Programmed cell death protein‐1 (PD‐1)‐targeted immunotherapy in advanced hepatocellular carcinoma: efficacy and safety data from an international multicentre real‐world cohort

Summary Background Programmed cell death protein‐1‐targeted immunotherapy has shown promising results in phase II studies of hepatocellular carcinoma. Aim To evaluate safety and efficacy of nivolumab and pembrolizumab in an international, multicentre, real‐world cohort of patients with advanced hepa...

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Vydáno v:	Alimentary pharmacology & therapeutics Ročník 49; číslo 10; s. 1323 - 1333
Hlavní autoři:	Scheiner, Bernhard, Kirstein, Martha M., Hucke, Florian, Finkelmeier, Fabian, Schulze, Kornelius, von Felden, Johann, Koch, Sandra, Schwabl, Philipp, Hinrichs, Jan B., Waneck, Fredrik, Waidmann, Oliver, Reiberger, Thomas, Müller, Christian, Sieghart, Wolfgang, Trauner, Michael, Weinmann, Arndt, Wege, Henning, Trojan, Jörg, Peck‐Radosavljevic, Markus, Vogel, Arndt, Pinter, Matthias
Médium:	Journal Article
Jazyk:	angličtina
Vydáno:	England Wiley Subscription Services, Inc 01.05.2019 John Wiley and Sons Inc
Témata:	Aged Antibodies, Monoclonal, Humanized - therapeutic use Antineoplastic Agents, Immunological - therapeutic use Apoptosis Austria Carcinoma, Hepatocellular - drug therapy Cell death Diarrhea Disease control Female Germany Hepatitis Hepatocellular carcinoma Humans Immunotherapy Liver cancer Liver Neoplasms - drug therapy Male Middle Aged Monoclonal antibodies Nivolumab - therapeutic use Original Pembrolizumab Programmed Cell Death 1 Receptor - antagonists & inhibitors Programmed Cell Death Protein‐1 Targeted Immunotherapy for Hepatocellular Carcinoma Proteins Pruritus Retrospective Studies Safety Targeted cancer therapy Austria Germany
ISSN:	0269-2813, 1365-2036, 1365-2036
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Shrnutí:	Summary Background Programmed cell death protein‐1‐targeted immunotherapy has shown promising results in phase II studies of hepatocellular carcinoma. Aim To evaluate safety and efficacy of nivolumab and pembrolizumab in an international, multicentre, real‐world cohort of patients with advanced hepatocellular carcinoma. Methods Sixty‐five patients treated with nivolumab (n = 34) or pembrolizumab (n = 31) between July 10, 2015 and December 31, 2018 (data cut‐off) across six centres in Austria and Germany were retrospectively analysed. Results Child‐Pugh class A/B/C was 32 (49%)/28 (43%)/5 (8%). Immunotherapy was used as systemic first‐/second‐/third‐/fourth‐line treatment in 9 (14%)/27 (42%)/26 (40%)/3 (5%) patients. Fifty‐four patients had at least one follow‐up imaging and were, therefore, available for radiological response assessment. The overall response and disease control rates were 12% and 49% respectively. Of 52 evaluable patients, four (8%) had hyperprogressive disease. Median time to progression was 5.5 (95% CI, 3.5‐7.4) months, median progression‐free survival was 4.6 (95% CI, 3.0‐6.2) months, and median overall survival was 11.0 (95% CI, 8.2‐13.8) months. Most common adverse events were infections (n = 7), rash (n = 6), pruritus (n = 3), fatigue (n = 3), diarrhoea (n = 3) and hepatitis (n = 3). Efficacy and safety results were comparable between Child‐Pugh A and B patients; however, median overall survival (OS) was shorter in Child‐Pugh B patients (16.7 vs 8.6 months; P = 0.065). There was no difference in terms of efficacy and adverse events between patients who received immunotherapy as first‐/second‐line and third‐/fourth‐line respectively. Conclusions Programmed cell death protein‐1‐targeted immunotherapy with nivolumab or pembrolizumab showed promising efficacy and safety in patients with advanced hepatocellular carcinoma, including subjects with Child‐Pugh stage B and patients with intensive pretreatment.
Bibliografie:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 14 content type line 23 Audio Podcast Bernhard Scheiner and Martha M. Kirstein contributed equally. The authors’ complete affiliations are listed in Appendix 1. The Handling Editor for this article was Dr Colin Howden, and it was accepted for publication after full peer‐review.
ISSN:	0269-2813 1365-2036 1365-2036
DOI:	10.1111/apt.15245