[Efficacy and safety analysis of the combination of cladribine, cytarabine, granulocyte colonystimulating factor (CLAG) regime in patients with refractory or relapsed acute myeloid leukemia].
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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.