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

(2010) BMC CANCER. 10.
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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 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.
Keywords
CANCER, CYCLOSPORINE, RAPAMYCIN, TUMOR PROGRESSION, RENAL-CELL CARCINOMA, EFFICACY, THERAPY, TARGET, MODEL, ENDOTHELIAL GROWTH-FACTOR

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Chicago
Schnitzbauer, Andreas A, Carl Zuelke, Christian Graeb, Justine Rochon, Itxarone Bilbao, Patrizia Burra, Koert P de Jong, et al. 2010. “A Prospective Randomised, Open-labeled, Trial Comparing Sirolimus-containing Versus mTOR-inhibitor-free Immunosuppression in Patients Undergoing Liver Transplantation for Hepatocellular Carcinoma.” Bmc Cancer 10.
APA
Schnitzbauer, A. A., Zuelke, C., Graeb, C., Rochon, J., Bilbao, I., Burra, P., de Jong, K. P., et al. (2010). A prospective randomised, open-labeled, trial comparing sirolimus-containing versus mTOR-inhibitor-free immunosuppression in patients undergoing liver transplantation for hepatocellular carcinoma. BMC CANCER, 10.
Vancouver
1.
Schnitzbauer AA, Zuelke C, Graeb C, Rochon J, Bilbao I, Burra P, et al. A prospective randomised, open-labeled, trial comparing sirolimus-containing versus mTOR-inhibitor-free immunosuppression in patients undergoing liver transplantation for hepatocellular carcinoma. BMC CANCER. 2010;10.
MLA
Schnitzbauer, Andreas A et al. “A Prospective Randomised, Open-labeled, Trial Comparing Sirolimus-containing Versus mTOR-inhibitor-free Immunosuppression in Patients Undergoing Liver Transplantation for Hepatocellular Carcinoma.” BMC CANCER 10 (2010): n. pag. Print.
@article{1067974,
  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.},
  articleno    = {190},
  author       = {Schnitzbauer, Andreas A and Zuelke, Carl and Graeb, Christian and Rochon, Justine and Bilbao, Itxarone and Burra, Patrizia and de Jong, Koert P and Duvoux, Christophe and Kneteman, Norman M and Adam, Rene and Bechstein, Wolf O and Becker, Thomas and Beckebaum, Susanne and Chazouilleres, Olivier and Cillo, Umberto and Colledan, Michele and Fandrich, Fred and Gugenheim, Jean and Hauss, Johann P and Heise, Michael and Hidalgo, Ernest and Jamieson, Neville and Konigsrainer, Alfred and Lamby, Philipp E and Lerut, Jan P and Makisalo, Heikki and Margreiter, Raimund and Mazzaferro, Vincenzo and Mutzbauer, Ingrid and Otto, Gerd and Pageaux, Georges-Philippe and Pinna, Antonio D and Pirenne, Jacques and Rizell, Magnus and Rossi, Giorgio and Rostaing, Lionel and Roy, Andre and Sanchez Turrion, Victor and Schmidt, Jan and Troisi, Roberto and van Hoek, Bart and Valente, Umberto and Wolf, Philippe and Wolters, Heiner and Mirza, Darius F and Scholz, Tim and Steininger, Rudolf and Soderdahl, Gunnar and Strasser, Simone I and Jauch, Karl-Walter and Neuhaus, Peter and Schlitt, Hans J and Geissler, Edward K},
  issn         = {1471-2407},
  journal      = {BMC CANCER},
  language     = {eng},
  pages        = {8},
  title        = {A prospective randomised, open-labeled, trial comparing sirolimus-containing versus mTOR-inhibitor-free immunosuppression in patients undergoing liver transplantation for hepatocellular carcinoma},
  url          = {http://dx.doi.org/10.1186/1471-2407-10-190},
  volume       = {10},
  year         = {2010},
}

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