[Multicenter prospective controlled study of therapy of chronic myeloid leukemia. Comparison of busulfan, hydroxyurea and interferon alpha (April 1990 status)].
In a multicenter study it is being determined, whether the use of hydroxyurea or of interferon alpha instead of busulfan prolongs the chronic phase of Philadelphia-positive CML. Additional goals are the examination, whether the types of disease evolution and the terminal phases differ between the treatment groups, and the prospective recognition of prognostic criteria for the duration of the chronic phase of CML. By September 5, 1990, 593 CML-patients had been randomized, 221 for busulfan, 228 for hydroxyurea and 144 for interferon alpha. The average age is about 51 years. By April 30, 1990, 106 patients had reached the end of the chronic phase, 126 had died. The median survival of Philadelphia-positive patients was 3.95 years, that of all patients 3.75 years. The median observation time of all patients was 1.34 years (mean 1.60 years). At present, no significant difference in survival is recognizable between the three treatment arms, although fewer adverse effects have been observed in the hydroxyurea arm.
Hehlmann
R
R
III. Med. Klinik Mannheim, Universität Heidelberg.
Heimpel
H
H
Heinze
B
B
Georgii
A
A
Kolb
H J
HJ
Hossfeld
D K
DK
von Wussow
P
P
Hochhaus
A
A
Griesshammer
M
M
Diehl
V
V
D002066:Busulfan / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006918:Hydroxyurea / Q000008:administration & dosage* / Q000009:adverse effects; D007370:Interferon Type I / Q000008:administration & dosage* / Q000009:adverse effects; D015464:Leukemia, Myelogenous, Chronic, BCR-ABL Positive / Q000188:drug therapy / Q000401:mortality / Q000628:therapy*; D015466:Leukemia, Myeloid, Chronic-Phase / Q000188:drug therapy / Q000401:mortality / Q000628:therapy*; D007958:Leukocyte Count / Q000187:drug effects; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011994:Recombinant Proteins; D015996:Survival Rate
D007370:Interferon Type I; D011994:Recombinant Proteins; D002066:Busulfan; D006918:Hydroxyurea
Multizentrische prospektive kontrollierte Studie zur Therapie der chronisch myeloischen Leukämie. Vergleich von Busulfan, Hydroxyurea und Interferon alpha (Stand April 1990).