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Schnitzbauer, Andreas ; Zuelke, Carl ; Graeb, Christian ; Rochon, Justine ; Bilbao, Itxarone ; Burra, Patrizia ; de Jong, Koert P. ; Duvoux, Christophe ; Kneteman, Norman M. ; Adam, Rene ; Bechstein, Wolf Otto ; Becker, Thomas ; Beckebaum, Susanne ; Chazouilleres, Olivier ; Cillo, Umberto ; Colledan, Michele ; Fandrich, Fred ; Gugenheim, Jean ; Hauss, Johann P. ; Heise, Michael ; Hidalgo, Ernest ; Jamieson, Neville ; Königsrainer, Alfred ; Lamby, Philipp E. ; Lerut, Jan P. ; Makisalo, 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. ; Hoek, Bart van ; 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.
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: 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 3-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 registered at www.clinicaltrials.gov: NCT00355862) (EudraCT Number: 2005-005362-36)
Abelev, Betty ; Adam, Jaroslav ; Adamová, Dagmar ; Adare, Andrew Marshall ; Aggarwal, Madan ; Rinella, Gianluca Aglieri ; Agocs, Andras Gabor ; Agostinelli, Andrea ; Salazar, Saul Aguilar ; Ahammed, Zubayer ; Ahmad, Arshad ; Ahmad, Nazeer ; Ahn, Sul-Ah ; Ahn, Sang Un ; Akindinov, Alexander ; Aleksandrov, Dmitry ; Alessandro, Bruno ; Molina, Jose Ruben Alfaro ; Alici, Andrea ; Alkin, Anton ; Avina, Erick Jonathan Almaraz ; Alme, Johan ; Alt, Torsten ; Altini, Valerio ; Altinpinar, Sedat ; Altsybeev, Igor ; Andrei, Cristian ; Andronic, Anton ; Anguelov, Venelin ; Anielski, Jonas ; Anson, Christopher Daniel ; Antičić, Tome ; Antinori, Federico ; Antonioli, Pietro ; Aphecetche, Laurent Bernard ; Appelshäuser, Harald ; Arbor, Nicolas ; Arcelli, Silvia ; Arend, Andreas ; Armesto, Nestor ; Arnaldi, Roberta ; Aronsson, Tomas Robert ; Arsene, Ionut Cristian ; Arslandok, Mesut ; Asryan, Andzhey ; Augustinus, Andre ; Averbeck, Ralf Peter ; Awes, Terry ; Aysto, Juha Heikki ; Azmi, Mohd Danish ; Bach, Matthias ; Badalà, Angela ; Baek, Yong Wook ; Bailhache, Raphaëlle ; Bala, Renu ; Ferroli, Rinaldo Baldini ; Baldisseri, Alberto ; Baldit, Alain ; Dos Santos Pedrosa, Fernando Baltasar ; Ban, Jaroslav ; Baral, Rama Chandra ; Barbera, Roberto ; Barile, Francesco ; Barnaföldi, Gergely Gábor ; Barnby, Lee Stuart ; Barret, Valérie ; Bartke, Jerzy ; Basile, Maurizio ; Bastid, Nicole ; Basu, Sumit ; Bathen, Bastian ; Batigne, Guillaume ; Batyunya, Boris ; Baumann, Christoph Heinrich ; Bearden, Ian Gardner ; Beck, Hans ; Behera, Nirbhay Kumar ; Belikov, Iouri ; Bellini, Francesca ; Bellwied, Rene ; Belmont-Moreno, Ernesto ; Bencédi, Gyula ; Beolè, Stefania ; Berceanu, Ionela ; Bercuci, Alexandru ; Berdnikov, Yaroslav ; Berényi, Dániel ; Bergognon, Anais Annick Erica ; Berzano, Dario ; Betev, Latchezar ; Bhasin, Anju ; Bhati, Ashok Kumar ; Bhom, Jihyun ; Bianchi, Livio ; Bianchi, Nicola ; Bianchin, Chiara ; Bielčík, Jaroslav ; Bielčíková, Jana ; Bilandzic, Ante ; Bjelogrlic, Sandro ; Blanco, Fernando ; Blanco, Francesco ; Blau, Dmitry S. ; Blume, Christoph ; Boccioli, Marco ; Bock, Nicolas ; Boettger, Stefan ; Bogdanov, Alexey A. ; Bøggild, Hans ; Bogolyubsky, Mikhail ; Boldizsar, Laszlo ; Bombara, Marek ; Book, Julian ; Borel, Herve ; Borissov, Alexander ; Bose, Suvendu Nath ; Bossú, Francesco ; Botje, Michiel ; Boyer, Bruno Alexandre ; Braidot, Ermes ; Braun-Munzinger, Peter ; Bregant, Marco ; Breitner, Timo ; Browning, Tyler Allen ; Broz, Michal ; Brun, Rene ; Bruna, Elena ; Bruno, Giuseppe Eugenio ; Budnikov, Dmitry ; Büsching, Henner ; Bufalino, Stefania ; Bugaiev, Kyrylo ; Busch, Oliver ; Buthelezi, Edith Zinhle ; Orduna, Diego Caballero ; Caffarri, Davide ; Cai, Xu ; Caines, Helen Louise ; Calvo Villar, Ernesto ; Camerini, Paolo ; Roman, Veronica Canoa ; Romeo, Giovanni Cara ; Carena, Francesco ; Carena, Wisla ; Filho, Nelson Carlin ; Carminati, Federico ; Montoya, Camilo Andres Carrillo ; Diaz, Amaya Ofelia Casanova ; Castellanos, Javier Ernesto Castillo ; Hernandez, Juan Francisco Castillo ; Casula, Ester Anna Rita ; Catanescu, Vasile ; Cavicchioli, Costanza ; Sanchez, Cesar Ceballos ; Čepila, Jan ; Cerello, Piergiorgio ; Chang, Beomsu ; Chapeland, Sylvain ; Charvet, Jean-Luc Fernand ; Chattopadhyay, Subhasis ; Chattopadhyay, Sukalyan ; Chawla, Isha ; Cherney, Michael Gerard ; Cheshkov, Cvetan Valeriev ; Cheynis, Brigitte ; Barroso, Vasco Miguel Chibante ; Chinellato, David ; Chochula, Peter ; Chojnacki, Marek ; Choudhury, Subikash ; Christakoglou, Panagiotis ; Christensen, Christian Holm ; Christiansen, Peter L. ; Chujo, Tatsuya ; Chung, Suh-Urk ; Cicalò, Corrado ; Cifarelli, Luisa ; Cindolo, Federico ; Cleymans, Jean Willy Andre ; Coccetti, Fabrizio ; Colamaria, Fabio Filippo ; Colella, Domenico ; Balbastre, Gustavo Conesa ; del Valle, Zaida Conesa ; Constantin, Paul ; Contin, Giacomo ; Contreras, Jesus Guillermo ; Cormier, Thomas Michael ; Morales, Yasser Corrales ; Cortese, Pietro ; Maldonado, Ismael Cortes ; Cosentino, Mauro Rogerio ; Costa, Filippo ; Cotallo, Manuel Enrique ; Crescio, Elisabetta ; Crochet, Philippe ; Alaniz, Emilia Cruz ; Cuautle, Eleazar ; Cunqueiro Mendez, Leticia ; Dainese, Andrea ; Dalsgaard, Hans Hjersing ; Danu, Andrea ; Das, Debasish ; Das, Indranil ; Das, Kushal ; Dash, Sadhana ; Dash, Ajay Kumar ; De, Sudipan ; de Barros, Gabriel ; De Caro, Annalisa ; De Cataldo, Giacinto ; Cuveland, Jan de ; De Falco, Alessandro ; De Gruttola, Daniele ; Delagrange, Hugues ; Deloff, Andrzej ; Demanov, Vyacheslav ; De Marco, Nora ; Denes, Ervin ; De Pasquale, Salvatore ; Deppman, Airton ; D’Erasmo, Ginevra ; de Rooij, Raoul Stefan ; Corchero, Miguel Angel Diaz ; Di Bari, Domenico ; Di Giglio, Carmelo ; Dietel, Thomas ; Di Liberto, Sergio ; Di Mauro, Antonio ; Di Nezza, Pasquale ; Divià, Roberto ; Djuvsland, Øystein ; Dobrin, Alexandru Florin ; Dobrowolski, Tadeusz Antoni ; Dominguez, Isabel ; Donigus, Benjamin ; Dordic, Olja ; Driga, Olga ; Dubey, Anand Kumar ; Ducroux, Laurent ; Dupieux, Pascal ; Majumdar, Mihir Ranjan Dutta ; Majumdar, A. K. Dutta ; Elia, Domenico ; Emschermann, David Philip ; Engel, Heiko ; Erdal, Hege Austrheim ; Espagnon, Bruno ; Estienne, Magali Danielle ; Esumi, ShinIchi ; Evans, David ; Eyyubova, Gyulnara ; Fabris, Daniela ; Faivre, Julien ; Falchieri, Davide ; Fantoni, Alessandra ; Fasel, Markus ; Fearick, Roger Worsley ; Fedunov, Anatoly ; Fehlker, Dominik ; Feldkamp, Linus ; Felea, Daniel ; Fenton-Olsen, Bo ; Feofilov, Grigory ; Tellez, Arturo Fernandez ; Ferretti, Alessandro ; Ferretti, Roberta ; Figiel, Jan ; Figueredo, Marcel ; Filchagin, Sergey ; Finogeev, Dmitry ; Fionda, Fiorella Maria Celeste ; Fiore, Enrichetta Maria ; Floris, Michele ; Förtsch, Siegfried ; Foka, Panagiota ; Fokin, Sergey ; Fragiacomo, Enrico ; Frankenfeld, Ulrich ; Fuchs, Ulrich ; Furget, Christophe ; Girard, Mario Fusco ; Gaardhoje, Jens Joergen ; Gagliardi, Martino ; Gago Medina, Alberto Martín ; Gallio, Mauro ; Gangadharan, Dhevan Raja ; Ganoti, Paraskevi ; Garabatos Cuadrado, Jose Maria ; Garcia-Solis, Edmundo Javier ; 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Pachmayer, Yvonne C. ; Pachr, Milos ; Padilla, Fatima ; Pagano, Paola ; Paic, Guy ; Painke, Florian ; Pajares Vales, Carlos ; Pal, S. ; Pal, Susanta Kumar ; Palaha, Arvinder Singh ; Palmeri, Armando ; Papikyan, Vardanush ; Pappalardo, Giuseppe Salvatore ; Park, Woo Jin ; Passfeld, Annika ; Pastircak, Blahoslav ; Patalakha, Dmitri Ivanovich ; Paticchio, Vincenzo ; Pavlinov, Alexei ; Pawlak, Tomasz Jan ; Peitzmann, Thomas ; Da Costa, Hugo Denis Antonio Pereira ; De Oliveira Filho, Elienos Pereira ; Peresunko, Dmitri ; Lara, Carlos Eugenio Perez ; Lezama, Edgar Perez ; Perini, Diego ; Perrino, Davide ; Peryt, Wiktor Stanislaw ; Pesci, Alessandro ; Peskov, Vladimir ; Pestov, Yury N. ; Petráček, Vojtech ; Petran, Michal ; Petris, Mariana ; Petrov, Plamen Rumenov ; Petrovici, Mihai A. ; Petta, Catia ; Piano, Stefano ; Piccotti, Anna ; Pikna, Miroslav ; Pillot, Philippe ; Pinazza, Ombretta ; Pinsky, Lawrence ; Pitz, Nora ; Piyarathna, Danthasinghe ; Płoskoń, Mateusz ; Pluta, Jan Marian ; Pocheptsov, Timur ; 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The ALICE experiment at the LHC has studied J/psi production at mid-rapidity in pp collisions at sqrt{s}=7 TeV through its electron pair decay on a data sample corresponding to an integrated luminosity L_int = 5.6nb-1. The fraction of J/psi from the decay of long-lived beauty hadrons was determined for J/psi candidates with transverse momentum p_t>1.3 GeV/c and rapidity |y|<0.9. The cross section for prompt J/psi mesons, i.e. directly produced J/psi and prompt decays of heavier charmonium states such as the Psi(2S) and Csi_c resonances, is sigma_prompt-J/psi(pt > 1.3 GeV/c, |y| < 0.9) = 8.3 +- 0.8(stat.) +- 1.1(syst.) + 1.5 - 1.4(syst. pol.) micro barn. The cross section for the production of b-hadrons decaying to J/psi with p_t>1.3 GeV/c and |y|<0.9 is sigma_{J/psi<-h_B} = 1.46 +- 0.38(stat.) + 0.26 -0.32(syst.) micro barn. The results are compared to QCD model predictions. The shape of the p_t and y distributions of b-quarks predicted by perturbative QCD model calculations are used to extrapolate the measured cross section to derive the b-bbar pair total cross section and dsigma/dy at mid-rapidity.
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