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1. ABO blood group does not influence Child‐Pugh A cirrhosis outcome: An observational study from CIRRAL and ANRS CO12 CIRVIR cohorts

Author

Ollivier-Hourmand, Isabelle, Repesse, yohann, Nahon, Pierre, Chaffaut, Cendrine, Dao, Thông, Nguyen, Thi Thu Nga, Marcellin, Patrick, Roulot, Dominique, de Ledinghen, Victor, Pol, Stanislas, Guyader, Dominique, Archambeaud, Isabelle, Zoulim, Fabien, Oberti, Frédéric, Tran, Albert, Bronowicki, Jean-Pierre, d'Alteroche, Louis, Ouzan, Denis, Peron, Jean-Marie, Zarski, Jean-Pierre, Bourliere, Marc, Larrey, Dominique, Louvet, Alexandre, Cales, Paul, Abergel, Armand, Mathurin, Philippe, Mallat, Ariane, Blanc, Jean-Frederic, Nguyen-Khac, Eric, Riachi, Ghassan, Alric, Laurent, Serfaty, Lawrence, Antonini, Teresa, Moreno, Christophe, Attali, Pierre, Thabut, Dominique, Pilette, Christophe, Grange, Jean-Didier, Silvain, Christine, Carbonell, Nicolas, Bernard-Chabert, Brigitte, Goria, Odile, Wartelle, Claire, Moirand, Romain, Christidis, Christos, Perlemuter, Gabriel, Ozenne, Violaine, Henrion, Jean, Hillaire, Sophie, Di Martino, Vincent, Amiot, Xavier, Sutton, Angela, Barget, Nathalie, Chevret, Sylvie, Ganne‐carrie, Nathalie, CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN), 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 (UPC), Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Conservatoire National des Arts et Métiers [CNAM] (CNAM), HESAM Université (HESAM)-HESAM Université (HESAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPC)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Hôpital Avicenne [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Institut Cochin (IC UM3 (UMR 8104 / U1016)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Paris Cité (UPC), Nutrition, Métabolismes et Cancer (NuMeCan), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), CHU Pontchaillou [Rennes], Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), Centre méditerranéen de médecine moléculaire (C3M), Université Nice Sophia Antipolis (1965 - 2019) (UNS), COMUE Université Côte d'Azur (2015-2019) (COMUE UCA)-COMUE Université Côte d'Azur (2015-2019) (COMUE UCA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Côte d'Azur (UCA), Institut Arnault Tzanck, Service de Gastro-entérologie - Hépatologie [Purpan], CHU Toulouse [Toulouse], CHU Grenoble, Groupe de Recherche sur l'alcool et les pharmacodépendances - UMR INSERM_S 1247 (GRAP), Université de Picardie Jules Verne (UPJV)-Institut National de la Santé et de la Recherche Médicale (INSERM), Nutrition, inflammation et dysfonctionnement de l'axe intestin-cerveau (ADEN), Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Institute for Research and Innovation in Biomedicine (IRIB), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Service d'Hépato-Gastroentérologie [CHU Rouen], Hôpital Charles Nicolle [Rouen]-CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU), UNIROUEN - UFR Santé (UNIROUEN UFR Santé), Normandie Université (NU)-Normandie Université (NU), Immunologie et virologie des cancers. Immunologie des interactions cellulaires et moléculaires (Inserm U152), Institut National de la Santé et de la Recherche Médicale (INSERM), Equipe 2 : ECSTRA - Epidémiologie Clinique, STatistique, pour la Recherche en Santé (CRESS - U1153), HESAM Université (HESAM)-HESAM Université (HESAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPC)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Conservatoire National des Arts et Métiers [CNAM] (CNAM), This work was supported by a research grant from the French National Society of Gastroenterology (SNFGE), a research grant from the French Agency for Research on AIDS and Viral Hepatitis (ANRS), and a research grant from Abbvie., 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), HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Paris Cité (UPCité), Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Centre de Recherche en Cancérologie de Lyon (UNICANCER/CRCL), Centre Léon Bérard [Lyon]-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Pôle Maladies de l'appareil digestif [CHU Toulouse], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Hôpital Charles Nicolle [Rouen], CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-CHU Rouen, and HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Conservatoire National des Arts et Métiers [CNAM] (CNAM)

