Evidence map›Paper›PMID 19908093›Full record

Trial reportCardiovascular and interventional radiology2010

Prospective randomized study of doxorubicin-eluting-bead embolization in the treatment of hepatocellular carcinoma: results of the PRECISION V study.

Johannes Lammer, Katarina Malagari, Thomas Vogl, Frank Pilleul, Alban Denys, Anthony Watkinson, Michael Pitton, Geraldine Sergent, Thomas Pfammatter, Sylvain Terraz and 11 more

4 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIComparative StudyMulticenter Study
In one paragraph

Trial report in Cardiovascular and interventional radiology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 644 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
644citing papers in PubMed, 9 pooled it
36.3field-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.

NCT01332669 phase4completednot on this mapstarted 2011, after this paper: background citation

Multicenter Registry of Chemoembolization Using Drug-eluting Bead in Patients With Unresectable Hepatocellular Carcinoma

TypeinterventionalSponsorSeoul National University HospitalRan2011 to 2015Enrolled200ConditionsHepatocellular CarcinomaArmsDebDox TACE
NCT02729506 phase4unknown statusnot on this mapstarted 2016, after this paper: background citation

Transarterial Radioembolization Versus Chemoembolization for the Treatment of Advanced Hepatocellular Carcinoma

TypeinterventionalSponsorKing Faisal Specialist Hospital & Research CenterRan2016 to 2017Enrolled150ConditionsHepatocellular CarcinomaArmsTransarterial Radioembolization, Transarterial Chemoembolization using drug-eluting beads
NCT04048317 early_phase1unknown statusnot on this mapstarted 2019, after this paper: background citation

Effectiveness of Drug Eluting & Conventional Trans-arterial Chemo-embolization in Treatment of Primary Hepatic Cell Carcinoma

TypeinterventionalSponsorAssiut UniversityRan2019 to 2020Enrolled75ConditionsHepatic Cell CarcinomaArmsHepaSphere Microspheres/Doxorubicin Hydrochloride, Lipiodol
NCT04653701 unknown statusnot on this mapstarted 2020, after this paper: background citation

A Single Center Experience:Safety and Efficacy of DEB-TACE Performed With a Novel Reflux-control Microcatheter in Patients With Early and Intermediate HCC.

Typeobservational_patient_registrySponsorJuan José Ciampi DopazoRan2020 to 2022Enrolled30ConditionsHepatocellular Carcinoma, Liver CancerArmsChemoembolization with preloaded microparticles 100 micron and reflux control microcatheter
3 · Its place in the literature

Who cites it

644 citing papers in PubMed, 9 syntheses or guidelines pooled it, 1,536 citations in OpenAlex.

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584 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 at 14 institutions in 7 countries.

Johannes LammerCardiovascular and Interventional Radiology, Medical University Vienna, Vienna, Austria. johannes.lammer@meduniwien.ac.at
Katarina Malagari
Thomas Vogl
Frank Pilleul
Alban Denys
Anthony Watkinson
Michael Pitton
Geraldine Sergent
Thomas Pfammatter
Sylvain Terraz
Yves Benhamou
Yves Avajon
Thomas Gruenberger
Maria Pomoni
Herbert Langenberger
Marcus Schuchmann
Jerome Dumortier
Christian Mueller
Patrick Chevallier
Riccardo Lencioni
PRECISION V Investigators
Medical University of Vienna · ATHôpital Edouard Herriot · FRJohannes Gutenberg University Mainz · DENational and Kapodistrian University of Athens · GRGoethe University Frankfurt · DEHôpital Beau-Séjour · CHHôpital Claude Huriez · FRHôpital l'Archet · FRHôpital Paul-Brousse · FROspedale Cisanello · ITRoyal Devon and Exeter Hospital · GBSorbonne Université · FRUniversity Hospital of Lausanne · CHUniversity Hospital of Zurich · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Transcatheter arterial chemoembolization (TACE) offers a survival benefit to patients with intermediate hepatocellular carcinoma (HCC). A widely accepted TACE regimen includes administration of doxorubicin-oil emulsion followed by gelatine sponge-conventional TACE. Recently, a drug-eluting bead (DC Bead) has been developed to enhance tumor drug delivery and reduce systemic availability. This randomized trial compares conventional TACE (cTACE) with TACE with DC Bead for the treatment of cirrhotic patients with HCC. Two hundred twelve patients with Child-Pugh A/B cirrhosis and large and/or multinodular, unresectable, N0, M0 HCCs were randomized to receive TACE with DC Bead loaded with doxorubicin or cTACE with doxorubicin. Randomization was stratified according to Child-Pugh status (A/B), performance status (ECOG 0/1), bilobar disease (yes/no), and prior curative treatment (yes/no). The primary endpoint was tumor response (EASL) at 6 months following independent, blinded review of MRI studies. The drug-eluting bead group showed higher rates of complete response, objective response, and disease control compared with the cTACE group (27% vs. 22%, 52% vs. 44%, and 63% vs. 52%, respectively). The hypothesis of superiority was not met (one-sided P = 0.11). However, patients with Child-Pugh B, ECOG 1, bilobar disease, and recurrent disease showed a significant increase in objective response (P = 0.038) compared to cTACE. DC Bead was associated with improved tolerability, with a significant reduction in serious liver toxicity (P < 0.001) and a significantly lower rate of doxorubicin-related side effects (P = 0.0001). TACE with DC Bead and doxorubicin is safe and effective in the treatment of HCC and offers a benefit to patients with more advanced disease.

Indexed as

AgedAntibiotics, AntineoplasticCarcinoma, HepatocellularChemoembolization, TherapeuticDoxorubicinDrug CarriersDrug ImplantsFemaleHumansLiver NeoplasmsMaleProspective StudiesSingle-Blind MethodTreatment OutcomeAntibiotics, AntineoplasticDoxorubicinDrug CarriersDrug Implants

Identifiers

PMID19908093
PMCPMC2816794
OpenAlexW2092759077

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.