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1. Cost-Utility Analysis of Transarterial Radioembolization With Yttrium-90 Resin Microspheres Compared With Sorafenib in Locally Advanced and Inoperable Hepatocellular Carcinoma

Author

Kevin Zarca, Maroua Mimouni, Helena Pereira, Gilles Chatellier, Valérie Vilgrain, Isabelle Durand-Zaleski, Eric Assenat, Elisabeth Delhom-Christol, Boris Guiu, Alina D. Ilonca, Julie Lonjon, Georges-Philippe Pageaux, Mohamed Abdel-Rehim, Wassim Al-laham, Mohamed Bouattour, Laurent Castera, Arnaud Dieudonné, Rachida Lebtahi, Maxime Ronot, Annie Sibert, Hélène Barraud, Christophe Bazin, Jean-Pierre Bronowicki, Valérie Laurent, Elodie Mathias, Carine Chagneau-Derrode, Rémy Perdrisot, Christine Silvain, Jean-Pierre Tasu, Patrick Borentain RenéGerolami, Olivier Mundler, Jean-Francois Seitz, Vincent Vidal, Christophe Aubé, Antoine Bouvier, Olivier Couturier, Frédéric Oberti, Laurent Vervueren, Isabelle Brenot-Rossi, Jean-Luc Raoul, Anthony Sar-ran, Julia Chalaye, Charlotte Costentin, Emmanuel Itti, Hicham Kobeiter, Alain Luciani, René Adam, Maïté Lewin, Didier Samuel, Julien Edeline, Etienne Garin, Yan Rolland, Isabelle Archambeaud, Thomas Eugene, Eric Frampas, Christophe Cassinotto, Martine Guyot, Jean-Baptiste Hiriart, Bruno Lapuyade, Julien Vergniol, Philippe Bachellier, Julien Detour, Bernard Duclos, Michel Greget, Francois Habersetzer, Alessio Imperiale, Philippe Merle, Agnès Rode, Julie Morvan, Eric Nguyen-Khac, Thierry Yzet, Guillaume Baudin, Patrick Chevallier, Abakar Mahamat, Thierry Piche, Micheline Razzouk, Patrick Hillon, Romaric Loffroy, Michel Toubeau, Julie Vincent, Gabriele Barabino, Nadia Bouarioua, Muriel Cuilleron, Marie Ecochard, Nathalie Prevot-Bitot, Vincent Leroy, Julie Roux, Christian Sengel, Valérie Bourcier, Nathalie Ganne- Carrie, Olivier Seror, Sylvie Costo, Thông Dao, Jean-Pierre Pelage, Jérôme Dumortier, Francesco Giammarile, Pierre-Jean Valette, Nadia Ghazzar, Olivier Pellerin, Julien Taieb, Pierre Weinmann, Alexandra Heurgue- Berlot, Claude Marcus, Daniele Sommacale, Maria-Angéla Castilla-Lièvre, Sophie Maitre, Lysiane Marthey, Direction de la Recherche Clinique et de l'Innovation [AP-HP] (DRCI), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Centre d'Investigation Clinique Henri Mondor (CIC Henri Mondor), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), 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 - 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), CIC - HEGP (CIC 1418), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), Centre de recherche sur l'Inflammation (CRI (UMR_S_1149 / ERL_8252 / U1149)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Paris Cité (UPCité), Equipe 2 : ECSTRA - Epidémiologie Clinique, STatistique, pour la Recherche en Santé (CRESS - U1153), 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), Département d'Hépato-Gastroentérologie et de Transplantation Hépatique [CHU Saint-Eloi], Hôpital Saint Eloi (CHRU Montpellier), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Université de Montpellier (UM), Département radiologie diagnostique et interventionnelle Saint Eloi [CHRU Montpellier], Pôle Digestif [CHRU Montpellier], Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Equipe IFTIM [ImViA - EA7535], Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon)-Centre Régional de Lutte contre le cancer Georges-François Leclerc [Dijon] (UNICANCER/CRLCC-CGFL), UNICANCER-UNICANCER-Imagerie et Vision Artificielle [Dijon] (ImViA), Université de Bourgogne (UB)-Université de Bourgogne (UB), 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), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPC), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Paris Cité (UPC), 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), and CHU Saint-Eloi-Université de Montpellier (UM)

