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973 results on '"Louvet A"'

1. LBP-027 Combined effect of obeticholic acid and bezafibrate in patients with primary biliary cholangitis and inadequate response or intolerance to ursodeoxycholic acid: 6-month results from a phase 2 trial

Author

Jones, David E., primary, Louvet, Alexandre, additional, Corpechot, Christophe, additional, Hejda, Vaclav, additional, Zou, Heng, additional, Civitarese, Antonio, additional, Villamil, Alejandra, additional, and Nevens, Frederik, additional

Published
2024
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2. TOP-108 Evaluation of the scoring systems dedicated to liver transplantation in acute-on-chronic liver failure (ACLF) in an international multicenter cohort

Author

L'Hermite, Sébastien, primary, Bedoya, José Ursic, additional, Halter, Sébastien, additional, Ichai, Philippe, additional, Ntandja Wandji, Line Carolle, additional, Coilly, Audrey, additional, Camus, Christophe, additional, Jaber, Samir, additional, Taylor, Rhiannon, additional, Dharancy, Sébastien, additional, Thorburn, Douglas, additional, Conti, Filomena, additional, Pageaux, Georges-Philippe, additional, Saliba, Faouzi, additional, Karvellas, Constantine, additional, Monsel, Antoine, additional, Louvet, Alexandre, additional, Bernal, William, additional, and Artru, Florent, additional

Published
2024
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3. LBO-003 Results of a phase 2b multicenter randomized trial of larsucosterol for the treatment of severe alcohol-associated hepatitis (AHFIRM trial)

Author

Shiffman, Mitchell, primary, Da, Ben, additional, Stein, Lance, additional, Moreno, Christophe, additional, Mehta, Ashwini, additional, Louvet, Alexandre, additional, Nicoll, Amanda, additional, Goel, Aparna, additional, Kwong, Allison, additional, Flamm, Steven, additional, Satapathy, Sanjaya, additional, Kuo, Alexander, additional, Pyrsopoulos, Nikolaos T., additional, Ganger, Daniel, additional, Aloman, Costica, additional, Strasser, Simone, additional, Tse, Edmund, additional, Russo, Mark, additional, Rockey, Don, additional, Gray, Meagan, additional, Mitchell, Mack, additional, Thursz, Mark R., additional, Krebs, William, additional, Scott, Deborah, additional, Blevins, Christina, additional, Brown, James, additional, Lin, WeiQi, additional, and Sussman, Norman, additional

Published
2024
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4. OS-097 Effect of rifaximin in severe cirrhotic patients with ascites: a double-blind randomized placebo-controlled phase 3 trial

Author

Thévenot, Thierry, primary, Elkrief, Laure, additional, Bureau, Christophe, additional, Bardou-Jacquet, Edouard, additional, Rosa, Isabelle, additional, Khac, Eric Nguyen, additional, Oberti, Frédéric, additional, Pitta, Anais, additional, Mallet, Maxime, additional, Lebosse, Fanny, additional, Louvet, Alexandre, additional, Meunier, Lucy, additional, Nahon, Pierre, additional, Ollivier-Hourmand, Isabelle, additional, Anty, Rodolphe, additional, Francoz, Claire, additional, Riachi, Ghassan, additional, Meunier, Alexandre, additional, Tio, Gregory, additional, Muller, Allison, additional, Curé-Martin, Audace, additional, Hocquet, Didier, additional, Di Martino, Vincent, additional, Weil-Verhoeven, Delphine, additional, and Desmarets, Maxime, additional

Published
2024
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5. SAT-439-YI Socioeconomic deprivation is independently associated with hepatocellular carcinoma mortality in a western european country with single-payer healthcare

Author

Ningarhari, Massih, primary, Lacour, Alexandre, additional, Dauchy, Simon, additional, Genin, Michael, additional, Bruandet, Amelie, additional, Cattan, Stéphane, additional, Wandji, Line Carolle Ntandja, additional, Lemaître, Elise, additional, Canva, Valérie, additional, Louvet, Alexandre, additional, Mathurin, Philippe, additional, Dharancy, Sébastien, additional, and Lassailly, Guillaume, additional

Published
2024
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6. GS-010 Early liver transplantation for severe alcohol-related hepatitis: long-term data of the french-belgian controlled study (QuickTrans)

Author

Louvet, Alexandre, primary, Favier, Laurie, additional, Labreuche, Julien, additional, Moreno, Christophe, additional, Vanlemmens, Claire, additional, Moirand, Romain, additional, Wandji, Line Carolle Ntandja, additional, Feray, Cyrille, additional, Dumortier, Jérôme, additional, Pageaux, Georges-Philippe, additional, Bureau, Christophe, additional, Chermak, Faiza, additional, Duvoux, Christophe, additional, Thabut, Dominique, additional, Hilleret, Marie-Noëlle, additional, Carbonell, Nicolas, additional, Salamé, Ephrem, additional, Anty, Rodolphe, additional, Gournay, Jérôme, additional, Delwaide, Jean, additional, Silvain, Christine, additional, Lassailly, Guillaume, additional, Dharancy, Sébastien, additional, Khac, Eric Nguyen, additional, Samuel, Didier, additional, Duhamel, Alain, additional, and Mathurin, Philippe, additional

Published
2024
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7. Biliary tract cancers: French national clinical practice guidelines for diagnosis, treatments and follow-up (TNCD, SNFGE, FFCD, UNICANCER, GERCOR, SFCD, SFED, AFEF, SFRO, SFP, SFR, ACABi, ACHBPT)

Author

Roth, Gael S., primary, Verlingue, Loic, additional, Sarabi, Matthieu, additional, Blanc, Jean-Frédéric, additional, Boleslawski, Emmanuel, additional, Boudjema, Karim, additional, Bretagne-Bignon, Anne-Laure, additional, Camus-Duboc, Marine, additional, Coriat, Romain, additional, Créhange, Gilles, additional, De Baere, Thierry, additional, de la Fouchardière, Christelle, additional, Dromain, Clarisse, additional, Edeline, Julien, additional, Gelli, Maximiliano, additional, Guiu, Boris, additional, Horn, Samy, additional, Laurent-Croise, Valérie, additional, Lepage, Côme, additional, Lièvre, Astrid, additional, Lopez, Anthony, additional, Manfredi, Sylvain, additional, Meilleroux, Julie, additional, Neuzillet, Cindy, additional, Paradis, Valérie, additional, Prat, Frédéric, additional, Ronot, Maxime, additional, Rosmorduc, Olivier, additional, Cunha, Antonio Sa, additional, Soubrane, Olivier, additional, Turpin, Anthony, additional, Louvet, Christophe, additional, Bouché, Olivier, additional, and Malka, David, additional

Published
2024
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11. Association between public health policies on alcohol and worldwide cancer, liver disease and cardiovascular disease outcomes

