Evidence map›Paper›PMID 33532866›Full record

ArticleCancer chemotherapy and pharmacology2021

Evaluating clinical impact of a shortened infusion duration for ramucirumab: a model-based approach.

Ling Gao, Yiu-Keung Lau, Ran Wei, Lisa O'Brien, Amanda Long, Yongzhe Piao, Paolo Abada

Open access · hybridAbstract read
In one paragraph

Article in Cancer chemotherapy and pharmacology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.6field-weighted citation impact, top 30% 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

6 citing papers in PubMed, 7 citations in OpenAlex.

  1. Trial
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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

7 authors at 2 institutions in 2 countries.

Ling GaoEli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.
Yiu-Keung LauEli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.
Ran WeiEli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.
Lisa O'BrienEli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.
Amanda LongEli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.
Yongzhe PiaoEli Lilly Japan K.K., Kobe, Japan.
Paolo AbadaEli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA. abada_paolo@lilly.com.ORCID http://orcid.org/0000-0003-1770-1041
Eli Lilly (United States) · USEli Lilly (Japan) · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeWe investigated the impact of infusion duration (30 and 60 min) on the pharmacokinetic profile of ramucirumab using a population pharmacokinetic (PopPK) modeling approach. We also assessed the relationship between infusion rate and incidence of immediate infusion-related reactions (IRRs; occurring on the day of administration) using ramucirumab phase II/III study data.

methodsThe impact of different infusion durations (30 vs. 60 min) on the time-course of ramucirumab concentration profiles were evaluated using a PopPK model, established using ramucirumab pharmacokinetic data from 2522 patients. Logistic regression was used to evaluate the association between ramucirumab infusion rate and incidence of immediate IRRs in clinical trials.

resultsRamucirumab time-course concentration profiles were equivalent following a 30- or 60-min infusion. In the pooled clinical study dataset, 254 of 3216 (7.9%) patients receiving ramucirumab experienced at least one immediate IRR (any grade). When grouped according to infusion rate quartile, the incidence of immediate IRRs (any grade or grade ≥ 3) was similar across quartiles; findings were confirmed in sensitivity analyses. The risk of immediate IRRs was not found to be associated with infusion rate based on multivariate logistic analysis.

conclusionShortening the infusion duration of ramucirumab from 60 to 30 min has no impact on ramucirumab exposure. Analysis of trial data found no relationship between an increased risk of immediate IRRs and a faster infusion rate. Such a change in infusion duration is unlikely to affect the clinical efficacy or overall safety profile of ramucirumab.

Indexed as

AdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic AgentsFemaleHumansInfusions, IntravenousLogistic ModelsMaleMiddle AgedModels, BiologicalRamucirumabTime FactorsAntibodies, Monoclonal, HumanizedAntineoplastic AgentsRamucirumabInfusion durationInfusion-related reactionsPharmacokineticsRamucirumabVascular endothelial growth factor receptor-2 antagonist

Identifiers

PMID33532866
PMCPMC8026424
OpenAlexW3126790863

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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.