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

BACKGROUND. Despite modern treatment programs, less than 20% of adult cases of acute lymphoblastic leukemia (ALL) are cured. For relapsing and/or refr actory patients, use of high dose cytosine arabinoside (ara-C) and anthracy clin achieved a complete remission (CR) rate of up to a 75%. The aim of thi s study was to evaluate in adult patients with ALL 1) the CR rate of a chem otherapy schedule similar to a schedule for acute myeloblastic leukemia (AM L) patients, 2) the antileukemic value and the tolerance of 3 intensive sta ge treatments, and 3) the impact of recombinant granulocyte-macrophage-colo ny stimulating factor (rGM-CSF) on chemotherapy-induced neutropenia and inf ectious 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 place bo. The induction treatment consisted of idarubicin, methylprednisolone, an d 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 tr ansplantation (BMT). All remaining patients received a first course of earl y intensification with high dose ara-C, mitoxantrone, etaposide, and methyl prednisolone, followed by autologous, unpurged BMT. RESULTS. Of the 64 eligible patients, 50 (78%) achieved CR. Sixteen allogen eic and 18 autologous BMTs were performed. The median survival was 10.2 mon ths. The 4-year survival was 24%. rGM-CSF only improved the incidence of se vere mucositis during the induction course (P = 0.003) and probably also im proved the median duration of fever (P = 0.07). CONCLUSIONS. This schedule, similar to that for the treatment of AML patien ts, 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 the rapy. (C) 1999 American Cancer Society.