A prospective randomised, open-labeled, trial comparing sirolimus-containing versus mTOR-inhibitor-free immunosuppression in patients undergoing liver transplantation for hepatocellular carcinoma
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 anti-neoplastic effects in the pure oncology setting, and at present, no oncology e...
Ausführliche Beschreibung
Autor*in: |
Schnitzbauer, Andreas A [verfasserIn] |
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Englisch |
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2010 |
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Anmerkung: |
© Schnitzbauer et al; licensee BioMed Central Ltd. 2010. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( |
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Übergeordnetes Werk: |
Enthalten in: BMC cancer - London : BioMed Central, 2001, 10(2010), 1 vom: 11. Mai |
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Übergeordnetes Werk: |
volume:10 ; year:2010 ; number:1 ; day:11 ; month:05 |
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DOI / URN: |
10.1186/1471-2407-10-190 |
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SPR027624730 |
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100 | 1 | |a Schnitzbauer, Andreas A |e verfasserin |4 aut | |
245 | 1 | 2 | |a A prospective randomised, open-labeled, trial comparing sirolimus-containing versus mTOR-inhibitor-free immunosuppression in patients undergoing liver transplantation for hepatocellular carcinoma |
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520 | |a 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 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 $ 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. 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) | ||
650 | 4 | |a Liver Transplant |7 (dpeaa)DE-He213 | |
650 | 4 | |a Sirolimus |7 (dpeaa)DE-He213 | |
650 | 4 | |a Milan Criterion |7 (dpeaa)DE-He213 | |
650 | 4 | |a Data Safety Monitoring Board |7 (dpeaa)DE-He213 | |
650 | 4 | |a Liver Allograft |7 (dpeaa)DE-He213 | |
700 | 1 | |a Zuelke, Carl |4 aut | |
700 | 1 | |a Graeb, Christian |4 aut | |
700 | 1 | |a Rochon, Justine |4 aut | |
700 | 1 | |a Bilbao, Itxarone |4 aut | |
700 | 1 | |a Burra, Patrizia |4 aut | |
700 | 1 | |a de Jong, Koert P |4 aut | |
700 | 1 | |a Duvoux, Christophe |4 aut | |
700 | 1 | |a Kneteman, Norman M |4 aut | |
700 | 1 | |a Adam, Rene |4 aut | |
700 | 1 | |a Bechstein, Wolf O |4 aut | |
700 | 1 | |a Becker, Thomas |4 aut | |
700 | 1 | |a Beckebaum, Susanne |4 aut | |
700 | 1 | |a Chazouillères, Olivier |4 aut | |
700 | 1 | |a Cillo, Umberto |4 aut | |
700 | 1 | |a Colledan, Michele |4 aut | |
700 | 1 | |a Fändrich, Fred |4 aut | |
700 | 1 | |a Gugenheim, Jean |4 aut | |
700 | 1 | |a Hauss, Johann P |4 aut | |
700 | 1 | |a Heise, Michael |4 aut | |
700 | 1 | |a Hidalgo, Ernest |4 aut | |
700 | 1 | |a Jamieson, Neville |4 aut | |
700 | 1 | |a Königsrainer, Alfred |4 aut | |
700 | 1 | |a Lamby, Philipp E |4 aut | |
700 | 1 | |a Lerut, Jan P |4 aut | |
700 | 1 | |a Mäkisalo, Heikki |4 aut | |
700 | 1 | |a Margreiter, Raimund |4 aut | |
700 | 1 | |a Mazzaferro, Vincenzo |4 aut | |
700 | 1 | |a Mutzbauer, Ingrid |4 aut | |
700 | 1 | |a Otto, Gerd |4 aut | |
700 | 1 | |a Pageaux, Georges-Philippe |4 aut | |
700 | 1 | |a Pinna, Antonio D |4 aut | |
700 | 1 | |a Pirenne, Jacques |4 aut | |
700 | 1 | |a Rizell, Magnus |4 aut | |
700 | 1 | |a Rossi, Giorgio |4 aut | |
700 | 1 | |a Rostaing, Lionel |4 aut | |
700 | 1 | |a Roy, Andre |4 aut | |
700 | 1 | |a Turrion, Victor Sanchez |4 aut | |
700 | 1 | |a Schmidt, Jan |4 aut | |
700 | 1 | |a Troisi, Roberto I |4 aut | |
700 | 1 | |a van Hoek, Bart |4 aut | |
700 | 1 | |a Valente, Umberto |4 aut | |
700 | 1 | |a Wolf, Philippe |4 aut | |
700 | 1 | |a Wolters, Heiner |4 aut | |
700 | 1 | |a Mirza, Darius F |4 aut | |
700 | 1 | |a Scholz, Tim |4 aut | |
700 | 1 | |a Steininger, Rudolf |4 aut | |
700 | 1 | |a Soderdahl, Gunnar |4 aut | |
700 | 1 | |a Strasser, Simone I |4 aut | |
