title: Intensive chemotherapy with idarubicin, ara-C, etoposide, and m-AMSA followed by immunotherapy with interleukin-2 for myelodysplastic syndromes and high-risk Acute Myeloid Leukemia (AML).
abstract: Intensive chemotherapy followed by treatment with interleukin-2 (IL-2) was evaluated in a prospective, randomized, multicenter trial including 18 patients with refractory anemia with excess of blasts in transformation (RAEB-T), 86 patients with acute myeloid leukemia (AML) evolving from myelodysplastic syndromes, and six patients with secondary AML after previous chemotherapy. Median age was 58 years (range: 18-76 years). Forty-nine patients (45%) achieved a complete remission (CR) after two induction cycles with idarubicin, ara-C, and etoposide, 52% of them aged </=60 years and 35% aged >60 years (p=0.06). After two consolidation courses, patients were randomized to four cycles of either high- or low-dose IL-2. Patients aged up to 55 years with an HLA-identical sibling donor were eligible for allogeneic bone marrow transplantation. The median relapse-free survival was 12.5 months, with a probability of ongoing CR at 6.5 years of 19%. Overall survival of all patients was 8 months, and 21 months for the CR patients. Median survival was significantly longer among patients aged </=60 years than among the older patients (16 vs 6 months, p<0.001). Median duration of survival and relapse-free survival were not statistically different in the two IL-2 treatment arms.
authors.affiliation: Medizinische Klinik III, Klinikum der Universität Frankfurt, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Ganser
authors.forename: G
authors.initials: G
authors.lastname: Heil
authors.forename: G
authors.initials: G
authors.lastname: Seipelt
authors.forename: W
authors.initials: W
authors.lastname: Hofmann
authors.forename: J T
authors.initials: JT
authors.lastname: Fischer
authors.forename: W
authors.initials: W
authors.lastname: Langer
authors.forename: W
authors.initials: W
authors.lastname: Brockhaus
authors.forename: K
authors.initials: K
authors.lastname: Kolbe
authors.forename: T H
authors.initials: TH
authors.lastname: Ittel
authors.forename: N
authors.initials: N
authors.lastname: Brack
authors.forename: H G
authors.initials: HG
authors.lastname: Fuhr
authors.forename: P
authors.initials: P
authors.lastname: Knuth
authors.forename: K
authors.initials: K
authors.lastname: Höffken
authors.forename: L
authors.initials: L
authors.lastname: Bergmann
authors.forename: D
authors.initials: D
authors.lastname: Hoelzer
mesh_terms: D000208:Acute Disease; D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D003561:Cytarabine / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D005047:Etoposide / Q000008:administration & dosage; D005260:Female; D006801:Humans; D015255:Idarubicin / Q000008:administration & dosage; D007167:Immunotherapy; D007376:Interleukin-2 / Q000627:therapeutic use*; D007951:Leukemia, Myeloid / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009190:Myelodysplastic Syndromes / Q000188:drug therapy* / Q000628:therapy*; D011446:Prospective Studies; D015996:Survival Rate
chemical_list: D007376:Interleukin-2; D003561:Cytarabine; D005047:Etoposide; D015255:Idarubicin