Evidence map›Paper›PMID 29381229›Full record

Trial reportBritish journal of clinical pharmacology2018

Time-to-event modelling of effect of codrituzumab on overall survival in patients with hepatocellular carcinoma.

Mikiko Nakamura, Chao Xu, Cheikh Diack, Norihisa Ohishi, Ruey-Min Lee, Satofumi Iida, Takehiko Kawanishi, Toshihiko Ohtomo, Ghassan K Abou-Alfa, Ya-Chi Chen

Open access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in British journal of clinical pharmacology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.4field-weighted citation impact, top 38% 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

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Trial
  2. Review
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

10 authors at 3 institutions in 2 countries.

Mikiko NakamuraTranslational Clinical Research Science & Strategy Dept., Chugai Pharmaceutical Co., Ltd., Tokyo, Japan.ORCID 0000-0002-0842-1710
Chao XuTranslational and Clinical Research Center, Hoffmann-La Roche Inc., New York City, USA.
Cheikh DiackClinical Pharmacology, F. Hoffmann-La Roche Ltd., Basel, Switzerland.
Norihisa OhishiTranslational Clinical Research Science & Strategy Dept., Chugai Pharmaceutical Co., Ltd., Tokyo, Japan.ORCID 0000-0001-5116-8370
Ruey-Min LeeTranslational and Clinical Research Center, Hoffmann-La Roche Inc., New York City, USA.
Satofumi IidaTranslational Clinical Research Science & Strategy Dept., Chugai Pharmaceutical Co., Ltd., Tokyo, Japan.
Takehiko KawanishiTranslational Clinical Research Science & Strategy Dept., Chugai Pharmaceutical Co., Ltd., Tokyo, Japan.
Toshihiko OhtomoProject Planning & Coordination Dept., Chugai Pharmaceutical Co., Ltd., Tokyo, Japan.ORCID 0000-0001-5017-0540
Ghassan K Abou-AlfaMemorial Sloan Kettering Cancer Center, New York, NY, USA.ORCID 0000-0002-1522-8054
Ya-Chi ChenTranslational and Clinical Research Center, Hoffmann-La Roche Inc., New York City, USA.
Chugai Pharma (United States) · USRoche (Switzerland) · CHMemorial Sloan Kettering Cancer Center · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

aimsCodrituzumab (GC33) is a recombinant, humanized mAb that binds to glypican-3 (GPC3), an oncofetal protein highly expressed in hepatocellular carcinoma (HCC). This investigation aimed to identify clinically relevant factors that may affect the overall survival (OS) in HCC patients treated with codrituzumab and to quantitatively annotate their effects.

methodsCodrituzumab exposure was estimated by a population pharmacokinetics model with a nonlinear elimination pathway. Analysis of OS was performed using a time-to-event model in 181 patients with advanced HCC. The model was tested with the addition of various covariates, including levels of immune biomarkers, such as CD16 (measured in terms of molecules of equivalent soluble fluorophore; CD16

resultsThe time-to-event model estimated a prolonged OS (>3 months) in patients with codrituzumab exposure of ≥230 μg ml

conclusionsThe final model indicates that adequate drug exposure plus a favourable immune environment are associated with prolonged OS. This quantitative model should be further validated with emerging data so as to guide study design in future clinical trials.

Indexed as

Antibodies, Monoclonal, HumanizedBiomarkers, TumorCarcinoma, HepatocellularCD4 AntigensDouble-Blind MethodGlypicansHumansLiver NeoplasmsProportional Hazards ModelsReceptors, IgGSurvival AnalysisAntibodies, Monoclonal, HumanizedBiomarkers, TumorCD4 AntigenscodrituzumabGlypicansGPC3 protein, humanReceptors, IgGGC33/codrituzumabGPC3hepatocellular carcinomaoverall survivalpharmacokineticstime-to-event model

Identifiers

PMID29381229
PMCPMC5903238
OpenAlexW2785576695

What OpenQuestion holds

Textmetadata
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.