The following is a summary of “Phase II study of cladribine, idarubicin, and ara-C (CLIA) with or without sorafenib as initial therapy for patients with acute myeloid leukemia,” published in the August 2023 issue of Hematology by Kadia et al.

Researchers performed a retrospective study to determine the efficacy of cladribine or sorafenib to standard chemotherapy in patients with newly diagnosed acute myeloid leukemia (AML).

They investigated cladribine, idarubicin, and intermediate-dose cytarabine (CLIA) in patients aged ≤65 with newly diagnosed AML who were eligible for intensive therapy. The CLIA regimen consisted of cladribine (5 mg/m2) IV on days 1–5, cytarabine (1 g/m2) on days 1-5, and idarubicin (10 mg/m2) on days 1-3. Sorafenib was added to CLIA, and 80 patients were enrolled, with 65 newly diagnosed AML and 15 with ts-AML from prior MDS treatment. The median age was 55 years (range 21–65). In the untreated AML cohort, the CR or CRi rate was 83% (54/65). In comparison, ts-AML group has 27%, 74% in the untreated group, and 75% in the ts-AML group achieved undetectable measurable residual disease (MRD).

The results showed that in FLT3-ITD mutated AML patients treated with CLIA+sorafenib, the combined CR and CRi rate was 95%, and 81% were MRD-negative. Over a 76-month median follow-up, the 2-year and 4-year OS rates were 57% and 50%, in contrast to 20% and 13% for ts-AML. CLIA+sorafenib achieved 63% and 59% 2-year and 5-year OS. The most common Grade ≥3 adverse events were infection/fever, elevated bilirubin, rash, and nausea. CLIA was effective and safe for newly diagnosed AML patients who were young and fit, though outcomes were less favorable for those with ts-AML. Sorafenib plus CLIA in FLT3-ITD AML led to high rates of durable remission and long-term survival.

They concluded sorafenib plus CLIA in FLT3-ITD AML led to durable remission and long-term survival.

Source: onlinelibrary.wiley.com/doi/10.1002/ajh.27054