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Induction with idarubicin, cytarabine, and cladribine in patients with ND AML: Results from a phase III trial
The “7+3” regimen (7 days of cytarabine plus 3 days of anthracycline agent) has been the standard of care for newly diagnosed AML for decades, with CR rates ranging from 50% to 80% (lower for those with adverse risk factors).1 Idarubicin plus cytarabine (IA) has shown better CR rates and long-term outcomes than daunorubicin. However, there are limited data on the use of IA with cladribine (IAC).1 Zhang et al.1 published results from a phase III trial (NCT02323022) in Clinical Cancer Research comparing the efficacy and safety of induction with IAC with low-dose idarubicin (n = 413) vs IA (n = 215) in adult patients with ND AML. The primary endpoint was CR after induction.1
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Key learnings |
The overall CR was 80.5% with IAC vs 72.4% with IA (p = 0.029). The 2-year OS was 81.3% vs 70.0% (p = 0.011), while 2-year DFS (75.7% vs 68.2%; p = 0.080) and CIR (18.5% vs 23.2%; p = 0.221) did not differ significantly between groups. |
IAC showed better outcomes than IA in patients with adverse risk (CR, 69.8% vs 49.1% [p = 0.008]; 2-year OS, 80.1% vs 58.1% [p = 0.014]; DFS, 78.8% vs 51.3% [p = 0.009]) and those aged >45 years (CR, 77.1% vs 62.6% [p = 0.033]; 2-year OS, 74.7% vs 55.0% [p = 0.019]). |
CTCAE Grade 4 thrombocytopenia and neutropenia were reported in all patients receiving a complete induction cycle. Median time to neutrophil recovery and platelet recovery, peripheral blood cell recovery, and Grade 3–5 nonhematologic AEs were similar between groups. |
Cladribine combined with IA was safe and effective in patients with ND AML, providing a better prognosis, particularly in those with adverse risk or aged >45 years. Additional studies with HMAs or targeted agents are needed to validate the findings. |
Abbreviations: AE, adverse event; AML, acute myeloid leukemia; CIR, cumulative incidence or relapse; CR, complete remission; CTCAE, Common Terminology Criteria for Adverse Events; DFS, disease-free survival; HMA, hypomethylating agent; IA, idarubicin-cytarabine; IAC, idarubicin-cytarabine-cladribine; ND, newly diagnosed; OS, overall survival.
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