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Increased risk of leukemia relapse with high-dose cyclosporine A after
allogeneic marrow transplantation for acute leukemia
A Bacigalupo, MT Van Lint, D Occhini, F Gualandi, T Lamparelli, G Sogno, E Tedone, F Frassoni, J Tong and AM Marmont
Department of Hematology, Ospedale San Martino Genova, Italy.
Eighty-one patients with acute myeloid leukemia (ANLL, n = 44) or acute
lymphoblastic leukemia (ALL, n = 37), aged 10 to 50 years were randomized
to receive 1 mg/kg per day (n = 41, group A) or 5 mg/kg per day (n = 40,
group B) of cyclosporine A (CyA) from day -1 to day +20 after bone marrow
transplant (BMT). All patients received CyA orally thereafter. All patients
were prepared with cyclophosphamide (CY) 120 mg/kg and fractionated total
body irradiation (TBI), and received unfractionated BM from an
HLA-identical sibling. The two groups were comparable for diagnosis,
disease status, French-American-British (FAB) classification, WBC count at
diagnosis, cytogenetic abnormalities, extramedullary disease before BMT,
donor/recipient age and sex, number of cells infused, and number of days
with intravenous (IV) CyA. Median follow-up for surviving patients in group
A was 983 v 632 days in group B. Patients in group A had lower serum levels
of CyA (295 v 686 ng/mL, P = .004), lower bilirubin levels (1.9 v 2.6
mg/dL, P = .07), lower creatinine levels (0.9 v 1.4 mg/dL, P = .06), and a
lower proportion of CD8+ cells in the peripheral blood (PB) within day +21
(19% v 28%, P = .07). First day to 0.5 x 10(9)/L neutrophils was comparable
in the two groups (13 v 14 days; P = .1). In a Cox model, the actuarial
risk of acute graft-v-host disease (GVHD) grade II+, after stratification
for age (less than 20 years greater than) was significantly lower in group
B patients (0.54, P = .04). The actuarial risk of developing chronic GVHD
was comparable (P = .9). Actuarial transplant-related mortality (TRM) at
240 days was 28% and 26% (P = .8) in group A and B: the major cause of
death was GVHD in group A (P = .02) and multiorgan toxicity in group B (P =
.07). The actuarial risk of relapse at 2 years overall was 20% in group A
and 52% in group B (P = .001); it was 9% v 43%, respectively, for patients
in first remission (P = .0001) and 48% v 63% for patients in non-first
complete remission (CR) (P = .1). Actuarial 2- year disease-free survival
(DFS) in group A and B was 58% v 32% (P = .02) for all patients, 71% v 35%
(P = .01), in first remissions, and 30% v 23% (P = .2) in advanced
disease.(ABSTRACT TRUNCATED AT 400 WORDS)
Volume 77,
Issue 7,
pp. 1423-1428,
04/01/1991
Copyright © 1991 by The American Society of Hematology
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Related Letter in Blood Online:
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Increased risk of leukemia relapse with high dose cyclosporine after allogeneic marrow transplantation for acute leukemia: 10 year follow-up of a randomized study
- Andrea Bacigalupo, Teresa Lamparelli, Francesca Gualandi, Stefania Bregante, AnnaMaria Raiola, Carmen di Grazia, Alida Dominietto, Chiara Romagnani, Domenico Occhini, Francesco Frassoni, and Maria Teresa van Lint
Blood 2001 98: 3174.
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