Post-registration experience of nivolumab in advanced hepatocellular carcinoma: an international study.


Journal

Journal for immunotherapy of cancer
ISSN: 2051-1426
Titre abrégé: J Immunother Cancer
Pays: England
ID NLM: 101620585

Informations de publication

Date de publication:
08 2020
Historique:
accepted: 06 07 2020
entrez: 2 9 2020
pubmed: 2 9 2020
medline: 16 9 2021
Statut: ppublish

Résumé

Nivolumab is Food and Drug Administration approved in sorafenib-experienced, advanced hepatocellular carcinoma (HCC). Post-registration data of treatment in a real-world setting is lacking. We performed an international, multicenter observational study to confirm safety and efficacy of nivolumab in 233 patients treated outside clinical trials from eight centers in North America, Europe and Asia. Patients received nivolumab for Barcelona Clinic Liver Cancer stage C (n This study confirms safety and efficacy of nivolumab in advanced HCC across various lines of therapy and degrees of liver dysfunction. Despite equal ORR and toxicity to nivolumab, patients with CP-B functional class have shorter survival than the patients with CP-A.

Sections du résumé

BACKGROUND
Nivolumab is Food and Drug Administration approved in sorafenib-experienced, advanced hepatocellular carcinoma (HCC). Post-registration data of treatment in a real-world setting is lacking.
PATIENTS AND METHODS
We performed an international, multicenter observational study to confirm safety and efficacy of nivolumab in 233 patients treated outside clinical trials from eight centers in North America, Europe and Asia.
RESULTS
Patients received nivolumab for Barcelona Clinic Liver Cancer stage C (n
CONCLUSIONS
This study confirms safety and efficacy of nivolumab in advanced HCC across various lines of therapy and degrees of liver dysfunction. Despite equal ORR and toxicity to nivolumab, patients with CP-B functional class have shorter survival than the patients with CP-A.

Identifiants

pubmed: 32868393
pii: jitc-2020-001033
doi: 10.1136/jitc-2020-001033
pmc: PMC7462152
pii:
doi:

Substances chimiques

Nivolumab 31YO63LBSN

Types de publication

Journal Article Multicenter Study Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Subventions

Organisme : Wellcome Trust
ID : PS3416
Pays : United Kingdom

Informations de copyright

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Déclaration de conflit d'intérêts

Competing interests: DP received lecture fees from ViiV Healthcare, Bayer Healthcare and travel expenses from BMS and Bayer Healthcare; consulting fees for Mina Therapeutics, EISAI, Roche, Astra Zeneca; received research funding (to institution) from MSD, BMS. DB has received lecture and speaker fees from Bayer Healthcare and the Falk Foundation Germany. LR received lecture fees from AbbVie, Amgen, Eisai, Gilead, Incyte, Ipsen, Lilly, Roche, Sanofi; advisory board/consulting fees from Amgen, ArQule, AstraZeneca, Basilea, Bayer, Celgene, Eisai, Exelixis, Hengrui, Incyte, Ipsen, Lilly, MSD, Nerviano Medical Sciences, Roche, Sanofi; travel expenses from Ipsen; received research funding (to institution) from Agios, ARMO BioSciences, AstraZeneca, BeiGene, Eisai, Exelixis, Fibrogen, Incyte, Ipsen, Lilly, MSD, Roche. NP received lecture fees from AbbVie and Gilead; travel expenses from ArQule. YHH has received advisory board/consulting fees for BMS, MSD, Bayer Healthcare, IPSEN, EISAI, Gilead and Lilly. AS received research funding (to institution) from AstraZeneca, Exelixis, BMS and Clovis; advisory board/consulting fees from BMS, AstraZeneca, and Exelixis.

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Auteurs

Petros Fessas (P)

Department of Surgery and Cancer, Imperial College London, London, UK.

Ahmed Kaseb (A)

Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, United States.

Yinghong Wang (Y)

Department of Gastroenterology, Hepatology & Nutrition, The University of Texas MD Anderson Cancer Center, Houston, Texas, United States.

