Gemtuzumab ozogamycin (GO) and toxic mortality (TM) in children and adolescents with acute myeloid leukemia (AML) enrolled on Children’s Oncology Group (COG) trial AAML0531.

10008 Background: Survival benefit in children with AML using GO was seen in COG AAML0531, though with greater TM. This retrospective analysis examines the overall causes of mortality focusing on the impact of GO and other potential risk factors of TM. Methods: Patients with de novoAML were randomized to chemotherapy with (GO) or without GO (noGO). Low risk and intermediate risk patients without a matched sib donor received 5 chemotherapy courses while all others received 3 chemotherapy courses and stem cell transplant (SCT). GO included a 3mg/m2/dose on day 6 of Induction I and, if not receiving SCT, on day 7 of Intensification II. Induction death (ID) was defined as any death during the two induction courses. Treatment-related mortality (TRM) was defined as death in the intensification cycles while in complete remission. ID and TRM risk factoring in patient, disease and treatment factors were analyzed. SCT recipients were censored after Intensification I. Results: 1,022 patients (511 per arm) age 0-29 y...