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Marrow transplantation for chronic myeloid leukemia: a randomized study
comparing cyclophosphamide and total body irradiation with busulfan and
cyclophosphamide
RA Clift, CD Buckner, ED Thomas, WI Bensinger, R Bowden, E Bryant, HJ Deeg, KC Doney, LD Fisher and JA Hansen
Fred Hutchinson Cancer Research Center, Seattle, WA 98104-2092.
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.
Volume 84,
Issue 6,
pp. 2036-2043,
09/15/1994
Copyright © 1994 by The American Society of Hematology
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