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Blood, Vol. 93 No. 7 (April 1), 1999:
pp. 2196-2201
Increased Risk of Chronic Graft-Versus-Host Disease, Obstructive
Bronchiolitis, and Alopecia With Busulfan Versus Total Body
Irradiation: Long-Term Results of a Randomized Trial in Allogeneic
Marrow Recipients With Leukemia
O. Ringdén,
M. Remberger,
T. Ruutu,
J. Nikoskelainen,
L. Volin,
L. Vindeløv,
T. Parkkali,
S. Lenhoff,
B. Sallerfors,
L. Mellander,
P. Ljungman, and
N. Jacobsen for the Nordic Bone Marrow
Transplantation Group
From the Division of Clinical Immunology, Centre for Allogeneic Stem
Cell Transplantation, and the Department of Hematology, Karolinska
Institute, Huddinge Hospital, Huddinge, Sweden; the Department of
Medicine, Helsinki University Hospital, Helsinki; the Department of
Medicine, Turku University Hospital, Turku, Finland; the Department of
Medicine, Rigshospitalet, Copenhagen, Denmark; the Department of
Medicine, Lund; and the Department of Pediatrics, Östra
Hospital, Gothenburg, Sweden.
Leukemic patients receiving marrow from HLA-identical sibling donors
were randomized to treatment with either busulfan 16 mg/kg (n = 88)
or total body irradiation ([TBI] n = 79) in addition to
cyclophosphamide 120 mg/kg. The patients were observed for a period of
5 to 9 years. Busulfan-treated patients had an increased risk of
veno-occlusive disease (VOD) of the liver (12% v 1%,
P = .01) and hemorrhagic cystitis (32% v 10%,
P = .003). Acute graft-versus-host disease (GVHD) was
similar in the two groups, but the 7-year cumulative incidence of
chronic GVHD was 59% in the busulfan-treated group versus 47% in the
TBI group (P = .05). Death from GVHD was more common in the
busulfan group (22% v 3%, P < .001). Obstructive bronchiolitis occurred in 26% of the busulfan patients but in only 5%
of the TBI patients (P < .01). Complete alopecia developed in 8 busulfan patients and partial alopecia in 17, versus five with
partial alopecia in the TBI group (P < .001). Cataracts
occurred in 5 busulfan-treated patients and 16 TBI patients
(P = .02). The incidence of relapse after 7 years was 29%
in both groups. Seven-year transplant-related mortality (TRM) in
patients with early disease was 21% in the busulfan group and 12% in
the TBI group. In patients with more advanced disease, the
corresponding figures were 64% and 22%, respectively
(P = .004). Leukemia-free survival (LFS) in patients with
early disease was 68% in busulfan-treated patients and 66% in TBI
patients. However, 7-year LFS in patients with more advanced disease
was 17% in the busulfan group versus 49% in the TBI group
(P < .01). In patients with chronic myeloid leukemia (CML)
in first chronic phase, 7-year LFS was 72% and 83% in the two groups, respectively.
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