A prospective randomised, open-labeled, trial comparing sirolimus-containing versus mTOR-inhibitor-free immunosuppression in patients undergoing liver transplantation for hepatocellular carcinoma

Schnitzbauer, Andreas A ; Zuelke, Carl ; Graeb, Christian ; Rochon, Justine ; Bilbao, Itxarone ; Burra, Patrizia ; de Jong, Koert P ; Duvoux, Christophe ; Kneteman, Norman M ; Adam, Rene ; Bechstein, Wolf O ; Becker, Thomas ; Beckebaum, Susanne ; Chazouillères, Olivier ; Cillo, Umberto ; Colledan, Michele ; Fändrich, Fred ; Gugenheim, Jean ; Hauss, Johann P ; Heise, Michael ; Hidalgo, Ernest ; Jamieson, Neville ; Königsrainer, Alfred ; Lamby, Philipp E ; Lerut, Jan P ; Mäkisalo, Heikki ; Margreiter, Raimund ; Mazzaferro, Vincenzo ; Mutzbauer, Ingrid ; Otto, Gerd ; Pageaux, Georges-Philippe ; Pinna, Antonio D ; Pirenne, Jacques ; Rizell, Magnus ; Rossi, Giorgio ; Rostaing, Lionel ; Roy, Andre ; Turrion, Victor Sanchez ; Schmidt, Jan ; Troisi, Roberto I ; van Hoek, Bart ; Valente, Umberto ; Wolf, Philippe ; Wolters, Heiner ; Mirza, Darius F ; Scholz, Tim ; Steininger, Rudolf ; Soderdahl, Gunnar ; Strasser, Simone I ; Jauch, Karl-Walter ; Neuhaus, Peter ; Schlitt, Hans J ; Geissler, Edward K

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Details

Item type:	Article
Journal or Publication Title:	BMC Cancer
Publisher:	BIOMED CENTRAL LTD
Place of Publication:	LONDON
Volume:	10
Number of Issue or Book Chapter:	1
Date:	2010
Institutions:	Medicine > Lehrstuhl für Chirurgie Medicine > Zentren des Universitätsklinikums Regensburg > Zentrum für Klinische Studien
Identification Number:	Value Type 10.1186/1471-2407-10-190 DOI
Keywords:	ENDOTHELIAL GROWTH-FACTOR; RENAL-CELL CARCINOMA; TUMOR PROGRESSION; RAPAMYCIN; CANCER; CYCLOSPORINE; EFFICACY; THERAPY; TARGET; MODEL;
Dewey Decimal Classification:	600 Technology > 610 Medical sciences Medicine
Status:	Published
Refereed:	Yes, this version has been refereed
Created at the University of Regensburg:	Yes
Item ID:	66130

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Abstract

Background: 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 antineoplastic 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 ...

Abstract

Background: 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 antineoplastic 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 2(1/2)-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.

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