Outcomes of Children and Adolescents with Acute Myeloid Leukemia Given a Low-Versus Standard-Dose Chemotherapy Regimen for Remission Induction (CALSIII-AML18): A Multicenter, Phase 3, Randomized, Noninferiority Trial
Backgroun d: Intensive chemotherapy is recommended for remission induction of pediatric acute myeloid leukemia (AML). However, life-threatening complications are common especially in vulnerable populations. We investigated whether a low-dose chemotherapy (LDC) regimen would be noninferior to a stand...
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Veröffentlicht in: | Blood 2023-11, Vol.142 (Supplement 1), p.729-729 |
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Format: | Artikel |
Sprache: | eng |
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Zusammenfassung: | Backgroun d: Intensive chemotherapy is recommended for remission induction of pediatric acute myeloid leukemia (AML). However, life-threatening complications are common especially in vulnerable populations. We investigated whether a low-dose chemotherapy (LDC) regimen would be noninferior to a standard-dose chemotherapy (SDC) regimen for induction remission.This study also aimed to assess whether LDC is not inferior to SDC in terms of survival outcomes.
Methods: We conducted a randomized, noninferiority study in children with AML who were admitted to 14 medical centers in China. Patients were randomly assigned to receive two remission-induction courses of either low-dose chemotherapy (LDC) (cytarabine 10 mg/m 2, subcutaneous, q12 hours, 20 doses; mitoxantrone or idarubicin 5 mg/m 2, intravenous, days 1, 3 and 5; and G-CSF 5 mcg/kg, subcutaneous, daily, 10 doses) (n = 246) or standard-dose chemotherapy (SDC) (cytarabine 100 mg/m 2, intravenous, q12 hours, 20 doses; daunomycin 50 mg/m 2, intravenous, days 1, 3, 5; and etoposide 100 mg 2, intravenous, days 1 to 5) (n = 251). Depending on the risk of relapse, patients in complete remission (CR) in both arms received two to three cycles of intensive consolidation chemotherapy and/or underwent hematopoietic stem cell transplantation (HSCT). The primary endpoint was to compare CR rates in patients randomized to the LDC or SDC regimens. The secondary endpoints were to determine the safety of the LDC regimen and to compare the time to platelet and neutrophil count recovery in the two groups. Finally, in a multivariate analysis, we determined the impact of the type of remission induction on the outcome. This trial is registered at chictr.org as # ChiCTR-18000015883 and has been completed.
Results: From June 2018 to June 2022,497 participants aged |
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ISSN: | 0006-4971 1528-0020 |
DOI: | 10.1182/blood-2023-189253 |