title: Interleukin-2 after autologous stem-cell transplantation for adult patients with acute myeloid leukemia in first complete remission.
abstract: OBJECTIVE
  To determine the disease-free survival (DFS) and toxicity of administering interleukin-2 (IL-2) immunotherapy early after autologous stem-cell transplantation (ASCT) to simulate a graft versus leukemia effect observed in allogeneic transplantation.
  
  
  METHODS
  Fifty-six patients with acute myeloid leukemia in first remission received a single consolidation of high-dose cytarabine-idarubicin at a median of 1.1 month postremission with the intent to proceed to ASCT and IL-2 9 x 10(6) U/m(2)/24 h for 4 days, followed by 10 days of IL-2 1.6 x 10(6) U/m(2)/24 h on hematologic recovery.
  
  
  RESULTS
  Eighty-four percent of patients received the intended ASCT, and 68% of patients received IL-2 treatment. With a median follow-up of 39.4 months (range, 1.2 to 76.3 months), the 2-year cumulative probability of DFS for all 56 patients is 68% (95% confidence interval [CI], 55% to 80%) and 74% (95% CI, 57% to 85%) for the 39 patients undergoing IL-2 treatment after ASCT. The 2-year cumulative probability of DFS for favorable, intermediate, and unfavorable cytogenetics is 88% (95% CI, 59% to 97%), 48% (95% CI, 26% to 67%), and 70% (95% CI, 23% to 93%), respectively. Toxicities from IL-2 were mainly thrombocytopenia, leukopenia, fever, and fluid retention. Two septic deaths occurred during neutropenia, which includes one during consolidation and one during transplant, for an overall 4% mortality rate.
  
  
  CONCLUSIONS
  These results suggest that a moderate dose of IL-2 after high-dose cytarabine-idarubicin-mobilized ASCT is associated with a low regimen-related toxicity and may improve DFS. A phase III study of IL-2 is now warranted.
authors.affiliation: Division of Hematology and Bone Marrow Transplantation, City of Hope National Medical Center, 1500 East Duarte Road, Duarte, CA 91010, USA. astein@coh.org
authors.forename: Anthony S
authors.initials: AS
authors.lastname: Stein
authors.forename: Margaret R
authors.initials: MR
authors.lastname: O'Donnell
authors.forename: Marilyn L
authors.initials: ML
authors.lastname: Slovak
authors.forename: David S
authors.initials: DS
authors.lastname: Snyder
authors.forename: Auayporn P
authors.initials: AP
authors.lastname: Nademanee
authors.forename: Pablo
authors.initials: P
authors.lastname: Parker
authors.forename: Arturo
authors.initials: A
authors.lastname: Molina
authors.forename: George
authors.initials: G
authors.lastname: Somlo
authors.forename: Henry C
authors.initials: HC
authors.lastname: Fung
authors.forename: Amrita
authors.initials: A
authors.lastname: Krishnan
authors.forename: Roberto
authors.initials: R
authors.lastname: Rodriguez
authors.forename: Ricardo T
authors.initials: RT
authors.lastname: Spielberger
authors.forename: Shirong
authors.initials: S
authors.lastname: Wang
authors.forename: Andrew
authors.initials: A
authors.lastname: Dagis
authors.forename: Nayana
authors.initials: N
authors.lastname: Vora
authors.forename: Daniel A
authors.initials: DA
authors.lastname: Arber
authors.forename: Joyce C
authors.initials: JC
authors.lastname: Niland
authors.forename: Stephen J
authors.initials: SJ
authors.lastname: Forman
mesh_terms: D000328:Adult; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016001:Confidence Intervals; D003561:Cytarabine / Q000008:administration & dosage; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D015255:Idarubicin / Q000008:administration & dosage; D007376:Interleukin-2 / Q000009:adverse effects / Q000627:therapeutic use*; D007951:Leukemia, Myeloid / Q000188:drug therapy* / Q000628:therapy; D008297:Male; D008875:Middle Aged; D033581:Stem Cell Transplantation
chemical_list: D000970:Antineoplastic Agents; D007376:Interleukin-2; D003561:Cytarabine; D015255:Idarubicin