Subjects
Sorafenib, Oncology, medicine.medical_specialty, Randomization, Carcinoma, Hepatocellular, Tare weight, Hepatocellular carcinoma, Cost-Benefit Analysis, [SDV.CAN]Life Sciences [q-bio]/Cancer, 02 engineering and technology, 030204 cardiovascular system & hematology, Transarterial Radioembolization, 03 medical and health sciences, 020210 optoelectronics & photonics, 0302 clinical medicine, Quality of life, Internal medicine, 0202 electrical engineering, electronic engineering, information engineering, medicine, Humans, Pharmacology (medical), Yttrium radioisotopes, Survival analysis, Pharmacology, Cost–utility analysis, business.industry, Liver Neoplasms, Cost-utility analysis, [SDV.SP]Life Sciences [q-bio]/Pharmaceutical sciences, medicine.disease, Microspheres, Quality of Life, business, medicine.drug
Abstract

International audience; Purpose: The SARAH (Sorafenib Versus Radioembolization in Advanced Hepatocellular Carcinoma) trial (ClinicalTrials.gov Identifier NCT01482442) did not show a significant survival benefit for patients treated with transarterial radioembolization (TARE) compared with continuous oral sorafenib. The improved toxicity profile of patients treated with TARE in the trial, however, could result in a quality of life benefit in economic evaluations. Our objective was to perform a cost-utility analysis of TARE versus sorafenib for locally advanced and inoperable hepatocellular carcinoma.Methods: This study used patient-level data of the SARAH trial regarding resource use, progression-free and overall survival, and quality of life for the within-trial period for the patients who received at least 1 dose of sorafenib or 1 treatment with TARE according to their randomization arm. Data were extrapolated by using a partitioned survival model that incorporated costs and health outcomes, measured in life-years and quality-adjusted life-years (QALYs).Findings: The use of TARE resulted in an average loss of 0.036 life-year and a gain of 0.006 QALY compared with sorafenib. The aerage cost for the TARE arm was €17,179 (95% CI, 9,926-24,280) higher than the sorafenib arm, for an incremental cost-effectiveness ratio of €3,153,086/QALY. The probabilistic sensitivity analysis revealed a 50% risk that the TARE strategy was dominated. TARE was consistently dominated by sorafenib or had an incremental cost-effectiveness ratio more than €450,000/QALY in all sensitivity analyses.Implications: This economic evaluation of SARAH found that using radioembolization with yttrium-90 microspheres for the treatment of hepatocellular carcinoma was not a cost-effective option at the usually accepted willingness-to-pay thresholds.

Published
2021

2. Macrotrabecular-massive hepatocellular carcinoma: A distinctive histological subtype with clinical relevance

Author

Boris Guiu, Jean-Charles Nault, Jonathan Derman, Nicolas Poté, Marianne Ziol, Jessica Zucman-Rossi, Cécile Charpy, Thomas Decaens, Sophie Michalak, Claire Francoz, Alexis Laurent, Julien Calderaro, Charlotte Costentin, Jeanne Ramos, Mohamed Bouattour, Valérie Vilgrain, Georges Philippe Pageaux, Nathalie Barget, Giuliana Amaddeo, Valérie Paradis, Nathalie Ganne-Carrié, Olivier Seror, Alain Luciani, Frédéric Oberti, Christophe Aubé, Hôpital Jean Verdier [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Génomique Fonctionnelle des Tumeurs Solides (U1162), Université Paris 13 (UP13)-Université Paris Diderot - Paris 7 (UPD7)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université Sorbonne Paris Cité (USPC), Centre de recherche sur l'Inflammation (CRI (UMR_S_1149 / ERL_8252 / U1149)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Paris Diderot - Paris 7 (UPD7), Institut Mondor de Recherche Biomédicale (IMRB), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12)-IFR10, CHU Henri Mondor, Service de chirurgie digestive, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor, Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), Service d'hépatologie, Hôpital Beaujon [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Centre Hospitalier Universitaire [Grenoble] (CHU), Hôpital Beaujon, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7)-Hôpital Beaujon [AP-HP], Hôpital Henri Mondor, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR10-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Cellules Souches, Plasticité Cellulaire, Médecine Régénératrice et Immunothérapies (IRMB), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), Hôpital Jean Verdier [Bondy], Assistance publique - Hôpitaux de Paris (AP-HP) (APHP), Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Hôpital Henri Mondor, Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Université Paris Diderot - Paris 7 (UPD7)-Hôpital Beaujon, Hôpital Beaujon-Université Paris Diderot - Paris 7 (UPD7)-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP), and Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Hôpital Henri Mondor-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12)

