Key clinical point: Intensification of induction II chemotherapy with mitoxantrone and high-dose cytarabine (MA) did not improve survival, but increased toxicity in pediatric patients with high-risk acute myeloid leukemia (AML) vs. cytarabine/daunorubicin/etoposide (ADE).
Major finding: Induction II with MA vs. ADE did not improve 5-year disease-free survival ( P = .632) and overall survival ( P = .658). Fewer patients receiving MA vs. ADE achieved neutrophil (52.6% vs. 79.3%; P = .011) and platelet (60.0% vs. 82.8%; P = .024) recovery.
Study details: This study included 124 patients with newly diagnosed de novo high-risk AML treated in AAML0531 (n = 29) and AAML1031 (n = 95) trials. For induction II, patients in AAML0531 received ADE and those in AAML1031 received MA. Also, stem cell transplant conditioning used busulfan/cyclophosphamide in AAML0531 and busulfan/fludarabine along with liberalized donor eligibility in AAML1031 trials.
Disclosures: This study was supported by grants from the COG NCTN Network Group Operations Centres and NCTN Statistics and Data Center. M Loken and LE Brodersen reported being an employee of Hematologics Inc.
Source: Elgarten CW et al. Pediatr Blood Cancer. 2021 Oct 1. doi: 10.1002/pbc.29281.