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

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.; for the Austrian CML Study Group,

doi:10.1016/S0145-2126(02)00223-0

« Previous Next »Leukemia Research
Volume 27, Issue 5 , Pages 405-411, May 2003

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

T. Kühr
- Department of Internal Medicine, General Hospital, Grieskirchnerstr. 42, Wels A-4600, Austria
- Corresponding author. Tel.: +43-7242-415-9-3454.
S. Burgstaller
- Department of Internal Medicine, General Hospital, Grieskirchnerstr. 42, Wels A-4600, Austria
U. Apfelbeck
- Department of Internal Medicine, University Hospital, Graz, Austria
W. Linkesch
- Department of Internal Medicine, University Hospital, Graz, Austria
H. Seewann
- Department of Internal Medicine, General Hospital, Fürstenfeld, Austria
M. Fridrik
- Department of Internal Medicine, General Hospital, Linz, Austria
G. Michlmayr
- Department of Internal Medicine, Hospital of the Sisters of Mercy, Linz, Austria
O. Krieger
- Department of Internal Medicine, Hospital of the Elizabethans, Linz, Austria
D. Lutz
- Department of Internal Medicine, Hospital of the Elizabethans, Linz, Austria
W. Lin
- Department of Internal Medicine, State Hospital, Villach, Austria
J. Pont
- Department of Internal Medicine, Kaiser Franz Josef Hospital, Wien, Austria
L. Köck
- Department of Internal Medicine, County Hospital, Lienz, Austria
K. Abbrederis
- Department of Internal Medicine, Municipal Hospital, Dornbirn, Austria
C. Baldinger
- Department of Internal Medicine, General Hospital, Grieskirchnerstr. 42, Wels A-4600, Austria
R. Buder
- Department of Internal Medicine, Hospital of the Brothers of Mercy, Linz, Austria
D. Geissler
- Department of Internal Medicine, State Hospital, Klagenfurt, Austria
H. Hausmaninger
- Department of Internal Medicine, State Hospital, Salzburg, Austria
A. Lang
- Department of Internal Medicine, State Hospital, Feldkirch, Austria
A. Zabernigg
- Department of Internal Medicine, County Hospital, Kufstein, Austria
C. Duba
- Department of Medical Biology and Human Genetics, University of Innsbruck, Innsbruck, Austria
W. Hilbe
- Department of Internal Medicine, University Hospital Innsbruck, Innsbruck, Austria
W. Eisterer
- Department of Internal Medicine, University Hospital Innsbruck, Innsbruck, Austria
M. Fiegl
- Department of Internal Medicine, University Hospital Innsbruck, Innsbruck, Austria
R. Greil
- Department of Internal Medicine, University Hospital Innsbruck, Innsbruck, Austria
G. Gastl
- Department of Internal Medicine, University Hospital Innsbruck, Innsbruck, Austria
J. Thaler
- Department of Internal Medicine, General Hospital, Grieskirchnerstr. 42, Wels A-4600, Austria
for the Austrian CML Study Group

Received 13 September 2002; accepted 28 September 2002.

Abstract

This multicenter randomized phase III study was designed to compare the efficacy and toxicity of IFNα-2c (3.5MU/d) in combination with either araC (10mg/m² d1-10) or hydroxyurea (HU: 25mg/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.