Author

Díaz, Luis Antonio, primary, Fuentes-López, Eduardo, additional, Idalsoaga, Francisco, additional, Ayares, Gustavo, additional, Corsi, Oscar, additional, Arnold, Jorge, additional, Cannistra, Macarena, additional, Vio, Danae, additional, Márquez-Lomas, Andrea, additional, Ramirez-Cadiz, Carolina, additional, Medel, María Paz, additional, Hernandez-Tejero, María, additional, Ferreccio, Catterina, additional, Lazo, Mariana, additional, Roblero, Juan Pablo, additional, Cotter, Thomas G., additional, Kulkarni, Anand V., additional, Kim, Won, additional, Brahmania, Mayur, additional, Louvet, Alexandre, additional, Tapper, Elliot B., additional, Dunn, Winston, additional, Simonetto, Douglas, additional, Shah, Vijay H., additional, Kamath, Patrick S., additional, Lazarus, Jeffrey V., additional, Singal, Ashwani K., additional, Bataller, Ramon, additional, Arrese, Marco, additional, and Arab, Juan Pablo, additional

Published
2024
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12. Good outcome of liver transplantation in patients with pre-existing renal cell carcinoma

Author

Lassailly, G., primary, Ningarhari, M., additional, Dumortier, J, additional, Lafforgue, C., additional, Bouye, S., additional, Amrani, M.El, additional, Lebuffe, G., additional, Villers, A., additional, Truant, S, additional, Mathurin, P., additional, Louvet, A., additional, Boillot, O, additional, Boleslawski, E, additional, and Dharancy, S., additional

Published
2023
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14. Time to recurrence and its relation to survival after recurrence in patients resected for stage III colon cancer

Author

Rasola, Cosimo, primary, Laurent-Puig, Pierre, additional, André, Thierry, additional, Falcoz, Antoine, additional, Lepage, Come, additional, Aparicio, Thomas, additional, Bouché, Olivier, additional, Lievre, Astrid, additional, Mineur, Laurent, additional, Bennouna, Jaafar, additional, Louvet, Christophe, additional, Bachet, Jean Baptiste, additional, Borg, Christophe, additional, Vernerey, Dewi, additional, Lonardi, Sara, additional, and Taieb, Julien, additional

Published
2023
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16. Hepatocyte-derived biomarkers predict liver-related events at 2 years in Child-Pugh class A alcohol-related cirrhosis

Author

Elkrief, Laure, primary, Ganne-Carrié, Nathalie, additional, Manceau, Hana, additional, Tanguy, Marion, additional, Valainathan, Shantha Ram, additional, Riescher-Tuczkiewicz, Alix, additional, Biquard, Louise, additional, Barget, Nathalie, additional, Chaffaut, Cendrine, additional, Louvet, Alexandre, additional, Paradis, Valérie, additional, Ziol, Marianne, additional, Bæk, Rikke, additional, Jørgensen, Malene Møller, additional, Van Niel, Guillaume, additional, Coly, Pierre-Michael, additional, Hammoutène, Adel, additional, Dujardin, Fanny, additional, Peoc’h, Katell, additional, Poynard, Thierry, additional, Chevret, Sylvie, additional, and Rautou, Pierre-Emmanuel, additional

Published
2023
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17. Neoadjuvant chemotherapy with or without nintedanib for advanced epithelial ovarian cancer: Lessons from the GINECO double-blind randomized phase II CHIVA trial

Author

Gwénaël Ferron, Gaëtan De Rauglaudre, Stéphanie Becourt, Nicolas Delanoy, Florence Joly, Alain Lortholary, Benoît You, Patrick Bouchaert, Emmanuelle Malaurie, Sebastien Gouy, Marie-Christine Kaminsky, Jérôme Meunier, Jérôme Alexandre, Dominique Berton, Nadine Dohollou, Coraline Dubot, Anne Floquet, Laure Favier, Laurence Venat-Bouvet, Michel Fabbro, Christophe Louvet, Jean-Pierre Lotz, Sophie Abadie-Lacourtoisie, Christophe Desauw, Francesco Del Piano, Marianne Leheurteur, Nathalie Bonichon-Lamichhane, Mansour Rastkhah, Philippe Follana, Justine Gantzer, Isabelle Ray-Coquard, and Eric Pujade-Lauraine

Subjects
Oncology, Obstetrics and Gynecology
Published
2023
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18. Integrating genetic variants into clinical models for hepatocellular carcinoma risk stratification in cirrhosis

Author

Pierre Nahon, Jessica Bamba-Funck, Richard Layese, Eric Trépo, Jessica Zucman-Rossi, Carole Cagnot, Nathalie Ganne-Carrié, Cendrine Chaffaut, Erwan Guyot, Marianne Ziol, Angela Sutton, Etienne Audureau, Tarik Asselah, Dominique Guyader, Stanislas Pol, Hélène Fontaine, Georges-Philippe Pageaux, Victor De Lédinghen, Denis Ouzan, Fabien Zoulim, Dominique Roulot, Albert Tran, Jean-Pierre Bronowicki, Thomas Decaensi, Ghassan Riachi, Paul Calès, Jean-Marie Péron, Laurent Alric, Marc Bourlière, Philippe Mathurin, Sebastien Dharancy, Jean-Frédéric Blanc, Armand Abergel, Olivier Chazouillères, Ariane Mallat, Jean-Didier Grangé, Pierre Attali, null Louis d’Alteroche, Claire Wartelle, Thông Dao, Dominique Thabut, Christophe Pilette, Christine Silvain, Christos Christidis, Eric Nguyen-Khac, Brigitte Bernard-Chabert, Sophie Hillaire, Vincent Di Martino, Isabelle Archambeaud, Louis d’Alteroche, Frédéric Oberti, Christophe Moreno, Alexandre Louvet, Romain Moirand, Odile Goria, Nicolas Carbonell, Jean-Charles Duclos-Vallée, Victor de Ledinghen, Violaine Ozenne, Jean Henrion, Gabriel Perlemuter, Xavier Amiot, Jean-Pierre Zarski, and Sylvie Chevret

