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Graft-Versus-Host Disease

Phase III study comparing tacrolimus (FK506) with cyclosporine for graft-versus-host disease prophylaxis after allogeneic bone marrow transplantation

Bone Marrow Transplantation volume 28, pages 181–185 (2001)Cite this article

Abstract

We report the results of a phase III trial comparing tacrolimus (FK506) with cyclosporine for GVHD prophylaxis after allogeneic BMT. From February 1995 to July 1996, 136 patients were enrolled and followed up to September 1997. During the first 100 days post-transplant the incidence of grade II–IV acute GVHD (the primary end-point) was lower in the tacrolimus group (17.5%) compared with the cyclosporine group (48.0%, P < 0.0001). A significant difference was observed between the tacrolimus and cyclosporine groups when subset analyses were performed based on recipients from HLA-matched siblings (13.3% vs 41.3%, P = 0.015) or donors other than HLA-matched siblings (21.4% vs 53.8%, P = 0.0029). The incidence of chronic GVHD (47.3% and 47.8%) and Kaplan–Meier estimate of overall survival (62.9% and 65.2%) were similar between the tacrolimus and cyclosporine groups, respectively. The overall leukemia relapse rate was not significantly different between the tacrolimus and cyclosporine groups (19.6% and 11.4%, respectively). However, the relapse rate among recipients from HLA-matched siblings was significantly higher in the tacrolimus group (30.9%) compared with the cyclosporine group (3.6%, P = 0.013). These results suggest the merit of tacrolimus for the prophylaxis of acute GVHD, but a lack of merit for a graft-versus-leukemia effect among recipients from HLA-matched sibling donors. Bone Marrow Transplantation (2001) 28, 181–185.

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Acknowledgements

The authors thank the investigators of centers participating in the Japanese FK506 BMT Study Group for their collaboration: Dr M Asaka (Hokkaido University), Dr M Kasai (Sapporo Hokuyu Hospital), Dr N Maseki (Saitama Cancer Center), Dr Y Saitoh (Chiba University), Drs S Takamoto, T Sasaki and Y Onozawa (Tokyo Metro Komagome Hospital), Dr Y Ikeda (Keio University), Dr Y Ichikawa (Tokai University), Dr H Kigasawa (Kanagawa Children's Medical Center), Dr Y Aisawa (Niigata University), Dr N Hirabayashi (Nagoya Daini Red Cross Hospital), Dr H Sao (Meitetsu Hospital), Dr T Matsuda (Kanazawa University), Dr T Yoshida (Toyama Pref. Central Hospital), Dr K Kawa-Ha (Osaka Medical Center and Res Inst for Maternal and Child Health), Dr A Horiuchi (Kinki University), Dr E Kakishita (Hyogo College of Medicine), Dr Y Niho (Kyushu Univesity), Dr S Hayashi (Sanshinkai Hara Hospital), and Dr M Tomonaga (Nagasaki University).

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Authors and Affiliations

  1. Fifth Department of Internal Medicine, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan

    A Hiraoka

  2. Department of Biostatistics, School of Health Sciences and Nursing, The University of Tokyo, Tokyo, Japan

    Y Ohashi

  3. Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan

    S Okamoto

  4. Tsubame Rosai Hospital, Tsubame, Japan

    Y Moriyama

  5. Kanagawa Children's Medical Center, Yokohama, Japan

    T Nagao

  6. Fourth Department of Internal Medicine, Japanese Red Cross Nagoya First Hospital, Nagoya, Japan

    Y Kodera

  7. Third Department of Internal Medicine, Kinki University School of Medicine, Osaka, Japan

    A Kanamaru

  8. Hiroshima Red Cross and Atomic Bomb Survivors Hospital, Hiroshima, Japan

    H Dohy

  9. Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan

    T Masaoka

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for the Japanese FK506 BMT Study Group

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Hiraoka, A., Ohashi, Y., Okamoto, S. et al. Phase III study comparing tacrolimus (FK506) with cyclosporine for graft-versus-host disease prophylaxis after allogeneic bone marrow transplantation. Bone Marrow Transplant 28, 181–185 (2001). https://doi.org/10.1038/sj.bmt.1703097

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