Subjects
Male, 0301 basic medicine, Pathology, medicine.medical_specialty, Carcinoma, Hepatocellular, recurrence, Radiofrequency ablation, Gastroenterology, Article, law.invention, histology, 03 medical and health sciences, Liver disease, 0302 clinical medicine, law, Internal medicine, Biopsy, Carcinoma, Humans, Medicine, Clinical significance, biopsy, Retrospective Studies, Radiofrequency Ablation, Hepatology, medicine.diagnostic_test, business.industry, Liver Neoplasms, Middle Aged, medicine.disease, 030112 virology, digestive system diseases, 3. Good health, Liver, 030220 oncology & carcinogenesis, Liver biopsy, Hepatocellular carcinoma, Female, 030211 gastroenterology & hepatology, prognosis, business, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract

We recently identified a histological subtype of hepatocellular carcinoma (HCC), designated as "macrotrabecular-massive" (MTM-HCC) and associated with specific molecular features. In order to assess the clinical relevance of this variant, we investigated its prognostic value in two large series of patients with HCC treated by either surgical resection or radiofrequency ablation (RFA). We retrospectively included 237 HCC surgical samples and 284 HCC liver biopsies from patients treated by surgical resection and RFA, respectively. Histological slides were reviewed by pathologists specialized in liver disease, and the MTM-HCC subtype was defined by the presence of a predominant (>50%) macrotrabecular architecture (more than six cells thick). The main clinical and biological features were recorded at baseline. Clinical endpoints were early and overall recurrence. The MTM-HCC subtype was identified in 12% of the whole cohort (16% of surgically resected samples, 8.5% of liver biopsy samples). It was associated at baseline with known poor prognostic factors (tumor size, alpha-fetoprotein level, satellite nodules, and vascular invasion). Multivariate analysis showed that MTM-HCC subtype was an independent predictor of early and overall recurrence (surgical series: hazard ratio, 3.03; 95% confidence interval, 1.38-6.65; P = 0.006; and 2.76; 1.63-4.67; P < 0.001; RFA series: 2.37; 1.36-4.13; P = 0.002; and 2.19; 1.35-3.54; P = 0.001, respectively). Its prognostic value was retained even after patient stratification according to common clinical, biological, and pathological features of aggressiveness. No other baseline parameter was independently associated with recurrence in the RFA series. CONCLUSION The MTM-HCC subtype, reliably observed in 12% of patients eligible for curative treatment, represents an aggressive form of HCC that may require more specific therapeutic strategies. (Hepatology 2018;68:103-112).

Published
2017

3. Efficacy and safety of selective internal radiotherapy with yttrium-90 resin microspheres compared with sorafenib in locally advanced and inoperable hepatocellular carcinoma (SARAH): an open-label randomised controlled phase 3 trial