Subjects
Hepatology
Abstract

This study aimed to evaluate the ability of single nucleotide polymorphisms (SNPs) to refine hepatocellular carcinoma (HCC) risk stratification.Six SNPs in PNPLA3, TM6SF2, HSD17B13, APOE, and MBOAT7 affecting lipid turnover and one variant involved in the Wnt-β-catenin pathway (WNT3A-WNT9A rs708113) were assessed in patients with alcohol-related and/or HCV-cured cirrhosis included in HCC surveillance programs (prospective CirVir and CIRRAL cohorts). Their prognostic value for HCC occurrence was assessed using Fine-Gray models combined into a 7-SNP genetic risk score (GRS). Prediction ability of two clinical scores (a routine nongenetic model determined by multivariate analysis and the external aMAP score) without then with the addition of the GRS was evaluated by C-indices. The standardized net benefit was derived from decision curves.Among 1145 patients, 86 (7.5%) developed HCC after 43.7 months. PNPLA3 and WNT3A-WNT9A variants were independently associated with HCC occurrence. The GRS stratified the population into 3 groups with progressively increased 5-yr HCC incidence [Group 1 (n=627, 5.4%), Group 2 (n=276, 10.7%), and Group 3 (n=242, 15.3%); P0.001]. The multivariate model identified age, male sex, diabetes, platelet count, GGT levels, albuminemia and the GRS as independent risk factors. The clinical model performance for 5-yr HCC prediction was similar to that of the aMAP score (C-Index 0.769). The addition of the GRS to both scores modestly improved their performance (C-Index 0.786 and 0.783, respectively). This finding was confirmed by decision curve analyses showing only fair clinical net benefit.Patients with cirrhosis can be stratified into HCC risk classes by variants affecting lipid turnover and Wnt-β-catenin pathway. The incorporation of this genetic information modestly improves the performance of clinical scores.The identification of patients at higher probability of developing liver cancer is pivotal to improve the performance of surveillance. Risk assessment can be achieved by combining several clinical and biological parameters used in routine practice. The addition of patients' genetic characteristics can modestly improve this prediction and will ultimately pave the way for precision medicine in patients eligible for HCC surveillance, allowing physicians to trigger personalized screening strategies.

Published
2023
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20. Prognosis and chemosensitivity of non-colorectal alimentary tract cancers with microsatellite instability

Author

Claire Boyer, David Sefrioui, Romain Cohen, Romain Chautard, Marine Perrier, Hugo Lebrun, Gael Goujon, Vincent Hautefeuille, Marie Dior, Thomas Walter, Florence Mary, Silvain Manfredi, Francois-Xavier Caroli-Bosc, Baptiste Cervantes, Romain Coriat, Elise Deluche, Aziz Zaanan, Raphael Olivier, Olivier Bouché, Guillaume Piessen, Thierry Lecomte, Christophe Louvet, Pierre Michel, Thomas Aparicio, Thierry André, Julien Taieb, Violaine Randrian, David Tougeron, Centre hospitalier universitaire de Poitiers (CHU Poitiers), Communications Cellulaires et Différenciation (CCD), Institut National de la Recherche Agronomique (INRA)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Groupe innovation et ciblage cellulaire (GICC), EA 7501 [2018-...] (GICC EA 7501), Université de Tours (UT), AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), CHU Amiens-Picardie, AP-HP - Hôpital Cochin Broca Hôtel Dieu [Paris], Université Paris Cité (UPCité), Centre de Bioinformatique (CBIO), Mines Paris - PSL (École nationale supérieure des mines de Paris), Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL), Cancer et génome: Bioinformatique, biostatistiques et épidémiologie d'un système complexe, Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL)-Institut Curie [Paris]-Institut National de la Santé et de la Recherche Médicale (INSERM), Université Paris sciences et lettres (PSL), Hôpital Avicenne [AP-HP], Hémodynamique, Interaction Fibrose et Invasivité tumorales Hépatiques (HIFIH), Université d'Angers (UA), Hôpital Cochin [AP-HP], CHU Limoges, Centre de Recherche des Cordeliers (CRC (UMR_S_1138 / U1138)), École Pratique des Hautes Études (EPHE), Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Université Paris Cité (UPCité), Université de Reims Champagne-Ardenne (URCA), Centre Hospitalier Universitaire de Reims (CHU Reims), Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Cancer Heterogeneity, Plasticity and Resistance to Therapies - UMR 9020 - U 1277 (CANTHER), Institut Pasteur de Lille, and Réseau International des Instituts Pasteur (RIIP)-Réseau International des Instituts Pasteur (RIIP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille)-Centre National de la Recherche Scientifique (CNRS)

Subjects
Hepatology, [SDV]Life Sciences [q-bio], Gastroenterology, Humans, Microsatellite Instability, Middle Aged, Prognosis, Colorectal Neoplasms, Colorectal Neoplasms, Hereditary Nonpolyposis, DNA Mismatch Repair
Abstract

Data on outcomes of microsatellite instable and/or mismatch repair deficient (dMMR/MSI) digestive non-colorectal tumors are limited.To evaluate overall survival (OS) of patients with dMMR/MSI digestive non-colorectal tumor.All consecutive patients with a dMMR/MSI digestive non-colorectal tumor were included in this French retrospective multicenter study.One hundred and sixteen patients were included with a mean age of 63.6 years and 32.6% with a Lynch syndrome. Most tumors were oesophago-gastric (54.3%) or small bowel (32.8%) adenocarcinomas and at a localized stage at diagnosis (86.7%). In patients with localized tumors and R0 resection, median OS was 134.0 ± 64.2 months. Median disease-free survival (DFS) was 100.3 ± 65.7 months. Considering oesophago-gastric tumors, median DFS was improved when chemotherapy was added to surgery (not reached versus 22.8 ± 10.0 months, p = 0.03). In patients with advanced tumors treated by chemotherapy, median OS was 14.2 ± 1.9 months and median progression-free survival was 7.4 ± 1.6 months.dMMR/MSI digestive non-colorectal tumors are mostly diagnosed at a non-metastatic stage with a good prognosis. Advanced dMMR/MSI digestive non-colorectal tumors have a poor prognosis with standard chemotherapy.

Published
2023
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22. MELD 3.0 adequately predicts mortality and renal replacement therapy requirements in patients with alcohol-associated hepatitis

Author

Díaz, Luis Antonio, primary, Fuentes-López, Eduardo, additional, Ayares, Gustavo, additional, Idalsoaga, Francisco, additional, Arnold, Jorge, additional, Valverde, María Ayala, additional, Perez, Diego, additional, Gómez, Jaime, additional, Escarate, Rodrigo, additional, Villalón, Alejandro, additional, Ramírez, Carolina A., additional, Hernandez-Tejero, Maria, additional, Zhang, Wei, additional, Qian, Steve, additional, Simonetto, Douglas A., additional, Ahn, Joseph C., additional, Buryska, Seth, additional, Dunn, Winston, additional, Mehta, Heer, additional, Agrawal, Rohit, additional, Cabezas, Joaquín, additional, García-Carrera, Inés, additional, Cuyàs, Berta, additional, Poca, Maria, additional, Soriano, German, additional, Sarin, Shiv K., additional, Maiwall, Rakhi, additional, Jalal, Prasun K., additional, Abdulsada, Saba, additional, Higuera-de-la-Tijera, Fátima, additional, Kulkarni, Anand V., additional, Rao, P. Nagaraja, additional, Salazar, Patricia Guerra, additional, Skladaný, Lubomir, additional, Bystrianska, Natália, additional, Clemente-Sanchez, Ana, additional, Villaseca-Gómez, Clara, additional, Haider, Tehseen, additional, Chacko, Kristina R., additional, Romero, Gustavo A., additional, Pollarsky, Florencia D., additional, Restrepo, Juan Carlos, additional, Castro-Sanchez, Susana, additional, Toro, Luis G., additional, Yaquich, Pamela, additional, Mendizabal, Manuel, additional, Garrido, Maria Laura, additional, Marciano, Sebastián, additional, Dirchwolf, Melisa, additional, Vargas, Victor, additional, Jiménez, César, additional, Louvet, Alexandre, additional, García-Tsao, Guadalupe, additional, Roblero, Juan Pablo, additional, Abraldes, Juan G., additional, Shah, Vijay H., additional, Kamath, Patrick S., additional, Arrese, Marco, additional, Singal, Ashwani K., additional, Bataller, Ramon, additional, and Arab, Juan Pablo, additional

