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Sirolimus Use in Liver Transplant Recipients With
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2015 Wolters Kluwer Geissler et al 117, class of immunosuppressants with activities that can inhibit studies 21 leaving the question largely open as to whether. tumor growth including antiangiogenic 8 antiproliferative 9 10 mTOR inhibitors provide a benefit to LTx patients with cancer. and even ironically have proimmunogenic 11 12 effects The The aim of the present study referred to as the Sirolimus in. mTOR inhibitors have proven effective in treating selective Liver Transplant Recipients with HCC study SiLVER was. types of cancer including renal cell adenocarcinoma 13 14 to perform a large prospective randomized trial comparing. Unfortunately in HCC patients receiving LTx the low level of recurrence free survival RFS in sirolimus mTOR inhibitor. evidence for a positive effect of mTOR inhibitors rests on ret containing versus mTOR inhibitor free immunosuppression pa. rospective data analyses 15 20 and small nonrandomized pilot tients undergoing LTx for HCC This trial was performed to. Received 7 July 2015 Revision requested 28 July 2015 Chirurgia terza e Chirurgia Toracica Azienda Ospedaliera Papa Giovanni XXIII. Accepted 6 September 2015 Bergamo Italy, Department of Surgery and Section of Experimental Surgery University Hospi Klinik f r Allgemeine Chirurgie Viszeral Thorax Transplantations und Kinderchirurgie. tal Regensburg Regensburg Germany Universit tsklinikum Schleswig Holstein Campus Kiel Kiel Germany. Klinik f r Allgemein und Viszeralchirurgie Universit tsklinikum Frankfurt Department of Transplantation Surgery Karolinska University Hospital Stockholm Sweden. Frankfurt am Main Germany Federation d Hepato Gastro Enterologie Service d Hepatologie H pital Saint. Unite d Hepatologie et de Transplantation Hepatique Centre Hospitalier Antoine Paris France. Universitaire Henri Mondor Service d Hepatologie et de Gastroenterologie Division of Transplantation and Liver Surgery Helsinki University Central Hospital. Universit Paris Est Cr teil Val de Marne Paris France Helsinki Finland. Dipartimento di Scienze Chirurgiche Oncologiche e Gastroenterologiche Service d Hepato Gastroent rologie et Transplantation Hepatique CHRU de. DiSCOG Universit degli Studi di Padova Padova Italy Montpellier APEMAD H pital Saint Eloi Montpellier France. Klinik f r Allgemeine Viszeral Transplantations Gef und Thoraxchirurgie Klinikum Abteilung f r Transplantation Universit tsklinik f r Chirurgie Medizinische Universit t. der Ludwig Maximilians Universit t M nchen Gro hadern M nchen Germany Wien AKH Wien Vienna Austria. Innere Medizin IV Sektion Lebertransplantation Universit tsklinikum Heidelberg Division of Hepato Pancreatico Biliary Surgery and Liver Transplantation. Heidelberg Germany Department of Surgery University Medical Center Groningen University of. Klinik f r Allgemein Viszeral und Gef sschirurgie Universit tsklinikum Jena Groningen Groningen The Netherlands. Jena Germany Abdominale Transplantatiechirurgie UZ Leuven Campus Gasthuisberg Leuven. Klinik f r Allgemein Viszeral und Transplantationschirurgie Universit tsmedizin der Belgium. Johannes Gutenberg Universit t Mainz Mainz Germany Universit tsklinik f r Visceral Transplantations Throaxchirurgie Medizinische. Centro Trapianti Fegato Fondazione IRCCS Ca Granda Ospedale Maggiore Universit t Innsbruck Innsbruck Austria. Policlinico IRCCS di Milano Milan Italy Chirurgia Generale e dei Trapianti Policlinico S Orsola Malpighi Universita. Chirurgia Epatobiliare e Trapianto Epatico Azienda Ospedaliera di Padova di Bologna Bologna Italy. Universit di Padova Padova Italy Klinik f r Visceral Transplantations Thorax und Gef chirurgie Universit tsklinikum. Alberta Health Services Liver Transplant Program University of Alberta Leipzig Leipzig Germany. Edmonton Alberta Canada AW Morrow Gastroenterology and Liver Centre and Liver Transplant Unit. Centre H pato Biliaire H pital Paul Brousse Villejuif Cedex Paris France Royal Prince Alfred Hospital Sydney NSW Australia. Department of Gastroenterology and Hepatology Leiden University Medical Klinik f r Allgemein Viszeral und Transplantationschirurgie Medizinische. Center LUMC Leiden Netherlands Hochschule Hannover Hannover Germany. Service de Chirurgie G n rale H patique Endocrinienne et Transplantation H pital Hepato Biliary and Pancreatic Surgery Ghent University Hospital and Medi. de Hautepierre Les H pitaux Universitaires de Strasbourg Strasbourg France cal School Ghent Belgium. Service de N phrologie HTA Dialyse Transplantation CHU Toulouse Rangueil