PMID- 10392964
OWN - NLM
STAT- MEDLINE
DCOM- 19990927
LR  - 20131121
IS  - 1083-8791 (Print)
IS  - 1083-8791 (Linking)
VI  - 5
IP  - 3
DP  - 1999
TI  - Tacrolimus vs. cyclosporine immunosuppression: results in advanced-stage disease 
      compared with historical controls treated exclusively with cyclosporine.
PG  - 180-6
AB  - A phase HI comparative trial of tacrolimus- vs. cyclosporine-based graft-vs.-host 
      disease (GVHD) prophylaxis for human leukocyte antigen (HLA)-identical sibling 
      bone marrow transplantation showed less GVHD but poorer survival in the 
      tacrolimus arm. To test the comparability of the two treatment arms with respect 
      to baseline survival prognosis, a matched control study using exclusively 
      cyclosporine-treated patients from the International Bone Marrow Transplant 
      Registry (IBMTR) database was performed. Controls were matched (2:1) based on age 
      (within 5 years), disease, and pretransplant disease status. Two-year survival 
      for tacrolimus-treated clinical trial patients was similar to that of their 
      cyclosporine-treated matched controls (27 and 24%, respectively), and 2-year 
      survival of the cyclosporine-treated clinical trial patients was similar to that 
      of their cyclosporine-treated matched IBMTR controls (42 and 45%, respectively). 
      Consistent with the clinical trial results, the cyclosporine-treated IBMTR 
      controls matched to the tacrolimus group had significantly poorer 2-year survival 
      than the cyclosporine-treated IBMTR controls matched to the cyclosporine group 
      (24 and 45%, respectively; p < 0.01). No significant difference was seen in GVHD 
      between the cyclosporine-treated clinical trial patients and their matched 
      controls; however, the tacrolimus-treated clinical trial patients had 
      significantly less GVHD than their cyclosporine-treated IBMTR controls (p < 
      0.01). These results support the hypothesis that the survival difference in the 
      phase III trial resulted from an imbalance in the underlying risk factors for 
      death in the two groups rather than from the randomized immunosuppressive 
      regimen.
FAU - Horowitz, M M
AU  - Horowitz MM
AD  - International Bone Marrow Transplant Registry, Medical College of Wisconsin, 
      Milwaukee, USA.
FAU - Przepiorka, D
AU  - Przepiorka D
FAU - Bartels, P
AU  - Bartels P
FAU - Buell, D N
AU  - Buell DN
FAU - Zhang, M J
AU  - Zhang MJ
FAU - Fitzsimmons, W E
AU  - Fitzsimmons WE
FAU - Erdman, J
AU  - Erdman J
FAU - Huang, C
AU  - Huang C
FAU - Hodosh, E
AU  - Hodosh E
FAU - Maher, R
AU  - Maher R
FAU - Wingard, J R
AU  - Wingard JR
LA  - eng
GR  - P01-CA-40053/CA/NCI NIH HHS/United States
PT  - Clinical Trial
PT  - Clinical Trial, Phase II
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PT  - Research Support, U.S. Gov't, P.H.S.
PL  - United States
TA  - Biol Blood Marrow Transplant
JT  - Biology of blood and marrow transplantation : journal of the American Society for 
      Blood and Marrow Transplantation
JID - 9600628
RN  - 0 (Immunosuppressive Agents)
RN  - 83HN0GTJ6D (Cyclosporine)
RN  - WM0HAQ4WNM (Tacrolimus)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Bone Marrow Transplantation/methods
MH  - Case-Control Studies
MH  - Cyclosporine/*therapeutic use
MH  - Female
MH  - Graft vs Host Disease/prevention & control
MH  - Humans
MH  - Immunosuppressive Agents/*therapeutic use
MH  - Leukemia/drug therapy
MH  - Lymphoma/drug therapy
MH  - Male
MH  - Middle Aged
MH  - Multiple Myeloma/drug therapy
MH  - Prospective Studies
MH  - Survival
MH  - Tacrolimus/*therapeutic use
EDAT- 1999/07/07 00:00
MHDA- 1999/07/07 00:01
CRDT- 1999/07/07 00:00
PHST- 1999/07/07 00:00 [pubmed]
PHST- 1999/07/07 00:01 [medline]
PHST- 1999/07/07 00:00 [entrez]
AID - S1083-8791(99)50023-2 [pii]
AID - 10.1053/bbmt.1999.v5.pm10392964 [doi]
PST - ppublish
SO  - Biol Blood Marrow Transplant. 1999;5(3):180-6. doi: 
      10.1053/bbmt.1999.v5.pm10392964.