地西他滨单药与CAG/HAG方案治疗难治性贫血伴有原始细胞增多的疗效和安全性比较

OBJECTIVE: To observe the clinical efficacy and safety of the patients of myelodysplastic syndromes-refractory anemia with excess blasts (MDS-REAB) treated with decitabine alone or based on low dose cytarabine (Ara-C) regimen CAG/HAG [aclarubrci (ACR) /homoharring-tonine (HHT) +cytarabine+granulocyte colony stimulating factor (G-CSF)]. METHODS: Totally 121 patients with MDS-REAB were retrospectively analyzed, including 59 patients treated with decitabine alone (20 mg·m(−2)·d(−1) for 5 days), the rest 62 ones treated with low-dose Ara-C-based regimen CAG/HAG. Overall response rate (ORR), overall survival (OS) and adverse events of the two groups were analyzed and compared retrospectively. RESULTS: The ORR of decitabine alone or CAG/HAG were 66.2% and 56.4% respectively, with no statistically significant differences (χ(2)=1.185, P=0.276). Initial response rate detected by the end of first cycle of CAG/HAG was higher than that of decitabine alone (94.3% vs 69.2%), there was statistically significant difference in the overall comparison of two groups (χ(2)=7.612, P=0.009). The median OS of decitabine alone was 19.5 (95% CI 10.5–28.4) months, the median OS of CAG/HAG was 20.3 (95% CI 10.7–29.9) months, with no statistically significant differences (χ(2)=0.004, P=0.947). Grade 3–4 cytopenia and infection were the most prevalent adverses of two group patients. Grade 3–4 cytopenia rate of CAG/HAG was higher than that of decitabine alone (100.0% vs 64.4%, P<0.001). The infection rate detected at third cycle of CAG/HAG was higher than that of decitabine alone (52.9% vs 15.2%, P=0.008). CONCLUSION: The efficacy of treating MDS-RAEB with decitabine alone or CAG/HAG was equivalent. CAG/HAG treatment came into effect faster, but decitabine alone treatment was safer.