PMID- 10090926
OWN - NLM
STAT- MEDLINE
DCOM- 19990419
LR  - 20210216
IS  - 0006-4971 (Print)
IS  - 0006-4971 (Linking)
VI  - 93
IP  - 7
DP  - 1999 Apr 1
TI  - 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.
PG  - 2191-5
AB  - 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.
FAU - Marsh, J
AU  - Marsh J
AD  - Department of Haematology, St George's Hospital Medical School, London, UK. 
      jmarsh@sghms.ac.uk
FAU - Schrezenmeier, H
AU  - Schrezenmeier H
FAU - Marin, P
AU  - Marin P
FAU - Ilhan, O
AU  - Ilhan O
FAU - Ljungman, P
AU  - Ljungman P
FAU - McCann, S
AU  - McCann S
FAU - Socie, G
AU  - Socie G
FAU - Tichelli, A
AU  - Tichelli A
FAU - Passweg, J
AU  - Passweg J
FAU - Hows, J
AU  - Hows J
FAU - Raghavachar, A
AU  - Raghavachar A
FAU - Locasciulli, A
AU  - Locasciulli A
FAU - Bacigalupo, A
AU  - Bacigalupo A
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - United States
TA  - Blood
JT  - Blood
JID - 7603509
RN  - 0 (Antilymphocyte Serum)
RN  - 0 (Hemoglobins)
RN  - 0 (Immunoglobulins)
RN  - 0 (Immunosuppressive Agents)
RN  - 0 (lymphoglobuline)
RN  - 83HN0GTJ6D (Cyclosporine)
SB  - IM
CIN - Blood. 1999 Sep 1;94(5):1833-4. PMID: 10507843
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Anemia, Aplastic/*drug therapy/mortality/therapy
MH  - Antilymphocyte Serum/*therapeutic use
MH  - Blood Transfusion
MH  - Combined Modality Therapy
MH  - Cyclosporine/administration & dosage/*therapeutic use
MH  - Drug Therapy, Combination
MH  - Europe/epidemiology
MH  - Female
MH  - Hemoglobins/analysis
MH  - Humans
MH  - Immunoglobulins
MH  - Immunosuppressive Agents/administration & dosage/*therapeutic use
MH  - Life Tables
MH  - Male
MH  - Middle Aged
MH  - Platelet Count
MH  - Prospective Studies
MH  - Survival Analysis
MH  - Survival Rate
MH  - T-Lymphocytes/*immunology
MH  - Treatment Outcome
EDAT- 1999/03/26 00:00
MHDA- 1999/03/26 00:01
CRDT- 1999/03/26 00:00
PHST- 1999/03/26 00:00 [pubmed]
PHST- 1999/03/26 00:01 [medline]
PHST- 1999/03/26 00:00 [entrez]
AID - S0006-4971(20)48974-8 [pii]
PST - ppublish
SO  - Blood. 1999 Apr 1;93(7):2191-5.