Efficacy and safety of cladribine addition to induction treatment of newly diagnosed acute myeloid leukemia: a systematic review and meta-analysis

Abstract

Objectives: Compared with the 3 + 7 regimen, the cladribine-containing regimen has led to improvements in the rate of complete remission (CR) in the treatment of newly diagnosed acute myeloid leukemia (AML) patients. We conducted a systematic review and metaanalysis to investigate the overall efficacy and safety of cladribine-containing regimens in the induction treatment of newly diagnosed AML patients. Methods: Eligible studies were identified from the PubMed, EMBASE, and Cochrane Library databases. Efficacy was assessed by CR rate, disease-free survival (DFS), and overall survival (OS). Safety was evaluated based on the early death (ED) rate, days for neutrophils<0.5 × 10 9 /L, days for platelets<50 × 10 9 /L, and duration of hospital stay after treatment. Results: A total of 14 clinical trials were included in this meta-analysis, enrolling a total of 1058 newly diagnosed AML patients. The pooled estimate with a 95% confidence interval (CI) for CR was 64% (95% CI: 58-70%). Compared with the control group, the CR rate of the cladribinecontaining regimen was higher (OR was 1.92 (95% CI: 1.55-2.38)). The combined ED rate was estimated to be 10% (95% CI: 5-14%). Compared with the control group, the ED rate of the cladribine-containing regimen was not increased (OR was 1.09 (95% CI: 0.78-1.53)). Conclusion:This meta-analysis suggests that cladribine-containing regimens are likely to be effective and safe for induction treatment of newly diagnosed AML patients. However, large sample size and prospective controlled studies are needed to confirm our findings.

A hybrid protocol CLAG-M, a possible player for the first-line therapy of patients with mixed phenotype acute leukemia. A Polish Adult Leukemia Group experience

“…Furthermore, we analyzed the safety profile of the CLAG-M regimen in first-line of treatment by examining the time to neutrophil and platelet recovery and infectious and non-infectious complications at the time of therapy. Considering the reported prolonged hematological recovery following CLAG-M administration and the consequent heightened risk of infectious complications, two distinct time frames were evaluated for hematological recovery ( 24 ). First, the durations of severe neutropenia and thrombocytopenia were evaluated.…”