Randomised, controlled study of intratumoral recombinant γ-interferon treatment in newly diagnosed glioblastoma

Abstract

The effect of intratumoral recombinant interferon γ (rIFN-γ) as adjuvant to open cytoreduction and external irradiation of 60 Gy on survival in adults with a newly diagnosed high-grade cerebral glioma was studied. The patients were randomised during surgery into the rIFN-γ group (n = 14) or the control group (n = 17), and the latter received a subcutaneous reservoir of rIFN-γ injections. Intratumoral rIFN-γ was given three times a week for 4 weeks until radiotherapy, escalating the dose from 5μg to 50 μg. Both groups received external whole-brain irradiation of 40 Gy and a local boost of 20 Gy. After radiotherapy, rIFN-γ was continued with 50 μg twice a week up to 9 weeks. The patients received no chemotherapy. Intratumoral rIFN-γ was tolerated well with transient fever only. There were 12 glioblastomas (GBs) in the control group and nine in the rIFN-γ group with completed irradiation. The patients were followed clinically and by computerised tomography (CT) every third month until death. Tumour responses were seen in three interferon-treated (one still alive 45 months after operation) and in two conventionally treated patients. The progression of the tumour volumes on CT did not differ between the IFN-treated and control groups. There were no differences in the survival times. Median survival of the rIFN-γ-treated patients was 54 weeks (95% CI 35-68) and of the control patients 55 weeks (95% CI 41-77). Intratumoral rIFN-γ given in the study doses does not seem to inhibit tumour growth or improve the prognosis of patients with high-grade glioma. © Macmillan Press Ltd., 1994.