Anwaar Saeed (A)

Division of Medical Oncology, Department of Medicine, Kansas University Cancer Center, Westwood, Kansas, United States.

David Szafron (D)

Department of Internal Medicine, Baylor College of Medicine, Houston, Texas, United States.

Tomi Jun (T)

Department of Medicine, Division of Hematology/Oncology, Tisch Cancer Institute, Mount Sinai Hospital, New York City, New York, United States.

Sirish Dharmapuri (S)

Department of Medicine, Division of Hematology/Oncology, Tisch Cancer Institute, Mount Sinai Hospital, New York City, New York, United States.

Abdul Rafeh Naqash (A)

Division of Hematology/Oncology, East Carolina University, Greenville, North Carolina, United States.

Mahvish Muzaffar (M)

Division of Hematology/Oncology, East Carolina University, Greenville, North Carolina, United States.

Musharraf Navaid (M)

Division of Hematology/Oncology, East Carolina University, Greenville, North Carolina, United States.

Uqba Khan (U)

Division of Hematology and Oncology, Weill Cornell Medicine/New York Presbyterian Hospital, New York City, New York, United States.

ChiehJu Lee (C)

Division of Gastroenterology and Hepatology, Department of Medicine at Taipei Veterans General Hospital and Institute of Clinical Medicine, National Yang-Ming University, Taipei, Taiwan.

Anushi Bulumulle (A)

Division of Hematology/Oncology, East Carolina University, Greenville, North Carolina, United States.

Bo Yu (B)

Department of Medicine, New York Presbyterian Brooklyn Methodist Hospital, Brooklyn, New York, United States.

Sonal Paul (S)

Department of Medicine, New York Presbyterian Brooklyn Methodist Hospital, Brooklyn, New York, United States.

Neil Nimkar (N)

Department of Medicine, New York Presbyterian Brooklyn Methodist Hospital, Brooklyn, New York, United States.

Dominik Bettinger (D)

Department of Medicine II, Faculty of Medicine, Medical Center University of Freiburg, Freiburg, Germany.

Francesca Benevento (F)

Department of Medical and Surgical Sciences, University of Bologna, S Orsola-Malpighi Hospital, Bologna, Italy.

Hannah Hildebrand (H)

Division of Medical Oncology, Department of Medicine, Kansas University Cancer Center, Westwood, Kansas, United States.

Tiziana Pressiani (T)

Medical Oncology and Hematology Unit, Humanitas Cancer Center, Humanitas Clinical and Research Center, IRCCS, Via Manzoni 56, 20089 Rozzano, Milan, Italy.

Yehia I Abugabal (YI)

Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, United States.

Nicola Personeni (N)

Medical Oncology and Hematology Unit, Humanitas Cancer Center, Humanitas Clinical and Research Center, IRCCS, Via Manzoni 56, 20089 Rozzano, Milan, Italy.
Department of Biomedical Sciences, Humanitas University, Via Rita Levi Montalcini 4, 20090 Pieve Emanuele, Milan, Italy.

Yi-Hsiang Huang (YH)

Division of Gastroenterology and Hepatology, Department of Medicine at Taipei Veterans General Hospital and Institute of Clinical Medicine, National Yang-Ming University, Taipei, Taiwan.

Lorenza Rimassa (L)

Medical Oncology and Hematology Unit, Humanitas Cancer Center, Humanitas Clinical and Research Center, IRCCS, Via Manzoni 56, 20089 Rozzano, Milan, Italy.
Department of Biomedical Sciences, Humanitas University, Via Rita Levi Montalcini 4, 20090 Pieve Emanuele, Milan, Italy.

Celina Ang (C)

Department of Medicine, Division of Hematology/Oncology, Tisch Cancer Institute, Mount Sinai Hospital, New York City, New York, United States.

Thomas Marron (T)

Department of Medicine, Division of Hematology/Oncology, Tisch Cancer Institute, Mount Sinai Hospital, New York City, New York, United States.

David J Pinato (DJ)

Department of Surgery and Cancer, Imperial College London, London, UK david.pinato@imperial.ac.uk.

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