title: Interferon-alpha-2C and LD ara-C for the treatment of patients with CML: results of the Austrian multi-center phase II study.
abstract: Small pilot studies of patients with CML have reported on encouraging response rates after treatment with interferon-alpha (IFNalpha) in combination with low-dose cytosine arabinoside (LD ara-C). We therefore initiated a multi-center phase II trial in order to investigate the efficacy and tolerability of this combination in newly diagnosed patients with Ph-positive chronic myelogenous leukemia (CML). Eighty-four patients were treated with IFN-alpha-2c at daily subcutaneous doses of 3.5 MU and LD ara-C added subcutaneously for 10 days every month at a dose of 10 mg/m2, following an initial reduction of WBC to less than 20 x 10(9)/l with hydroxyurea (HU). Within a median observation period of 28 (5-59) months the patients received a median of 7 (1-35) IFNalpha and LD ara-C cycles. Treatment was stopped due to side effects in 16 cases (19%) and to primary or secondary treatment failure in 38 cases (45%). In 45 patients (54%) complete hematological response (CHR) was achieved; in 39 patients (46%) cytogenetic responses including 15 (18%) complete cytogenetic responses (CHR) were observed. Median duration of cytogenetic responses was 15 months. Relapses were seen in 8/15 patients (53%) with complete cytogenetic remission (CCR), in 3/6 patients (50%) with partial cytogenetic response and in 9/18 patients (50%) with minor cytogenetic response. In conclusion, the combination of IFNalpha and LD ara-C resulted in encouraging rates of hematological and cytogenetic responses in patients with CML with low to moderate toxicity.
authors.affiliation: Department of Internal Medicine, University Hospital, Innsbruck, Austria.
authors.forename: J
authors.initials: J
authors.lastname: Thaler
authors.forename: W
authors.initials: W
authors.lastname: Hilbe
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: Sill
authors.forename: H
authors.initials: H
authors.lastname: Seewann
authors.forename: J
authors.initials: J
authors.lastname: Pont
authors.forename: M
authors.initials: M
authors.lastname: Bernhart
authors.forename: M
authors.initials: M
authors.lastname: Stöger
authors.forename: H
authors.initials: H
authors.lastname: Niessner
authors.forename: K
authors.initials: K
authors.lastname: Abbrederis
authors.forename: D
authors.initials: D
authors.lastname: Geissler
authors.forename: H
authors.initials: H
authors.lastname: Hausmaninger
authors.forename: W
authors.initials: W
authors.lastname: Lin
authors.forename: H
authors.initials: H
authors.lastname: Ludwig
authors.forename: A
authors.initials: A
authors.lastname: Lang
authors.forename: C
authors.initials: C
authors.lastname: Duba
authors.forename: T
authors.initials: T
authors.lastname: Fluckinger
authors.forename: R
authors.initials: R
authors.lastname: Greil
authors.forename: K
authors.initials: K
authors.lastname: Grünewald
authors.forename: G
authors.initials: G
authors.lastname: Konwalinka
authors.forename: D
authors.initials: D
authors.lastname: Niederwieser
authors.forename: M
authors.initials: M
authors.lastname: Fridrik
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D003561:Cytarabine / Q000008:administration & dosage; D006801:Humans; D007370:Interferon Type I / Q000008:administration & dosage; D015464:Leukemia, Myelogenous, Chronic, BCR-ABL Positive / Q000188:drug therapy*; D008875:Middle Aged; D011446:Prospective Studies; D011994:Recombinant Proteins; D012074:Remission Induction
chemical_list: D007370:Interferon Type I; D011994:Recombinant Proteins; D003561:Cytarabine