From: "Dr. D. Kossove" <doctordee@telkomsa.net>
To: "LMS List" <L-M-SARCOMA@LISTSERV.ACOR.ORG>; "Rare Cancer List" <RARE-CANCER@LISTSERV.ACOR.ORG>
Subject: Oral Mesna with Ifos
Date: Thursday, January 01, 2004 1:08 PM

http://clincancerres.aacrjournals.org/cgi/content/abstract/9/16/5829
~~~~~~~~~~~~~`

Crossover Randomized Comparison of Intravenous versus Intravenous/Oral
Mesna in Soft Tissue Sarcoma Treated with High-Dose Ifosfamide  --
Clinical Cancer Research

 http://www.mdlinx.com/HemeOncLinx/thearts.cfm?artid=804887&specid=17

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 patient tolerance and convenience, allow for a
reduction in elective hospitalizations for ifosfamide chemotherapy,
reduce the potential morbidity associated with inpatient
administration of chemotherapy, and likely result in decreased costs
of care...


~~~~~~~~~~~~~~~~~~~~~~~


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Clinical Cancer Research Vol. 9, 5829-5834, December 1, 2003
 2003 American Association for Cancer Research 

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Clinical Trials 

Crossover Randomized Comparison of Intravenous versus Intravenous/Oral Mesna in Soft Tissue Sarcoma Treated with High-Dose Ifosfamide 
Joseph R. Mace1, Mary L. Keohan2, Heinz Bernardy3, Klaus Junge3, Georg Niebch3, Peter Romeis3, Aangelika Thoma3, Thomas Wagner4, Udo Mueller3, George Demetri5 and Laurence H. Baker1 
1 Division of Hematology/Oncology, University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan;
2 Herbert Irving Comprehensive Cancer Center, Columbia University, New York, New York;
3 Biometrical Department, ASTA Medica AG Frankfurt, Germany;
4 University Hospital Luebeck, Luebeck, Germany; and
5 Division of Medical Oncology, Dana-Farber Cancer Institute, Harvard University, Boston, Massachusetts 

ABSTRACT

Purpose: We conducted our study to determine the pharmacokinetics (PK) and clinical efficacy of oral mesna in patients receiving ifosfamide for soft tissue sarcoma. 

Experimental Design: Seventeen patients were enrolled in a randomized prospective Phase I/II study. Seventeen patients were exposed to study medication. Ifosfamide was given at a dose of 2 g/m2/day for 5 days on a 21-day cycle. Before the first cycle, all patients 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% ifosfamide dose) at 0, 4, and 8 h. The i.v./oral arm consisted of an i.v. mesna dosing (20% ifosfamide dose) at 0 h, followed by oral tablet dosing (40% ifosfamide dose) at 2 and 6 h. In-patient clinical monitoring and phlebotomy and urine sampling for mesna, dimesna, and ifosfamide PK were performed on all chemotherapy days. 

Results: Thirteen patients were evaluable for PK and 17 for efficacy and toxicity. No significant differences were detected in the plasma PK of the concomitantly infused ifosfamide. Rates of hemorrhagic cystitis were similar across mesna schedules. 

Four of 10 evaluable patients 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 patient tolerance and convenience, allow for a reduction in elective hospitalizations for ifosfamide chemotherapy, reduce the potential morbidity associated with inpatient administration of chemotherapy, and likely result in decreased costs of care. 









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Copyright  2003 by the American Association for Cancer Research.  