Evidence map›Paper›PMID 29563636›Full record

Trial reportBritish journal of cancer2018

A multicentre, open-label, phase-I/randomised phase-II study to evaluate safety, pharmacokinetics, and efficacy of nintedanib vs. sorafenib in European patients with advanced hepatocellular carcinoma.

D H Palmer, Y T Ma, M Peck-Radosavljevic, P Ross, J Graham, L Fartoux, A Deptala, M Studeny, D Schnell, J Hocke and 2 more

Abstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in British journal of cancer, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 5 pooled it
–field-weighted citation impact
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

19 citing papers in PubMed, 5 syntheses or guidelines pooled it.

  1. Pooled it
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  3. Objective Response Predicts Survival in Advanced Hepatocellular Carcinoma Treated with Systemic Therapies.Clinical cancer research : an official journal of the American Association for Cancer Research · 2022
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  16. Recent progress in treatment of hepatocellular carcinoma.American journal of cancer research · 2020
    Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

D H PalmerDepartment of Molecular and Clinical Cancer Medicine, University of Liverpool, Liverpool, United Kingdom. Daniel.Palmer@liverpool.ac.uk.
Y T MaSchool of Cancer Sciences, University of Birmingham, Birmingham, United Kingdom.
M Peck-RadosavljevicDepartment of Gastroenterology & Hepatology, Medizinische Universität Wien, Vienna, Austria.
P RossKing's College Hospital NHS Foundation Trust, London, United Kingdom.
J GrahamBeatson West of Scotland Cancer Centre and University of Glasgow, Glasgow, United Kingdom.
L FartouxHôpital Saint-Antoine, Paris, France.
A DeptalaCentral Clinical Hospital of the Ministry of Interior, Department of Oncology and Hematology, Medical University of Warsaw, Warsaw, Poland.
M StudenyBoehringer Ingelheim, Pharma GmbH & Co. KG, Biberach, Germany.
D SchnellBoehringer Ingelheim, Pharma GmbH & Co. KG, Biberach, Germany.
J HockeBoehringer Ingelheim, Pharma GmbH & Co. KG, Biberach, Germany.
A-B LoembéBoehringer Ingelheim B.V., Alkmaar, The Netherlands.
T MeyerUCL Cancer Institute, University College London, London, United Kingdom.

Funding

Wellcome Trust
6 · The paper itself

Abstract

backgroundThis multicentre, open-label, phase-I/randomised phase-II trial evaluated safety, pharmacokinetics, maximum-tolerated-dose (MTD) per dose-limiting toxicities (DLTs), and efficacy of nintedanib vs. sorafenib in European patients with unresectable advanced hepatocellular carcinoma (aHCC).

methodsPhase I: Patients were stratified into two groups per baseline aminotransferase/alanine aminotransferase and Child-Pugh score; MTD was determined. Phase II: Patients were randomised 2:1 to nintedanib (MTD) or sorafenib (400-mg bid) in 28-day cycles until intolerance or disease progression. Time-to-progression (TTP, primary endpoint), overall survival (OS) and progression-free survival (PFS) were determined.

resultsPhase-I: no DLTs observed; nintedanib MTD in both groups was 200 mg bid. Phase-II: patients (N = 93) were randomised to nintedanib (n = 62) or sorafenib (n = 31); TTP was 5.5 vs. 4.6 months (HR = 1.44 [95% CI, 0.81-2.57]), OS was 11.9 vs. 11.4 months (HR = 0.88 [95% CI, 0.52-1.47]), PFS was 5.3 vs. 3.9 months (HR = 1.35 [95% CI, 0.78-2.34]), respectively (all medians). Dose intensity and tolerability favoured nintedanib. Fewer patients on nintedanib (87.1%) vs. sorafenib (96.8%) had drug-related adverse events (AEs) or grade ≥ 3 AEs (67.7% vs. 90.3%), but more patients on nintedanib (28 [45.2%]) had AEs leading to drug discontinuation than did those on sorafenib (7 [22.6%]).

conclusionsNintedanib may have similar efficacy to sorafenib in aHCC.

Indexed as

IndolesSorafenibAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, HepatocellularDisease-Free SurvivalDisease ProgressionEuropeFemaleHumansLiver NeoplasmsMaleMaximum Tolerated DoseMiddle AgedIndolesnintedanibSorafenib

Identifiers

PMID29563636
PMCPMC5943284

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

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.