SINGLE-CENTER EXPERIENCE WITH PRIMARY ORTHOTOPIC LIVER-TRANSPLANTATION WITH FK-506 IMMUNOSUPPRESSION

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 y ears of preclinical research, a clinical trial of FK 506 for orthotopi c liver transplantation was begun in February 1989, first as a rescue therapy for patients with intractable rejection with conventional immu nosuppression, then as a primary drug. Methods Between August 1989 and December 1993, 1391 recipients (1188 adult and 203 pediatric) of prim ary liver allografts were treated with FK 506 from the outset. Results from these patients were analyzed and compared with those of 1212 his torical control patients (971 adult and 241 pediatric) given cyclospor ine-based immunosuppression. Results Actuarial survival at 4 years was 86.2% with FK 506 versus 65.5% with cyclosporine in the pediatric pat ients (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 pa tients. Four-year graft survival was 77.0% with FK 506 versus 48.4% wi th 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 gr aft loss from uncontrollable rejection, sepsis, technical failure, and recurrent original liver disease were responsible for the improved re sults with FK 506 therapy. Conclusions FK 506 is a potent and superior immunosuppressive agent for orthotopic liver transplantation.