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NABTT 0502: a phase II and pharmacokinetic study of erlotinib and sorafenib for patients with progressive or recurrent glioblastoma multiforme.

Al's Comment:

 Unfortunately, this reports that the combination of treatments mentioned did not work as well as hoped. 


Posted on: 01/19/2013

Neuro Oncol. 2013 Jan 17. [Epub ahead of print]

NABTT 0502: a phase II and pharmacokinetic study of erlotinib and sorafenib for patients with progressive or recurrent glioblastoma multiforme.

Peereboom DM, Ahluwalia MS, Ye X, Supko JG, Hilderbrand SL, Phuphanich S, Nabors LB, Rosenfeld MR, Mikkelsen T, Grossman SA; for the New Approaches to Brain Tumor Therapy (NABTT) Consortium.

Cleveland Clinic, Cleveland, Ohio (D.M.P., M.S.A.); Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore, Maryland (X.Y., S.A.G.); Massachusetts General Hospital, Boston, Massachusetts (J.G.S., S.L.H.); Cedars-Sinai Medical Center, Los Angeles, California (S.P.); University of Alabama, Birmingham, Alabama (L.B.N.); Hospital Clinic/IDIBAPS, Barcelona, Spain (M.R.R.); Henry Ford Hospital, Detroit, Michigan (T.M.).

 

Abstract

BackgroundThe signal transduction pathways of epidermal growth factor receptor and Ras are both important in the growth of glioblastoma multiforme (GBM). We hypothesized that inhibition of both pathways would improve the survival time of patients with recurrent GBM.MethodsPatients with recurrent/progressive GBM with 0-2 prior chemotherapy regimens received erlotinib 150 mg once daily and sorafenib 400 mg twice daily until progression. The primary endpoint was overall survival. Pharmacokinetic sampling was performed during cycle 1.ResultsThe median overall survival was 5.7 months. Progression-free survival at 6 months was 14%. Toxicity was manageable. Clearance of erlotinib was markedly enhanced by sorafenib.ConclusionThe study did not meet its objective of a 30% increase in overall survival time compared with historical controls. Erlotinib and sorafenib have significant pharmacokinetic interactions that may negatively impact the efficacy of the combination regimen.

 

 PMID: 23328813 [PubMed - as supplied by publisher] 

 

 


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