Single-center experience with primary orthotopic liver transplantation with FK 506 immunosuppression

Satoru Todo, John J. Fung, Thomas E. Starzl, Andreas Tzakis, Howard Doyle, Kareem Abu-Elmagd, Ashok Jain, Rick Selby, Oscar Bronsther, Wallis Marsh, Hector Ramos, Jorge Reyes, Timothy Gayowski, Adrian Casavilla, Forrest Dodson, Hiroyuki Furukawa, Ignazio Marino, Antonio Pinna, Bakr Nour, Nicholas Jabbour & 8 others George Mazanegos, John McMichael, Shimon Kusne, Raman Venkataramanan, Vijay Warty, Noriko Murase, Anthony J. Demetris, Shunzaburo Iwatsuki

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Abstract

Objective: The efficacy for primary orthotopic liver transplantation of a new immunosuppressive agent, FK 506 (tacrolimus, Prograf, Fujisawa USA, Deerfield, IL), was determined. Summary Background Data: After 3 years of preclinical research, a clinical trial of FK 506 for orthotopic liver transplantation was begun in February 1989, first as a rescue therapy for patients with intractable rejection with conventional immunosuppression, then as a primary drug. Methods: Between August 1989 and December 1993, 1391 recipients (1188 adult and 203 pediatric) of primary liver allografts were treated with FK 506 from the outset. Results from these patients were analyzed and compared with those of 1212 historical control patients (971 adult and 241 pediatric) given cyclosporine-based immunosuppression. Results: Actuarial survival at 4 years was 86.2% with FK 506 versus 65.5% with cyclosporine in the pediatric patients (p < 0.0000) and 71.4% versus 65.5% in the adults (p < 0.0005). The need for retransplantation was reduced significantly for FK 506 patients. Four-year graft survival was 77.0% with FK 506 versus 48.4% with cyclosporine in the pediatric patients (p < 0.0000), and 61.9% with FK 506 versus 51.4% with cyclosporine in the adult recipients (p < 0.0000). Regression analysis revealed that reductions in mortality or graft loss from uncontrollable rejection, sepsis, technical failure, and recurrent original liver disease were responsible for the improved results with FK 506 therapy. Conclusions: FK 506 is a potent and superior immunosuppressive agent for orthotopic liver transplantation.

Original languageEnglish
Pages (from-to)297-309
Number of pages13
JournalAnnals of Surgery
Volume220
Issue number3
Publication statusPublished - Sep 1994
Externally publishedYes

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Tacrolimus
Liver Transplantation
Immunosuppression
Cyclosporine
Pediatrics
Immunosuppressive Agents
Graft Survival
Allografts
Liver Diseases
Sepsis
Regression Analysis
Clinical Trials
Transplants

ASJC Scopus subject areas

  • Surgery

Cite this

Todo, S., Fung, J. J., Starzl, T. E., Tzakis, A., Doyle, H., Abu-Elmagd, K., ... Iwatsuki, S. (1994). Single-center experience with primary orthotopic liver transplantation with FK 506 immunosuppression. Annals of Surgery, 220(3), 297-309.

Single-center experience with primary orthotopic liver transplantation with FK 506 immunosuppression. / Todo, Satoru; Fung, John J.; Starzl, Thomas E.; Tzakis, Andreas; Doyle, Howard; Abu-Elmagd, Kareem; Jain, Ashok; Selby, Rick; Bronsther, Oscar; Marsh, Wallis; Ramos, Hector; Reyes, Jorge; Gayowski, Timothy; Casavilla, Adrian; Dodson, Forrest; Furukawa, Hiroyuki; Marino, Ignazio; Pinna, Antonio; Nour, Bakr; Jabbour, Nicholas; Mazanegos, George; McMichael, John; Kusne, Shimon; Venkataramanan, Raman; Warty, Vijay; Murase, Noriko; Demetris, Anthony J.; Iwatsuki, Shunzaburo.

In: Annals of Surgery, Vol. 220, No. 3, 09.1994, p. 297-309.

