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Prepublished online as a Blood First Edition Paper on October 10, 2002; DOI 10.1182/blood-2002-04-1134.
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Blood, 15 February 2003, Vol. 101, No. 4, pp. 1236-1242
CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS
Antithymocyte globulin with or without cyclosporin A:
11-year follow-up of a randomized trial comparing treatments of
aplastic anemia
Norbert Frickhofen,
Hermann Heimpel,
Joachim P. Kaltwasser, and
Hubert Schrezenmeier for the German
Aplastic Anemia Study Group
From the Department of Hematology/Oncology,
Dr-Horst-Schmidt-Kliniken, Wiesbaden; Department of
Hematology/Oncology, University of Ulm; Department of
Hematology/Oncology, University of Frankfurt; and Department of
Hematology/Oncology, Benjamin-Franklin-Hospital, Free University of
Berlin, Germany.
Immunosuppression with antithymocyte globulin,
(methyl)prednisolone, and cyclosporin A is considered the treatment of
choice for the patient with aplastic anemia without a donor for
standard-risk stem cell transplantation. This consensus is supported by
the results of several series, including a randomized German trial. Here we report 11-year results of the latter trial. With stringent response criteria and 4 months as the time to evaluate responses, this
analysis confirms the superiority of the cyclosporine regimen regarding
the response rate in all patients treated (70% vs 41%, with or
without cyclosporine; P = .015) and in patients with
severe aplastic anemia (65% vs 31%; P = .011). Patients
responded more rapidly after treatment with cyclosporine (median, 60 vs
82 days; P = .019). Most patients treated with
cyclosporine needed only one course of immunosuppression, whereas many
patients treated without cyclosporine required repeated
immunosuppressive treatment. Because of the efficacy of salvage
treatment, overall survival was not different between the 2 treatment
groups. However, failure-free survival favored the cyclosporine regimen
(39% vs 24%; P = .04). The relapse rate, projected at
38% after 11.3 years, was similar between the 2 treatment groups.
Remissions were cyclosporine dependent in 26% of the patients
responding to a regimen that included cyclosporine. Clonal or malignant
diseases developed in 25% of the patients. These data demonstrate that
antithymocyte globulin, methylprednisolone, and cyclosporin A are an
effective regimen for the treatment of aplastic anemia. However,
remissions are unstable, and secondary diseases are common. In contrast
to the results of stem cell transplantation, most patients are not cured.
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