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Article ; Online: Repeated pancreatic resection for pancreatic metastases from renal cell Carcinoma: A Spanish multicenter study (PANMEKID).

Rojas-Holguín, Adela / Fondevila-Campo, Constantino / Sanjuanbenito, Alfonso / Fabregat-Prous, Joan / Secanella-Medayo, Luís / Rotellar-Sastre, Fernando / Pardo-Sánchez, Fernando / Prieto-Calvo, Mikel / Marín-Ortega, Héctor / Sánchez-Cabús, Santiago / Diez-Valladares, Luis / Alonso-Casado, Óscar / González-Serrano, Carmen / Rodríguez-Sanjuan, Juan Carlos / García-Plaza, Gabriel / Jaén-Torrejimeno, Isabel / Suárez-Muñoz, Miguel Ángel / Becerra-Massare, Antonio / Rio, Paula Senra-Del /

Pando, Elizabeth / López-Andújar, Rafael / Muñoz-Forner, Elena / Rodriguez-López, Mario / Pereira, Fernando / Serrablo-Requejo, Alejandro / Turrión, Víctor Sánchez / Garrido, Manuel Jiménez / Burdío, Fernando / Martín-Pérez, Elena / Estevan-Estevan, Rafael / López-Guerra, Diego / Castell-Gómez, José / Salinas-Gómez, Javier / López-Baena, José Ángel / López-Ben, Santiago / Solar-García, Lorena / Pérez-Alonso, Alejandro J / Martínez-Insfran, Luis Alberto / Blas, Juan Luis / Cornejo, Marian / Gutierrez-Calvo, Alberto / Pozo, Carlos Domingo-Del / Ochando-Cerdan, Federico / Muñoz-Bellvís, Luis / Rebollar-Saenz, José / Sánchez, Belinda / Jover, José María / Gómez-Bravo, Miguel Ángel / Ramia, José M / Blanco-Fernández, Gerardo

Surgical oncology

2024 Volume 52, Page(s) 102039

Abstract: Background and objectives: Recurrent isolated pancreatic metastasis from Renal Cell Carcinoma (RCC) after pancreatic resection is rare. The purpose of our study is to describe a series of cases of relapse of pancreatic metastasis from renal cancer in ... ...

Abstract	Background and objectives: Recurrent isolated pancreatic metastasis from Renal Cell Carcinoma (RCC) after pancreatic resection is rare. The purpose of our study is to describe a series of cases of relapse of pancreatic metastasis from renal cancer in the pancreatic remnant and its surgical treatment with a repeated pancreatic resection, and to analyse the results of both overall and disease-free survival. Methods: Multicenter retrospective study of patients undergoing pancreatic resection for RCC pancreatic metastases, from January 2010 to May 2020. Patients were grouped into two groups depending on whether they received a single pancreatic resection (SPS) or iterative pancreatic resection. Data on short and long-term outcome after pancreatic resection were collected. Results: The study included 131 pancreatic resections performed in 116 patients. Thus, iterative pancreatic surgery (IPS) was performed in 15 patients. The mean length of time between the first pancreatic surgery and the second was 48.9 months (95 % CI: 22.2-56.9). There were no differences in the rate of postoperative complications. The DFS rates at 1, 3 and 5 years were 86 %, 78 % and 78 % vs 75 %, 50 % and 37 % in the IPS and SPS group respectively (p = 0.179). OS rates at 1, 3, 5 and 7 years were 100 %, 100 %, 100 % and 75 % in the IPS group vs 95 %, 85 %, 80 % and 68 % in the SPS group (p = 0.895). Conclusion: Repeated pancreatic resection in case of relapse of pancreatic metastasis of RCC in the pancreatic remnant is justified, since it achieves OS results similar to those obtained after the first resection.
MeSH term(s)	Humans ; Carcinoma, Renal Cell/surgery ; Carcinoma, Renal Cell/pathology ; Retrospective Studies ; Pancreatectomy/methods ; Pancreatic Neoplasms/pathology ; Kidney Neoplasms/surgery ; Kidney Neoplasms/pathology ; Recurrence
Language	English
Publishing date	2024-01-27
Publishing country	Netherlands
Document type	Multicenter Study ; Journal Article
ZDB-ID	1107810-8
ISSN	1879-3320 ; 0960-7404
ISSN (online)	1879-3320
ISSN	0960-7404
DOI	10.1016/j.suronc.2024.102039
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Article ; Conference proceedings: The Effect of C1 Esterase Inhibitor on Ischemic Reperfusion Injury in Rat Epigastric Skin Flaps: Preliminary Results

Jurado, Inmaculada Masa / Rodríguez, Alberto Ballestín / Vázquez, Carmen Calles / Velasco, Víctor Salinas / Turrión, Víctor Sánchez / Sánchez, César Casado

Journal of Reconstructive Microsurgery

2014

Abstract: Introduction: In free tissue transfer and replantations, restored blood flow following a prolonged ischemic period may lead to tissue damage as a result of ischemia reperfusion injury. Several studies have shown that the complement system plays an ... ...

