Objective: To analyze efficacy and safety of CLAG regimen in patients with refractory or relapsed acute myeloid leukemia (AML).
Methods: Efficacy and adverse events of patients with refractory or relapsed AML who were treated with one course of CLAG from April 1st, 2014 through December 9th, 2015 in our hospital were retrospectively reviewed.
Results: Thirty- three patients (16 males and 17 females) with refractory or relapsed AML were treated with one course of CLAG with a median age of 49 (14-68) years. According to FAB subtype, there were 22 patients with M2, and 11 with other types. According to NCCN criteria, there were 6, 18 and 9 patients with favorable, intermediate and unfavorable risk respectively, including 5 with FLT3- ITD mutation. Of 16 refractory and 17 relapsed patients; the median previous chemotherapy courses were 2(1-36). After one course of CLAG, 78.8% (26/33) patients achieved hematological complete response (CR), with 93.8 %(15/16) in relapsed and 64.7 %(11/17) in refractory groups respectively. All five patients with FLT3- ITD mutation achieved CR. All patients had grade 4 neutropenia and thrombocytopenia and infection in different sites; three patients died early from infections. Five patients received allogeneic hematopoietic stem cell transplantation (allo- HSCT). Ten patients relapsed and thirteen patients died after the median follow-up 142(9-525) days. The median EFS and OS were 230 (9- 525) and 419(9- 525) days respectively, which in CR group (n=26) were significantly longer than those in NR one (n=7) [447 (165- 525) d vs 52 (9- 162) d,P <0.001].
Conclusions: CLAG regimen was effective and well tolerable in patients with refractory or relapsed AML, with the CR rate in relapsed patients higher than in refractory counterparts. Control of infections was imperative for treatment.
目的: 分析CLAG方案（克拉屈滨＋阿糖胞苷+ G-CSF）对难治复发急性髓系白血病（AML）的疗效及安全性。
方法: 回顾性分析2014年4月1日至2015年12月9日采用1个疗程CLAG方案治疗的33例难治复发AML患者的临床资料。
结果: 33例难治复发AML患者中，男16例，女17例，中位年龄49(14~68）岁。按照WHO分类（第4版）诊断：伴有重现性遗传学异常AML 7例（21.2%），伴有多系病态造血AML 5例（15.2%），治疗相关AML 2例（6.1%），其他类型19例（57.5%）。NCCN危险分层低危、中危、高危组分别为6、18、9例，其中FLT3-ITD基因突变5例。复发16例，难治17例，既往化疗疗程中位数为2(1~36）个。经CLAG方案1个疗程化疗后，26例（78.8%）获得完全缓解（CR），难治组CR率低于复发组[64.7%（11/17）对93.8%（15/16），P=0.041]。5例FLT3-ITD基因突变患者均获CR。所有患者均出现4级白细胞减少和血小板减少和不同部位感染，3例因感染而早期死亡。5例患者CR后接受异基因造血干细胞移植。中位随访142(9~525) d，复发10例，死亡13例，中位无事件生存期为230(9~525）d，中位总生存期为419(9~525) d。获CR患者（26例）中位总生存期长于未缓解患者（7例）[447(165~525) d对52(9~162) d，P <0.001]。
结论: CLAG方案对难治复发AML疗效肯定，复发患者CR率高于难治患者。控制感染是治疗成功的关键。