Marrow transplantation for chronic myeloid leukemia: a randomized study comparing cyclophosphamide and total body irradiation with busulfan and cyclophosphamide.
A prospective randomized study was conducted comparing two conditioning regimens for the treatment of patients with chronic myeloid leukemia in chronic phase by marrow transplantation from HLA identical siblings. Sixty-nine patients received 60 mg/kg of cyclophosphamide on each of 2 successive days followed by 6 fractions of total body irradiation each of 2.0 Gy (CY-TBI), and 73 patients received 16 mg/kg of busulfan delivered over 4 days followed by 60 mg/kg CY on each of 2 successive days (BU-CY). There was no significant difference between the CY-TBI and the BU-CY groups in the 3-year probabilities of survival (0.80 for both), relapse (0.13 for both), or event-free survival (CY-TBI, 0.68; BU-CY, 0.71) or in speed of engraftment or incidence of venocclusive disease of the liver. The 4-year probabilities of survival and event-free survival for patients transplanted within 1 year of diagnosis were 0.86 and 0.72, respectively, for each group. Significantly more patients in the CY-TBI group experienced major creatinine elevations. There was significantly more acute graft-versus-host disease in the CY-TBI group. Fever days, positive blood cultures, hospitalizations, and inpatient hospital days were significantly more common in the CY-TBI group than in the BU-CY group. In conclusion, the BU-CY regimen was better tolerated than, and associated with survival and relapse probabilities that compare favorably with, the CY-TBI regimen.
Clift
R A
RA
Fred Hutchinson Cancer Research Center, Seattle, WA 98104-2092.
Buckner
C D
CD
Thomas
E D
ED
Bensinger
W I
WI
Bowden
R
R
Bryant
E
E
Deeg
H J
HJ
Doney
K C
KC
Fisher
L D
LD
Hansen
J A
JA
D000293:Adolescent; D000328:Adult; D001663:Bilirubin / Q000097:blood; D016026:Bone Marrow Transplantation / Q000009:adverse effects; D002066:Busulfan / Q000008:administration & dosage / Q000627:therapeutic use*; D002648:Child; D003404:Creatinine / Q000097:blood; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D006086:Graft vs Host Disease / Q000453:epidemiology / Q000517:prevention & control; D006801:Humans; D007239:Infections / Q000209:etiology; D007902:Length of Stay; D015464:Leukemia, Myelogenous, Chronic, BCR-ABL Positive / Q000401:mortality / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D018805:Sepsis / Q000209:etiology; D015996:Survival Rate; D015430:Weight Gain; D014916:Whole-Body Irradiation
D003520:Cyclophosphamide; D003404:Creatinine; D002066:Busulfan; D001663:Bilirubin