Agency Fact Sheet, Office of Governor of Drug Control Policy, FY2009

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In vivo evaluation of the anti-tumoral effect of sunitinib eluting beads in the rabbit VX2 tumor model

Purpose: To study the anti-tumoral effect of sunitinib eluting beads in the rabbit VX2 tumor modelMaterials: VX2 tumor were implanted in the left liver lobe of New-Zealand white rabbits. Seven animals received 0.2ml of DC Beads loaded with 6mg of sunitinb (group 1), 6 animals received 0.2ml of DC Beads (group 2) and 6 animals received NaCl 0.9% intra arterially in the left hepatic artery. One animal in each group was sacrificed at 24 hours and the others were left to survive. Liver enzyme were measured daily. In group 1 plasmatic sunitinib concentration were measured daily by LC MS/MS tandem mass spectroscopy. At day 15 all living animals were sacrficed. After sacrifice, or premature euthanasia the livers were harvested for determination of the VEGF receptor tyrosine kinase activity by western blot and histopathological examination.Results: In group 1, no animal died during follow-up. In group 2 and 3, respectively 2 and 3 animals died during follow-up. In group 1 plasmatic sunitinib level remained under therapeutic concentration during the whole experiment. There was an evident lack of phosphorylation of the RTK In group 1 and there was an augmentation of the RTK phosphorylation in group 2 at 24 hours. No difference in RTK activity was noticable at 15 days. From the histopathological point of view it was unpossible to differentiate treatment induced from spontaneous necrosis of tumors.Conclusions: Administration of sunitinib eluting Beads in VX2 carrying rabbits inhibits the activation of RTK's triggered by ischemia. It also seems to prolong survival of the treated animals.

Suivi thérapeutique de l'imatinib = Therapeutische Drug-Monitoring von Imatinib

Monitoring spielt eine wichtige Rolle zur Therapieevaluierung und Behandlungsentscheidung - solange es auf der Basis der Messung von entsprechenden klinischen oder validierten Surrogat-Markern stattfindet. Im Hinblick auf die Imatinib-Therapie scheint das «Therapeutische Drug-Monitoring» (TDM) ein nützlicher Ansatz zum Therapie-Monitoring der CML-Behandlung zu sein, welches die Plasmakonzentration des Arzneimittels als Marker zur Therapieüberwachung verwendet. Imatinib-Plasmakonzentrationen variieren beträchtlich von Patient zu Patient unter dem gleichen Dosierungsschema, aufgrund der interindividuell unterschiedlichen Pharmakokinetik des Arzneimittels. Für die Plasmaexposition wurde gezeigt, dass sie mit dem klinischen Outcome von CML-Patienten korreliert - sowohl im Bezug auf das Therapieansprechen als auch auf das Nebenwirkungsprofil. Es ist noch unklar, ob das TDM von Imatinib nur im Falle von klinischen Problemen Verwendung finden sollte oder ob CML-Patienten bereits von einem systematischen, präventiven «Routine»-Monitoring zur Therapieindividualisierung - zur Steuerung der Plasmakonzentration in einen therapeutischen Bereich - profitieren könnten, welches in letzter Zeit immer häufiger empfohlen wird. Um diese Fragestellung zu beantworten, nimmt eine prospektive, randomisiert kontrollierte Schweizer Studie CML-Patienten auf, die seit weniger als 5 Jahren mit Imatinib behandelt werden, und bietet das TDM zudem für alle Patienten im Falle von klinischen Problemen an.

Agency Fact Sheet, Governor's Office of Drug Control Policy, FY2010

This document produced by the Iowa Department of Administrative Services has been developed to provide a multitude of information about executive branch agencies/department on a single sheet of paper. The facts provides general information, contact information, workforce data, leave and benefits information and affirmative action data.

Agency Fact Sheet, Governors Office of Drug Control Policy, FY2011

This document produced by the Iowa Department of Administrative Services has been developed to provide a multitude of information about executive branch agencies/department on a single sheet of paper. The facts provides general information, contact information, workforce data, leave and benefits information and affirmative action data.