Gefitinib (ZD1839) treatment for adult patients with progressive high-grade gliomas (HGG): An open label, single-arm, phase II study of the Gruppo Italiano Cooperativo di Neuro-Oncologia (GICNO).

1564 Background: HGG comprehend a heterogeneous group of brain tumors with different histologies and prognosis. However, at second relapse, the response rate and PFS-6 are always discouraging for all subtypes.,Adult pts with histologically confirmed HGG recurrent following first-line chemotherapy, were eligible. Pts were treated with Iressa 250 mg/day continuously until disease progression or unacceptable toxicity/pt refusal. Primary endpoint was disease-control rate (DCR=CR+PR+SD). Secondary endpoints were TTP, PFS-6, PFS-12, safety and OS.,Twenty-eight pts were enrolled and all were evaluable for activity and safety (median age: 55 years (range 29-70), male/female: 17/11, PS0/1/2: 3/21/4). Sixteen pts had GBM, 3 pts had anaplastic oligodendrogliomas and 9 pts had anaplastic astrocytoma. One pt had an unconfirmed PR (3.6%), 5 pts (17.9%) had confirmed SD, 3 pts (10.7%) had unconfirmed SD. The overall mTTP was 56 days (range 4-472) and PFS-6 and PFS-12 were 14.3% and 7.1%, respectively. In GBM pts subgroup the DCR was 12.5% (2/16), the mTTP was 60 days (range 28-472), PFS-6 and PFS-12 were both 12.5%. mOS was 172 days (range 28-607+), OS at 6 months was 50% and OS at 12 months was 14.3%. G3-4 toxicities consisted in: G3 diarrhoea in 1 pt, G3 neutropenia in 1 pt, G4 acute pulmonary oedhema in 1 pt, G4 pulmonary thromboembolism in 1 pt, G4 CNS hemorrage in 1 pt. G1-2 dermatological toxicity was common (32.1%).,In our trial Iressa as second line treatment in HGG at the dose of 250 mg/day achieved interesting DCR and PFS-6. In the GBM subgroup, these data seem to confirm the results of the 500 mg/day previous study in terms of PFS-6. [Table: see text].