Assessment of bioequivalence of a generic cyclosporine (Equoral) by a prospective randomized controlled trial on allogeneic stem cell transplant recipients.

INTRODUCTION: Bioequivalence of Equoral has been suggested by measurements of pharmacokinetic parameters in healthy volunteers and in stable renal transplant recipients, but not study in allogeneic stem cell transplant (ASCT) recipients. The aim of our study was to compare the pharmacokinetics and safety of Equoral to Neoral solution among ASCT recipients. PATIENTS AND METHODS: Our open-label, two-way crossover, randomized controlled trial compared Equoral versus Neoral solutions in ASCT recipients. The 30 enrolled patients from June 2007 to November 2008 had a 7 to 14-day duration of the test period. A 10-point blood sampling from 0 to 12 hours measured Cmax (extent of absorption), tmax (rate of absorption) and AUC(0-12h) (area under the concentration-time curve) calculated by the linear trapezoid rule. The study protocol was approved by the ethics committee. RESULTS: Median age was 26 years (range = 6-47). The mean pharmacokinetic features were: AUC(0-12h): Equoral 4162 ± 1231 ng·mL/h vs Neoral 4370 ± 1059 ng·mL/h (P = .50); Cmax: Equoral 821 ± 244 ng/mL vs Neoral 834 ± 298 ng/mL (P = .86); and tmax: 105 minutes for both formulations. Comparable toxicities and rates of graft-versus-host disease were recorded in both groups. CONCLUSION: We suggest that Equoral and Neoral solution can be considered interchangeable in ASCT recipients.

[Histologic and prognostic study of nephroblastoma in central Tunisia]. / Etude anatomoclinique et pronostique des néphroblastomes dans le centre tunisien.

Nephroblastoma is a common malignant tumour in childhood that benefited from therapeutic progress. This is a retrospective study of 35 nephroblastoma diagnosed and treated in the central region of Tunisia within the last 8 years (1991-1999). We report and compare clinical features, therapeutic results and prognostic factors with those reported in the literature. The mean age was 3-years and 9 months, and the main clinical symptom was abdominal mass. Pre-operative chemotherapy was done in 32 cases and the objective response rate was 58%. Thirty-three patients had radical nephrectomy and only one had partial nephrectomy. Histologic analysis concluded to an anaplastic nephroblastoma in 2 cases. Using the classification of the international society of pediatric oncology, 11.4% of tumours were stage I, 48.6% stage II, 5.7% stage III, 11.4% stage IV and 2.9% stage V. The overall 5 years survival was 80%; tumour relapse was only independent prognosis factor in multivariate analysis (P < 0.01). Prognosis of nephroblastoma has been improved with chemotherapy and the pluridisciplinar treatment.