Author

Valérie Vilgrain, Helena Pereira, Eric Assenat, Boris Guiu, Alina Diana Ilonca, Georges-Philippe Pageaux, Annie Sibert, Mohamed Bouattour, Rachida Lebtahi, Wassim Allaham, Hélène Barraud, Valérie Laurent, Elodie Mathias, Jean-Pierre Bronowicki, Jean-Pierre Tasu, Rémy Perdrisot, Christine Silvain, René Gerolami, Olivier Mundler, Jean-Francois Seitz, Vincent Vidal, Christophe Aubé, Frédéric Oberti, Olivier Couturier, Isabelle Brenot-Rossi, Jean-Luc Raoul, Anthony Sarran, Charlotte Costentin, Emmanuel Itti, Alain Luciani, René Adam, Maïté Lewin, Didier Samuel, Maxime Ronot, Aurelia Dinut, Laurent Castera, Gilles Chatellier, Elisabeth Delhom - Christol, Alina D Ilonca, Julie Lonjon, Mohamed Abdel-Rehim, Arnaud Dieudonné, Christophe Bazin, Carine Chagneau-Derrode, Patrick Borentain, Antoine Bouvier, Laurent Vervueren, Julia Chalaye, Hicham Kobeiter, Julien Edeline, Etienne Garin, Yan Rolland, Isabelle Archambeaud, Thomas Eugene, Eric Frampas, Christophe Cassinotto, Martine Guyot, Jean-Baptiste Hiriart, Bruno Lapuyade, Julien Vergniol, Philippe Bachellier, Julien Detour, Bernard Duclos, Michel Greget, Francois Habersetzer, Alessio Imperiale, Philippe Merle, Agnès Rode, Julie Morvan, Eric Nguyen-Khac, Thierry Yzet, Guillaume Baudin, Patrick Chevallier, Abakar Mahamat, Thierry Piche, Micheline Razzouk, Patrick Hillon, Romaric Loffroy, Michel Toubeau, Julie Vincent, Gabriele Barabino, Nadia Bouarioua, Muriel Cuilleron, Marie Ecochard, Nathalie Prevot-Bitot, Vincent Leroy, Julie Roux, Christian Sengel, Valérie Bourcier, Nathalie Ganne-Carrie, Olivier Seror, Sylvie Costo, Thông Dao, Jean-Pierre Pelage, Jérôme Dumortier, Francesco Giammarile, Pierre-Jean Valette, Nadia Ghazzar, Olivier Pellerin, Julien Taieb, Pierre Weinmann, Alexandra Heurgue-Berlot, Claude Marcus, Daniele Sommacale, Maria-Angéla Castilla-Lièvre, Sophie Maitre, Lysiane Marthey, Hôpital Beaujon, Hôpital Beaujon-Université Paris Diderot - Paris 7 (UPD7)-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP), Centre de recherche sur l'Inflammation (CRI (UMR_S_1149 / ERL_8252 / U1149)), Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), CIC - HEGP (CIC 1418), Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Hôpital Européen Georges Pompidou [APHP] (HEGP), Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Saint-Eloi, Hôpital Gui de Chauliac, Université Montpellier 1 (UM1)-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Centre hospitalier universitaire de Poitiers (CHU Poitiers), Hôpital de la Timone [CHU - APHM] (TIMONE), Hôpital Beaujon [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Paris Diderot - Paris 7 (UPD7), Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Européen Georges Pompidou [APHP] (HEGP), and Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)

Subjects
Male, medicine.medical_treatment, Brachytherapy, Administration, Oral, Kaplan-Meier Estimate, Liver transplantation, Gastroenterology, 0302 clinical medicine, Yttrium Radioisotopes, MESH: Carcinoma, Hepatocellular/drug therapy, education.field_of_study, Liver Neoplasms, Radiotherapy Dosage, MESH: Carcinoma, Hepatocellular/radiotherapy, Middle Aged, Sorafenib, Microspheres, MESH: Niacinamide/analogs & derivatives, 3. Good health, MESH: Liver Neoplasms/drug therapy, Treatment Outcome, Oncology, 030220 oncology & carcinogenesis, Hepatocellular carcinoma, Female, 030211 gastroenterology & hepatology, MESH: Phenylurea Compounds/administration & dosage, Liver cancer, medicine.drug, Adult, Niacinamide, medicine.medical_specialty, Carcinoma, Hepatocellular, Population, Antineoplastic Agents, [SDV.CAN]Life Sciences [q-bio]/Cancer, Disease-Free Survival, Drug Administration Schedule, 03 medical and health sciences, Internal medicine, medicine, Carcinoma, Humans, Neoplasm Invasiveness, education, Aged, Neoplasm Staging, Dose-Response Relationship, Drug, Performance status, business.industry, Phenylurea Compounds, medicine.disease, Survival Analysis, Surgery, MESH: Yttrium Radioisotopes/therapeutic use, Liver function, business, Follow-Up Studies
Abstract

