title: A randomized study comparing interferon (IFN alpha) plus low-dose cytarabine and interferon plus hydroxyurea (HU) in early chronic-phase chronic myeloid leukemia (CML).
abstract: This multicenter randomized phase III study was designed to compare the efficacy and toxicity of IFN alpha-2c (3.5 MU/d) in combination with either araC (10 mg/m(2) d1-10) or hydroxyurea (HU: 25 mg/kg per day) in newly diagnosed CML patients. A total of 114 patients were randomized. Following a median observation period of 36 (range 1-73) months the major cytogenetic response rates were 25 and 27% and the 4-year survival probabilities 62.5 and 63% for the araC and HU group, respectively. While the overall toxicity profile was comparable between both groups, patients in the HU arm exhibited a slightly higher degree of WHO grades 3 and 4 non-hematological toxicities.
authors.affiliation: Department of Internal Medicine, General Hospital, Grieskirchnerstr. 42, A-4600 Wels, Austria. thomas.kuehr@khwels.at
authors.forename: T
authors.initials: T
authors.lastname: Kühr
authors.forename: S
authors.initials: S
authors.lastname: Burgstaller
authors.forename: U
authors.initials: U
authors.lastname: Apfelbeck
authors.forename: W
authors.initials: W
authors.lastname: Linkesch
authors.forename: H
authors.initials: H
authors.lastname: Seewann
authors.forename: M
authors.initials: M
authors.lastname: Fridrik
authors.forename: G
authors.initials: G
authors.lastname: Michlmayr
authors.forename: O
authors.initials: O
authors.lastname: Krieger
authors.forename: D
authors.initials: D
authors.lastname: Lutz
authors.forename: W
authors.initials: W
authors.lastname: Lin
authors.forename: J
authors.initials: J
authors.lastname: Pont
authors.forename: L
authors.initials: L
authors.lastname: Köck
authors.forename: K
authors.initials: K
authors.lastname: Abbrederis
authors.forename: C
authors.initials: C
authors.lastname: Baldinger
authors.forename: R
authors.initials: R
authors.lastname: Buder
authors.forename: D
authors.initials: D
authors.lastname: Geissler
authors.forename: H
authors.initials: H
authors.lastname: Hausmaninger
authors.forename: A
authors.initials: A
authors.lastname: Lang
authors.forename: A
authors.initials: A
authors.lastname: Zabernigg
authors.forename: C
authors.initials: C
authors.lastname: Duba
authors.forename: W
authors.initials: W
authors.lastname: Hilbe
authors.forename: W
authors.initials: W
authors.lastname: Eisterer
authors.forename: M
authors.initials: M
authors.lastname: Fiegl
authors.forename: R
authors.initials: R
authors.lastname: Greil
authors.forename: G
authors.initials: G
authors.lastname: Gastl
authors.forename: J
authors.initials: J
authors.lastname: Thaler
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D003561:Cytarabine / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006402:Hematologic Diseases / Q000139:chemically induced; D006801:Humans; D006918:Hydroxyurea / Q000008:administration & dosage / Q000009:adverse effects; D016898:Interferon-alpha / Q000008:administration & dosage / Q000009:adverse effects; D015466:Leukemia, Myeloid, Chronic-Phase / Q000188:drug therapy* / Q000401:mortality; D015993:Life Tables; D008297:Male; D008875:Middle Aged; D009422:Nervous System Diseases / Q000139:chemically induced; D011994:Recombinant Proteins; D016896:Treatment Outcome
chemical_list: D016898:Interferon-alpha; D011994:Recombinant Proteins; D003561:Cytarabine; C554129:interferon alfa-2c; D006918:Hydroxyurea