title: A pilot study of everolimus and gefitinib in the treatment of recurrent glioblastoma (GBM).
abstract: Twenty-two patients with recurrent glioblastoma (GBM) were prospectively treated with everolimus and gefitinib, designed to test the combined inhibition of mammalian target of rapamycin (mTOR) and epidermal growth factor receptor (EGFR) as part of a larger clinical trial. The primary endpoint was radiographic response rate. Secondary endpoints included progression-free survival and correlation of molecular profiles with treatment response. 36% of patients had stable disease and 14% a partial response; however, responses were not durable and only one patient was progression-free at six months. Radiographic changes were not well characterized by conventional response criteria, and implied differential effects of therapy within the tumor and/or antiangiogenic effects. EGFR and PTEN status did not clearly predict response to treatment.
authors.affiliation: Neuro-Oncology Branch, National Cancer Institute, 9030 Old Georgetown Road, Bethesda, MD 20892, USA.
authors.forename: Teri N
authors.initials: TN
authors.lastname: Kreisl
authors.forename: Andrew B
authors.initials: AB
authors.lastname: Lassman
authors.forename: Paul S
authors.initials: PS
authors.lastname: Mischel
authors.forename: Neal
authors.initials: N
authors.lastname: Rosen
authors.forename: Howard I
authors.initials: HI
authors.lastname: Scher
authors.forename: Julie
authors.initials: J
authors.lastname: Teruya-Feldstein
authors.forename: David
authors.initials: D
authors.lastname: Shaffer
authors.forename: Eric
authors.initials: E
authors.lastname: Lis
authors.forename: Lauren E
authors.initials: LE
authors.lastname: Abrey
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001932:Brain Neoplasms / Q000188:drug therapy* / Q000378:metabolism / Q000401:mortality; D018572:Disease-Free Survival; D066246:ErbB Receptors / Q000096:biosynthesis; D000068338:Everolimus; D005260:Female; D000077156:Gefitinib; D005909:Glioblastoma / Q000188:drug therapy* / Q000378:metabolism / Q000401:mortality; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D051059:PTEN Phosphohydrolase / Q000096:biosynthesis; D010865:Pilot Projects; D051057:Proto-Oncogene Proteins c-akt; D011799:Quinazolines / Q000008:administration & dosage / Q000009:adverse effects; D020123:Sirolimus / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives
chemical_list: D011799:Quinazolines; D000068338:Everolimus; D066246:ErbB Receptors; D051057:Proto-Oncogene Proteins c-akt; D051059:PTEN Phosphohydrolase; C494929:PTEN protein, human; D000077156:Gefitinib; D020123:Sirolimus