700 | 1 | |a Jauch, Karl-Walter |4 aut | |
700 | 1 | |a Neuhaus, Peter |4 aut | |
700 | 1 | |a Schlitt, Hans J |4 aut | |
700 | 1 | |a Geissler, Edward K |4 aut | |
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10.1186/1471-2407-10-190 doi (DE-627)SPR027624730 (SPR)1471-2407-10-190-e DE-627 ger DE-627 rakwb eng Schnitzbauer, Andreas A verfasserin aut A prospective randomised, open-labeled, trial comparing sirolimus-containing versus mTOR-inhibitor-free immunosuppression in patients undergoing liver transplantation for hepatocellular carcinoma 2010 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Schnitzbauer et al; licensee BioMed Central Ltd. 2010. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( 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 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 $ 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. 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) Liver Transplant (dpeaa)DE-He213 Sirolimus (dpeaa)DE-He213 Milan Criterion (dpeaa)DE-He213 Data Safety Monitoring Board (dpeaa)DE-He213 Liver Allograft (dpeaa)DE-He213 Zuelke, Carl aut Graeb, Christian aut Rochon, Justine aut Bilbao, Itxarone aut Burra, Patrizia aut de Jong, Koert P aut Duvoux, Christophe aut Kneteman, Norman M aut Adam, Rene aut Bechstein, Wolf O aut Becker, Thomas aut Beckebaum, Susanne aut Chazouillères, Olivier aut Cillo, Umberto aut Colledan, Michele aut Fändrich, Fred aut Gugenheim, Jean aut Hauss, Johann P aut Heise, Michael aut Hidalgo, Ernest aut Jamieson, Neville aut Königsrainer, Alfred aut Lamby, Philipp E aut Lerut, Jan P aut Mäkisalo, Heikki aut Margreiter, Raimund aut Mazzaferro, Vincenzo aut Mutzbauer, Ingrid aut Otto, Gerd aut Pageaux, Georges-Philippe aut Pinna, Antonio D aut Pirenne, Jacques aut Rizell, Magnus aut Rossi, Giorgio aut Rostaing, Lionel aut Roy, Andre aut Turrion, Victor Sanchez aut Schmidt, Jan aut Troisi, Roberto I aut van Hoek, Bart aut Valente, Umberto aut Wolf, Philippe aut Wolters, Heiner aut Mirza, Darius F aut Scholz, Tim aut Steininger, Rudolf aut Soderdahl, Gunnar aut Strasser, Simone I aut Jauch, Karl-Walter aut Neuhaus, Peter aut Schlitt, Hans J aut Geissler, Edward K aut Enthalten in BMC cancer London : BioMed Central, 2001 10(2010), 1 vom: 11. Mai (DE-627)326643710 (DE-600)2041352-X 1471-2407 nnns volume:10 year:2010 number:1 day:11 month:05 https://dx.doi.org/10.1186/1471-2407-10-190 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 10 2010 1 11 05 |
spelling |
10.1186/1471-2407-10-190 doi (DE-627)SPR027624730 (SPR)1471-2407-10-190-e DE-627 ger DE-627 rakwb eng Schnitzbauer, Andreas A verfasserin aut A prospective randomised, open-labeled, trial comparing sirolimus-containing versus mTOR-inhibitor-free immunosuppression in patients undergoing liver transplantation for hepatocellular carcinoma 2010 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Schnitzbauer et al; licensee BioMed Central Ltd. 2010. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( 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 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 $ 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. 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) Liver Transplant (dpeaa)DE-He213 Sirolimus (dpeaa)DE-He213 Milan Criterion (dpeaa)DE-He213 Data Safety Monitoring Board (dpeaa)DE-He213 Liver Allograft (dpeaa)DE-He213 Zuelke, Carl aut Graeb, Christian aut Rochon, Justine aut Bilbao, Itxarone aut Burra, Patrizia aut de Jong, Koert P aut Duvoux, Christophe aut Kneteman, Norman M aut Adam, Rene aut Bechstein, Wolf O aut Becker, Thomas aut Beckebaum, Susanne aut Chazouillères, Olivier aut Cillo, Umberto aut Colledan, Michele aut Fändrich, Fred aut Gugenheim, Jean aut Hauss, Johann P aut Heise, Michael aut Hidalgo, Ernest aut Jamieson, Neville aut Königsrainer, Alfred aut Lamby, Philipp E aut Lerut, Jan P aut Mäkisalo, Heikki aut Margreiter, Raimund aut Mazzaferro, Vincenzo aut Mutzbauer, Ingrid aut Otto, Gerd aut Pageaux, Georges-Philippe aut Pinna, Antonio D aut