Event/congress	Presentation Abstracts, Barcelona, 2014
Abstract	Introduction: In free tissue transfer and replantations, restored blood flow following a prolonged ischemic period may lead to tissue damage as a result of ischemia reperfusion injury. Several studies have shown that the complement system plays an important role in the pathogenesis of ischemic reperfusion injury. C1 esterase inhibitor prevents complement activation during ischemia reperfusion injury by targeting the classical and lecitin pathways. The purpose of this study was to evaluate the effect of C1 esterase inhibitor on flap survival, using an inferior epigastric artery skin flap as a flap ischemia reperfusion injury model. Methodology and Material: Epigastric island skin flaps were elevated in 50 rats. The rats were randomly divided in 5 groups. Group 0 was the sham group and did not undergo ischemic insult. In groups 1 to 4, primary global ischemia of 8 hours was performed. Group 1 (control group) underwent primary ischemia without any therapeutic intervention. Group 2 was subjected to an ischemic preconditioning protocol (3 cycles of 10 minutes of repeated ischemia/reperfusion periods) prior to primary ischemia. In group 3, we used intravenous administration of C1 esterase inhibitor 5 minutes before reperfusion. And in group 4, we combined both ischemic preconditioning technique and C1 esterase inhibitor infusion. Results: The preliminary results of our study have shown that the mean surviving flap areas of groups 0, 1, 2, 3 and 4 were 100%, 94´1%, 98%, 97´1% and 98,2% respectively. Our study showed a slightly higher survival rate in the intervention groups (groups 2, 3 and 4) than group 1 (control) and lower survival rate than group 0 (sham), with no statistical differences (p > 0,05). Conclusions: According to the preliminary results, none of our treatments (the ischemic preconditioning protocol, the C1 esterase inhibitor administration or the combined therapy) had statistically significant effect on flap survival. Histological and biochemical assays might be useful to confirm our macroscopic results.
Language	English
Publishing date	2014-04-01
Publishing place	Stuttgart ; New York
Document type	Article ; Conference proceedings
ZDB-ID	605983-1
ISSN	1098-8947 ; 0743-684X ; 0743-684X
ISSN (online)	1098-8947 ; 0743-684X
ISSN	0743-684X
DOI	10.1055/s-0034-1373959
Database	Thieme publisher's database

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Zs.A 2035: Show issues

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Article: Adrenergic response of splanchnic arteries from cirrhotic patients: role of nitric oxide, prostanoids, and reactive oxygen species.

Salcedo, Adely / Garijo, Jesús / Monge, Luis / Fernández, Nuria / García-Villalón, Angel Luis / Turrión, Víctor Sánchez / Cuervas-Mons, Valentín / Diéguez, Godofredo

Experimental biology and medicine (Maywood, N.J.)

2007 Volume 232, Issue 10, Page(s) 1360–1367

Abstract: Peripheral and splanchnic vasodilatation in cirrhotic patients has been related to hyporesponsiveness to vasoconstrictors, but studies to examine the vascular adrenergic response provide contradictory results. Hepatic arteries from cirrhotic patients ... ...

