Evidence map›Paper›PMID 27299940›Full record

SynthesisCPT: pharmacometrics & systems pharmacology2016

Clinical Trial Simulations From a Model-Based Meta-Analysis of Studies in Patients With Advanced Hepatocellular Carcinoma Receiving Antiangiogenic Therapy.

M L Zierhut, Y Chen, Y K Pithavala, D J Nickens, O Valota, M A Amantea

Abstract readMeta-Analysis
In one paragraph

Synthesis in CPT: pharmacometrics & systems pharmacology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing 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

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

  1. Pooled it
  2. Joint longitudinal model-based meta-analysis of FEVJournal of pharmacokinetics and pharmacodynamics · 2023
    Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Article
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

6 authors.

M L ZierhutPharmacometrics, Clinical Pharmacology, Pfizer, La Jolla, California, USA.
Y ChenOncology, Clinical Pharmacology, Pfizer, La Jolla, California, USA.
Y K PithavalaOncology, Clinical Pharmacology, Pfizer, La Jolla, California, USA.
D J NickensPharmacometrics, Clinical Pharmacology, Pfizer, La Jolla, California, USA.
O ValotaOncology, Clinical Development, Pfizer, Milan, Italy.
M A AmanteaPharmacometrics, Clinical Pharmacology, Pfizer, La Jolla, California, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A mixed effect model describing median overall survival (mOS) in patients with advanced hepatocellular carcinoma (aHCC) treated with antiangiogenic therapy (AAT) was developed from literature data. Data were extracted from 59 studies, representing 4,813 patients. The final model included estimates of mOS after AAT (8.5 months) or placebo (7.1 months) administration. The mOS increased 21% when the AAT was sorafenib (SOR) or 42% when locoregional therapy was coadministered. The mOS decreased when patients received prior systemic therapy (↓7%) or concomitant chemotherapy (↓4%) or the percentage of patients with hepatitis B increased (↓∼0.4%/%). Clinical trial simulations of a phase II comparative trial predicted an mOS ratio (placebo:AAT) of 0.687 or 0.831, with a 65% or 22% probability of demonstrating superiority, for SOR or other AATs, respectively. Additionally, the 95% confidence interval (CI) of the simulated median mOS ratio for non-SOR AATs was similar to the 95% CI of the hazard ratio (HR) observed in the trial.

Indexed as

Angiogenesis InhibitorsCarcinoma, HepatocellularClinical Trials, Phase II as TopicLiver NeoplasmsNiacinamidePhenylurea CompoundsAgedComputer SimulationFemaleHumansMaleMiddle AgedSorafenibAngiogenesis InhibitorsNiacinamidePhenylurea CompoundsSorafenib

Identifiers

PMID27299940
PMCPMC4879476

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.