Summary Background Sorafenib is the recommended treatment for patients with advanced hepatocellular carcinoma. We aimed to compare the efficacy and safety of sorafenib to that of selective internal radiotherapy (SIRT) with yttrium-90 ( 90 Y) resin microspheres in patients with hepatocellular carcinoma. Methods SARAH was a multicentre, open-label, randomised, controlled, investigator-initiated, phase 3 trial done at 25 centres specialising in liver diseases in France. Patients were eligible if they were aged at least 18 years with a life expectancy greater than 3 months, had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, Child-Pugh liver function class A or B score of 7 or lower, and locally advanced hepatocellular carcinoma (Barcelona Clinic Liver Cancer [BCLC] stage C), or new hepatocellular carcinoma not eligible for surgical resection, liver transplantation, or thermal ablation after a previously cured hepatocellular carcinoma (cured by surgery or thermoablative therapy), or hepatocellular carcinoma with two unsuccessful rounds of transarterial chemoembolisation. Patients were randomly assigned (1:1) by a permutated block method with block sizes two and four to receive continuous oral sorafenib (400 mg twice daily) or SIRT with 90 Y-loaded resin microspheres 2–5 weeks after randomisation. Patients were stratified according to randomising centre, ECOG performance status, previous transarterial chemoembolisation, and presence of macroscopic vascular invasion. The primary endpoint was overall survival. Analyses were done on the intention-to-treat population; safety was assessed in all patients who received at least one dose of sorafenib or underwent at least one of the SIRT work-up exams. This study has been completed and the final results are reported here. The trial is registered with ClinicalTrials.gov, number NCT01482442. Findings Between Dec 5, 2011, and March 12, 2015, 467 patients were randomly assigned; after eight patients withdrew consent, 237 were assigned to SIRT and 222 to sorafenib. In the SIRT group, 53 (22%) of 237 patients did not receive SIRT; 26 (49%) of these 53 patients were treated with sorafenib. Median follow-up was 27·9 months (IQR 21·9–33·6) in the SIRT group and 28·1 months (20·0–35·3) in the sorafenib group. Median overall survival was 8·0 months (95% CI 6·7–9·9) in the SIRT group versus 9·9 months (8·7–11·4) in the sorafenib group (hazard ratio 1·15 [95% CI 0·94–1·41] for SIRT vs sorafenib; p=0·18). In the safety population, at least one serious adverse event was reported in 174 (77%) of 226 patients in the SIRT group and in 176 (82%) of 216 in the sorafenib group. The most frequent grade 3 or worse treatment-related adverse events were fatigue (20 [9%] vs 41 [19%]), liver dysfunction (25 [11%] vs 27 [13%]), increased laboratory liver values (20 [9%] vs 16 [7%]), haematological abnormalities (23 [10%] vs 30 [14%]), diarrhoea (three [1%] vs 30 [14%]), abdominal pain (six [3%] vs 14 [6%]), increased creatinine (four [2%] vs 12 [6%]), and hand-foot skin reaction (one [ vs 12 [6%]). 19 deaths in the SIRT group and 12 in the sorafenib group were deemed to be treatment related. Interpretation In patients with locally advanced or intermediate-stage hepatocellular carcinoma after unsuccessful transarterial chemoembolisation, overall survival did not significantly differ between the two groups. Quality of life and tolerance might help when choosing between the two treatments. Funding Sirtex Medical Inc.