Abstract	Peripheral and splanchnic vasodilatation in cirrhotic patients has been related to hyporesponsiveness to vasoconstrictors, but studies to examine the vascular adrenergic response provide contradictory results. Hepatic arteries from cirrhotic patients undergoing liver transplantation and mesenteric arteries from liver donors were obtained. Segments 3 mm long from these arteries were mounted in organ baths for testing isometric adrenergic response. The concentration-dependent contraction to noradrenaline (10(-8) to 10(-4) M) was similar in hepatic and mesenteric arteries, and prazosin (alpha 1-adrenergic antagonist, 10(-6) M), but not yohimbine (alpha 2-adrenergic antagonist, 10(-6) M), produced a rightward parallel displacement of this contraction in both types of arteries. Phenylephrine (alpha 1-adrenergic agonist, 10(-8) to 10(-4) M) and clonidine (alpha 2-adrenergic agonist, 10(-8) to 10(-4) M) also produced concentration-dependent contractions that were comparable in hepatic and mesenteric arteries. The inhibitor of cyclooxygenase meclofenamate (10(-5) M), but not the inhibitor of nitric oxide synthesis N(w)-nitro-l-arginine methyl ester (l-NAME, 10(-4) M), potentiated the response to noradrenaline in hepatic arteries; neither inhibitor affected the response to noradrenaline in mesenteric arteries. Diphenyleneiodonium (DPI; 5 x 10(-6) M), but neither catalase (1000 U/ml) nor tiron (10(-4) M), decreased the maximal contraction for noradrenaline similarly in hepatic and mesenteric arteries. Therefore, it is suggested that, in splanchnic arteries from cirrhotic patients, the adrenergic response and the relative contribution of alpha 1- and alpha 2-adrenoceptors in this response is preserved, and prostanoids, but not nitric oxide, may blunt that response. Products dependent on NAD(P)H oxidase might contribute to the adrenergic response in splanchnic arteries from control and cirrhotic patients.
MeSH term(s)	Adult ; Aged ; Female ; Hepatic Artery/drug effects ; Hepatic Artery/physiopathology ; Humans ; Liver Cirrhosis/physiopathology ; Male ; Mesenteric Arteries/drug effects ; Mesenteric Arteries/physiopathology ; Middle Aged ; Muscle Contraction ; Muscle, Smooth, Vascular/drug effects ; Muscle, Smooth, Vascular/physiopathology ; NG-Nitroarginine Methyl Ester/pharmacology ; Nitric Oxide/physiology ; Norepinephrine/pharmacology ; Phenylephrine/pharmacology ; Prostaglandins/physiology ; Reactive Oxygen Species/metabolism ; Splanchnic Circulation/physiology
Chemical Substances	Prostaglandins ; Reactive Oxygen Species ; Phenylephrine (1WS297W6MV) ; Nitric Oxide (31C4KY9ESH) ; NG-Nitroarginine Methyl Ester (V55S2QJN2X) ; Norepinephrine (X4W3ENH1CV)
Language	English
Publishing date	2007-11
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ISSN	1535-3702
ISSN	1535-3702
DOI	10.3181/0701-RM-112
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Article ; Online: mTOR Inhibition Is Most Beneficial After Liver Transplantation for Hepatocellular Carcinoma in Patients With Active Tumors.

Schnitzbauer, Andreas A / Filmann, Natalie / Adam, René / Bachellier, Philippe / Bechstein, Wolf O / Becker, Thomas / Bhoori, Sherrie / Bilbao, Itxarone / Brockmann, Jens / Burra, Patrizia / Chazoullières, Olivier / Cillo, Umberto / Colledan, Michele / Duvoux, Christoph / Ganten, Tom M / Gugenheim, Jean / Heise, Michael / van Hoek, Bart / Jamieson, Neville /

de Jong, Koert P / Klein, Christian G / Klempnauer, Jürgen / Kneteman, Norman / Lerut, Jan / Mäkisalo, Heikki / Mazzaferro, Vincenzo / Mirza, Darius F / Nadalin, Silvio / Neuhaus, Peter / Pageaux, George-Philippe / Pinna, Antonio D / Pirenne, Jaques / Pratschke, Johann / Powel, James / Rentsch, Markus / Rizell, Magnus / Rossi, Giorgio / Rostaing, Lionel / Roy, André / Scholz, Tim / Settmacher, Utz / Soliman, Thomas / Strasser, Simone / Söderdahl, Gunnar / Troisi, Roberto I / Turrión, Victor Sánchez / Schlitt, Hans J / Geissler, Edward K

Annals of surgery

2020 Volume 272, Issue 5, Page(s) 855–862

Abstract: Objective: The aim of this study was to evaluate the survival benefit of sirolimus in patients undergoing liver transplantation (LT) for hepatocellular carcinoma (HCC) (exploratory analysis of the SiLVER-trial).: Summary and background data: Patients ...

