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Allogeneic bone marrow transplantation for chronic myeloid leukemia in
first chronic phase: a randomized trial of busulfan-cytoxan versus
cytoxan-total body irradiation as preparative regimen: a report from the
French Society of Bone Marrow Graft (SFGM)
A Devergie, D Blaise, M Attal, JD Tigaud, JP Jouet, JP Vernant, P Bordigoni, N Ifrah, C Dauriac and JY Cahn
Bone Marrow Transplant Units of Hopital Saint-Louis, Paris, France.
From March 1988 to March 1991, 19 French bone marrow transplant (BMT)
centers participated in a prospective randomized trial comparing two
conditioning regimens for patients with chronic myeloid leukemia
transplanted in first chronic phase with an HLA identical sibling donor. A
total of 120 consecutive patients were randomized to receive either 120
mg/kg of cyclophosphamide followed by total body irradiation (CY-TBI; n =
55) or 16 mg/kg of busulfan followed by 120 mg/kg of CY (BU-CY; n = 65).
Two different TBI regimens were used. Thirteen patients received a 10-Gy
single-dose TBI (SDTBI), and 42 received a fractionated TBI (FTBI). Median
time between diagnosis and BMT was 315 days. Overall 5-year actuarial
survival was 62.9% (65.8% +/- 12.5% for CY-TBI and 60.6 +/- 11.7% for
BU-CY; P = .5), and overall disease-free survival was 55% (51% +/- 14% for
CY-TBI and 59.1% +/- 11.8% for BU-CY; P = .75). All patients conditioned
with CY-TBI experienced sustained engraftment; in contrast, 4 of 65
patients conditioned with BU-CY rejected the graft (P = .18). There was no
significant statistical difference between the two groups regarding
transplant-related mortality (29% for CY-TBI and 38% for BU-CY; P = .44).
So far, with a median follow up of 42 months, 11 patients have relapsed; 9
relapses occurred after CY-TBI, mostly after FTBI (8 of 9) and 2 after
BU-CY (P = .02). The actuarial risk of relapse was 4.4% +/- 6.7% after
BU-CY, 11.1% +/- 20.8% after SDTBI, and 31.3% +/- 18.1% after FTBI (P =
.039). In addition, independently of the conditioning regimen, the increase
of posttransplant immunosuppression in 16 patients with an anti-
interleukin-2 receptor monoclonal antibody (MoAb) in addition to a short
course of methotrexate and cyclosporine was shown to increase the actuarial
risk of relapse (57% +/- 30% with MoAb v 9% +/- 7.3% without MoAb; P =
.001). We conclude that BU is an acceptable alternative to TBI for patients
with chronic myeloid leukemia in first chronic phase receiving BMT from HLA
identical sibling donors. Both BU-CY and CY-TBI regimens gave similar
transplant-related mortality, and the antileukemic efficiency of BU-CY
regimen was either similar or even higher than that of CY-TBI.
Volume 85,
Issue 8,
pp. 2263-2268,
04/15/1995
Copyright © 1995 by The American Society of Hematology
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