INTERFERON ALPHA-2A AND EXTERNAL-BEAM RADIOTHERAPY IN THE INITIAL MANAGEMENT OF PATIENTS WITH GLIOMA - A PILOT-STUDY OF THE NATIONAL BIOTHERAPY STUDY-GROUP

The National Biotherapy Study Group conducted a phase I/II trial of al pha-interferon (IFN) plus radiation therapy (RT) in glioma patients to confirm the feasibility of combining these two modalities. Patients n ewly diagnosed gliomasreceived external beam RT as 180 cGy in 33 fract ions over six to seven weeks, five days a week, and IFN at a dose of 3 MIU SC Monday, Wednesday and Friday of each week. IFN was increased t o 5 MIU after two weeks and was given for up to 16 weeks. Patients wer e monitored for toxicity and failure-free and overall survival. There were 12 men and seven women with an age range of 24-77, and a median a ge of 64 years. There were 12 glioblastomas and seven advanced astrocy tomas. Complete surgical resection was carried out in two patients, ni ne had a partial resection, and eight had a biopsy only. Two patients in the latter group deteriorated rapidly and received <2 weeks of RT/I FN. One patient stopped IFN because of a skin rash, another stopped be cause of concurrent pneumonia, and one patient was noncompliant RT and IFN were well-tolerated 14 of the 19 patients completed the eight wee ks of IFN/RT. However, only three patients took IFN for the maximum of 16 weeks. The only grade 4 toxicities noted were up arrow SGOT in thr ee, up arrow alk phos in two, and severe fatigue in four patients. The median failure-free survival was two months, median survival was 7.5 months, and four patients survived beyond one year. The longest surviv or was 29.1 months, and one patient is still alive after 20.7 months. IFN/RT can be safely co-administered in patients with gliomas. A rando mized trial would be needed to establish clinical benefit.