Abstract	Objective: The aim of this study was to evaluate the survival benefit of sirolimus in patients undergoing liver transplantation (LT) for hepatocellular carcinoma (HCC) (exploratory analysis of the SiLVER-trial). Summary and background data: Patients receiving LT) for HCC are at a high risk for tumor recurrence. Calcineurin inhibitors have shown evidence to promote cancer growth, whereas mammalian target of rapamycin (mTOR) inhibitors like sirolimus have anticancer effects. In the SiLVER-trial (Clinicaltrials.gov: NCT00355862), the effect of sirolimus on the recurrence of HCC after LT was investigated in a prospective randomized trial. Although the primary endpoint of improved disease-free survival (DFS) with sirolimus was not met, outcomes were improved for patients in the sirolimus-treatment arm in the first 3 to 5 years. To learn more about the key variables, a multivariate analysis was performed on the SiLVER-trial data. Patients and methods: Data from 508 patients of the intention-to-treat analysis were included in exploratory univariate and multivariate models for overall survival (OS), DFS and a competing risk analysis for HCC recurrence. Results: Sirolimus use for ≥3 months after LT for HCC independently reduced the hazard for death in the multivariate analysis [hazard ratio (HR): 0.7 (95% confidence interval, CI: 0.52-0.96, P = 0.02). Most strikingly, patients with an alpha-fetoprotein (AFP) ≥10 ng/mL and having used sirolimus for ≥3 months, benefited most with regard to OS, DFS, and HCC-recurrence (HR: 0.49-0.59, P = 0.0079-0.0245). Conclusions: mTOR-inhibitor treatment with sirolimus for ≥3 months improves outcomes in LT for HCC, especially in patients with AFP-evidence of higher tumor activity, advocating particularly for mTOR inhibitor use in this subgroup of patients. Clinical trial registration: EudraCT: 2005-005362-36 CLINICALTRIALS.GOV:: NCT00355862.
MeSH term(s)	Aged ; Carcinoma, Hepatocellular/mortality ; Carcinoma, Hepatocellular/surgery ; Female ; Humans ; Immunosuppressive Agents/therapeutic use ; Intention to Treat Analysis ; Liver Neoplasms/mortality ; Liver Neoplasms/surgery ; Liver Transplantation/mortality ; Male ; Middle Aged ; Neoplasm Recurrence, Local/prevention & control ; Sirolimus/therapeutic use ; Survival Rate
Chemical Substances	Immunosuppressive Agents ; Sirolimus (W36ZG6FT64)
Language	English
Publishing date	2020-09-01
Publishing country	United States
Document type	Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	340-2
ISSN	1528-1140 ; 0003-4932
ISSN (online)	1528-1140
ISSN	0003-4932
DOI	10.1097/SLA.0000000000004280
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Article ; Online: Pancreatic metastases from renal cell carcinoma. Postoperative outcome after surgical treatment in a Spanish multicenter study (PANMEKID).

Blanco-Fernández, Gerardo / Fondevila-Campo, Constantino / Sanjuanbenito, Alfonso / Fabregat-Prous, Joan / Secanella-Medayo, Luís / Rotellar-Sastre, Fernando / Pardo-Sánchez, Fernando / Prieto-Calvo, Mikel / Marín-Ortega, Héctor / Sánchez-Cabús, Santiago / Diez-Valladares, Luis / Alonso-Casado, Óscar / González-Serrano, Carmen / Rodríguez-Sanjuan, Juan Carlos / García-Plaza, Gabriel / Jaén-Torrejimeno, Isabel / Suárez-Muñoz, Miguel Ángel / Becerra-Massare, Antonio / Rio, Paula Senra-Del /

European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology

2021 Volume 48, Issue 1, Page(s) 133–141

Abstract: Background: Renal Cell Carcinoma (RCC) occasionally spreads to the pancreas. The purpose of our study is to evaluate the short and long-term results of a multicenter series in order to determine the effect of surgical treatment on the prognosis of these ...

