title: Intensive short term therapy with granulocyte-macrophage-colony stimulating factor support, similar to therapy for acute myeloblastic leukemia, does not improve overall results for adults with acute lymphoblastic leukemia. GOELAMS Group.
abstract: BACKGROUND
  Despite modern treatment programs, less than 20% of adult cases of acute lymphoblastic leukemia (ALL) are cured. For relapsing and/or refractory patients, use of high dose cytosine arabinoside (ara-C) and anthracyclin achieved a complete remission (CR) rate of up to a 75%. The aim of this study was to evaluate in adult patients with ALL 1) the CR rate of a chemotherapy schedule similar to a schedule for acute myeloblastic leukemia (AML) patients, 2) the antileukemic value and the tolerance of 3 intensive stage treatments, and 3) the impact of recombinant granulocyte-macrophage-colony stimulating factor (rGM-CSF) on chemotherapy-induced neutropenia and infectious complications, as well as the effect of dose intensity.
  
  
  METHODS
  Between November 1990 and April 1992, 67 patients ages 15-55 years with de novo ALL were randomly assigned to receive either rGM-CSF or placebo. The induction treatment consisted of idarubicin, methylprednisolone, and high dose ara-C. After achieving CR, patients up to age 45 years who had an HLA-identical sibling were assigned to undergo allogeneic bone marrow transplantation (BMT). All remaining patients received a first course of early intensification with high dose ara-C, mitoxantrone, etoposide, and methylprednisolone, followed by autologous, unpurged BMT.
  
  
  RESULTS
  Of the 64 eligible patients, 50 (78%) achieved CR. Sixteen allogeneic and 18 autologous BMTs were performed. The median survival was 10.2 months. The 4-year survival was 24%. rGM-CSF only improved the incidence of severe mucositis during the induction course (P = 0.003) and probably also improved the median duration of fever (P = 0.07).
  
  
  CONCLUSIONS
  This schedule, similar to that for the treatment of AML patients, with early BMT included, did not prove to be a satisfactory approach to the treatment of most adult ALL patients, although CR was achieved in 78% of cases. In this study, no major improvement was obtained with rGM-CSF therapy.
authors.affiliation: Service de Médecine D, CHU, Angers, France.
authors.forename: N
authors.initials: N
authors.lastname: Ifrah
authors.forename: F
authors.initials: F
authors.lastname: Witz
authors.forename: J P
authors.initials: JP
authors.lastname: Jouet
authors.forename: S
authors.initials: S
authors.lastname: François
authors.forename: T
authors.initials: T
authors.lastname: Lamy
authors.forename: C
authors.initials: C
authors.lastname: Linassier
authors.forename: B
authors.initials: B
authors.lastname: Pignon
authors.forename: C
authors.initials: C
authors.lastname: Berthou
authors.forename: D
authors.initials: D
authors.lastname: Guyotat
authors.forename: J Y
authors.initials: JY
authors.lastname: Cahn
authors.forename: J L
authors.initials: JL
authors.lastname: Harousseau
mesh_terms: D000293:Adolescent; D000328:Adult; D016026:Bone Marrow Transplantation; D003131:Combined Modality Therapy; D005260:Female; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000627:therapeutic use*; D006801:Humans; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy* / Q000401:mortality / Q000628:therapy; D008297:Male; D008875:Middle Aged; D054198:Precursor Cell Lymphoblastic Leukemia-Lymphoma / Q000188:drug therapy* / Q000401:mortality / Q000628:therapy; D011994:Recombinant Proteins; D012074:Remission Induction; D016019:Survival Analysis; D015996:Survival Rate; D013997:Time Factors; D014182:Transplantation, Autologous; D014184:Transplantation, Homologous; D016896:Treatment Outcome
chemical_list: D011994:Recombinant Proteins; D016178:Granulocyte-Macrophage Colony-Stimulating Factor