去甲氧柔红霉素联合预激方案治疗初发老年急性髓细胞白血病的疗效分析

An evaluation of therapeutic effect of idarubicin combined with CAG regimen on previously untreated elderly patients with acute myeloid leukemia

目的探讨去甲氧柔红霉素（IDA）联合预激方案（IDA＋CAG）治疗初发老年急性髓细胞白血病（AML）的疗效及不良反应。方法回顾性分析2002年1月至2011年1月本院收治的138例初发老年AML患者的临床资料，分为治疗组（68例）和对照组（70例）。治疗组采用IDA—CAG方案：IDA3mg／m2dl～2；粒细胞集落刺激因子（G—CSF）300雌d2、150p-gd3—14，阿克拉霉素10mg／dd3—5，阿糖胞苷15mg／m2、q12hd3～14；白细胞计数（WBC）〈1．0×109／L或骨髓增生极度减低时停药。对照组采用羟基脲加最佳支持治疗方案：羟基脲1．5gbid，WBC〈10．0×109／L停药，并给予血液制品、抗感染等支持治疗。观察两组患者疾病完全缓解（CR）、部分缓解（PR）、稳定（SD）、进展（PD）例数及总生存（0s）、无病生存（DFS）时间和不良反应。结果治疗组CR5例（7．3％），PR35例（51．5％），SDl7例（25．O％），PDI1例（16．2％），总有效率58．8％，疾病控制率83．8％；中位OS14个月，中位DFS12个月。对照组SD60例（85．7％），PD10例（14．3％），疾病控制率85．7％；中位OS6个月，中位DFS0个月。主要不良反应为感染、中性粒细胞下降、贫血和胃肠道反应，治疗组≥Ⅲ度呕吐5例（7．4％），≥III度血液学毒性27例（39．7％）；对照组≥Ⅲ度呕吐0（0），≥Ⅲ度血液学毒性12例（17．1％）。结论IDA联合CAG方案疗效好，药物副作用少，并发症相对较少，耐受性较好。明显提高患者OS及DFS。

Objective To evaluate the efficacy as well as adverse effects of idarubicin（IDA） combined with CAG regimen （IDA＋CAG） on previously untreated elderly patients with acute myeloid leukemia （AML）. Methods One hundred and thirty-eight previously untreated elderly patients with AML enrolled from January 2002 to January 2011 in our center were retrospectively analyzed, and then they were separated into two groups ： a treatment group （68 cases） and a control group （70 cases）. The treatment group was managed with IDA combined with CAG regimen ： IDA 3 mg/m2 dayl-2 ; granulocyte-colony stimulating factor （G-CSF） 300 txg day2, 150 txg day3-14 ; aclarubicin 10 mg/d day3-5 ; cytarabine 15 mg/m2, q12 h day3-14. The treatment would not be ceased until the white blood cell count （WBC）〈1.0~ 109/L or bone marrow extremely hypoplastic. The control group was managed with hydroxyurea and best supportive care ： hydroxyurea 1.5 g bid and ceased when WBC〈 10.0 ~ 109/L, meanwhile, supportive care such as transfusion and anti-infection therapy was given when necessary. The following parameters in both groups ： complete remission （CR）, partial remission （PR）, stable disease （SD）, progressive disease （PD）, overall survival （OS）, disease-free survival （DFS） and adverse events were documented and analyzed. Results In treatment group, there were CR 5 cases （7.3%）, PR 35 cases （51.5%）, SD 17 （25.0%）, PD 11 （16.2%）, overall responding rate （CR＋PR） 58.8%, disease control rate 83.8%, median OS 14 months and median DFS 12 months. In control group, there were SD 60 cases （85.7%）, PD 10 cases （14.3%）, disease control rate 85.7%, median OS 6 months and median DFS 0 months. The main adverse events included infection, neutropenia, anemia and gastroenteric symptoms. In treatment group, there were 5 cases （7.4%） with I〉 ]I[ degree vomiting and 27 cases （39.7%） with 〉/Ill degree hematological toxicity. In control group, there were no patient （0）with I〉 Ⅱ degree vomiting,12 cases （17.1%） with I〉 III degree hematological toxicity. Conclusion The therapeutic effect of IDA combined with CAG regimen is good, well tolerated with less adverse events and can significantly elevate the OS and DFS of elderly patients with AML previously untreated.