Subjects
Liver Cirrhosis, Hepatology, [SDV]Life Sciences [q-bio], alcoholic cirrhosis, ABO blood group, non-malignant portal vein thrombosis, ABO Blood-Group System, Hypertension, Portal, Disease Progression, outcome, Humans, Prospective Studies, viral cirrhosis, Child-Pugh A cirrhosis
Abstract

International audience; Background and aims: Non-O blood group promotes deep vein thrombosis and liver fibrosis in both general population and hepatitis C. We aimed to evaluate the influence of Non-O group on the outcome of Child-Pugh A cirrhotic patients.Methods: We used two prospective cohorts of Child-Pugh A cirrhosis due to either alcohol or viral hepatitis. Primary end point was the cumulated incidence of 'Decompensation' at 3 years, defined as the occurrence of ascites , hydrothorax, encephalopathy, gastrointestinal bleeding related to portal hypertension, or bilirubin >45 μmol/L. Secondary end points were the cumulated incidences of (1) 'Disease Progression' including a « decompensation» or « the occurrence of one or more parameters » among: prothrombin time (PT)

Published
2022
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2. Additional file 1 of A first-in-human phase 1/2 study of FGF401 and combination of FGF401 with spartalizumab in patients with hepatocellular carcinoma or biomarker-selected solid tumors

Author

Chan, Stephen L., Schuler, Martin, Kang, Yoon-Koo, Yen, Chia-Jui, Edeline, Julien, Choo, Su Pin, Lin, Chia-Chi, Okusaka, Takuji, Weiss, Karl-Heinz, Macarulla, Teresa, Cattan, Stéphane, Blanc, Jean-Frederic, Lee, Kyung-Hun, Maur, Michela, Pant, Shubham, Kudo, Masatoshi, Assenat, Eric, Zhu, Andrew X., Yau, Thomas, Lim, Ho Yeong, Bruix, Jordi, Geier, Andreas, Guillén-Ponce, Carmen, Fasolo, Angelica, Finn, Richard S., Fan, Jia, Vogel, Arndt, Qin, Shukui, Riester, Markus, Katsanou, Vasiliki, Chaudhari, Monica, Kakizume, Tomoyuki, Gu, Yi, Porta, Diana Graus, Myers, Andrea, and Delord, Jean-Pierre

Subjects
Data_FILES
Abstract

Additional file 1.

Published
2022
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3. Additional file 2 of A first-in-human phase 1/2 study of FGF401 and combination of FGF401 with spartalizumab in patients with hepatocellular carcinoma or biomarker-selected solid tumors

Author

Chan, Stephen L., Schuler, Martin, Kang, Yoon-Koo, Yen, Chia-Jui, Edeline, Julien, Choo, Su Pin, Lin, Chia-Chi, Okusaka, Takuji, Weiss, Karl-Heinz, Macarulla, Teresa, Cattan, Stéphane, Blanc, Jean-Frederic, Lee, Kyung-Hun, Maur, Michela, Pant, Shubham, Kudo, Masatoshi, Assenat, Eric, Zhu, Andrew X., Yau, Thomas, Lim, Ho Yeong, Bruix, Jordi, Geier, Andreas, Guillén-Ponce, Carmen, Fasolo, Angelica, Finn, Richard S., Fan, Jia, Vogel, Arndt, Qin, Shukui, Riester, Markus, Katsanou, Vasiliki, Chaudhari, Monica, Kakizume, Tomoyuki, Gu, Yi, Porta, Diana Graus, Myers, Andrea, and Delord, Jean-Pierre

Subjects
Data_FILES
Abstract

Additional file 2.

