Abstract Objective: The primary objective was to determine if consolidation with two short chemotherapy cycles using cytarabine plus idarubicin (AI) and high dose cytarabine plus mitoxantrone (haM) (two-cycle) reduced the cumulative incidence of relapse compared to the standard regimen of a 6-week consolidation phase (CONS) among newly diagnosed pediatric patients with acute myeloid leukemia (AML).   Methods:  GATLA 8-LMA-P’07 was a phase III trial conducted in 26 centers in Argentina. We included newly diagnosed pediatric patients with AML 0-18 years of age. Patients with M3 AML were excluded. After two cycles of induction, patients in remission were randomized to either CONS or two-cycle consolidation chemotherapy. High risk patients received matched family stem cell transplantation or maintenance therapy for 12 months.  Results: One hundred seven  patients younger than 18 years with de novo AML were randomized to CONS (n=52) or two-cycle (n=57). Cumulative incidence (standard error) of relapse was not significantly different between CONS (31% (0.1)) and two-cycle (39% (0.1)) consolidation (P=0.25). There was no significant difference in 5-year event free survival (53.6% (0.8) vs 44.3 (0.7), P= 0.31) or 5-year overall survival (55.0% (0.8) vs. 53.7% (0.7), P=0.91) for CONS and two-cycle consolidation respectively.  Conclusions: Consolidation with two cycles of chemotherapy was not significantly better than the standard consolidation in reducing the cumulative risk of relapse among newly diagnosed children with AML from Argentina. Future research should evaluate new approaches to improves outcomes for pediatric patients with AML.

The value of reporting on end-of-treatment outcome of patients in low-income settingsTrijn Israels MD PhD1,2, Ramandeep Singh Arora DCH, MD3, Lillian Sung MD PhD41 Collaborative African Network for Childhood Cancer Care and Research (CANCaRe Africa), 2 Kamuzu University of Health Sciences, Blantyre, Malawi, 3 Max Super Speciality Hospital, New Delhi, India, 4 Sick Children’s Hospital, Toronto, CanadaCorresponding author:Dr Trijn Israels, CANCaRe Africa, Department of Paediatrics, Kamuzu University of Health Sciences (KuHES), Blantyre, Malawi. Email: [email protected] count: 1256 wordsNumber of Tables: 0Number of Figures: 0Short running title: End-of-treatment outcome reportingKey words: childhood cancer, survival, LIC, indicatorsLIC Low-income countryHIC High-income countryGICC Global Initiative for Childhood CancerEFS Event-free survivalOS Overall survivalTRM Treatment related mortalityDRM Disease related mortalityCANCaRe Africa Collaborative African Network for Childhood Cancer Care and Research