A randomized study comparing interferon (IFN alpha) 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 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.
Kühr
T
T
Department of Internal Medicine, General Hospital, Grieskirchnerstr. 42, A-4600 Wels, Austria. thomas.kuehr@khwels.at
Burgstaller
S
S
Apfelbeck
U
U
Linkesch
W
W
Seewann
H
H
Fridrik
M
M
Michlmayr
G
G
Krieger
O
O
Lutz
D
D
Lin
W
W
Pont
J
J
Köck
L
L
Abbrederis
K
K
Baldinger
C
C
Buder
R
R
Geissler
D
D
Hausmaninger
H
H
Lang
A
A
Zabernigg
A
A
Duba
C
C
Hilbe
W
W
Eisterer
W
W
Fiegl
M
M
Greil
R
R
Gastl
G
G
Thaler
J
J
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
D016898:Interferon-alpha; D011994:Recombinant Proteins; D003561:Cytarabine; C554129:interferon alfa-2c; D006918:Hydroxyurea