Published
2017

4. Tolérance de la chimio-embolisation pour le traitement du carcinome hépatocellulaire chez les patients âgés

Author

Hernandez, Olivier, Université Grenoble Alpes - UFR Médecine (UGA UFRM), Université Grenoble Alpes (UGA), and Charlotte Costentin

Subjects
Elderly patients, Chimio-embolisation, Hepatocellular carcinoma, Patients âgés, Tolérance, Carcinome hépatocellulaire, Safety, Transarterial chemo-embolization, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract

Introduction: Transarterial chemo-embolization is the most widely used treatment for hepatocellular carcinoma (HCC) in the world. Its efficacy has been demonstrated by several studies. However, safety data are limited, especially in the elderly. The aim of our study is to describe the safety profile of chemo-embolization for hepatocellular carcinoma in patients aged 70 years or more compared to younger patients. Materials and Methods: In this retrospective study, patients who received a first transarterial chemo-embolization for hepatocellular carcinoma at Grenoble University Hospital from January 2012 to March 2017 were included. They are divided into two groups according to age greater or below 70 years. The rates of early (during initial hospitalization), late (between discharge from hospital and oncological reassessment) and overall complications are assessed in each group and compared. Predictive factors of severe adverse events are studied using univariate and multivariate analyzes. Results: 271 patients were included in our study: 88 aged 70 or more and 183 in the younger group. The rate of severe adverse events in elderly patients is 20.5% compared to 21.3% in younger patients. There is no significant difference between the two groups (p = 0.87). The predictive factors of severe adverse events are a Child-Pugh score ≥ B7 (p < 0.0001), a PS ≥ 1 (p = 0.0019) and a MELD score ≥ 9 (p = 0.0415). Multifocal HCC and the use of idarubicin as chemotherapy are associated with reduced occurrence of severe adverse events (p = 0.0396 and p = 0.0351, respectively). Age 70 years or older is not associated with the occurrence of severe adverse events (p = 0.87). Conclusion: Our results show that safety profile of transarterial chemo-embolization for hepatocellular carcinoma in elderly is comparable to that of younger patients.; Introduction : La chimio-embolisation est le traitement du carcinome hépatocellulaire (CHC) le plus pratiqué dans le monde. Son efficacité est démontrée par plusieurs études. En revanche, peu de données sont disponibles concernant sa tolérance, en particulier chez les sujets âgés, qui représentent une part croissante des patients avec CHC. Le but de notre étude est de décrire le profil de tolérance de la chimio-embolisation pour CHC chez les patients âgés de 70 ans ou plus comparé aux patients plus jeunes. Matériels et méthodes : Dans cette étude rétrospective, les patients ayant bénéficié d’une première chimio-embolisation pour carcinome hépatocellulaire au CHU de Grenoble de janvier 2012 à mars 2017 ont été inclus. Ils sont répartis en deux groupes selon l’âge : les plus et les moins de 70 ans. Les taux de complications précoces (pendant l’hospitalisation initiale), tardives (entre la sortie d’hospitalisation et la réévaluation oncologique) et globales sont évalués dans chaque groupe puis comparés. Les facteurs prédictifs d’évènements indésirables sévères sont étudiés par des analyses univariées et multivariées. Résultats : 271 patients ont été inclus dans notre étude : 88 dans le groupe des 70 ans ou plus et 183 dans le groupe des moins de 70 ans. Le taux d’évènements indésirables sévères chez les patients âgés est de 20,5% contre 21,3 % chez les plus jeunes. Il n’y a pas de différence significative entre les deux groupes (p = 0.87). Les facteurs prédictifs d’évènements indésirables sévères sont : un score de Child-Pugh ≥ B7 (p < 0.0001), un score OMS ≥ 1 (p = 0.0019) et un score de MELD ≥ 9 (p = 0.0415). Un CHC multifocal et l’utilisation l’idarubicine comme chimiothérapie sont associés à une moindre survenue d’évènements indésirables sévères (respectivement p = 0.0396 et p = 0.0351). L’âge de 70 ans ou plus n’est pas associé à la survenue d’évènements indésirables sévères (p = 0,87). Conclusion : Nos résultats montrent qu’il n’y a pas de différence de tolérance de la chimio-embolisation pour le traitement du carcinome hépatocellulaire entre les patients âgés de 70 ans ou plus et les patients plus jeunes.

Published
2020

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