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Blood, 1 September 2000, Vol. 96, No. 5, pp. 1690-1697
CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS
Cyclosporin A and short-term methotrexate versus cyclosporin A as
graft versus host disease prophylaxis in patients with severe aplastic
anemia given allogeneic bone marrow transplantation from an
HLA-identical sibling: results of a GITMO/EBMT randomized
trial
Franco Locatelli,
Barbara Bruno,
Marco Zecca,
Maria Teresa Van-Lint,
Shaun McCann,
William Arcese,
Sandro Dallorso,
Paolo Di
Bartolomeo,
Franca Fagioli,
Anna Locasciulli,
Mark Lawler, and
Andrea Bacigalupo on
behalf of GITMO/EBMT
From the Dipartimento di Scienze Pediatriche,
Università di Pavia, IRCCS Policlinico San Matteo, Pavia;
Divisione di Ematologia II, Ospedale San Martino, Genoa; Cattedra di
Ematologia, Università La Sapienza, Rome; Dipartimento di
Ematologia e Oncologia Pediatrica, Istituto Giannina Gaslini, Genoa;
Unità Terapia Intensiva Ematologica per il Trapianto Emopoietico,
Dipartimento di Ematologia, Ospedale Civile, Pescara; Clinica
Pediatrica, Università di Torino, Ospedale Regina Margherita,
Turin; Clinica Pediatrica, Ospedale Nuovo San Gerardo, Monza,
Università di Milano, Milan, Italy; and the Department of
Hematology, St James Trinity College, Dublin, Ireland.
A randomized trial was carried out comparing cyclosporin A (CsA)
and short-term methotrexate (MTX) versus CsA alone for graft versus
host disease (GVHD) prophylaxis in patients with severe aplastic anemia
(SAA) undergoing allogeneic bone marrow transplantation (BMT) from a
compatible sibling. Seventy-one patients (median age, 19 years; range,
4-46 years) were randomized to receive either CsA and MTX or CsA alone
for the first 3 weeks after BMT. Subsequently, both groups received CsA
orally, with gradual drug reduction until discontinuation 8 to 12 months after BMT. Patients randomized in both arms had comparable
characteristics and received the same preparative regimen (ie,
cyclophosphamide 200 mg/kg over 4 days). The median time for neutrophil
engraftment was 17 days (range, 11-31 days) and 12 days (range, 4-45 days) for patients in the CsA/MTX group and the CsA alone group,
respectively (P = .01). No significant difference was
observed in the probability of either grade 2, grade 3, or grade 4 acute GVHD or chronic GVHD developing in the 2 groups. The Kaplan-Meier
estimates of 1-year transplantation-related mortality rates for
patients given either CsA/MTX or CsA alone were 3% and 15%,
respectively (P = .07). With a median follow-up of 48 months from BMT, the 5-year survival probability is 94% for patients
in the CsA/MTX group and 78% for those in the CsA alone group
(P = .05). These data indicate that the use of CsA with
MTX is associated with improved survival in patients with SAA who
receive transplants from compatible siblings.
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