Clinical research of arabinoside cytosine and aclarubicin combined with granulocyte colony stimulating factor in treatment of myelodysplastic syndrome

Abstract

Objective To investigate the efficacy and safety of arabinoside cytosine (Ara-c) and aclarubicin (Acla) combined with granulocyte colony stimulating factor (G-CSF) in treatment of myelodysplastic syndrome (MDS). Methods From January 2011 to January 2013, a total of 56 cases of newly diagnosed MDS patients from the Fourth People's Hospital of Shenzhen were randomly divided into study group (n=28) and control group (n=28). Study group were given Ara-c, Acla and G-CSF treatment and control group were given standardized chemotherapy treatment. The clinical efficacy, peripheral blood and percentage of bone marrow blast cells, adverse reactions, maintenance therapy and survival of two groups were compared. Informed consent was obtained from all participants in the study. There were no significant differences between two groups among age, gender, course of disease, type of disease, International Prognostic Scoring System (IPSS) typing, platelet count, hemoglobin (Hb) level, neutrophil (Neut) count and percentage of bone marrow blast cells (P>0.05). Results ① The complete remission (CR) rate of study group was 50.0% (14/28), which was significantly higher than that of control group (32.1%, 9/28), and the difference was statistically significant (P 0.05), while platelet count, Hb level and Neut count in control group all increased compared with before treatment, and the percentage of bone marrow blast cells decreased, all the differences were statistically significant (P<0.05). ③ The rate of Ⅲ ~ Ⅳ grade bone marrow suppression, lung infections, mouth ulcers and gastrointestinal side effects in study group were significantly lower than those in control group, and the differences were statistically significant (χ2=12.847, 17.044, 7.212, 14.684; P<0.05). ④ Acute myelocytic leukemia (AML) transformation rate of study group was significantly lower than that of control group (14.3% vs 25.0%, P<0.05). The median overall survival time of study group was significantly longer than that of the control group (22.0 months vs 18.2 months, P<0.05). Conclusions Ara-c and Acla combined with G-CSF therapeutic regimen for MDS has significant treatment efficiency and fewer adverse reactions. As the sample size of this study is small, whether it is a safe and reliable treatment options and worthy of clinical application, it still needs more multi-center, large randomized controlled trials to confirm. Key words: Myelodysplastic syndromes; Granulocyte colony-stimulating factor; Aclarubicin; Cytarabine; Drug therapy, combination