Evidence map›Paper›PMID 35748220›Full record

ArticlePharmaceutical statistics2022

A semi-mechanistic dose-finding design in oncology using pharmacokinetic/pharmacodynamic modeling.

Xiao Su, Yisheng Li, Peter Müller, Chia-Wei Hsu, Haitao Pan, Kim-Anh Do

Abstract read
In one paragraph

Article in Pharmaceutical statistics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–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

1 citing paper in PubMed.

  1. 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.

Xiao SuPlayStation, California, USA.
Yisheng LiDepartment of Biostatistics, The University of Texas MD Anderson Cancer Center, Texas, USA.ORCID 0000-0001-9847-8544
Peter MüllerDepartment of Mathematics, The University of Texas at Austin, Texas, USA.ORCID 0000-0002-2948-1229
Chia-Wei HsuBiostatistics Department, St. Jude Children's Research Hospital, Tennessee, USA.
Haitao PanBiostatistics Department, St. Jude Children's Research Hospital, Tennessee, USA.ORCID 0000-0003-4457-7349
Kim-Anh DoDepartment of Biostatistics, The University of Texas MD Anderson Cancer Center, Texas, USA.ORCID 0000-0001-8710-7131

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Fabien Delerue · 1985 to 2026
$290.8M
Convalescent Plasma to Limit Coronavirus Associated ComplicationsUL1TR003167 · NCATS · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI KARP, DANIEL D, MCPHERSON, DAVID D · 2019 to 2023
$45.3M
Targeting Tumor Microenvironment-Induced Therapy Resistance in Prostate Cancer Bone MetastasisP50CA140388 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI THOMPSON, TIMOTHY CHARLES · 2009 to 2022
$23.4M
The University of Texas MD Anderson Cancer Center SPORE in Hepatocellular CarcinomaP50CA217674 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI BERETTA, LAURA, KASEB, AHMED · 2019 to 2023
$11.3M
Viral miRs and cellular miRs in sepsisR01GM122775 · NIGMS · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI CALIN, GEORGE A., LUPU, FLOREA · 2018 to 2020
$1.1M
NCATS NIH HHS UL1 TR003167NCI NIH HHS P30 CA016672NCI NIH HHS P50 CA140388NCI NIH HHS P50 CA217674NIGMS NIH HHS R01 GM122775
6 · The paper itself

Abstract

While a number of phase I dose-finding designs in oncology exist, the commonly used ones are either algorithmic or empirical model-based. We propose a new framework for modeling the dose-response relationship, by systematically incorporating the pharmacokinetic (PK) data collected in the trial and the hypothesized mechanisms of the drug effects, via dynamic PK/PD modeling, as well as modeling of the relationship between a latent cumulative pharmacologic effect and a binary toxicity outcome. This modeling framework naturally incorporates the information on the impact of dose, schedule and method of administration (e.g., drug formulation and route of administration) on toxicity. The resulting design is an extension of existing designs that make use of pre-specified summary PK information (such as the area under the concentration-time curve [AUC] or maximum serum concentration [C

Indexed as

Medical OncologyNeoplasmsBayes TheoremComputer SimulationDose-Response Relationship, DrugHumansMaximum Tolerated DoseResearch Designarea under the concentration-time curve (AUC)dose responsemaximum tolerated dosepharmacologic effectphase I trialtoxicity

Identifiers

PMID35748220
PMCPMC10134386

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.