title: Dexamethasone compared to prednisolone for adults with acute lymphoblastic leukemia or lymphoblastic lymphoma: final results of the ALL-4 randomized, phase III trial of the EORTC Leukemia Group.
abstract: BACKGROUND
  Corticosteroids are a standard component of the treatment of acute lymphoblastic leukemia and lymphoblastic lymphoma. Our aim was to determine whether dexamethasone results in a better outcome than prednisolone.
  
  
  METHODS
  Adult patients with acute lymphoblastic leukemia or lymphoblastic lymphoma were randomized to receive, as part of their induction therapy on days 1-8 and 15-22, either dexamethasone 8 mg/m(2) or prednisolone 60 mg/m(2). Those who reached complete remission were given two courses of consolidation therapy with high-dose cytarabine and mitoxantrone and methotrexate and asparaginase. Subsequently patients younger than 50 years, with a suitable donor, were to undergo allogeneic stem cell transplantation, whereas the others were planned to receive either an autologous stem cell transplant or high-dose maintenance chemotherapy with prophylactic central nervous system irradiation. Randomization was done with a minimization technique. The primary endpoint was event-free survival and the analyses was conducted on an intention-to-treat basis.
  
  
  RESULTS
  Between August 1995 and October 2003, 325 patients between 15 to 72 years of age were randomized to receive either dexamethasone (163 patients) or prednisolone (162 patients). After induction and the course of first consolidation therapy, 131 (80.4%) patients in the dexamethasone group and 124 (76.5%) in the prednisolone group achieved complete remission. No significant difference was observed between the two treatment groups with regards to 6-year event-free survival rates (+/-SE) which were 25.9% (3.6%) and 28.7% (3.5%) in the dexamethasone and prednisolone groups, respectively (P=0.82, hazard ratio 0.97; 95% confidence interval, 0.75-1.25). Disease-free survival after complete remission was also similar in the dexamethasone and prednisolone groups, the 6-year rates being 32.3% and 37.5%, respectively (hazard ratio 1.03; 95% confidence interval 0.76-1.40). The 6-year cumulative incidences of relapse were 49.8% and 53.5% (Gray's test: P=0.30) while the 6-year cumulative incidences of death were 18% and 9% (Gray's test: P=0.07).
  
  
  CONCLUSIONS
  In the ALL-4 trial in adult patients with acute lymphoblastic leukemia or lymphoblastic lymphoma, treatment with dexamethasone did not show any advantage over treatment with prednisolone.
authors.affiliation: Department of Hematology University Hospital Center Rebro, Kispatic street 12 1000 Zagreb, Croatia. boris.labar@inet.hr
authors.forename: Boris
authors.initials: B
authors.lastname: Labar
authors.forename: Stefan
authors.initials: S
authors.lastname: Suciu
authors.forename: Roel
authors.initials: R
authors.lastname: Willemze
authors.forename: Petra
authors.initials: P
authors.lastname: Muus
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Marie
authors.forename: Georges
authors.initials: G
authors.lastname: Fillet
authors.forename: Zwi
authors.initials: Z
authors.lastname: Berneman
authors.forename: Branimir
authors.initials: B
authors.lastname: Jaksic
authors.forename: Walter
authors.initials: W
authors.lastname: Feremans
authors.forename: Dominique
authors.initials: D
authors.lastname: Bron
authors.forename: Harm
authors.initials: H
authors.lastname: Sinnige
authors.forename: Martin
authors.initials: M
authors.lastname: Mistrik
authors.forename: Gerard
authors.initials: G
authors.lastname: Vreugdenhil
authors.forename: Robrecht
authors.initials: R
authors.lastname: De Bock
authors.forename: Damir
authors.initials: D
authors.lastname: Nemet
authors.forename: Caroline
authors.initials: C
authors.lastname: Gilotay
authors.forename: Sergio
authors.initials: S
authors.lastname: Amadori
authors.forename: Theo
authors.initials: T
authors.lastname: de Witte
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D018931:Antineoplastic Agents, Hormonal; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D003131:Combined Modality Therapy; D003907:Dexamethasone / Q000008:administration & dosage*; D018572:Disease-Free Survival; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation / Q000379:methods; D006801:Humans; D008297:Male; D008875:Middle Aged; D054198:Precursor Cell Lymphoblastic Leukemia-Lymphoma / Q000188:drug therapy; D011239:Prednisolone / Q000008:administration & dosage*; D012074:Remission Induction; D055815:Young Adult
chemical_list: D018931:Antineoplastic Agents, Hormonal; D003907:Dexamethasone; D011239:Prednisolone