Published
2022
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4. Ramucirumab versus placebo as second-line treatment in patients with advanced hepatocellular carcinoma following first-line therapy with sorafenib (REACH): a randomised, double-blind, multicentre, phase 3 trial

Author

Dufour, Jean-François, Schwartz, Jonathan D, Zhu, Andrew X, Pastorelli, Davide, Chau, Ian, REACH Trial, Investigators., Chang, Shao-Chun, Okusaka, Takuji, Ryoo, Baek-Yeol, Chung, Hyun Cheol, Blanc, Jean-Frederic, Trojan, Jorg, Sastre, Javier, Kubackova, Katerina, Abada, Paolo B, Yen, Chia-Jui, Yang, Ling, Pfiffer, Tulio Eduardo Flesch, Kudo, Masatoshi, Baron, Ari D, Poon, Ronnie, Park, Joon Oh, Zhu AX, Park JO, Ryoo BY, Yen CJ, Poon R, Pastorelli D, Blanc JF, Chung HC, Baron AD, Pfiffer TE, Okusaka T, Kubackova K, Trojan J, Sastre J, Chau I, Chang SC, Abada PB, Yang L, Schwartz JD, Kudo M, REACH Trial Investigator, Brandi G., Zhu A.X., Park J.O., Ryoo B.-Y., Yen C.-J., Poon R., Pastorelli D., Blanc J.-F., Chung H.C., Baron A.D., Pfiffer T.E.F., Okusaka T., Kubackova K., Trojan J., Sastre J., Chau I., Chang S.-C., Abada P.B., Yang L., Schwartz J.D., Kudo M., and Craxì Antonio.

Subjects
Male, Time Factors, Kaplan-Meier Estimate, Gastroenterology, Liver disease, Clinical endpoint, 610 Medicine & health, ramucirumab, sorafenib, HCC, Aged, 80 and over, education.field_of_study, Liver Neoplasms, Remission Induction, Antibodies, Monoclonal, Middle Aged, Sorafenib, Treatment Outcome, Oncology, Liver Neoplasm, Hepatocellular carcinoma, Female, Survival Analysi, Human, medicine.drug, Adult, Niacinamide, Phenylurea Compound, medicine.medical_specialty, Carcinoma, Hepatocellular, Time Factor, Population, Antibodies, Monoclonal, Humanized, Placebo, Disease-Free Survival, Drug Administration Schedule, Follow-Up Studie, Ramucirumab, Double-Blind Method, Internal medicine, Confidence Intervals, medicine, Carcinoma, Humans, education, Proportional Hazards Models, Aged, Dose-Response Relationship, Drug, business.industry, Phenylurea Compounds, Patient Selection, medicine.disease, Survival Analysis, digestive system diseases, Surgery, Proportional Hazards Model, business, Confidence Interval, Follow-Up Studies
Abstract

Background: VEGF and VEGF receptor-2-mediated angiogenesis contribute to hepatocellular carcinoma pathogenesis. Ramucirumab is a recombinant IgG1 monoclonal antibody and VEGF receptor-2 antagonist. We aimed to assess the safety and efficacy of ramucirumab in advanced hepatocellular carcinoma following first-line therapy with sorafenib. Methods: In this randomised, placebo-controlled, double-blind, multicentre, phase 3 trial (REACH), patients were enrolled from 154 centres in 27 countries. Eligible patients were aged 18 years or older, had hepatocellular carcinoma with Barcelona Clinic Liver Cancer stage C disease or stage B disease that was refractory or not amenable to locoregional therapy, had Child-Pugh A liver disease, an Eastern Cooperative Oncology Group performance status of 0 or 1, had previously received sorafenib (stopped because of progression or intolerance), and had adequate haematological and biochemical parameters. Patients were randomly assigned (1:1) to receive intravenous ramucirumab (8 mg/kg) or placebo every 2 weeks, plus best supportive care, until disease progression, unacceptable toxicity, or death. Randomisation was stratified by geographic region and cause of liver disease with a stratified permuted block method. Patients, medical staff, investigators, and the funder were masked to treatment assignment. The primary endpoint was overall survival in the intention-to-treat population. This study is registered with ClinicalTrials.gov, number NCT01140347. Findings: Between Nov 4, 2010, and April 18, 2013, 565 patients were enrolled, of whom 283 were assigned to ramucirumab and 282 were assigned to placebo. Median overall survival for the ramucirumab group was 9·2 months (95% CI 8·0-10·6) versus 7·6 months (6·0-9·3) for the placebo group (HR 0·87 [95% CI 0·72-1·05]; p=0·14). Grade 3 or greater adverse events occurring in 5% or more of patients in either treatment group were ascites (13 [5%] of 277 patients treated with ramucirumab vs 11 [4%] of 276 patients treated with placebo), hypertension (34 [12%] vs ten [4%]), asthenia (14 [5%] vs five [2%]), malignant neoplasm progression (18 [6%] vs 11 [4%]), increased aspartate aminotransferase concentration (15 [5%] vs 23 [8%]), thrombocytopenia (13 [5%] vs one [