Published
2023
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23. Natural history and management of recurrent hepatocellular carcinoma after liver transplantation: a multicenter nationwide study

Author

Ningarhari, Massih, primary, Henry, Camille, additional, Boleslawski, Emmanuel, additional, Besch, Camille, additional, Faitot, François, additional, Assenat, Eric, additional, Herrero, Astrid, additional, Ursic-Bedoya, Jose, additional, Robin, Fabien, additional, Uguen, Thomas, additional, Antonini, Teresa, additional, Erard, Domitille, additional, Radenne, Sylvie, additional, Brusset, Bleuenn, additional, Decaens, Thomas, additional, Allaire, Manon, additional, Conti, Filomena, additional, Barraud, Hélène, additional, Elkrief, Laure, additional, Salamé, Ephrem, additional, Boillot, Olivier, additional, Dumortier, Jérôme, additional, Ntandja Wandji, Line Carolle, additional, Louvet, Alexandre, additional, Mathurin, Philippe, additional, Dharancy, Sebastien, additional, and Lassailly, Guillaume, additional

Published
2023
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24. Characterization of fibrogenesis in severe alcohol-related hepatitis using a 3D model of coculture of organoids and fibroblasts from patients

Author

Ntandja Wandji, Line Carolle, primary, Saleh, Mohamed Bou, additional, Sobolewski, Cyril, additional, Gnemmi, Viviane, additional, Boleslawski, Emmanuel, additional, Bray, Fabrice, additional, Rolando, Christian, additional, Mathurin, Philippe, additional, Dubuquoy, Laurent, additional, and Louvet, Alexandre, additional

Published
2023
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27. Long-term outcome following liver transplantation for patients with acute on chronic liver failure grade 3 (ACLF-3): a retrospective matched-controlled study

Author

Artru, Florent, primary, Sacleux, Sophie-Caroline, additional, Bedoya, José Ursic, additional, Levy, Clementine, additional, Khaldi, Marion, additional, Le Goffic, Charles, additional, Levesque, Eric, additional, Dharancy, Sébastien, additional, Boleslawski, Emmanuel, additional, Lebuffe, Gilles, additional, Ichai, Philippe, additional, Coilly, Audrey, additional, De Martin, Eleonora, additional, Vibert, Eric, additional, Jaber, Samir, additional, Herrero, Astrid, additional, Meszaros, Magdalena, additional, Monet, Clement, additional, Samuel, Didier, additional, Mathurin, Philippe, additional, Pageaux, Georges-Philippe, additional, Saliba, Faouzi, additional, and Louvet, Alexandre, additional

Published
2023
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28. Sub-optimal global public health policies and strategies to combat hepatocellular carcinoma

Author

Diaz, Luis Antonio, primary, Norero, Blanca, additional, Corsi, Oscar, additional, Ayares, Gustavo, additional, Idalsoaga, Francisco, additional, García, Sergio, additional, Vázquez, Valeria, additional, Lacalle, Lucas, additional, Lazo, Mariana, additional, Ferreccio, Catterina, additional, Mendizabal, Manuel, additional, Piñero, Federico, additional, Martinez, Edmundo, additional, Ijeoma, Ifeorah, additional, Louvet, Alexandre, additional, Piano, Salvatore, additional, Cortez-Pinto, Helena, additional, Wong, Vincent Wai-Sun, additional, Kulkarni, Anand, additional, Cotter, Thomas, additional, Brahmania, Mayur, additional, roblero, Juan Pablo, additional, Dirchwolf, Melisa, additional, Pollarsky, Florencia, additional, George, Jacob, additional, Stauber, Rudolf E., additional, Francque, Sven, additional, Guerra, Patricia, additional, Oliveira, Claudia, additional, Araujo, Roberta, additional, Álvares-da-Silva, Mario, additional, Blaise, Nkegoum, additional, Abraldes, Juan G, additional, Zheng, Ming-Hua, additional, Toro, Luis, additional, Restrepo, Juan Carlos, additional, Ramirez, Wagner, additional, Grgurević, Ivica, additional, Infante, Mirtha, additional, Mbendi, Charles, additional, Carrera, Enrique, additional, El Kassas, Mohamed, additional, Mahmoud, Abdelmajeed, additional, Tesfaye, Yonas Gedamu, additional, Tadesse, Sewale Anagaw, additional, Akalu, Tiruwork Fekadu, additional, Desalegn, Hailemichael, additional, Allaire, Manon, additional, Patrizia, Carrieri, additional, Schattenberg, Jörn, additional, Aguyire, Joan, additional, Micah, Eileen Akonobea, additional, Tachi, Kenneth, additional, Maldonado Cardona, Katherine Emilia, additional, Sanchez, Abel, additional, Sánchez, Marco, additional, Björnsson, Einar S., additional, Iavarone, Massimo, additional, Okamoto, Ryuichi, additional, Some, Fatuma, additional, Hellani, Mohammad Fadel, additional, Prado Gonzalez, Veronica Enith, additional, Chávez-Tapia, Norberto Carlos, additional, Méndez-Sánchez, Nahum, additional, Mabote Mucumbi, Sheila Constância, additional, Ugiagbe, Rose Ashinedu, additional, Akande, Kolawole, additional, Nwoko, Chinenye, additional, Ezenkwa, Uchenna Simon, additional, Okoye, Ifeoma Joy, additional, Hamid, Saeed Sadiq, additional, Quezada, Julissa Lombardo, additional, Girala, Marcos, additional, Padilla, P. Martin, additional, Diaz-Ferrer, Javier, additional, Tagle, Martin, additional, Kukla, Michał, additional, Odeghe, Emuobor, additional, wemimo, Rasheed mumini, additional, Reis, Daniela, additional, Mozgovoi, Sergei, additional, Ismail, Mona, additional, Koller, Tomas, additional, Spearman, Wendy, additional, Elhassan, Moawia, additional, Stal, Per, additional, Pazi, Swaleh, additional, Ocanit, Anthony, additional, Masson, Steven, additional, Dunn, Winston, additional, Kamath, Patrick S., additional, Singal, Ashwani, additional, Debes, Jose, additional, Reig, María, additional, Loomba, Rohit, additional, Bataller, Ramon, additional, Lazarus, Jeffrey, additional, Arrese, Marco, additional, and Arab, Juan Pablo, additional

