Comparison of consecutive versus alternate day schedules of high-dose cytarabine consolidation chemotherapy in Acute Myeloid Leukemia: Single-center randomized controlled trial from India

Abstract INTRODUCTION The treatment strategy of patients with Acute myeloid leukaemia (AML) includes induction chemotherapy which is to achieve remission and consolidation. High-dose cytarabine (HiDAC) is considered the standard consolidation therapy in patients achieving complete remission (CR), the standard dosage 10 x 109/L. RESULTS Total 59 patients were treated between January 202431 patients receiving HiDAC-123 37(12.88) years in HiDAC-123 group p 0.001]. Median time to platelet recovery was also significantly reduced in HiDAC-123 group compared to HiDAC-135 group 13.58(1.84) days vs 18.04(3.77) days;(p 0.001). All patients experienced grade 4 neutropenia; however, there was no significant difference in the incidence of grade 3/4 febrile neutropenia between the 2 groups. The median number of platelets transfused was lower in HiDAC-123 group [8(6,11.5) units compared to HiDAC-135 group11(8,13) units), but the difference was not statistically significant(p=0.09). The mean number of G-CSF doses administered was significantly lower in HiDAC-123 group compared to HiDAC-135 group [9.32(2.05) vs. 18.5(2.92) ;(p 0.001). The HiDAC-123 schedule was associated with shorter mean duration of hospitalization 14.52(2.37)days vs. 18.5(2.92) days; p 0.001. There was no statistically significant difference in red blood cell transfusion requirement between the two groups. The commonest non-hematologic adverse events observed in both arms was nausea (grade 1-2). There was no incidence of grade 3-4 non-hematological AE, & no treatment-related mortality in the study. CONCLUSION In our single-institution experience, the condensed consecutive-day schedule of high-dose cytarabine (HiDAC-123) was associated with more rapid hematologic recovery, reduced number of GCSF doses and duration of hospital stay compared to the alternate-day HiDAC-135 regimen. These findings suggest that HiDAC-123 may be a more favorable schedule in terms of tolerability and resource utilization.