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.

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.

MedLine Citation:	PMID: 10090926 Owner: NLM Status: MEDLINE
Abstract/OtherAbstract:	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 x 10(9)/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.

Authors:	J Marsh; H Schrezenmeier; P Marin; O Ilhan; P Ljungman; S McCann; G Socie; A Tichelli; J Passweg; J Hows; A Raghavachar; A Locasciulli; A Bacigalupo
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Publication Detail:	Type: Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial
Journal Detail:	Title: Blood Volume: 93 ISSN: 0006-4971 ISO Abbreviation: Blood Publication Date: 1999 Apr
Date Detail:	Created Date: 1999-04-19 Completed Date: 1999-04-19 Revised Date: 2006-12-08
Medline Journal Info:	Nlm Unique ID: 7603509 Medline TA: Blood Country: UNITED STATES
Other Details:	Languages: eng Pagination: 2191-5 Citation Subset: AIM; IM
Affiliation:	Department of Haematology, St George's Hospital Medical School, London, UK. jmarsh@sghms.ac.uk
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MeSH Terms
Descriptor/Qualifier:	Adolescent Adult Aged Aged, 80 and over Anemia, Aplastic / drug therapy, mortality, therapy Antilymphocyte Serum / therapeutic use Blood Transfusion Combined Modality Therapy Cyclosporine / administration & dosage, therapeutic use* Drug Therapy, Combination Europe / epidemiology Female Hemoglobins / analysis Humans Immunoglobulins Immunosuppressive Agents / administration & dosage, therapeutic use* Life Tables Male Middle Aged Platelet Count Prospective Studies Survival Analysis Survival Rate T-Lymphocytes / immunology* Treatment Outcome
Chemical
Reg. No./Substance:	0/Antilymphocyte Serum; 0/Hemoglobins; 0/Immunoglobulins; 0/Immunosuppressive Agents; 0/lymphoglobuline; 59865-13-3/Cyclosporine
Comments/Corrections
Comment In:	Blood. 1999 Sep 1;94(5):1833-4 [PMID: 10507843 ]

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