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Low Transplant Mortality in Allogeneic Bone Marrow Transplantation
for Acute Myeloid Leukemia: A Randomized Study of Low-Dose Cyclosporin
Versus Low-Dose Cyclosporin and Low-Dose Methotrexate
P. Zikos,
M.T. Van Lint,
F. Frassoni,
T. Lamparelli,
F. Gualandi,
D. Occhini,
N. Mordini,
G. Berisso,
S. Bregante,
F. De Stefano,
M. Soracco,
V. Vitale, and
A. Bacigalupo
From the Divisione Ematologia II Ospedale San Martino, Istituto
Medicina Legale, Universitá, Servizio Radioterapia Istituto
Tumori, Genova, Italy.
Sixty patients undergoing allogeneic bone marrow transplant for
acute myeloid leukemia (AML) in first remission (CR1; n = 49) or
more advanced phase (n = 11) were entered in a prospective trial of
graft-versus-host disease (GvHD) prophylaxis: low-dose cyclosporin A
(IdCSA; 1 mg/kg/d from day  1 to +20 day; n = 28) or IdCSA plus
low-dose methotrexate (IdMTX; 10 mg/m2 for day +1, 8 mg/m2 for days +3, +6, and +11; n = 32). Primary
end points were acute GvHD (aGvHD) and transplant-related mortality
(TRM); secondary end points were relapse and survival. The conditioning
regimen consisted of cyclophosphamide (120 mg/kg) and fractionated
total body irradiation (3.3 Gy/d for 3 consecutive days). The actuarial risk of developing aGvHD grade II-III was 61% for IdCSA alone and 34%
for IdCSA + IdMTX (P = .02). The actuarial risk of TRM at
1 year was 11% versus 13%, respectively, and older patients ( 29
years) had higher TRM than younger patients (22% v 5%,
P = .01). The age effect was significant in the IdCSA group
(P = .04) but not in the IdCSA + IdMTX group
(P = .1). The median follow-up is 4.4 years, with an
overall actuarial survival of 78% for CR1 patients and 36% for
patients with advanced disease. For patients in CR1 the outcome of the
two regimens was as follows: survival 77% versus 80%
(P = .6), relapse 20% versus 9% (P = .1), and
TRM 13% versus 17% (P = .6). This study suggests that TRM
can be reduced in AML patients undergoing allogeneic marrow transplants
with a mild conditioning regimen and low-dose immunosuppression, and this translates in a 78% 5-year survival for CR1 patients. Beyond CR1
the major obstacle remains leukemia relapse, which is not prevented by
low-dose in vivo immunosuppression.
Blood, Vol. 91 No. 9 (May 1), 1998:
pp. 3503-3508
© 1998 by The American Society of Hematology.
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