Research output: Contribution to journalArticle

Todo, S, Fung, JJ, Starzl, TE, Tzakis, A, Doyle, H, Abu-Elmagd, K, Jain, A, Selby, R, Bronsther, O, Marsh, W, Ramos, H, Reyes, J, Gayowski, T, Casavilla, A, Dodson, F, Furukawa, H, Marino, I, Pinna, A, Nour, B, Jabbour, N, Mazanegos, G, McMichael, J, Kusne, S, Venkataramanan, R, Warty, V, Murase, N, Demetris, AJ & Iwatsuki, S 1994, 'Single-center experience with primary orthotopic liver transplantation with FK 506 immunosuppression', Annals of Surgery, vol. 220, no. 3, pp. 297-309.
Todo S, Fung JJ, Starzl TE, Tzakis A, Doyle H, Abu-Elmagd K et al. Single-center experience with primary orthotopic liver transplantation with FK 506 immunosuppression. Annals of Surgery. 1994 Sep;220(3):297-309.
Todo, Satoru ; Fung, John J. ; Starzl, Thomas E. ; Tzakis, Andreas ; Doyle, Howard ; Abu-Elmagd, Kareem ; Jain, Ashok ; Selby, Rick ; Bronsther, Oscar ; Marsh, Wallis ; Ramos, Hector ; Reyes, Jorge ; Gayowski, Timothy ; Casavilla, Adrian ; Dodson, Forrest ; Furukawa, Hiroyuki ; Marino, Ignazio ; Pinna, Antonio ; Nour, Bakr ; Jabbour, Nicholas ; Mazanegos, George ; McMichael, John ; Kusne, Shimon ; Venkataramanan, Raman ; Warty, Vijay ; Murase, Noriko ; Demetris, Anthony J. ; Iwatsuki, Shunzaburo. / Single-center experience with primary orthotopic liver transplantation with FK 506 immunosuppression. In: Annals of Surgery. 1994 ; Vol. 220, No. 3. pp. 297-309.
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abstract = "Objective: The efficacy for primary orthotopic liver transplantation of a new immunosuppressive agent, FK 506 (tacrolimus, Prograf, Fujisawa USA, Deerfield, IL), was determined. Summary Background Data: After 3 years of preclinical research, a clinical trial of FK 506 for orthotopic liver transplantation was begun in February 1989, first as a rescue therapy for patients with intractable rejection with conventional immunosuppression, then as a primary drug. Methods: Between August 1989 and December 1993, 1391 recipients (1188 adult and 203 pediatric) of primary liver allografts were treated with FK 506 from the outset. Results from these patients were analyzed and compared with those of 1212 historical control patients (971 adult and 241 pediatric) given cyclosporine-based immunosuppression. Results: Actuarial survival at 4 years was 86.2{\%} with FK 506 versus 65.5{\%} with cyclosporine in the pediatric patients (p < 0.0000) and 71.4{\%} versus 65.5{\%} in the adults (p < 0.0005). The need for retransplantation was reduced significantly for FK 506 patients. Four-year graft survival was 77.0{\%} with FK 506 versus 48.4{\%} with cyclosporine in the pediatric patients (p < 0.0000), and 61.9{\%} with FK 506 versus 51.4{\%} with cyclosporine in the adult recipients (p < 0.0000). Regression analysis revealed that reductions in mortality or graft loss from uncontrollable rejection, sepsis, technical failure, and recurrent original liver disease were responsible for the improved results with FK 506 therapy. Conclusions: FK 506 is a potent and superior immunosuppressive agent for orthotopic liver transplantation.",
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T1 - Single-center experience with primary orthotopic liver transplantation with FK 506 immunosuppression

AU - Todo, Satoru

AU - Fung, John J.

AU - Starzl, Thomas E.

AU - Tzakis, Andreas

AU - Doyle, Howard

AU - Abu-Elmagd, Kareem

AU - Jain, Ashok

AU - Selby, Rick

AU - Bronsther, Oscar

AU - Marsh, Wallis

AU - Ramos, Hector

AU - Reyes, Jorge

AU - Gayowski, Timothy

AU - Casavilla, Adrian

AU - Dodson, Forrest

AU - Furukawa, Hiroyuki

AU - Marino, Ignazio

AU - Pinna, Antonio

AU - Nour, Bakr

AU - Jabbour, Nicholas

AU - Mazanegos, George

AU - McMichael, John

AU - Kusne, Shimon

AU - Venkataramanan, Raman

AU - Warty, Vijay

AU - Murase, Noriko

AU - Demetris, Anthony J.

AU - Iwatsuki, Shunzaburo

PY - 1994/9

Y1 - 1994/9

N2 - Objective: The efficacy for primary orthotopic liver transplantation of a new immunosuppressive agent, FK 506 (tacrolimus, Prograf, Fujisawa USA, Deerfield, IL), was determined. Summary Background Data: After 3 years of preclinical research, a clinical trial of FK 506 for orthotopic liver transplantation was begun in February 1989, first as a rescue therapy for patients with intractable rejection with conventional immunosuppression, then as a primary drug. Methods: Between August 1989 and December 1993, 1391 recipients (1188 adult and 203 pediatric) of primary liver allografts were treated with FK 506 from the outset. Results from these patients were analyzed and compared with those of 1212 historical control patients (971 adult and 241 pediatric) given cyclosporine-based immunosuppression. Results: Actuarial survival at 4 years was 86.2% with FK 506 versus 65.5% with cyclosporine in the pediatric patients (p < 0.0000) and 71.4% versus 65.5% in the adults (p < 0.0005). The need for retransplantation was reduced significantly for FK 506 patients. Four-year graft survival was 77.0% with FK 506 versus 48.4% with cyclosporine in the pediatric patients (p < 0.0000), and 61.9% with FK 506 versus 51.4% with cyclosporine in the adult recipients (p < 0.0000). Regression analysis revealed that reductions in mortality or graft loss from uncontrollable rejection, sepsis, technical failure, and recurrent original liver disease were responsible for the improved results with FK 506 therapy. Conclusions: FK 506 is a potent and superior immunosuppressive agent for orthotopic liver transplantation.

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