Pirenne, Jacques aut Rizell, Magnus aut Rossi, Giorgio aut Rostaing, Lionel aut Roy, Andre aut Turrion, Victor Sanchez aut Schmidt, Jan aut Troisi, Roberto I aut van Hoek, Bart aut Valente, Umberto aut Wolf, Philippe aut Wolters, Heiner aut Mirza, Darius F aut Scholz, Tim aut Steininger, Rudolf aut Soderdahl, Gunnar aut Strasser, Simone I aut Jauch, Karl-Walter aut Neuhaus, Peter aut Schlitt, Hans J aut Geissler, Edward K aut Enthalten in BMC cancer London : BioMed Central, 2001 10(2010), 1 vom: 11. Mai (DE-627)326643710 (DE-600)2041352-X 1471-2407 nnns volume:10 year:2010 number:1 day:11 month:05 https://dx.doi.org/10.1186/1471-2407-10-190 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 10 2010 1 11 05 |
allfields_unstemmed |
10.1186/1471-2407-10-190 doi (DE-627)SPR027624730 (SPR)1471-2407-10-190-e DE-627 ger DE-627 rakwb eng Schnitzbauer, Andreas A verfasserin aut A prospective randomised, open-labeled, trial comparing sirolimus-containing versus mTOR-inhibitor-free immunosuppression in patients undergoing liver transplantation for hepatocellular carcinoma 2010 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Schnitzbauer et al; licensee BioMed Central Ltd. 2010. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( 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 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 $ 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. 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) Liver Transplant (dpeaa)DE-He213 Sirolimus (dpeaa)DE-He213 Milan Criterion (dpeaa)DE-He213 Data Safety Monitoring Board (dpeaa)DE-He213 Liver Allograft (dpeaa)DE-He213 Zuelke, Carl aut Graeb, Christian aut Rochon, Justine aut Bilbao, Itxarone aut Burra, Patrizia aut de Jong, Koert P aut Duvoux, Christophe aut Kneteman, Norman M aut Adam, Rene aut Bechstein, Wolf O aut Becker, Thomas aut Beckebaum, Susanne aut Chazouillères, Olivier aut Cillo, Umberto aut Colledan, Michele aut Fändrich, Fred aut Gugenheim, Jean aut Hauss, Johann P aut Heise, Michael aut Hidalgo, Ernest aut Jamieson, Neville aut Königsrainer, Alfred aut Lamby, Philipp E aut Lerut, Jan P aut Mäkisalo, Heikki aut Margreiter, Raimund aut Mazzaferro, Vincenzo aut Mutzbauer, Ingrid aut Otto, Gerd aut Pageaux, Georges-Philippe aut Pinna, Antonio D aut Pirenne, Jacques aut Rizell, Magnus aut Rossi, Giorgio aut Rostaing, Lionel aut Roy, Andre aut Turrion, Victor Sanchez aut Schmidt, Jan aut Troisi, Roberto I aut van Hoek, Bart aut Valente, Umberto aut Wolf, Philippe aut Wolters, Heiner aut Mirza, Darius F aut Scholz, Tim aut Steininger, Rudolf aut Soderdahl, Gunnar aut Strasser, Simone I aut Jauch, Karl-Walter aut Neuhaus, Peter aut Schlitt, Hans J aut Geissler, Edward K aut Enthalten in BMC cancer London : BioMed Central, 2001 10(2010), 1 vom: 11. Mai (DE-627)326643710 (DE-600)2041352-X 1471-2407 nnns volume:10 year:2010 number:1 day:11 month:05 https://dx.doi.org/10.1186/1471-2407-10-190 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 10 2010 1 11 05 |
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10.1186/1471-2407-10-190 doi (DE-627)SPR027624730 (SPR)1471-2407-10-190-e DE-627 ger DE-627 rakwb eng Schnitzbauer, Andreas A verfasserin aut A prospective randomised, open-labeled, trial comparing sirolimus-containing versus mTOR-inhibitor-free immunosuppression in patients undergoing liver transplantation for hepatocellular carcinoma 2010 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Schnitzbauer et al; licensee BioMed Central Ltd. 2010. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( 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 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 $ 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. 