Evidence map›Paper›PMID 22727733›Full record

Trial reportJournal of hepatology2012

Efficacy and safety of sorafenib in patients with advanced hepatocellular carcinoma: subanalyses of a phase III trial.

Jordi Bruix, Jean-Luc Raoul, Morris Sherman, Vincenzo Mazzaferro, Luigi Bolondi, Antonio Craxi, Peter R Galle, Armando Santoro, Michel Beaugrand, Angelo Sangiovanni and 8 more

Open access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of hepatology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 445 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
445citing papers in PubMed, 10 pooled it
28.1field-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

445 citing papers in PubMed, 10 syntheses or guidelines pooled it, 819 citations in OpenAlex.

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

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

18 authors at 16 institutions in 6 countries.

Jordi BruixBarcelona Clínic Liver Cancer Group, Liver Unit, CIBERehd, Institut d'Investigacions Biomèdiques, August Pi i Sunyer, Hospital Clínic Barcelona, Barcelona, Spain. jbruix@clinic.ub.es
Jean-Luc Raoul
Morris Sherman
Vincenzo Mazzaferro
Luigi Bolondi
Antonio Craxi
Peter R Galle
Armando Santoro
Michel Beaugrand
Angelo Sangiovanni
Camillo Porta
Guido Gerken
Jorge A Marrero
Andrea Nadel
Michael Shan
Marius Moscovici
Dimitris Voliotis
Josep M Llovet
Bayer (United States) · USAssistance Publique – Hôpitaux de Paris · FRBayer (Italy) · ITCentre Eugène Marquis · FRCentro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas · ESEssen University Hospital · DEHospital Clínic de Barcelona · ESHumanitas University · ITIstituti di Ricovero e Cura a Carattere Scientifico · ITOspedale Maggiore · ITPoliclinico S.Orsola-Malpighi · ITToronto General Hospital · CAUniversity Medical Center of the Johannes Gutenberg University Mainz · DEUniversity of Michigan–Ann Arbor · USUniversity of Palermo · ITUniversity of Pavia · IT

Funding

Integrative genomic analysis in hepatocellular carcinomaR01DK076986 · NIDDK · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · PI LLOVET, JOSEP M · 2007 to 2011
$1.3M
NIDDK NIH HHS 1R01DK076986-01NIDDK NIH HHS R01 DK076986
6 · The paper itself

Abstract

BACKGROUND &

aimsThe Sorafenib Hepatocellular Carcinoma (HCC) Assessment Randomized Protocol (SHARP) trial demonstrated that sorafenib improves overall survival and is safe for patients with advanced HCC. In this trial, 602 patients with well-preserved liver function (>95% Child-Pugh A) were randomized to receive either sorafenib 400mg or matching placebo orally b.i.d. on a continuous basis. Because HCC is a heterogeneous disease, baseline patient characteristics may affect individual responses to treatment. In a comprehensive series of exploratory subgroup analyses, data from the SHARP trial were analyzed to discern if baseline patient characteristics influenced the efficacy and safety of sorafenib.

methodsFive subgroup domains were assessed: disease etiology, tumor burden, performance status, tumor stage, and prior therapy. Overall survival (OS), time to progression (TTP), disease control rate (DCR), and safety were assessed for subgroups within each domain.

resultsSubgroup analyses showed that sorafenib consistently improved median OS compared with placebo, as reflected by hazard ratios (HRs) of 0.50-0.85, similar to the complete cohort (HR=0.69). Sorafenib also consistently improved median TTP (HR, 0.40-0.64), except in HBV-positive patients (HR, 1.03), and DCR. Results are limited by small patient numbers in some subsets. The most common grade 3/4 adverse events included diarrhea, hand-foot skin reaction, and fatigue; the incidence of which did not differ appreciably among subgroups.

conclusionsThese exploratory subgroup analyses showed that sorafenib consistently improved median OS and DCR compared with placebo in patients with advanced HCC, irrespective of disease etiology, baseline tumor burden, performance status, tumor stage, and prior therapy.

Indexed as

AgedAlcoholismAntineoplastic AgentsCarcinoma, HepatocellularDiarrheaDisease ProgressionFatigueFemaleHand-Foot SyndromeHepatitis B, ChronicHepatitis C, ChronicHumansKaplan-Meier EstimateLiver NeoplasmsMaleMiddle AgedAntineoplastic AgentsNiacinamidePhenylurea CompoundsSorafenib

Identifiers

PMID22727733
PMCPMC12261288
OpenAlexW2058887247

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.