Phase II trial of anti-epidermal growth factor receptor radioimmunotherapy in the treatment of anaplastic astrocytoma

Objective The efficacy and safety of adjuvant radioimmunotherapywith 125 I-labeled anti-epidermal growth factor receptor 425 murine antibody ( 125 I-425 mAb) in patients with newly diagnosed anaplastic astrocytoma(AA) is evaluated in this single-institution phase II study. Methods Patients with newly diagnosed and histologically proven AA were eligible. A total of 80 patients received three weekly intravenous injections of 1.8 GBq of 125 I-425 mAb following surgery and radiation therapy to a mediandose of 60 Gy. Medianoverall survival was the primary endpoint and the secondary endpoint was toxicity. Results The medianage was 43 years (range 22–75 years), and the median Karnofsky Performance Statuswas 80 (range 50–100). The percentage of patients who underwent surgical debulking, radiation therapy, temozolomide, and nitrosourea-based chemotherapy are 57.5, 99, 25, and 25 % respectively. The overall mediansurvival was 55.6 months (95 % CI 42.7–68.5 months). The 2- and 5-year survivals were 74 and 47 %, respectively. There was no grade 3 or higher toxicity with the administration of 125 I-425 mAb. Conclusion Treatment with 125 I-425 mAb in newly diagnosed AA patients was safe and well tolerated. Survival benefits are encouraging and warrant further study.