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) Liver Transplant (dpeaa)DE-He213 Sirolimus (dpeaa)DE-He213 Milan Criterion (dpeaa)DE-He213 Data Safety Monitoring Board (dpeaa)DE-He213 Liver Allograft (dpeaa)DE-He213 Zuelke, Carl aut Graeb, Christian aut Rochon, Justine aut Bilbao, Itxarone aut Burra, Patrizia aut de Jong, Koert P aut Duvoux, Christophe aut Kneteman, Norman M aut Adam, Rene aut Bechstein, Wolf O aut Becker, Thomas aut Beckebaum, Susanne aut Chazouillères, Olivier aut Cillo, Umberto aut Colledan, Michele aut Fändrich, Fred aut Gugenheim, Jean aut Hauss, Johann P aut Heise, Michael aut Hidalgo, Ernest aut Jamieson, Neville aut Königsrainer, Alfred aut Lamby, Philipp E aut Lerut, Jan P aut Mäkisalo, Heikki aut Margreiter, Raimund aut Mazzaferro, Vincenzo aut Mutzbauer, Ingrid aut Otto, Gerd aut Pageaux, Georges-Philippe aut Pinna, Antonio D aut Pirenne, Jacques aut Rizell, Magnus aut Rossi, Giorgio aut Rostaing, Lionel aut Roy, Andre aut Turrion, Victor Sanchez aut Schmidt, Jan aut Troisi, Roberto I aut van Hoek, Bart aut Valente, Umberto aut Wolf, Philippe aut Wolters, Heiner aut Mirza, Darius F aut Scholz, Tim aut Steininger, Rudolf aut Soderdahl, Gunnar aut Strasser, Simone I aut Jauch, Karl-Walter aut Neuhaus, Peter aut Schlitt, Hans J aut Geissler, Edward K aut Enthalten in BMC cancer London : BioMed Central, 2001 10(2010), 1 vom: 11. Mai (DE-627)326643710 (DE-600)2041352-X 1471-2407 nnns volume:10 year:2010 number:1 day:11 month:05 https://dx.doi.org/10.1186/1471-2407-10-190 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 10 2010 1 11 05 |
allfieldsSound |
10.1186/1471-2407-10-190 doi (DE-627)SPR027624730 (SPR)1471-2407-10-190-e DE-627 ger DE-627 rakwb eng Schnitzbauer, Andreas A verfasserin aut A prospective randomised, open-labeled, trial comparing sirolimus-containing versus mTOR-inhibitor-free immunosuppression in patients undergoing liver transplantation for hepatocellular carcinoma 2010 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Schnitzbauer et al; licensee BioMed Central Ltd. 2010. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( 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 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 $ 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. 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) Liver Transplant (dpeaa)DE-He213 Sirolimus (dpeaa)DE-He213 Milan Criterion (dpeaa)DE-He213 Data Safety Monitoring Board (dpeaa)DE-He213 Liver Allograft (dpeaa)DE-He213 Zuelke, Carl aut Graeb, Christian aut Rochon, Justine aut Bilbao, Itxarone aut Burra, Patrizia aut de Jong, Koert P aut Duvoux, Christophe aut Kneteman, Norman M aut Adam, Rene aut Bechstein, Wolf O aut Becker, Thomas aut Beckebaum, Susanne aut Chazouillères, Olivier aut Cillo, Umberto aut Colledan, Michele aut Fändrich, Fred aut Gugenheim, Jean aut Hauss, Johann P aut Heise, Michael aut Hidalgo, Ernest aut Jamieson, Neville aut Königsrainer, Alfred aut Lamby, Philipp E aut Lerut, Jan P aut Mäkisalo, Heikki aut Margreiter, Raimund aut Mazzaferro, Vincenzo aut Mutzbauer, Ingrid aut Otto, Gerd aut Pageaux, Georges-Philippe aut Pinna, Antonio D aut Pirenne, Jacques aut Rizell, Magnus aut Rossi, Giorgio aut Rostaing, Lionel aut Roy, Andre aut Turrion, Victor Sanchez aut Schmidt, Jan aut Troisi, Roberto I aut van Hoek, Bart aut Valente, Umberto aut Wolf, Philippe aut Wolters, Heiner aut Mirza, Darius F aut Scholz, Tim aut Steininger, Rudolf aut Soderdahl, Gunnar aut Strasser, Simone I aut Jauch, Karl-Walter aut Neuhaus, Peter aut Schlitt, Hans J aut Geissler, Edward K aut Enthalten in BMC cancer London : BioMed Central, 2001 10(2010), 1 vom: 11. Mai (DE-627)326643710 (DE-600)2041352-X 1471-2407 nnns volume:10 year:2010 number:1 day:11 month:05 https://dx.doi.org/10.1186/1471-2407-10-190 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 10 2010 1 11 05 |
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Enthalten in BMC cancer 10(2010), 1 vom: 11. Mai volume:10 year:2010 number:1 day:11 month:05 |
