title: [Efficacy and safety analysis of the combination of cladribine, cytarabine, granulocyte colonystimulating factor (CLAG) regime in patients with refractory or relapsed acute myeloid leukemia].
abstract: 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.
authors.affiliation: Department of Hematology, PUMC Hospital, CAMS & PUMC, Beijing 100730, China.
authors.forename: M H
authors.initials: MH
authors.lastname: Duan
authors.forename: Y
authors.initials: Y
authors.lastname: Zhang
authors.forename: M
authors.initials: M
authors.lastname: Zhang
authors.forename: X
authors.initials: X
authors.lastname: Han
authors.forename: Y
authors.initials: Y
authors.lastname: Zhang
authors.forename: C
authors.initials: C
authors.lastname: Yang
authors.forename: J
authors.initials: J
authors.lastname: Feng
authors.forename: L
authors.initials: L
authors.lastname: Zhang
authors.forename: W
authors.initials: W
authors.lastname: Zhang
authors.forename: J
authors.initials: J
authors.lastname: Li
authors.forename: L P
authors.initials: LP
authors.lastname: Tian
authors.forename: Y
authors.initials: Y
authors.lastname: Zhang
authors.affiliation: Department of Hematology, PUMC Hospital, CAMS & PUMC, Beijing 100730, China.
authors.forename: D B
authors.initials: DB
authors.lastname: Zhou
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D017338:Cladribine / Q000627:therapeutic use; D003561:Cytarabine / Q000627:therapeutic use; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy* / Q000628:therapy; D008297:Male; D008875:Middle Aged; D009503:Neutropenia; D012008:Recurrence; D012189:Retrospective Studies; D055815:Young Adult
chemical_list: D003561:Cytarabine; D016179:Granulocyte Colony-Stimulating Factor; D017338:Cladribine