Department of Surgery Transplantation and Hepatobiliary Cancer Unit Fondazione. Toulouse France IRCCS Istituto Nazionale dei Tumori National Cancer Institute Milan Milan Italy. Department of Surgery and Transplantation Sahlgrenska University Hospital Department of Abdominal and Transplantation Surgery SCTA UCL Transplant. G teborg Sweden Centre University Hospitals Saint Luc Brussels Belgium. Hepatic Pancreatico Biliary Surgical Services and Edinburgh Transplant Servicio de Cirug a General Unidad de Trasplante Hepatico Hospital Universitari. Unit Royal Infirmary of Edinburgh Edinburgh Scotland United Kingdom Vall d Hebron Barcelona Spain. Service de Chirurgie Digestive Centre de Transplantation H patique H pital The Queen Elizabeth Hospital Liver and Hepato Pancreato Biliary HPB Unit NHS. ARCHET 2 Centre Hospitalier Universitaire de Nice Nice France Foundation Trust University Hospitals Birmingham Edgbaston Birmingham United Kingdom. Klinik f r Allgemein und Viszeralchirurgie Universit tsklinikum M nster Klinik f r Allgemein Visceral und Transplantationschirurgie Charit Campus. M nster Germany Virchow Klinikum Universit tsmedizin Berlin Berlin Germany. Hepatobiliary and Pancreatic Surgery Unit Hopital St Luc Centre Hospitalier de E K G s institution University of Regensburg University Hospital Regensburg. l Universit Montr al CHUM Principal Pavillion Montreal Quebec Canada received a research grant from Pfizer Inc to support the conduct of this trial A A S. C Z P E L A P I M A S and H J S are or were employees of this same. Klinik f r Allgemein Viszeral und Transplantationschirurgie Universit tsklinikum institution E K G and L R received honoraria from Pfizer Inc as compensation for. Essen Essen Germany lectures A A S received funding from Pfizer for travel to scientific meetings The. Klinik f r Allgemeine Viszeral und Transplantationschirurgie Klinikum der other authors declare no conflict of interest. Universit t T bingen T bingen Germany The study was sponsored by the University Hospital Regensburg and was. Chirurgia Generale e Trapianti d Organo Universit di Genova Azienda supported by a research grant from Pfizer Inc. Ospedaliera Universitaria San Martino di Genova Genova Italy E K G initiated the study and contributed to the study design coordinated the trial as. Unidad de Trasplante Hep tico Departamento de Cirug a Hospital Universitario the chief investigator collected and interpreted the data for analysis and wrote the first. Puerta de Hierro Majadahonda Madrid Spain manuscript draft A A S C Z P E L C D K W H N K C G N J T S Scholz O C. R S G S K P dJ J H J K J L A K D F M P N and H J S participated in study. Department of Surgery NHS Foundation Trust Addenbrooke s Hospital design A A S C Z P E L A P C D K W H M R T M G J S U S M H G R. Cambridge University Hospitals Cambridge United Kingdom U C N K R A B vH P B Bachellier P W L R W O B M R J P Powell E H. Section for Transplant Surgery Clinic for Cancer Surgery and Transplanta J G H W J B A R S B Beckebaum C G S N U V V S T N J T S. tion Department of Transplantation Medicine Oslo University Hospital Scholz M C F F T B G S O C H M G P P R S T S Soliman K Pd J J P. Rikshospitalet Oslo Norway Pirenne R M J P Pratschke A D P J H S S Schreiber S S Strasser J K. 118 Transplantation January 2016 Volume 100 Number 1 www transplantjournal com. R I T S B Bhoori J L I B C G K A K D F M G O V M P N and H J S par Clinicaltrials gov NCT00355862. ticipated in patient recruitment and data collection A A S C Z P E L A P I M Supplemental digital content SDC is available for this article Direct URL citations. and A S managed and analyzed the study A A S P E L A P I M A S and H appear in the printed text and links to the digital files are provided in the HTML. J S handled pharmacovigilance monitoring and surveillance All authors reviewed text of this article on the journal s Web site www transplantjournal com. the article, Copyright 2015 Wolters Kluwer Health Inc All rights reserved This is an open. Correspondence Edward K Geissler PhD University Hospital Regensburg access article distributed under the terms of the Creative Commons Attribution. University of Regensburg Department of Surgery Section of Experimental NonCommercial NoDerivatives 3 0 License where it is permissible to download. Surgery Franz Josef Strauss Allee 11 D 93053 Regensburg Germany edward and share the work provided it is properly cited The work cannot be changed in. geissler klinik uni regensburg de any way or used commercially http creativecommons org licenses by nc nd 3 0. Clinical Trial Registration NCT00355862 ISSN 0041 1337 16 10001 116. EudraCT 2005 005362 36 