Pooled safety analysis of high-specific-activity I-131 MIBG in iobenguane scan positive cancer patients.

388Background: Iobenguane scan positive cancers include pheochromocytoma and paraganglioma (PPGL), neuroblastoma, and gastroenteropancreatic neuroendocrine tumors. A pooled analysis was conducted to assess the safety profile of high-specific-activity I-131 metaiodobenzylguanidine (HSA I-131 MIBG [AZEDRA]) in PPGL and neuroblastoma. Methods: Safety data were pooled from four clinical studies with 118 subjects who received HSA I-131 MIBG. Adverse events (AEs) were described by age, gender, race, number of HSA I-131 MIBG doses, temporal association of AEs within 12 weeks after therapeutic dose 1, vital signs, laboratory values, hematological events of Grade 3/4 or serious AEs, and changes in mean hematology values over a period of 12 months. Results: Out of 118 subjects, mean age was 47.0 ± 18.9 years (range 3-76); 57.6% were males and 74.6% were white. A total of 102 (86.4%) subjects had at least one AE assessed as treatment-related. The incidences of most AEs were similar among both genders and all racial ...