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Schnitzbauer, Andreas A @@aut@@ Zuelke, Carl @@aut@@ Graeb, Christian @@aut@@ Rochon, Justine @@aut@@ Bilbao, Itxarone @@aut@@ Burra, Patrizia @@aut@@ de Jong, Koert P @@aut@@ Duvoux, Christophe @@aut@@ Kneteman, Norman M @@aut@@ Adam, Rene @@aut@@ Bechstein, Wolf O @@aut@@ Becker, Thomas @@aut@@ Beckebaum, Susanne @@aut@@ Chazouillères, Olivier @@aut@@ Cillo, Umberto @@aut@@ Colledan, Michele @@aut@@ Fändrich, Fred @@aut@@ Gugenheim, Jean @@aut@@ Hauss, Johann P @@aut@@ Heise, Michael @@aut@@ Hidalgo, Ernest @@aut@@ Jamieson, Neville @@aut@@ Königsrainer, Alfred @@aut@@ Lamby, Philipp E @@aut@@ Lerut, Jan P @@aut@@ Mäkisalo, Heikki @@aut@@ Margreiter, Raimund @@aut@@ Mazzaferro, Vincenzo @@aut@@ Mutzbauer, Ingrid @@aut@@ Otto, Gerd @@aut@@ Pageaux, Georges-Philippe @@aut@@ Pinna, Antonio D @@aut@@ Pirenne, Jacques @@aut@@ Rizell, Magnus @@aut@@ Rossi, Giorgio @@aut@@ Rostaing, Lionel @@aut@@ Roy, Andre @@aut@@ Turrion, Victor Sanchez @@aut@@ Schmidt, Jan @@aut@@ Troisi, Roberto I @@aut@@ van Hoek, Bart @@aut@@ Valente, Umberto @@aut@@ Wolf, Philippe @@aut@@ Wolters, Heiner @@aut@@ Mirza, Darius F @@aut@@ Scholz, Tim @@aut@@ Steininger, Rudolf @@aut@@ Soderdahl, Gunnar @@aut@@ Strasser, Simone I @@aut@@ Jauch, Karl-Walter @@aut@@ Neuhaus, Peter @@aut@@ Schlitt, Hans J @@aut@@ Geissler, Edward K @@aut@@ |
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Schnitzbauer, Andreas A misc Liver Transplant misc Sirolimus misc Milan Criterion misc Data Safety Monitoring Board misc Liver Allograft A prospective randomised, open-labeled, trial comparing sirolimus-containing versus mTOR-inhibitor-free immunosuppression in patients undergoing liver transplantation for hepatocellular carcinoma |
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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 Liver Transplant (dpeaa)DE-He213 Sirolimus (dpeaa)DE-He213 Milan Criterion (dpeaa)DE-He213 Data Safety Monitoring Board (dpeaa)DE-He213 Liver Allograft (dpeaa)DE-He213 |
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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 |
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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 |
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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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Schnitzbauer, Andreas A |
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prospective randomised, open-labeled, trial comparing sirolimus-containing versus mtor-inhibitor-free immunosuppression in patients undergoing liver transplantation for hepatocellular carcinoma |
title_auth |
A prospective randomised, open-labeled, trial comparing sirolimus-containing versus mTOR-inhibitor-free immunosuppression in patients undergoing liver transplantation for hepatocellular carcinoma |
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 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 $ 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. 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) © Schnitzbauer et al; licensee BioMed Central Ltd. 2010. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( |
abstractGer |
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 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 $ 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. 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) © Schnitzbauer et al; licensee BioMed Central Ltd. 2010. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( |
abstract_unstemmed |
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 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 $ 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. 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) © Schnitzbauer et al; licensee BioMed Central Ltd. 2010. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( |
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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 |
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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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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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|
score |
7.399884 |