Published
2023
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29. Norucholic acid for the treatment of primary sclerosing cholangitis: baseline data from a phase III trial

Author

Trauner, Michael, primary, Fickert, Peter, additional, Trivedi, Palak, additional, Denk, Gerald, additional, Färkkilä, Martti, additional, Dill, Michael, additional, Villadsen, Gerda Elisabeth, additional, Berg, Christoph, additional, Jørgensen, Kristin Kaasen, additional, Vetter, Marcel, additional, Müller, Tobias, additional, Müllhaupt, Beat, additional, Schramm, Christoph, additional, Strassburg, Christian, additional, Bantel, Heike, additional, Böttler, Tobias, additional, Beuers, Ulrich, additional, Louvet, Alexandre, additional, Halilbasic, Emina, additional, Stiess, Michael, additional, Proels, Markus, additional, and Manns, Michael P., additional

Published
2023
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30. Current prognosis of gastric variceal bleeding in France: preliminary results from a multicenter prospective cohort of 87 cirrhotic patients

Author

Weil-Verhoeven, Delphine, primary, Cervoni, Jean Paul, additional, Oberti, Frédéric, additional, Louvet, Alexandre, additional, D’alteroche, Louis, additional, Faure, Stéphanie, additional, Latournerie, Marianne, additional, Carbonell, Nicolas, additional, Jezequel, Caroline, additional, Billioud, Claire, additional, Saliba, Faouzi, additional, Bouzbib, Charlotte, additional, Tanne, Florence, additional, Ollivier-Hourmand, Isabelle, additional, Jean-Baptiste, Hiriart, additional, Chermak, Faiza, additional, Sacleux, Sophie-Caroline, additional, Elkrief, Laure, additional, Rode, Agnès, additional, Théophile, Gerster, additional, Mabile-Archambeaud, Isabelle, additional, Khac, Eric Nguyen, additional, Legros, Ludivine, additional, Adrien, Lannes, additional, Robic, Marie-Angèle, additional, Borentain, Patrick, additional, Desmarets, Maxime, additional, Thabut, Dominique, additional, Di Martino, Vincent, additional, Rudler, Marika, additional, and Bureau, Christophe, additional

Published
2023
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31. Impact of trough concentrations of regorafenib and its major metabolites M-2 and M-5 on overall survival of chemorefractory metastatic colorectal cancer patients: Results from a multicentre GERCOR TEXCAN phase II study

Author

Benoit Rousseau, Arezki K. Boukerma, Julie Henriques, Romain Cohen, Olivier Lucidarme, Christophe Borg, Christophe Tournigand, Stefano Kim, Jean-Baptiste Bachet, Thibault Mazard, Christophe Louvet, Benoist Chibaudel, Dewi Vernerey, Thierry Andre, and Anne Hulin

Subjects
Cancer Research, Oncology, Pyridines, Rectal Neoplasms, Phenylurea Compounds, Antineoplastic Combined Chemotherapy Protocols, Colonic Neoplasms, Humans, Prospective Studies, Colorectal Neoplasms
Abstract

This prospective pharmacokinetic (PK) ancillary study of the TEXCAN phase II GERCOR trial of patients with chemorefractory metastatic colorectal cancer and treated with regorafenib (REGO) investigated correlations between overall survival (OS) and concentrations (C) of REGO and its active metabolites, M-2 and M-5.55 patients received REGO 160 mg/day for 21 days of a 28-day cycle (NCT02699073). REGO, M-2, M-5 were measured by liquid chromatography-mass spectrometry assay on day 15 of cycle 1 (C1) and 2 (C2). We studied the association between OS and Cmin of REGO, M-2 and M-5 at C1 and their accumulations between C1 and C2.Medians of C2/C1 M-2 and M-5 ratios were 0.82 (interquartile range 0.50-1.78) and 0.75 (interquartile range 0.41-1.93), respectively. Patients with C2/C1 M-2 ratio ≥ median had improved survival compared to those median (12.6 versus 4.0 months, P = 0.023), corresponding to a 66% mortality risk reduction in multivariate analysis. The C2/C1 M-2 ratio correlated with C1 REGO+M-2+M-5 (Csum; P = 0.006). Restricted cubic spline analysis showed an increased OS benefit as the C2/C1 M-2 ratio raises and when C1 Csum ranged between 2.5 and 5.5 mg/L. Patients within the Csum range had a reduced incidence of serious adverse events and improved OS.We identified PK parameters associated with a survival benefit in patients with metastatic colorectal cancer treated by REGO. OS and safety were favourable when C1 REGO+M-2+M-5 Csum ranged between 2.5 and 5.5 mg/L. These results pave the way for individual REGO dose modification strategies based on PK monitoring.NCT02699073.

Published
2022
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34. O-11 THE PUBLIC HEALTH POLICIES REDUCE THE LONG-TERM BURDEN OF ALCOHOL-ASSOCIATED LIVER DISEASE WORLDWIDE: DEVELOPMENT OF A PREPAREDNESS INDEX

Author

Díaz, Luis Antonio, primary, Fuentes-López, Eduardo, additional, Idalsoaga, Francisco, additional, Arnold, Jorge, additional, Ayares, Gustavo, additional, Cannistra, Macarena, additional, Vio, Danae, additional, Márquez-Lomas, Andrea, additional, Corsi, Oscar, additional, Ramírez, Carolina A., additional, Medel, María Paz, additional, Ferreccio, Catterina, additional, Lazo, Mariana, additional, Roblero, Juan Pablo, additional, Cotter, Thomas, additional, Kulkarni, Anand V., additional, Kim, Won, additional, Brahmania, Mayur, additional, Louvet, Alexandre, additional, Tapper, Elliot, additional, Dunn, Winston, additional, Simonetto, Douglas, additional, Shah, Vijay, additional, Kamath, Patrick, additional, Lazarus, Jeffrey V., additional, Singal, Ashwani K., additional, Bataller, Ramon, additional, Arrese, Marco, additional, and Arab, Juan Pablo, additional

Published
2023
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35. Neoadjuvant chemotherapy with or without nintedanib for advanced epithelial ovarian cancer: Lessons from the GINECO double-blind randomized phase II CHIVA trial

Author

Ferron, Gwénaël, primary, De Rauglaudre, Gaëtan, additional, Becourt, Stéphanie, additional, Delanoy, Nicolas, additional, Joly, Florence, additional, Lortholary, Alain, additional, You, Benoît, additional, Bouchaert, Patrick, additional, Malaurie, Emmanuelle, additional, Gouy, Sebastien, additional, Kaminsky, Marie-Christine, additional, Meunier, Jérôme, additional, Alexandre, Jérôme, additional, Berton, Dominique, additional, Dohollou, Nadine, additional, Dubot, Coraline, additional, Floquet, Anne, additional, Favier, Laure, additional, Venat-Bouvet, Laurence, additional, Fabbro, Michel, additional, Louvet, Christophe, additional, Lotz, Jean-Pierre, additional, Abadie-Lacourtoisie, Sophie, additional, Desauw, Christophe, additional, Del Piano, Francesco, additional, Leheurteur, Marianne, additional, Bonichon-Lamichhane, Nathalie, additional, Rastkhah, Mansour, additional, Follana, Philippe, additional, Gantzer, Justine, additional, Ray-Coquard, Isabelle, additional, and Pujade-Lauraine, Eric, additional

