Crossover randomized comparison of intravenous versus intravenous/oral mesna in soft tissue @entity242 treated with high-dose XXXX .

@entity1 @entity137 @entity242 @entity1260 @entity2335
PURPOSE: We conducted our study to determine the pharmacokinetics (PK) and clinical efficacy of oral mesna in @entity1 receiving @entity1260 for soft tissue @entity242 . EXPERIMENTAL DESIGN: Seventeen @entity1 were enrolled in a randomized prospective Phase I/II study. Seventeen @entity1 were exposed to study medication. @entity1260 was given at a dose of 2 g/m2/day for 5 days on a 21-day cycle. Before the first cycle, all @entity1 were randomized onto a crossover design and received either the approved i.v. or i.v./oral mesna regimen, with crossover for the second cycle of chemotherapy. The i.v. mesna regimen consisted of dosings (20% @entity1260 dose) at 0, 4, and 8 h. The i.v./oral arm consisted of an i.v. mesna dosing (20% @entity1260 dose) at 0 h, followed by oral tablet dosing (40% @entity1260 dose) at 2 and 6 h. In- @entity1 clinical monitoring and phlebotomy and urine sampling for mesna, dimesna, and @entity1260 PK were performed on all chemotherapy days. RESULTS: Thirteen @entity1 were evaluable for PK and 17 for efficacy and @entity137 . No significant differences were detected in the plasma PK of the concomitantly infused @entity1260 . Rates of @entity2335 were similar across mesna schedules. Four of 10 evaluable @entity1 demonstrated objective response. CONCLUSION: On the basis of our study, an i.v./oral mesna regimen is at least as uroprotective as the approved i.v. regimen. The i.v./oral regimen will improve @entity1 tolerance and convenience, allow for a reduction in elective hospitalizations for @entity1260 chemotherapy, reduce the potential morbidity associated with inpatient administration of chemotherapy, and likely result in decreased costs of care.
