows that Dovitinib is no better than Sorafenib for third-l
Posted: Aug 05, 2014
A recent publication on "The Lancet Oncology" by Dr. Robert J Motzer, Dr. Bernard Escudier and their group compared the effect of Dovitinibvs Sorafebib on the treatment of patients with metastatic renal cell carcinoma. Following are the details:
An unmet medical need exists for patients with metastatic renal cell carcinoma who have progressed on VEGF-targeted and mTOR-inhibitor therapies. Fibroblast growth factor (FGF) pathway activation has been proposed as a mechanism of escape from VEGF-targeted therapies. Dovitinib is an oral tyrosine-kinase inhibitor that inhibits VEGF and FGF receptors. We therefore compared dovitinib with sorafenib as third-line targeted therapies in patients with metastatic renal cell carcinoma.
In this multicentre phase 3 study, patients with clear cell metastatic renal cell carcinoma who received one previous VEGF-targeted therapy and one previous mTOR inhibitor were randomly assigned through an interactive voice and web response system to receive open-label dovitinib (500 mg orally according to a 5-days-on and 2-days-off schedule) or sorafenib (400 mg orally twice daily) in a 1:1 ratio. Randomisation was stratified by risk group and region. The primary endpoint was progression-free survival (PFS) assessed by masked central review. Efficacy was assessed in all patients who were randomly assigned and safety was assessed in patients who received at least one dose of study drug. This study is registered with ClinicalTrials.gov, number NCT01223027.
284 patients were randomly assigned to the dovitinib group and 286 to the sorafenib group. Median follow-up was 11·3 months. Median PFS was 3·7 months in the dovitinib group and 3·6 monthsin the sorafenib group. 280 patients in the dovitinib group and 284 in the sorafenib group received at least one dose of study drug. Common grade 3 or 4 adverse events included hypertriglyceridaemia, fatigue, hypertension, and diarrhoea in the dovitinib group, and hypertension, fatigue, dyspnoea, and palmar-plantar erythrodysaesthesia in the sorafenib group. The most common serious adverse event was dyspnoea.
Dovitinib showed activity, but this was no better than that of sorafenib in patients with renal cell carcinoma who had progressed on previous VEGF-targeted therapies and mTOR inhibitors. This trial provides reference outcome data for future studies of targeted inhibitors in the third-line setting.
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