地西他滨单药及联合半程和全程CAG方案治疗骨髓增生异常综合征和急性髓系白血病疗效观察

The clinical efficacy of the patients of acute myeloid leukemia and myelodysplastic syndromes treated with decitabine alone, combined with half or one couse of CAG regimen

目的 比较单药地西他滨方案、地西他滨联合半程CAG方案[G-CSF、阿糖胞苷（Ara-C）、阿克拉霉素]及地西他滨联合全程CAG方案治疗骨髓增生异常综合征或急性髓系白血病（MDS/AML）患者的临床疗效及安全性.方法 回顾性分析30例接受单药地西他滨5d方案、23例接受地西他滨联合半程CAG方案、26例接受地西他滨联合全程CAG方案治疗的MDS/AML患者的临床资料,分别比较三组患者的总反应率（ORR）、总生存（OS）率及不良反应发生率.结果 单药地西他滨组、地西他滨联合半程CAG组及地西他滨联合全程CAG组的ORR分别为53.3％、56.5％和69.2％,三组比较差异无统计学意义（P＞0.05）.截至2014年4月1日,20例存活,45例死亡,14例失访,中位随访时间9（1～62）个月.79例患者5年累积生存率为25.3％,三组2年OS率分别为34.8％、24.8％和29.2％,三组比较差异无统计学意义（P＞0.05）.应用地西他滨后的主要不良反应为骨髓抑制所致的感染和出血,72例患者发生3～4级血液学不良反应,平均粒细胞缺乏时间14.8 d.59例患者发生感染并发症,其中3～4级感染14例,1～2级感染45例.三组患者在应用地西他滨后,感染发生率、出血发生率、平均粒细胞缺乏时间、平均红细胞输注量、平均血小板输注量差异均无统计学意义（P＞0.05）.经抗感染及支持治疗后,79例患者均安全度过骨髓抑制期,无一例发生治疗相关死亡.结论 地西他滨单药、联合半程及全程CAG方案治疗MDS/AML均有较好的疗效,其中联合全程CAG方案诱导治疗有效率相对较高.三组患者治疗耐受性均良好.

Objective To observe the clinical safety and efficacy of decitabine in patients of acute myeloid leukemia and myelodysplastic syndromes （MDS/AML）.Methods Totally 79 patients with MDS/AML were divided into three groups：①Treated with decitabine alone （20 mg/m2 for 5 days）.② Combination of decitabine with half dose CAG chemotherapy （Acla 20 mg qod × 3 d,Ara-C 10 mg/m2 q12 h×7 d,G-CSF 300 μg/d,the dose of G-CSF adjust to the amount of blood routine）.③Combination of decitabine with CAG chemotherapy （Acla 20 mg qod×4 d,Ara-C 10 mg/m2 q12 h× 14 d,G-CSF 300 μg/d,the dose of G-CSF adjust to the amount of blood routine）.We observed complete remission （CR） rate,overall response rate （ORR） and overall survival （OS） of the three groups; meanwhile,we analyzed the factors relevant to decitabine efficacy and the prognosis.Results ORR in the three groups were 53.3％,56.5％ and 69.2％ respectively,with no statistically significant differences （P＞0.05）.Due to the last follow-up at 2014.04.01,20 patients still survived,45 died,14 were lost to follow-up.The 5-year cumulative survival rate of 79 patients was 25.3％,the 2-year survival were of the three groups were 34.8％,24.8 and 29.2％ respectively with no statistically significant differences （P＞0.05）.Adverse events of infection and bleeding were mainly caused by decitabine.Grade 3 to 4 hematological toxicities were observed in 72 cases with the average time for the lack of granulocytes as 14.8 days.59 patients experienced infectious events,including grade 3 or 4 infections in 14 cases,grade 1 or 2 infections in 45 cases.There were no statistically significant differences （P＞0.05） among the three groups in terms of infection rates,bleeding rates,duration of neutrophenia,mean MAP transfusion and mean platelet transfusion.79 patients were safely through bone marrow suppression by anti-infective and supportive treatment without treatment-related deaths.Conclusions Treating MDS/AML with decitabine alone,in combination with half or one course CAG regimen produced high efficacy.ORR of the combination of decitabine with one course CAG regimen was relatively higher.Three groups of patients were all well tolerated.