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Blood, 15 December 2001, Vol. 98, No. 13, pp. 3569-3574
CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS
Busulfan plus cyclophosphamide compared with total-body
irradiation plus cyclophosphamide before marrow transplantation for
myeloid leukemia: long-term follow-up of 4 randomized studies
Gérard Socié,
Reginald A. Clift,
Didier Blaise,
Agnès Devergie,
Olle Ringden,
Paul J. Martin,
Mats Remberger,
H. Joachim Deeg,
Tapani Ruutu,
Mauricette Michallet,
Keith M. Sullivan, and
Sylvie Chevret
From the Service d'Hématologie Greffe de Moelle
and Département de Bio-Informatique, Hôpital Saint Louis,
Paris, France; Fred Hutchinson Cancer Research Center, Seattle, WA;
Service de Greffe de Moelle, Institut Paoli Calmette, Marseille,
France; Center for Allogeneic Stem Cell Transplantation, Huddinge
University Hospital, Stockholm, Sweden; Service d'hematologie,
Hôpital Edouard Heriot, Lyon, France; and Department of Medicine,
Helsinki University Central Hospital, Finland.
In the early 1990s, 4 randomized studies compared conditioning
regimens before transplantation for leukemia with either
cyclophosphamide (CY) and total-body irradiation (TBI), or busulfan
(Bu) and CY. This study analyzed the long-term outcomes for 316 patients with chronic myeloid leukemia (CML) and 172 patients with
acute myeloid leukemia (AML) who participated in these 4 trials, now
with a mean follow-up of more than 7 years. Among patients with CML, no
statistically significant difference in survival or disease-free survival emerged from testing the 2 regimens. The projected 10-year survival estimates were 65% and 63% with Bu-CY versus CY-TBI, respectively. Among patients with AML, the projected 10-year survival estimates were 51% and 63% (95% CI, 52%-74%) with Bu-CY versus CY-TBI, respectively. At last follow-up, most surviving patients had
unimpaired health and had returned to work, regardless of the
conditioning regimen. Late complications were analyzed after adjustment
for patient age and for acute and chronic graft-versus-host disease
(GVHD). CML patients who received CY-TBI had an increased risk of
cataract formation, and patients treated with Bu-CY had an increased
risk of irreversible alopecia. Chronic GVHD was the primary risk factor
for late pulmonary disease and avascular osteonecrosis. Thus, Bu-CY and
CY-TBI provided similar probabilities of cure for patients with CML. In
patients with AML, a nonsignificant 10% lower survival rate was
observed after Bu-CY. Late complications occurred equally after both
conditioning regimens (except for increased risk of cataract after
CY-TBI and of alopecia with Bu-CY).
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