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Subcutaneous injection or continuous intravenous infusion with cytarabine were similarly efficacious for the treatment of young adults with acute myeloid leukemia (AML). These findings were presented during the American Society of Hematology (ASH) 62nd Annual Meeting and Exposition.
Patients (N=240) with de novo AML were recruited at 10 centers in China between 2015 and 2017 for this open-label, prospective, multicenter, noninferior, clinical trial. Participants were randomized to receive 10 mg/m2 idarubicin for 3 days with 100 mg/m2 of continuous intravenous cytarabine infusion daily for 7 days (n=120) or 10 mg/m2 idarubicin for 3 days with 100 mg/m2 subcutaneous cytarabine every 12 hours for 7 days (n=120). They were assessed for complete remission, event-free survival, overall survival, and toxicity.
Patients were well balanced for demographics and clinical characteristics at baseline, median age was 40 (range, 16 to 58) and 43 (range, 16 to 60) years and 45.0% and 57.5% were men in the intravenous and subcutaneous treatment groups, respectively. During the study duration, 15.4% of patients were lost to follow up.
After the first cycle, complete remission was achieved by 71.67% of patients in the subcutaneous group and 70.83% of the infusion group (difference, 0.84%; 95% CI, -8.78% to ¥; P =.003). After the second cycle, complete remission was achieved by 77.50% of the subcutaneous and 75.83% of the infusion cohorts (difference, 1.67%; 95% CI, -7.31% to ¥; P =.001).
Overall survival at 3 years was 60% (95% CI, 50%-69%) in the subcutaneous cohort and 58% (95% CI, 49%-67%) among the infusion recipients. Adjusting for demographics and baseline clinical characteristics, the adjusted hazard ratio (aHR) for 3-year overall survival of subcutaneous vs intravenous cytarabine was 0.95 (95% CI, 0.62-1.47; P =.830).
The 3-year event-free survival was 49% (95% CI, 39%-58%) for the subcutaneous recipients and 44% (95% CI, 35%-53%) among the infusion recipients, which corresponded with an aHR of 0.84 (95% CI, 0.58-1.22; P =.857).
Instance of hemorrhagic (P ³.084) and non-hemorrhagic (P ³.141) toxic events did not differ significantly between treatment arms.
This trial was limited by its small sample size and homogenous study population.
These data indicated that subcutaneous injections of cytarabine was noninferior to cytarabine continuous infusions for the treatment of de novo AML among young adults.
If subsequent studies have similarly noninferior results, Huafeng Wang, MD, coauthor of the study, speculated that following these promising findings, there is a possibility for administering cytarabine therapy in the outpatient or home-care setting.
Wang H, Liu L, Zhou J, et al. Comparison of subcutaneous injection versus intravenous infusion of cytarabine for induction therapy in young adult acute myeloid leukemia: results of a prospective, multicenter, noninferiority, randomized trial. Presented at: American Society of Hematology (ASH) 62nd Annual Meeting and Exposition; December 5-8, 2020. Abstr 459.