SINGLE CENTER EXPERIENCE OF 50 CONSECUTIVE PANCREAS TRANSPLANT RECIPIENTS RECEIVING MYCOPHENOLATE MOFETIL (MMF) AND TACROLIMUS (TAC) AS PRIMARY MAINTENANCE IMMUNOTHERAPY.

Abstract

687 In an attempt to contribute useful data on the use of MMF and TAC as primary maintenance immunotherapy in a meaningful number of pts, we describe our experience with 50 consecutive pancreas tx recipients (47 SPK, 2 PTA, 1 PAK) receiving tx from 7/95 to 1/98. The mean (± SD) follow-up time was 10 ± 7 months (range 1-30). All pts were given MMF (3 gm/d × 6 mo, then 2 gm/d), TAC (target 12 hr trough level 10 ng/ml), anti-lymphocyte globulin induction (20 mg/kg/d × 7-14 d), and prednisone. The tx outcomes in terms of 2 yr actuarial pt and graft survival, and1 yr actuarial rejection rates were evaluated. The incidence of CMV infection, PTLD, and length of initial post-operative stay were determined. Pt demographics: 33M:17F; mean age: 36 yrs; race: 40 caucasian, 6 black, 4 hispanic; mean duration of diabetes: 24 yrs; mean HLA match: AB=0.86, DR=0.3; mean peak PRA: 9%. In all cases bladder drainage was used. MMF was tolerated in all pts. 7 pts on TAC were converted to Neoral® due to: alopecia (n=1), GI distress (n=3), or hyperglycemia (n=3). 2 yr actuarial pt, kidney and pancreas survivals, and 1 yr actuarial rejection rates are shown for the entire group (N=50) and stratified as to whether conversion from TAC to Neoral® occurred:TableThe 2 yr actuarial patient and graft survivals were all >90%. There was one death (suicide); 2 kidney losses (1 death, 1 rupture); and 3 pancreas losses (death, thrombosis, pancreatitis). 9 pts out of 50 had a rejection episode within a year (24.1%). However, among the 43 pts maintained on MMF / TAC, only 5 pts had rejection (14.4%), versus 4 of 7 (42.8%) pts that had rejection after conversion to Neoral®. This is a statistically significant difference (p<0.006). There have been 3 cases of CMV (all tissue invasive, all successfully treated). 2 of 20 pts with CMV were high risk (+ donor / - recipient combinations). No cases of PTLD occurred. The mean initial hospital stay post-tx was 6.9 ± 2.1 d. Conclusion: The combination of MMF and TAC resulted in excellent pt and graft survival rates, a very low rate of rejection, and rare CMV.