A Phase II study of anti–epidermal growth factor receptor radioimmunotherapy in the treatment of glioblastoma multiforme

Object This single-institution Phase II study tests the efficacy of adjuvant radioimmunotherapy with 125I-labeled anti–epidermal growth factor receptor 425 murine monoclonal antibody (125I-mAb 425) in patients with newly diagnosed glioblastoma multiforme (GBM). Methods A total of 192 patients with GBM were treated with 125I-mAb 425 over a course of 3 weekly intravenous injections of 1.8 GBq following surgery and radiation therapy. The primary end point was overall survival, and the secondary end point was toxicity. Additional subgroup analyses were performed comparing treatment with 125I-mAb 425 (RIT, 132 patients), 125I-mAb 425 and temozolomide (TMZ+RIT, 60 patients), and a historical control group (CTL, 81 patients). Results The median age was 53 years (range 19–78 years), and the median Karnofsky Performance Scale score was 80 (range 60–100). The percentage of patients who underwent debulking surgery was 77.6% and that of those receiving temozolomide was 31.3%. The overall median survival was 15.7 mont...