Abstract	Background: Renal Cell Carcinoma (RCC) occasionally spreads to the pancreas. The purpose of our study is to evaluate the short and long-term results of a multicenter series in order to determine the effect of surgical treatment on the prognosis of these patients. Methods: Multicenter retrospective study of patients undergoing surgery for RCC pancreatic metastases, from January 2010 to May 2020. Variables related to the primary tumor, demographics, clinical characteristics of metastasis, location in the pancreas, type of pancreatic resection performed and data on short and long-term evolution after pancreatic resection were collected. Results: The study included 116 patients. The mean time between nephrectomy and pancreatic metastases' resection was 87.35 months (ICR: 1.51-332.55). Distal pancreatectomy was the most performed technique employed (50 %). Postoperative morbidity was observed in 60.9 % of cases (Clavien-Dindo greater than IIIa in 14 %). The median follow-up time was 43 months (13-78). Overall survival (OS) rates at 1, 3, and 5 years were 96 %, 88 %, and 83 %, respectively. The disease-free survival (DFS) rate at 1, 3, and 5 years was 73 %, 49 %, and 35 %, respectively. Significant prognostic factors of relapse were a disease free interval of less than 10 years (2.05 [1.13-3.72], p 0.02) and a history of previous extrapancreatic metastasis (2.44 [1.22-4.86], p 0.01). Conclusions: Pancreatic resection if metastatic RCC is found in the pancreas is warranted to achieve higher overall survival and disease-free survival, even if extrapancreatic metastases were previously removed. The existence of intrapancreatic multifocal compromise does not always warrant the performance of a total pancreatectomy in order to improve survival.
MeSH term(s)	Aged ; Carcinoma, Renal Cell/secondary ; Carcinoma, Renal Cell/surgery ; Female ; Humans ; Kidney Neoplasms/pathology ; Kidney Neoplasms/surgery ; Male ; Metastasectomy ; Middle Aged ; Nephrectomy ; Pancreatectomy ; Pancreatic Neoplasms/secondary ; Pancreatic Neoplasms/surgery ; Postoperative Complications/epidemiology ; Spain/epidemiology ; Treatment Outcome
Language	English
Publishing date	2021-08-11
Publishing country	England
Document type	Journal Article ; Multicenter Study
ZDB-ID	632519-1
ISSN	1532-2157 ; 0748-7983
ISSN (online)	1532-2157
ISSN	0748-7983
DOI	10.1016/j.ejso.2021.08.011
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Zs.A 1149: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Sirolimus Use in Liver Transplant Recipients With Hepatocellular Carcinoma: A Randomized, Multicenter, Open-Label Phase 3 Trial.

Geissler, Edward K / Schnitzbauer, Andreas A / Zülke, Carl / Lamby, Philipp E / Proneth, Andrea / Duvoux, Christophe / Burra, Patrizia / Jauch, Karl-Walter / Rentsch, Markus / Ganten, Tom M / Schmidt, Jan / Settmacher, Utz / Heise, Michael / Rossi, Giorgio / Cillo, Umberto / Kneteman, Norman / Adam, René / van Hoek, Bart / Bachellier, Philippe /

Wolf, Philippe / Rostaing, Lionel / Bechstein, Wolf O / Rizell, Magnus / Powell, James / Hidalgo, Ernest / Gugenheim, Jean / Wolters, Heiner / Brockmann, Jens / Roy, André / Mutzbauer, Ingrid / Schlitt, Angela / Beckebaum, Susanne / Graeb, Christian / Nadalin, Silvio / Valente, Umberto / Turrión, Victor Sánchez / Jamieson, Neville / Scholz, Tim / Colledan, Michele / Fändrich, Fred / Becker, Thomas / Söderdahl, Gunnar / Chazouillères, Olivier / Mäkisalo, Heikki / Pageaux, Georges-Philippe / Steininger, Rudolf / Soliman, Thomas / de Jong, Koert P / Pirenne, Jacques / Margreiter, Raimund / Pratschke, Johann / Pinna, Antonio D / Hauss, Johann / Schreiber, Stefan / Strasser, Simone / Klempnauer, Jürgen / Troisi, Roberto I / Bhoori, Sherrie / Lerut, Jan / Bilbao, Itxarone / Klein, Christian G / Königsrainer, Alfred / Mirza, Darius F / Otto, Gerd / Mazzaferro, Vincenzo / Neuhaus, Peter / Schlitt, Hans J

Transplantation

2016 Volume 100, Issue 1, Page(s) 116–125

Abstract: Background: We investigated whether sirolimus-based immunosuppression improves outcomes in liver transplantation (LTx) candidates with hepatocellular carcinoma (HCC).: Methods: In a prospective-randomized open-label international trial, 525 LTx ... ...