Published
2023
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36. Individual patient data meta-analysis of adjuvant gemcitabine-based chemotherapy for biliary tract cancer: combined analysis of the BCAT and PRODIGE-12 studies

Author

Julien Edeline, Satoshi Hirano, Aurélie Bertaut, Masaru Konishi, Meher Benabdelghani, Katsuhiko Uesaka, Jérôme Watelet, Masayuki Ohtsuka, Pascal Hammel, Yuji Kaneoka, Jean-Paul Joly, Masakazu Yamamoto, Laure Monard, Yoshiyasu Ambo, Christophe Louvet, Masahiko Ando, David Malka, Masato Nagino, Jean-Marc Phelip, and Tomoki Ebata

Subjects
Cancer Research, Bile Ducts, Intrahepatic, Biliary Tract Neoplasms, Bile Duct Neoplasms, Oncology, Chemotherapy, Adjuvant, Antineoplastic Combined Chemotherapy Protocols, Humans, Neoplasm Recurrence, Local, Deoxycytidine, Gemcitabine, Randomized Controlled Trials as Topic
Abstract

Although gemcitabine-based chemotherapy is the standard of care for advanced biliary tract cancers (BTCs), adjuvant phase III studies (BCAT in Japan, PRODIGE 12 in France) failed to show benefit, possibly owing to fewer patients (n = 225 and n = 194) compared with the adjuvant capecitabine BILCAP trial (n = 447). We performed a combined analysis of both gemcitabine-based chemotherapy adjuvant studies.We performed individual patient data meta-analysis of all patients included in BCAT and PRODIGE 12. BCAT study randomised patients with extrahepatic cholangiocarcinoma to single-agent gemcitabine or observation. PRODIGE 12 randomised patients with all BTC subtypes to gemcitabine-oxaliplatin combination or observation. Combined analysis was performed using Kaplan-Meier curves and a Cox regression model stratified on the trial.Two hundred and twelve versus 207 patients were randomised in the gemcitabine-based chemotherapy versus observation arms. Baseline characteristics were balanced between arms. The median follow-up was 5.5 years. After 258 relapse-free survival (RFS) events, there was no difference in RFS (log-rank p = 0.45; hazard ratio [HR] = 0.91 [95% confidence interval [CI] 0.71-1.16]; p = 0.46). RFS rates at five years were 40.8% (95%CI: 33.9%-47.5%) for gemcitabine-based chemotherapy versus 36.6% (95%CI: 29.8%-43.4%) for observation. After 201 deaths, there was no difference in overall survival (OS) (log-rank p = 0.83; HR = 1.03 [95%CI: 0.78-1.35]; p = 0.85). OS rates at five years were 50.5% (95%CI: 43.1%-57.4%) for gemcitabine-based chemotherapy versus 49.3% (95%CI: 41.6%-56.5%) for observation.With 419 patients included, this analysis did not show significant improvement in RFS and no trend in improvement in OS. Gemcitabine-based chemotherapy should not be used as an adjuvant treatment for BTC.

Published
2022
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38. 59P Expression of CD47 a potent ‘don’t eat me signal' in ovarian cancer (OC): Correlation with other immune features and evolution under neoadjuvant chemotherapy (NACT), a GINEGEPS study

Author

Chardin, L., primary, Yaniz Galende, E., additional, Genestie, C., additional, Le Formal, A., additional, Schneider, C., additional, Jeanne, A., additional, Venat-Bouvet, L., additional, Louvet, C., additional, Favier, L., additional, Lortholary, A., additional, Berton-Rigaud, D., additional, Dohollou, N., additional, Desauw, C., additional, Fabbro, M., additional, Malaurie, E., additional, Dubot, C., additional, Kurtz, J.E., additional, Bonichon Lamichhane, N., additional, Dedieu, S., additional, and Leary, A., additional

Published
2023
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41. The Central-Versus Peripheral-Mediated Effects of Liraglutide Enhancement on Insulin Secretion is Dependent on the Stage of Diabetes

Author

Saponaro, Chiara, primary, Imbernon, Monica, additional, Louvet, Isaline, additional, Acosta-Montalvo, Ana, additional, Deligia, Eleonora, additional, Chen, Shiqian, additional, Auger, Florent, additional, Wemelle, Eve, additional, Zubiaga, Lorea, additional, Moreno Lopez, Maria, additional, Delalleau, Nathalie, additional, Thevenet, Julien, additional, Muehlemann, Markus, additional, Pasquetti, Gianni, additional, Gmyr, Valery, additional, Pfrieger, Frank, additional, Nogueiras, Ruben, additional, Schwaninger, Markus, additional, Kerr-Conte, Julie, additional, Knauf, Claude, additional, Staels, Bart, additional, Jones, Ben, additional, Pattou, Francois, additional, Prevot, Vincent, additional, and Bonner, Caroline, additional

Published
2023
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43. Prognosis and chemosensitivity of non-colorectal alimentary tract cancers with microsatellite instability

Author

Boyer, Claire, primary, Sefrioui, David, additional, Cohen, Romain, additional, Chautard, Romain, additional, Perrier, Marine, additional, Lebrun, Hugo, additional, Goujon, Gael, additional, Hautefeuille, Vincent, additional, Dior, Marie, additional, Walter, Thomas, additional, Mary, Florence, additional, Manfredi, Silvain, additional, Caroli-Bosc, Francois-Xavier, additional, Cervantes, Baptiste, additional, Coriat, Romain, additional, Deluche, Elise, additional, Zaanan, Aziz, additional, Olivier, Raphael, additional, Bouché, Olivier, additional, Piessen, Guillaume, additional, Lecomte, Thierry, additional, Louvet, Christophe, additional, Michel, Pierre, additional, Aparicio, Thomas, additional, André, Thierry, additional, Taieb, Julien, additional, Randrian, Violaine, additional, and Tougeron, David, additional

Published
2023
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45. Sarcopenia should be evaluated in patients with acute-on-chronic liver failure and candidates for liver transplantation

Author

Florent Artru, Alexandre Louvet, Faouzi Saliba, Georges-Philippe Pageaux, and Charles le Goffic

Subjects
medicine.medical_specialty, Cirrhosis, Hepatology, business.industry, medicine.medical_treatment, Liver transplantation, medicine.disease, Gastroenterology, Sarcopenia, Internal medicine, Medicine, Acute on chronic liver failure, In patient, business
Published
2022
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47. 390P Impact of age on treatment strategies in RAS/BRAF wild-type metastatic colorectal cancer (mCRC): A prespecified subgroup analysis of the GERCOR-PRODIGE STRATEGIC-1 phase III study

