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Clinical Trial
. 2007 Apr 10;96(7):1047-51.
doi: 10.1038/sj.bjc.6603669. Epub 2007 Mar 13.

Gefitinib in patients with progressive high-grade gliomas: a multicentre phase II study by Gruppo Italiano Cooperativo di Neuro-Oncologia (GICNO)

E Franceschi  1 , G Cavallo, S Lonardi, E Magrini, A Tosoni, D Grosso, L Scopece, V Blatt, B Urbini, A Pession, G Tallini, L Crinò, A A Brandes
Affiliations
Clinical Trial

Gefitinib in patients with progressive high-grade gliomas: a multicentre phase II study by Gruppo Italiano Cooperativo di Neuro-Oncologia (GICNO)

E Franceschi et al. Br J Cancer. .

Abstract

To investigate the role of gefitinib in patients with high-grade gliomas (HGGs), a phase II trial (1839IL/0116) was conducted in patients with disease recurrence following surgery plus radiotherapy and first-line chemotherapy. Adult patients with histologically confirmed recurrent HGGs following surgery, radiotherapy and first-line chemotherapy, were considered eligible. Patients were treated with gefitinib (250 mg day(-1)) continuously until disease progression. The primary end point was progression-free survival at 6 months progression-free survival at 6 months (PFS-6). Tissue biomarkers (epidermal growth factor receptor (EGFR) gene status and expression, phosphorylated Akt (p-Akt) expression) were assessed. Twenty-eight patients (median age, 55 years; median ECOG performance status, 1) were enrolled; all were evaluable for drug activity and safety. Sixteen patients had glioblastoma, three patients had anaplastic oligodendrogliomas and nine patients had anaplastic astrocytoma. Five patients (17.9%, 95% CI 6.1-36.9%) showed disease stabilisation. The overall median time to progression was 8.4 (range 2-104+) weeks and PFS-6 was 14.3% (95% CI 4.0-32.7%). The median overall survival was 24.6 weeks (range 4-104+). No grade 3-4 gefitinib-related toxicity was found. Gefitinib showed limited activity in patients affected by HGGs. Epidermal growth factor receptor expression or gene status, and p-Akt expression do not seem to predict activity of this drug.

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Figures

Figure 1
Figure 1
Kaplan–Meier curves for progression-free survival. (A) In overall population; (B) by rash.
Figure 2
Figure 2
P-Akt IHC expression examples: (A) negative, (B) positive; EGFR IHC expression examples: (C) negative, (D) positive, EGFR gene status by FISH examples: (E) diploid, (F) amplified.
See this image and copyright information in PMC

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