Evidence map›Paper›PMID 26312161›Full record

ArticleCPT: pharmacometrics & systems pharmacology2015

Integrated Simulation Framework for Toxicity, Dose Intensity, Disease Progression, and Cost Effectiveness for Castration-Resistant Prostate Cancer Treatment With Eribulin.

J G C van Hasselt, A Gupta, Z Hussein, J H Beijnen, J H M Schellens, A D R Huitema

Open access · goldAbstract read
In one paragraph

Article in CPT: pharmacometrics & systems pharmacology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 2 pooled it
2.9field-weighted citation impact, top 9% 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

11 citing papers in PubMed, 2 syntheses or guidelines pooled it, 21 citations in OpenAlex.

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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 at 3 institutions in 2 countries.

J G C van HasseltDepartment of Clinical Pharmacology, Netherlands Cancer Institute Amsterdam, The Netherlands ; Department of Pharmacy & Pharmacology, Netherlands Cancer Institute Amsterdam, The Netherlands ; Division of Pharmacology, Cluster Systems Pharmacology, Leiden Academic Centre for Drug Research, Leiden University Leiden, The Netherlands.
A GuptaEisai Ltd. Hatfield, UK.
Z HusseinEisai Ltd. Hatfield, UK.
J H BeijnenDepartment of Clinical Pharmacology, Netherlands Cancer Institute Amsterdam, The Netherlands ; Division of Pharmacoepidemiology & Clinical Pharmacology, Department of Pharmaceutical Sciences, Utrecht University Utrecht, The Netherlands.
J H M SchellensDepartment of Pharmacy & Pharmacology, Netherlands Cancer Institute Amsterdam, The Netherlands ; Division of Pharmacoepidemiology & Clinical Pharmacology, Department of Pharmaceutical Sciences, Utrecht University Utrecht, The Netherlands.
A D R HuitemaDepartment of Clinical Pharmacology, Netherlands Cancer Institute Amsterdam, The Netherlands ; Department of Pharmacy & Pharmacology, Netherlands Cancer Institute Amsterdam, The Netherlands.
Altrecht GGZ · NLEisai (United Kingdom) · GBThe Netherlands Cancer Institute · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Quantitative model-based analyses are helpful to support decision-making in drug development. In oncology, disease progression/clinical outcome (DPCO) models have been used for early predictions of clinical outcome, but most of such approaches did not include adverse events or dose intensity. In addition, cost-effectiveness evaluations of investigational compounds are becoming increasingly important. Here, we developed an integrated model-based framework including relevant treatment effects for patients with castration-resistant prostate cancer treated with the anticancer agent eribulin. The framework included (i) a DPCO model relating prostate-specific antigen (PSA) dynamics to survival; (ii) models for adverse events including dose-limiting neutropenia and other graded toxicities; (iii) a model for Eastern Cooperative Oncology Group (ECOG) performance score; (iv) a model for dropout; (v) the consideration of cost effectiveness. The model allowed simulation of realistic treatment courses. Subsequently, simulations evaluating alternative treatment protocols or patient characteristics were performed in order to derive inferences on expected efficacy and cost effectiveness.

Identifiers

PMID26312161
PMCPMC4544051
OpenAlexW1656584150

What OpenQuestion holds

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LicenceCC BY-NC
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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.