A randomized study comparing interferon (IFNα) plus low-dose cytarabine and interferon plus hydroxyurea (HU) in early chronic-phase chronic myeloid leukemia (CML)

This multicenter randomized phase III study was designed to compare the efficacy and toxicity of IFNα-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 obs...

Full description

Saved in:
Bibliographic Details
Published in:Leukemia research 2003-05, Vol.27 (5), p.405-411
Main Authors: Kühr, T., Burgstaller, S., Apfelbeck, U., Linkesch, W., Seewann, H., Fridrik, M., Michlmayr, G., Krieger, O., Lutz, D., Lin, W., Pont, J., Köck, L., Abbrederis, K., Baldinger, C., Buder, R., Geissler, D., Hausmaninger, H., Lang, A., Zabernigg, A., Duba, C., Hilbe, W., Eisterer, W., Fiegl, M., Greil, R., Gastl, G., Thaler, J.
Format: Article
Language:English
Subjects:
Adult
Aged
Antineoplastic agents
Antineoplastic Combined Chemotherapy Protocols - adverse effects
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Biological and medical sciences
Chemotherapy
CML
Cytarabine
Cytarabine - administration & dosage
Cytarabine - adverse effects
Female
Gastrointestinal Diseases - chemically induced
Hematologic and hematopoietic diseases
Hematologic Diseases - chemically induced
Humans
Hydroxyurea
Hydroxyurea - administration & dosage
Hydroxyurea - adverse effects
Interferon
Interferon-alpha - administration & dosage
Interferon-alpha - adverse effects
Leukemia, Myeloid, Chronic-Phase - drug therapy
Leukemia, Myeloid, Chronic-Phase - mortality
Leukemias. Malignant lymphomas. Malignant reticulosis. Myelofibrosis
Life Tables
Male
Medical sciences
Middle Aged
Nervous System Diseases - chemically induced
Pharmacology. Drug treatments
Randomised study
Recombinant Proteins
Treatment Outcome
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:This multicenter randomized phase III study was designed to compare the efficacy and toxicity of IFNα-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.
ISSN:0145-2126
1873-5835
DOI:10.1016/S0145-2126(02)00223-0