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Blood, Vol. 93 No. 7 (April 1), 1999:
pp. 2191-2195
Prospective Randomized Multicenter Study Comparing Cyclosporin Alone
Versus the Combination of Antithymocyte Globulin and Cyclosporin for
Treatment of Patients With Nonsevere Aplastic Anemia: A Report From the
European Blood and Marrow Transplant (EBMT) Severe Aplastic Anaemia
Working Party
J. Marsh,
H. Schrezenmeier,
P. Marin,
O. Ilhan,
P. Ljungman,
S. McCann,
G. Socie,
A. Tichelli,
J. Passweg,
J. Hows,
A. Raghavachar,
A. Locasciulli, and
A. Bacigalupo on behalf of the EBMT Severe
Aplastic Anaemia Working Party
From the Department of Haematology, St George's Hospital Medical
School, London, UK.
We report the results of the first prospective randomized
multicenter study of immunosuppressive treatment in patients with previously untreated nonsevere aplastic anemia (AA) as defined by a
neutrophil count of at least 0.5 × 109/L and transfusion
dependence. Patients were randomized to receive cyclosporin (CSA) alone
or the combination of horse antithymocyte globulin
([ATG] Lymphoglobuline; Merieux, Lyon, France) and CSA. The endpoint
of the study was the hematologic response at 6 months. One hundred
fifteen patients were randomized and assessable with a median follow-up
period of 36 months; 61 received CSA and 54 ATG and CSA. In the CSA
group, the percentage of complete and partial responders was 23% and
23%, respectively, for an overall response rate of 46%. A
significantly higher overall response rate of 74% was found in the ATG
and CSA group, with 57% complete and 17% partial responders
(P = .02). Compared with CSA alone, the combination of ATG
and CSA resulted in a significantly higher median hemoglobin level and
platelet count at 6 months. Fewer patients required a second course of
treatment before 6 months due to a nonresponse. In the CSA group, 15 of
61 (25%) patients required a course of ATG before 6 months because of
disease progression, compared with only 3 of 54 (6%) in the ATG and
CSA group. The survival probabilities for the two groups were
comparable, 93% (CSA group) and 91% (ATG and CSA group), but at 180 days, the prevalence of patients surviving free of transfusions, which
excluded patients requiring second treatment because of nonresponse,
death, disease progression, or relapse, was 67% in the CSA group and 90% in the ATG and CSA group (P = .001). We conclude that
the combination of ATG and CSA is superior to CSA alone in terms of the
hematologic response, the quality of response, and early mortality, and
a second course of immunosuppression is less frequently required.
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