Published
2015
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5. Patient-reported outcomes for the phase 3 TOPAZ-1 study of durvalumab plus gemcitabine and cisplatin in advanced biliary tract cancer

Author

Burris, Howard A., Okusaka, Takuji, Vogel, Arndt, Lee, Myung Ah, Hidenori Takahashi, Breder, Valeriy Vladimirovich, Blanc, Jean-Frederic, Li, Junhe, Watras, Magdalena, Xiong, Julia, Abraham, Jayne, Patel, Nikunj, Wang, Julie, Rokutanda, Nana, Cohen, Gordon, and Oh, Do-Youn

Subjects
Cancer Research, Oncology
Abstract

4070 Background: TOPAZ-1 (NCT03875235) is a randomized, double-blind, global, Phase 3 study evaluating the efficacy and safety of durvalumab (D) in combination with (+) gemcitabine and cisplatin (GC) as first-line treatment for patients (pts) with advanced biliary tract cancer (BTC).1 D + GC significantly improved overall survival (OS) versus placebo (PBO) + GC and represents a new treatment option. Methods: A pre-planned secondary objective of TOPAZ-1 was to assess pt-reported outcomes (PROs) for pts receiving D + GC versus PBO + GC. Pts with BTC were randomized 1:1 to D (1500 mg) or PBO, + G (1000 mg/m2) and C (25 mg/m2), for up to 8 cycles, followed by D or PBO monotherapy until disease progression, unacceptable toxicity, or other discontinuation criteria were met. PROs were assessed with the European Organisation for Research and Treatment of Cancer 30-item Quality of Life (QoL) Questionnaire, EORTC QLQ-C30 (C30), and the BTC 21-item module, EORTC QLQ-BIL21 (BIL21). Time to deterioration (TTD) was the primary assessment of PROs; defined as the time from randomization to the date of the first pre-specified, clinically meaningful deterioration (e.g. disease progression). The PRO analysis set included all pts from the full analysis set who completed a questionnaire. Results: Compliance rates for PROs were high at baseline (>81%) and remained high (majority >70% over 28 cycles) for both treatment groups. Baseline scores were comparable between treatment groups. Addition of D was well tolerated, with no significant difference in TTD in D + GC versus PBO + GC for pt-reported symptoms or functioning using either C30 or BIL21 (Table), or Global Health Status/QoL (hazard ratio [HR], 0.87; 95% confidence interval [CI], 0.69–1.12; p=0.279). Conclusions: Addition of D to GC improved OS (Oh D-Y, et al. J Clin Oncol 2022;40(suppl 4). Abs 378) and was well tolerated with no difference in TTD of QoL for pts, supporting D + GC as a new treatment option for pts with BTC. Clinical trial information: NCT03875235. [Table: see text]

6. Sorafenib in advanced hepatocellular carcinoma

Author

Llovet, Josep M., Ricci, Sergio, Mazzaferro, Vincenzo, Hilgard, Philip, Gane, Edward, Blanc, Jean-Frederic, Cosme Oliveira, Andre, Santoro, Armando, Raoul, Jean-Luc, Forner, Alejandro, Schwartz, Myron, Porta, Camillo, Zeuzem, Stefan, Bolondi, Luigi, Greten, Tim F., Galle, Peter R., Seitz, Jean-François, Borbath, Ivan, Haussinger, Dieter, Giannaris, Tom, Shan, Minghua, Moscovici, Marius, Voliotis, Dimitris, Bruix, Jordi, Sharp Investigators Study Group, The, and Hans Van Vlierberghe

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