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

被引:149
作者
Franceschi, E.
Cavallo, G.
Lonardi, S.
Magrini, E.
Tosoni, A.
Grosso, D.
Scopece, L.
Blatt, V.
Urbini, B.
Pession, A.
Tallini, G.
Crino, L.
Brandes, A. A. [1 ]
机构
[1] IRCCS, Ist Oncol Veneto, Dept Med Oncol, Padua, Italy
[2] Bellaria Hosp, Dept Med Oncol, Bologna, Italy
[3] Bellaria Hosp, Dept Pathol, Bologna, Italy
[4] St Anna Hosp, Dept Med Oncol, Ferrara, Italy
关键词
high-grade gliomas; gefitinib; EGFR; Akt;
D O I
10.1038/sj.bjc.6603669
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
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.
引用
收藏
页码:1047 / 1051
页数:5
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