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dc.contributor.authorSchnitzbauer, Andreas A
dc.contributor.authorZuelke, Carl
dc.contributor.authorGraeb, Christian
dc.contributor.authorRochon, Justine
dc.contributor.authorBilbao, Itxarone
dc.contributor.authorBurra, Patrizia
dc.contributor.authorde Jong, Koert P
dc.contributor.authorDuvoux, Christophe
dc.contributor.authorKneteman, Norman M
dc.contributor.authorAdam, Rene
dc.contributor.authorBechstein, Wolf O
dc.contributor.authorBecker, Thomas
dc.contributor.authorBeckebaum, Susanne
dc.contributor.authorChazouillères, Olivier
dc.contributor.authorCillo, Umberto
dc.contributor.authorColledan, Michele
dc.contributor.authorFändrich, Fred
dc.contributor.authorGugenheim, Jean
dc.contributor.authorHauss, Johann P
dc.contributor.authorHeise, Michael
dc.contributor.authorHidalgo, Ernest
dc.contributor.authorJamieson, Neville
dc.contributor.authorKönigsrainer, Alfred
dc.contributor.authorLamby, Philipp E
dc.contributor.authorLerut, Jan P
dc.contributor.authorMäkisalo, Heikki
dc.contributor.authorMargreiter, Raimund
dc.contributor.authorMazzaferro, Vincenzo
dc.contributor.authorMutzbauer, Ingrid
dc.contributor.authorOtto, Gerd
dc.contributor.authorPageaux, Georges-Philippe
dc.contributor.authorPinna, Antonio D
dc.contributor.authorPirenne, Jacques
dc.contributor.authorRizell, Magnus
dc.contributor.authorRossi, Giorgio
dc.contributor.authorRostaing, Lionel
dc.contributor.authorRoy, Andre
dc.contributor.authorTurrion, Victor Sanchez
dc.contributor.authorSchmidt, Jan
dc.contributor.authorTroisi, Roberto I
dc.contributor.authorvan Hoek, Bart
dc.contributor.authorValente, Umberto
dc.contributor.authorWolf, Philippe
dc.contributor.authorWolters, Heiner
dc.contributor.authorMirza, Darius F
dc.contributor.authorScholz, Tim
dc.contributor.authorSteininger, Rudolf
dc.contributor.authorSoderdahl, Gunnar
dc.contributor.authorStrasser, Simone I
dc.contributor.authorJauch, Karl-Walter
dc.contributor.authorNeuhaus, Peter
dc.contributor.authorSchlitt, Hans J
dc.contributor.authorGeissler, Edward K
dc.date.accessioned2011-06-16T16:04:19Z
dc.date.available2011-06-16T16:04:19Z
dc.date.issued2010-05-11
dc.identifier.citationBMC Cancer 2010, 10:190
dc.identifier.issn1471-2407
dc.identifier.urihttp://www.dspace.cam.ac.uk/handle/1810/237837
dc.descriptionRIGHTS : This article is licensed under the BioMed Central licence at http://www.biomedcentral.com/about/license which is similar to the 'Creative Commons Attribution Licence'. In brief you may : copy, distribute, and display the work; make derivative works; or make commercial use of the work - under the following conditions: the original author must be given credit; for any reuse or distribution, it must be made clear to others what the license terms of this work are.
dc.description.abstractBACKGROUND: The potential anti-cancer effects of mammalian target of rapamycin (mTOR) inhibitors are being intensively studied. To date, however, few randomised clinical trials (RCT) have been performed to demonstrate anti-neoplastic effects in the pure oncology setting, and at present, no oncology endpoint-directed RCT has been reported in the high-malignancy risk population of immunosuppressed transplant recipients. Interestingly, since mTOR inhibitors have both immunosuppressive and anti-cancer effects, they have the potential to simultaneously protect against immunologic graft loss and tumour development. Therefore, we designed a prospective RCT to determine if the mTOR inhibitor sirolimus can improve hepatocellular carcinoma (HCC)-free patient survival in liver transplant (LT) recipients with a pre-transplant diagnosis of HCC. METHODS/DESIGN: The study is an open-labelled, randomised, RCT comparing sirolimus-containing versus mTOR-inhibitor-free immunosuppression in patients undergoing LT for HCC. Patients with a histologically confirmed HCC diagnosis are randomised into 2 groups within 4-6 weeks after LT; one arm is maintained on a centre-specific mTOR-inhibitor-free immunosuppressive protocol and the second arm is maintained on a centre-specific mTOR-inhibitor-free immunosuppressive protocol for the first 4-6 weeks, at which time sirolimus is initiated. A 21/2 -year recruitment phase is planned with a 5-year follow-up, testing HCC-free survival as the primary endpoint. Our hypothesis is that sirolimus use in the second arm of the study will improve HCC-free survival. The study is a non-commercial investigator-initiated trial (IIT) sponsored by the University Hospital Regensburg and is endorsed by the European Liver and Intestine Transplant Association; 13 countries within Europe, Canada and Australia are participating. DISCUSSION: If our hypothesis is correct that mTOR inhibition can reduce HCC tumour growth while simultaneously providing immunosuppression to protect the liver allograft from rejection, patients should experience less post-transplant problems with HCC recurrence, and therefore could expect a longer and better quality of life. A positive outcome will likely change the standard of posttransplant immunosuppressive care for LT patients with HCC. TRIAL REGISTER: Trial registered at http://www.clinicaltrials.gov: NCT00355862(EudraCT Number: 2005-005362-36).
dc.language.isoen
dc.publisherSpringer Science and Business Media LLC
dc.rightsAll Rights Reserved
dc.rights.urihttps://www.rioxx.net/licenses/all-rights-reserved/
dc.titleA prospective randomised, open-labeled, trial comparing sirolimus-containing versus mTOR-inhibitor-free immunosuppression in patients undergoing liver transplantation for hepatocellular carcinoma.
dc.typeArticle
dc.type.versionPublished Version
dc.date.updated2011-06-16T16:04:19Z
dc.rights.holderSchnitzbauer et al.; licensee BioMed Central Ltd.
prism.publicationNameBMC Cancer
pubs.declined2017-10-11T13:54:29.678+0100
dcterms.dateAccepted2010-05-11
rioxxterms.versionofrecord10.1186/1471-2407-10-190
dc.identifier.eissn1471-2407
cam.issuedOnline2010-05-11


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