Abstract	Background: We investigated whether sirolimus-based immunosuppression improves outcomes in liver transplantation (LTx) candidates with hepatocellular carcinoma (HCC). Methods: In a prospective-randomized open-label international trial, 525 LTx recipients with HCC initially receiving mammalian target of rapamycin inhibitor-free immunosuppression were randomized 4 to 6 weeks after transplantation into a group on mammalian target of rapamycin inhibitor-free immunosuppression (group A: 264 patients) or a group incorporating sirolimus (group B: 261). The primary endpoint was recurrence-free survival (RFS); intention-to-treat (ITT) analysis was conducted after 8 years. Overall survival (OS) was a secondary endpoint. Results: Recurrence-free survival was 64.5% in group A and 70.2% in group B at study end, this difference was not significant (P = 0.28; hazard ratio [HR], 0.84; 95% confidence interval [95% CI], 0.62; 1.15). In a planned analysis of RFS rates at yearly intervals, group B showed better outcomes 3 years after transplantation (HR, 0.7; 95% CI, 0.48-1.00). Similarly, OS (P = 0.21; HR, 0.81; 95% CI, 0.58-1.13) was not statistically better in group B at study end, but yearly analyses showed improvement out to 5 years (HR, 0.7; 95% CI, 0.49-1.00). Interestingly, subgroup (Milan Criteria-based) analyses revealed that low-risk, rather than high-risk, patients benefited most from sirolimus; furthermore, younger recipients (age ≤60) also benefited, as well sirolimus monotherapy patients. Serious adverse event numbers were alike in groups A (860) and B (874). Conclusions: Sirolimus in LTx recipients with HCC does not improve long-term RFS beyond 5 years. However, a RFS and OS benefit is evident in the first 3 to 5 years, especially in low-risk patients. This trial provides the first high-level evidence base for selecting immunosuppression in LTx recipients with HCC.
MeSH term(s)	Adult ; Age Factors ; Aged ; Australia ; Canada ; Carcinoma, Hepatocellular/mortality ; Carcinoma, Hepatocellular/pathology ; Carcinoma, Hepatocellular/surgery ; Disease Progression ; Disease-Free Survival ; Drug Therapy, Combination ; Europe ; Female ; Humans ; Immunosuppressive Agents/therapeutic use ; Intention to Treat Analysis ; Kaplan-Meier Estimate ; Liver Neoplasms/mortality ; Liver Neoplasms/pathology ; Liver Neoplasms/surgery ; Liver Transplantation/adverse effects ; Liver Transplantation/mortality ; Male ; Middle Aged ; Neoplasm Recurrence, Local ; Prospective Studies ; Risk Assessment ; Risk Factors ; Sirolimus/therapeutic use ; TOR Serine-Threonine Kinases/antagonists & inhibitors ; TOR Serine-Threonine Kinases/metabolism ; Time Factors ; Treatment Outcome ; Young Adult
Chemical Substances	Immunosuppressive Agents ; MTOR protein, human (EC 2.7.1.1) ; TOR Serine-Threonine Kinases (EC 2.7.1.1) ; Sirolimus (W36ZG6FT64)
Language	English
Publishing date	2016-01
Publishing country	United States
Document type	Clinical Trial, Phase III ; Journal Article ; Multicenter Study ; Randomized Controlled Trial
ZDB-ID	208424-7
ISSN	1534-6080 ; 0041-1337
ISSN (online)	1534-6080
ISSN	0041-1337
DOI	10.1097/TP.0000000000000965
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Article ; Online: 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

BMC cancer

2010 Volume 10, Page(s) 190

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 ...

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 21/2 -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).
MeSH term(s)	Australia ; Canada ; Carcinoma, Hepatocellular/drug therapy ; Carcinoma, Hepatocellular/enzymology ; Carcinoma, Hepatocellular/mortality ; Carcinoma, Hepatocellular/surgery ; Disease-Free Survival ; Europe ; Humans ; Immunosuppressive Agents/therapeutic use ; Intracellular Signaling Peptides and Proteins/antagonists & inhibitors ; Intracellular Signaling Peptides and Proteins/metabolism ; Kaplan-Meier Estimate ; Liver Neoplasms/drug therapy ; Liver Neoplasms/enzymology ; Liver Neoplasms/mortality ; Liver Neoplasms/surgery ; Liver Transplantation/adverse effects ; Liver Transplantation/mortality ; Prospective Studies ; Protein-Serine-Threonine Kinases/antagonists & inhibitors ; Protein-Serine-Threonine Kinases/metabolism ; Recurrence ; Risk Factors ; Sirolimus/therapeutic use ; TOR Serine-Threonine Kinases ; Time Factors ; Transplantation, Homologous ; Treatment Outcome
Chemical Substances	Immunosuppressive Agents ; Intracellular Signaling Peptides and Proteins ; MTOR protein, human (EC 2.7.1.1) ; TOR Serine-Threonine Kinases (EC 2.7.1.1) ; Protein-Serine-Threonine Kinases (EC 2.7.11.1) ; Sirolimus (W36ZG6FT64)
Language	English
Publishing date	2010-05-11
Publishing country	England
Document type	Comparative Study ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ISSN	1471-2407
ISSN (online)	1471-2407
DOI	10.1186/1471-2407-10-190
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