Author

Carola, E., primary, Chibaudel, B., additional, Boulahssass, R., additional, Dourthe, L.M., additional, André, T., additional, Henriques, J., additional, Bourgeois, V., additional, Etienne, P-L., additional, Desrame, J., additional, Dupuis, O., additional, Baba-Hamed, N., additional, Auby, D., additional, Louvet, C., additional, Maillard, E., additional, Tournigand, C., additional, Garcia-Larnicol, M-L., additional, Shacham Shmueli, E., additional, Bird, B.H., additional, Ghiringhelli, F., additional, and de Gramont, A., additional

Published
2022
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48. Cirrosis asociada al alcohol

Author

A. Louvet

Subjects
Ocean Engineering, Safety, Risk, Reliability and Quality
Abstract

Resumen La cirrosis corresponde al ultimo estadio de la fibrogenesis provocada por un consumo cronico y excesivo de alcohol. En la mayoria de los paises occidentales, la cirrosis asociada al alcohol es la primera causa de mortalidad relacionada con el higado. El diagnostico de cirrosis esta basado en un abanico de argumentos clinicos y biologicos, y los metodos no invasivos permiten reducir el numero de biopsias hepaticas. Una vez establecido el diagnostico, se recurre a escalas y cuestionarios pronosticos (escala MELD y de Child-Pugh) para evaluar la gravedad de la cirrosis. Las complicaciones de la cirrosis no son especificas del consumo excesivo de alcohol, salvo el caso de la hepatitis alcoholica, cuadro inflamatorio grave que puede comprometer el pronostico vital y cuyo tratamiento incluye la corticoterapia. La cirrosis es un estado irreversible cuyo unico tratamiento sintomatico es la abstinencia de bebidas alcoholicas. Cuando, a pesar de la abstinencia, la gravedad de la hepatopatia sigue siendo importante, se debe plantear la posibilidad de un trasplante.

Published
2021
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49. Severe acute respiratory syndrome coronavirus 2 vaccination for patients with solid cancer: Review and point of view of a French oncology intergroup (GCO, TNCD, UNICANCER)

Author

Jean-Yves Blay, Virgine Westeel, Khê Hoang-Xuan, Philippe Gorphe, Thomas Aparicio, Thierry Lecomte, David Tougeron, Astrid Lièvre, Pierre Michel, Sébastien Gaujoux, Amélie Servettaz, Pascale Mariani, Maxime Hentzien, Michel Ducreux, Léon Maggiori, Firouzé Bani-Sadr, Laura Mansi, Jean Bourhis, Olivier Bouché, Boris Guiu, Christophe Louvet, Florence Huguet, Barbara Seitz-Polski, Juliette Thariat, Centre hospitalier universitaire de Poitiers (CHU Poitiers), Centre Hospitalier Universitaire de Reims (CHU Reims), CHU Nice [Cimiez], Hôpital Cimiez [Nice] (CHU), Centre Hospitalier Universitaire Vaudois [Lausanne] (CHUV), Institut Gustave Roussy (IGR), Département de médecine oncologique [Gustave Roussy], CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Département de cancérologie cervico-faciale [Gustave Roussy] (CCF), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Institut Desbrest de santé publique (IDESP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), Institut Universitaire de Cancérologie [Sorbonne Université] (IUC), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS), Nutrition, croissance et cancer (U 1069) (N2C), Université de Tours (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Trousseau [Tours], Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Département d'hépato-gastro-entérologie [Hôpital Trousseau : CHRU Tours], Chemistry, Oncogenesis, Stress and Signaling (COSS), Université de Rennes (UR)-CRLCC Eugène Marquis (CRLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM), Cooperator Multidisciplinary Oncology Group (GERCOR), Hopital Saint-Louis [AP-HP] (AP-HP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Interactions hôte-greffon-tumeur, ingénierie cellulaire et génique - UFC (UMR INSERM 1098) (RIGHT), Institut National de la Santé et de la Recherche Médicale (INSERM)-Etablissement français du sang [Bourgogne-Franche-Comté] (EFS BFC)-Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC), Institut Curie [Paris], Génomique et Médecine Personnalisée du Cancer et des Maladies Neuropsychiatriques (GPMCND), Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Régional de Lutte contre le Cancer François Baclesse [Caen] (UNICANCER/CRLC), Normandie Université (NU)-UNICANCER-Tumorothèque de Caen Basse-Normandie (TCBN), Centre Léon Bérard [Lyon], None, University Hospital of Montpellier, Institut Universitaire de Cancérologie [Paris] (IUC), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-CHU Trousseau [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-CRLCC Eugène Marquis (CRLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC)-Etablissement français du sang [Bourgogne-Franche-Comté] (EFS [Bourgogne-Franche-Comté]), UNICANCER-Tumorothèque de Caen Basse-Normandie (TCBN)-Normandie Université (NU), Jonchère, Laurent, CHU Trousseau [APHP], Institut National de la Santé et de la Recherche Médicale (INSERM)-Etablissement français du sang [Bourgogne-Franche-Comté] (EFS [Bourgogne-Franche-Comté])-Université de Franche-Comté (UFC), Université de Tours-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Hospitalier Régional Universitaire de Tours (CHRU TOURS)-CHU Trousseau [APHP], Institut National de la Santé et de la Recherche Médicale (INSERM)-CRLCC Eugène Marquis (CRLCC)-Université de Rennes 1 (UR1), and Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)

Subjects
0301 basic medicine, Cancer Research, Pediatrics, medicine.medical_specialty, COVID-19 Vaccines, medicine.medical_treatment, Population, [SDV.CAN]Life Sciences [q-bio]/Cancer, Neutropenia, medicine.disease_cause, Current Perspective, 03 medical and health sciences, 0302 clinical medicine, [SDV.CAN] Life Sciences [q-bio]/Cancer, Neoplasms, Pandemic, medicine, Humans, Chemotherapy, education, Coronavirus, education.field_of_study, Radiotherapy, SARS-CoV-2, business.industry, Vaccination, COVID-19, Cancer, medicine.disease, 3. Good health, Radiation therapy, Solid cancers, 030104 developmental biology, Oncology, 030220 oncology & carcinogenesis, business
Abstract

International audience; The impacts of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic on cancer care are multiple, entailing a high risk of death from coronavirus disease 2019 (COVID-19) in patients with cancer treated by chemotherapy. SARS-CoV-2 vaccines represent an opportunity to decrease the rate of severe COVID-19 cases in patients with cancer and also to restore normal cancer care. Patients with cancer to be targeted for vaccination are difficult to define owing to the limited contribution of these patients in the phase III trials testing the different vaccines. It seems appropriate to vaccinate not only patients with cancer with ongoing treatment or with a treatment having been completed less than 3 years ago but also household and close contacts. High-risk patients with cancer who are candidates for priority access to vaccination are those treated by chemotherapy. The very high-priority population includes patients with curative treatment and palliative first- or second-line chemotherapy, as well as patients requiring surgery or radiotherapy involving a large volume of lung, lymph node and/or haematopoietic tissue. When possible, vaccination should be carried out before cancer treatment begins. SARS-CoV-2 vaccination can be performed during chemotherapy while avoiding periods of neutropenia and lymphopenia. For organisational reasons, vaccination should be performed in cancer care centres with messenger RNA vaccines (or non-replicating adenoviral vaccines in non-immunocompromised patients). Considering the current state of knowledge, the benefit-risk ratio strongly favours SARS-CoV-2 vaccination of all patients with cancer. To obtain more data concerning the safety and effectiveness of vaccines, it is necessary to implement cohorts of vaccinated patients with cancer.

