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Blood, Vol. 95 No. 5 (March 1), 2000:
pp. 1572-1579
Graft versus host disease prophylaxis with low-dose cyclosporine-A
reduces the risk of relapse in children with acute leukemia given
HLA-identical sibling bone marrow transplantation: results of a
randomized trial
Franco Locatelli,
Marco Zecca,
Roberto Rondelli,
Federico Bonetti,
Giorgio Dini,
Arcangelo Prete,
Chiara Messina,
Cornelio Uderzo,
Mimmo Ripaldi,
Fulvio Porta,
Giovanna Giorgiani,
Eugenia Giraldi, and
Andrea Pession
From the Department of Pediatrics, University of Pavia, IRCCS
Policlinico San Matteo, Pavia; Department of Pediatrics, University of
Bologna, Ospedale Sant'Orsola, Bologna; Department of Pediatric
Hematology and Oncology, Giannina Gaslini Institute, Genova; Department
of Pediatrics, University of Padova; Department of Pediatrics, Ospedale
Nuovo San Gerardo, Monza, University of Milan; BMT Unit, Pausillipon
Hospital, Napoli; Department of Pediatrics, University of Brescia,
Spedali Civili, Brescia, Italy.
Leukemia relapse is a major cause of treatment failure for patients
with acute leukemia given allogeneic bone marrow transplantation (BMT).
This study evaluated whether a reduction of the dosage of
cyclosporine-A (Cs-A) used for graft versus host disease (GVHD) prophylaxis could reduce relapse rate (RR) in children with acute leukemia given BMT. Fifty-nine children who had transplantation from
HLA-identical siblings were randomized to receive Cs-A intravenously at
a dosage of 1 mg/kg/d (Cs-A1) or of 3 mg/kg/d (Cs-A3) until patients
were able to tolerate oral intake. Subsequently, both groups received
Cs-A orally at a dosage of 6 mg/kg/d, with discontinuation 5 months
after BMT. The probability of developing grade II-IV acute GVHD was
57% for the Cs-A1 group versus 38% for the Cs-A3 group
(P = .06); the probability of developing chronic GVHD was 30% for the Cs-A1 group and 26% for the Cs-A3 group
(P = NS). Three patients died of grade IV acute GVHD: 2 were in the Cs-A1 and the third in the Cs-A3 group. The RR was 15% for
the Cs-A1 group and 41% for the Cs-A3 group (P = .034);
1-year transplant-related mortality estimates were 17% and 7%,
respectively (P = NS). With a median observation time of 44 months from BMT, the 5-year event-free survival for children belonging
to Cs-A1 and Cs-A3 groups was 70% and 51%, respectively
(P = .15). Our data demonstrate that the use of low Cs-A
doses is associated with a statistically significant reduction of
leukemia relapse, probably due to an increased graft versus leukemia effect.
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