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 mgday-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.
| Original language | English |
|---|---|
| Pages (from-to) | 1047-1051 |
| Number of pages | 5 |
| Journal | British Journal of Cancer |
| Volume | 96 |
| Issue number | 7 |
| DOIs | |
| Publication status | Published - Apr 10 2007 |
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Keywords
- Akt
- EGFR
- Gefitinib
- High-grade gliomas
ASJC Scopus subject areas
- Cancer Research
- Oncology
Cite this
Gefitinib in patients with progressive high-grade gliomas : A multicentre phase II study by Gruppo Italiano Cooperativo di Neuro-Oncologia (GICNO). / Franceschi, E.; Cavallo, G.; Lonardi, S.; Magrini, E.; Tosoni, A.; Grosso, D.; Scopece, L.; Blatt, V.; Urbini, B.; Pession, A.; Tallini, G.; Crinò, L.; Brandes, A. A.
In: British Journal of Cancer, Vol. 96, No. 7, 10.04.2007, p. 1047-1051.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Gefitinib in patients with progressive high-grade gliomas
T2 - A multicentre phase II study by Gruppo Italiano Cooperativo di Neuro-Oncologia (GICNO)
AU - Franceschi, E.
AU - Cavallo, G.
AU - Lonardi, S.
AU - Magrini, E.
AU - Tosoni, A.
AU - Grosso, D.
AU - Scopece, L.
AU - Blatt, V.
AU - Urbini, B.
AU - Pession, A.
AU - Tallini, G.
AU - Crinò, L.
AU - Brandes, A. A.
PY - 2007/4/10
Y1 - 2007/4/10
N2 - 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 mgday-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.
AB - 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 mgday-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.
KW - Akt
KW - EGFR
KW - Gefitinib
KW - High-grade gliomas
UR - http://www.scopus.com/inward/record.url?scp=34247218483&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=34247218483&partnerID=8YFLogxK
U2 - 10.1038/sj.bjc.6603669
DO - 10.1038/sj.bjc.6603669
M3 - Article
VL - 96
SP - 1047
EP - 1051
JO - British Journal of Cancer
JF - British Journal of Cancer
SN - 0007-0920
IS - 7
ER -