Evidence map›Paper›PMID 24283303›Full record

Trial reportInternational journal of clinical practice2014

GIDEON (Global Investigation of therapeutic DEcisions in hepatocellular carcinoma and Of its treatment with sorafeNib): second interim analysis.

R Lencioni, M Kudo, S-L Ye, J-P Bronowicki, X-P Chen, L Dagher, J Furuse, J F Geschwind, L Ladrón de Guevara, C Papandreou and 6 more

Abstract readClinical Trial, Phase IV
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International journal of clinical practice, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 114 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
114citing papers in PubMed, 6 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

114 citing papers in PubMed, 6 syntheses or guidelines pooled it.

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54 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

16 authors.

R LencioniDivision of Diagnostic Imaging and Intervention, Pisa University Hospital and School of Medicine, Pisa, Italy.
M Kudo
S-L Ye
J-P Bronowicki
X-P Chen
L Dagher
J Furuse
J F Geschwind
L Ladrón de Guevara
C Papandreou
T Takayama
S K Yoon
K Nakajima
R Lehr
S Heldner
A J Sanyal

Funding

Center for Clinical and Translational ResearchUL1TR000058 · NCATS · VIRGINIA COMMONWEALTH UNIVERSITY · PI MOELLER, FREDERICK GERARD · 2012 to 2015
$12.5M
NCATS NIH HHS UL1 TR000058
6 · The paper itself

Abstract

backgroundGIDEON (Global Investigation of therapeutic DEcisions in hepatocellular carcinoma [HCC] and Of its treatment with sorafeNib) is a global, prospective, non-interventional study undertaken to evaluate the safety of sorafenib in patients with unresectable HCC in real-life practice, including Child-Pugh B patients who were excluded from clinical trials.

methodsPatients with unresectable HCC, for whom the decision to treat with sorafenib, based on the approved label and prescribing guidelines, had been taken by their physician, were eligible for inclusion. Demographic data and disease/medical history were recorded at entry. Sorafenib dosing and adverse events (AEs) were collected at follow-up visits. The second interim analysis was undertaken when ~1500 treated patients were followed up for ≥ 4 months.

resultsOf the 1571 patients evaluable for safety, 61% had Child-Pugh A status and 23% Child-Pugh B. The majority of patients (74%) received the approved 800 mg initial sorafenib dose, regardless of Child-Pugh status; however, median duration of therapy was shorter in Child-Pugh B patients. The majority of drug-related AEs were grade 1 or 2, and the most commonly reported were consistent with previous reports. The incidence and nature of drug-related AEs were broadly similar across Child-Pugh, Barcelona Clinic Liver Cancer (BCLC) and initial dosing subgroups, and consistent with the overall population.

conclusionsConsistent with the first interim analysis, overall safety profile and dosing strategy are similar across Child-Pugh subgroups. Safety findings also appear comparable irrespective of initial sorafenib dose or BCLC stage. Final analyses in > 3000 patients are ongoing.

Indexed as

AdolescentAdultAgedAged, 80 and overAntineoplastic AgentsCarcinoma, HepatocellularFemaleHumansLiver NeoplasmsMaleMiddle AgedNiacinamidePhenylurea CompoundsProspective StudiesSorafenibYoung AdultAntineoplastic AgentsNiacinamidePhenylurea CompoundsSorafenib

Identifiers

PMID24283303
PMCPMC4265239

What OpenQuestion holds

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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.