Meta-Analysis of CAG (cytarabine, aclarubicin, G-CSF) Regimen for the Treatment of 580 Patients with Acute Leukemia In China and Japan.

Current therapy is still unsatisfactory in patients with high-risk AML (elderly, relapsed, refractory, and secondary). A CAG regimen has been commonly used in China and Japan for the treatment of this type of patients (pts). The CAG regimen consists of low-dose cytarabine 10 mg/m² q12 SQ on d1–14, aclarubicin 7 mg/m², QD on d1–8, or 14 mg/m², QD on d1–4, and G-CSF 200 μg/m², QD on d1–14. The aim of this study is to summarize the data and to analyze the efficacy as well as the toxic effects of CAG regimen in acute leukemia (AL) patients.

A meta-analysis of 15 trials with a total of 580 AL pts was performed to summarize and analyze the efficacy of CAG regimen as well as the toxic effects. The literature search was conducted in PubMed, Google Scholar, and Medline, as well as ASH and ASCO meeting abstracts.

Among the 580 pts treated with CAG, 456 pts were AML, 100 pts were MDS/tAML,19 pts were ALL, 5 pts were BAL. 163 pts were newly diagnosed AML, 141/75 pts were relapsed/refractory (R/R). The CR rates of CAG in newly-diagnosed, relapsed, refractory, elderly AML patients were 63.9% (49%-67.6%), 83% (40%-86%), 30.4 (12.5%-48.4%), and 53.5% (31.5%-67%), respectively. The median OS in new, relapsed, elderly AML patients were 14.5m (9m-17m), 16m (15m-17m), and 8m (7m-9m), respectively. Data available from 4 trials which studied the efficacy of CAG in MDS/tAML patients showed that CR rate was 40.5% (38.5%-46.4%). There were only two small studies of CAG in ALL and in BAL that showed ORR of 100%. The toxicity of CAG in all reports were mild and the CAG regimen were well tolerated.

This low-intensity CAG regimen appears to be very well tolerated with clear activity in high-risk AL pts. Randomized study may be warranted.

No relevant conflicts of interest to declare.