DOI 10 1097 TP 0000000000000965. completion according to our protocol at internationally lo clinical protocol including guidelines for immunosuppres. cated clinical sites over an 8 year period sion use have been published previously 22. The enrolled population included patients with HCC tu. mors that demonstrated liver cirrhosis and were within the. guidelines of the Milan Criteria 2 hereafter referred to as. MATERIALS AND METHODS low risk patients Additionally a fraction of recipients. Patient Selection showed more extensive disease on posttransplant histopatho. The LTx recipients were recruited from 45 transplant logical assessment These recipients with tumors outside the. centers in Europe 42 Canada 2 and Australia 1 in a limits of the Milan Criteria were also included into the study. multicenter randomized open labeled parallel group trial and are referred to as extended criteria or high risk recipi. EudraCT 2005 005362 36 Clinicaltrials gov NCT00355862 ents patients without liver cirrhosis regardless of tumor size. SiLVER was approximately an 8 year study consisting of and patients undergoing salvage LTx were also consid. roughly a 3 year enrollment period January 2006 to April ered high risk 25 Minimization method using an interactive. 2009 with at least a 5 year follow up patients remained in voice response system IVRS was applied for treatment. the study for its entire duration regardless of when they were group allocation to obtain minimal imbalance within each. randomized The first patient was randomized in January study site and regarding Milan Criteria In all patients in. 2006 and the last patient last visit was conducted in March cluding those receiving pre LTx anti tumor therapy eg. 2014 The study included all patients eligible for LTx with chemoembolization radiofrequency ablation for histologi. the inclusion criteria being 18 years or older histologically cally proven HCC Milan Criteria stratification was based. proven HCC before randomization and signed written in on post LTx histopathological data The IVRS randomiza. formed consent The main exclusion criteria were the pres tion was performed between day 22 and day 42 after LTx. ence of extrahepatic HCC and non HCC malignancies allowing for confirmation of HCC in the post LTx explanta. within the past 5 years excluding successfully treated non tion pathology assessment when pre LTx histological confir. melanoma skin cancer Multiple organ recipients patients mation was not available. with a known sirolimus hypersensitivity hyperlipidemia re. fractory to management evidence of infection platelets less Outcomes. than 75 000 mm3 and women of child bearing potential not. The primary endpoint of RFS was defined as HCC recur. willing to take contraception were also exclusion criteria. rence or patient death Patients underwent a standardized. Randomization was completed in April 2009, tumor specific follow up at every scheduled visit These regu. lar examinations included ultrasound a chest X ray as well. Randomization as fetoprotein measurements along with a clinical examina. Patients were randomized into 2 groups Group A was tion to detect potentially related symptoms In case of suspicious. maintained for the study duration on a center specific mTOR findings a computed tomography scan magnetic resonance. inhibitor free generally calcineurin inhibitor based immu imaging positron emission tomography bone scintigraphy. nosuppressive protocol This control group of patients was recommended in accordance with existing guidelines a. was compared to a second group group B that received biopsy was also recommended to further confirm the HCC. mTOR inhibitor free immunosuppression for the first 4 diagnosis Confirmation of an HCC diagnosis was double. to 6 weeks at which time sirolimus was incorporated checked by on site monitoring For the purpose of the study. into the regime target range 4 10 ng mL either as a mono because of normal delays in establishing a definitive diagnosis. therapy or as a combination therapy with non mTOR of HCC the first day of tumor suspicion constituted time of. inhibitor based drugs As a safety precaution the protocol recurrence All mentioned time measurements were calculated. included a Doppler ultrasound to show hepatic artery pa based on the day of LTx In the first year after LTx patients. tency before initiating sirolimus Guidelines were given to were followed up at months 1 3 6 9 and 12 t. Sirolimus Use in Liver Transplant Recipients With Hepatocellular Carcinoma A Randomized Multicenter Open Label Phase 3 Trial Edward K Geissler PhD 1 Andreas A

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