Published
2021
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50. Neoadjuvant chemotherapy with FOLFIRINOX and preoperative chemoradiotherapy for patients with locally advanced rectal cancer (UNICANCER-PRODIGE 23): a multicentre, randomised, open-label, phase 3 trial

Author

Thierry Conroy, Jean-François Bosset, Pierre-Luc Etienne, Emmanuel Rio, Éric François, Nathalie Mesgouez-Nebout, Véronique Vendrely, Xavier Artignan, Olivier Bouché, Dany Gargot, Valérie Boige, Nathalie Bonichon-Lamichhane, Christophe Louvet, Clotilde Morand, Christelle de la Fouchardière, Najib Lamfichekh, Béata Juzyna, Claire Jouffroy-Zeller, Eric Rullier, Frédéric Marchal, Sophie Gourgou, Florence Castan, Christophe Borg, Philippe Ronchin, Jean-François Seitz, Stéphane Corbinais, Emmanuel Maillard, Monique Noirclerc, Farid El Hajbi, Anne-Laure Villing, Yves Bécouarn, Lam Foong Fat Lam Kam Sang, Pascal Artru, Jean-Baptiste Bachet, Fayçal Hocine, Catherine Ligeza-Poisson, Claire Vautravers, Meher Ben Abdelghani, Thomas Aparicio, Elise Desot, and Isabelle Marquis

Subjects
Adult, Male, medicine.medical_specialty, FOLFIRINOX, medicine.medical_treatment, Population, Leucovorin, Irinotecan, Gastroenterology, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Adjuvant therapy, Humans, 030212 general & internal medicine, education, Neoadjuvant therapy, Aged, education.field_of_study, Performance status, Rectal Neoplasms, business.industry, Chemoradiotherapy, Middle Aged, Total mesorectal excision, Neoadjuvant Therapy, Oxaliplatin, Oncology, 030220 oncology & carcinogenesis, Quality of Life, Female, Fluorouracil, business, medicine.drug
Abstract

Summary Background Treatment of locally advanced rectal cancer with chemoradiotherapy, surgery, and adjuvant chemotherapy controls local disease, but distant metastases remain common. We aimed to assess whether administering neoadjuvant chemotherapy before preoperative chemoradiotherapy could reduce the risk of distant recurrences. Methods We did a phase 3, open-label, multicentre, randomised trial at 35 hospitals in France. Eligible patients were adults aged 18–75 years and had newly diagnosed, biopsy-proven, rectal adenocarcinoma staged cT3 or cT4 M0, with a WHO performance status of 0–1. Patients were randomly assigned (1:1) to either the neoadjuvant chemotherapy group or standard-of-care group, using an independent web-based system by minimisation method stratified by centre, extramural extension of the tumour into perirectal fat according to MRI, tumour location, and stage. Investigators and participants were not masked to treatment allocation. The neoadjuvant chemotherapy group received neoadjuvant chemotherapy with FOLFIRINOX (oxaliplatin 85 mg/m2, irinotecan 180 mg/m2, leucovorin 400 mg/m2, and fluorouracil 2400 mg/m2 intravenously every 14 days for 6 cycles), chemoradiotherapy (50 Gy during 5 weeks and 800 mg/m2 concurrent oral capecitabine twice daily for 5 days per week), total mesorectal excision, and adjuvant chemotherapy (3 months of modified FOLFOX6 [intravenous oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2, followed by intravenous 400 mg/m2 fluorouracil bolus and then continuous infusion at a dose of 2400 mg/m2 over 46 h every 14 days for six cycles] or capecitabine [1250 mg/m2 orally twice daily on days 1–14 every 21 days]). The standard-of-care group received chemoradiotherapy, total mesorectal excision, and adjuvant chemotherapy (for 6 months). The primary endpoint was disease-free survival assessed in the intention-to-treat population at 3 years. Safety analyses were done on treated patients. This trial was registered with EudraCT (2011-004406-25) and ClinicalTrials.gov ( NCT01804790 ) and is now complete. Findings Between June 5, 2012, and June 26, 2017, 461 patients were randomly assigned to either the neoadjuvant chemotherapy group (n=231) or the standard-of-care group (n=230). At a median follow-up of 46·5 months (IQR 35·4–61·6), 3-year disease-free survival rates were 76% (95% CI 69–81) in the neoadjuvant chemotherapy group and 69% (62–74) in the standard-of-care group (stratified hazard ratio 0·69, 95% CI 0·49–0·97; p=0·034). During neoadjuvant chemotherapy, the most common grade 3–4 adverse events were neutropenia (38 [17%] of 225 patients) and diarrhoea (25 [11%] of 226). During chemoradiotherapy, the most common grade 3–4 adverse event was lymphopenia (59 [28%] of 212 in the neoadjuvant chemotherapy group vs 67 [30%] of 226 patients in the standard-of-care group). During adjuvant chemotherapy, the most common grade 3–4 adverse events were lymphopenia (18 [11%] of 161 in the neoadjuvant chemotherapy group vs 42 [27%] of 155 in the standard-of-care group), neutropenia (nine [6%] of 161 vs 28 [18%] of 155), and peripheral sensory neuropathy (19 [12%] of 162 vs 32 [21%] of 155). Serious adverse events occurred in 63 (27%) of 231 participants in the neoadjuvant chemotherapy group and 50 (22%) of 230 patients in the standard-of-care group (p=0·167), during the whole treatment period. During adjuvant therapy, serious adverse events occurred in 18 (11%) of 163 participants in the neoadjuvant chemotherapy group and 36 (23%) of 158 patients in the standard-of-care group (p=0·0049). Treatment-related deaths occurred in one ( Interpretation Intensification of chemotherapy using FOLFIRINOX before preoperative chemoradiotherapy significantly improved outcomes compared with preoperative chemoradiotherapy in patients with cT3 or cT4 M0 rectal cancer. The significantly improved disease-free survival in the neoadjuvant chemotherapy group and the decreased neurotoxicity indicates that the perioperative approach is more efficient and better tolerated than adjuvant chemotherapy. Therefore, the PRODIGE 23 results might change clinical practice. Funding Institut National du Cancer, Ligue Nationale Contre le Cancer, and R&D Unicancer.

Published
2021
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