Evidence map›Paper›PMID 30980420›Full record

ArticleAlimentary pharmacology & therapeutics2019

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

Bernhard Scheiner, Martha M Kirstein, Florian Hucke, Fabian Finkelmeier, Kornelius Schulze, Johann von Felden, Sandra Koch, Philipp Schwabl, Jan B Hinrichs, Fredrik Waneck and 11 more

Open access · hybridAbstract readMulticenter Study
In one paragraph

Article in Alimentary pharmacology & therapeutics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 71 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
71citing papers in PubMed, 7 pooled it
12.0field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

71 citing papers in PubMed, 7 syntheses or guidelines pooled it, 130 citations in OpenAlex.

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11 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors.

Bernhard ScheinerVienna, Austria.ORCID 0000-0002-4904-5133
Martha M KirsteinHannover, Germany.
Florian HuckeKlagenfurt, Austria.
Fabian FinkelmeierFrankfurt/Main, Germany.ORCID 0000-0001-8559-9910
Kornelius SchulzeHamburg, Germany.
Johann von FeldenHamburg, Germany.ORCID 0000-0003-2839-5174
Sandra KochMainz, Germany.
Philipp SchwablVienna, Austria.
Jan B HinrichsHannover, Germany.
Fredrik WaneckVienna, Austria.
Oliver WaidmannFrankfurt/Main, Germany.
Thomas ReibergerVienna, Austria.ORCID 0000-0002-4590-3583
Christian MüllerVienna, Austria.
Wolfgang SieghartVienna, Austria.
Michael TraunerVienna, Austria.
Arndt WeinmannMainz, Germany.
Henning WegeHamburg, Germany.
Jörg TrojanFrankfurt/Main, Germany.
Markus Peck-RadosavljevicKlagenfurt, Austria.
Arndt VogelHannover, Germany.
Matthias PinterVienna, Austria.ORCID 0000-0002-7260-532X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundProgrammed cell death protein-1-targeted immunotherapy has shown promising results in phase II studies of hepatocellular carcinoma.

aimTo evaluate safety and efficacy of nivolumab and pembrolizumab in an international, multicentre, real-world cohort of patients with advanced hepatocellular carcinoma.

methodsSixty-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.

resultsChild-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.

conclusionsProgrammed 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.

Indexed as

AgedAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalAustriaCarcinoma, HepatocellularFemaleGermanyHumansImmunotherapyLiver NeoplasmsMaleMiddle AgedNivolumabProgrammed Cell Death 1 ReceptorRetrospective StudiesAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalNivolumabPDCD1 protein, humanpembrolizumabProgrammed Cell Death 1 Receptor

Identifiers

PMID30980420
PMCPMC6593858
OpenAlexW2940287925

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.