Evidence map›Paper›PMID 34213592›Full record

SynthesisCancer chemotherapy and pharmacology2021

The impact of hepatic and renal function on panitumumab exposures in patients with metastatic RAS wild-type colorectal cancer.

Michael Z Liao, Hans Prenen, Sandeep Dutta, Vijay V Upreti

3 registry-linked trialsOpen access · hybridAbstract readMeta-Analysis
In one paragraph

Synthesis in Cancer chemotherapy and pharmacology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact, top 90% 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.

NCT00083616 phase2completednot on this map

A Phase 2 Multicenter Single Arm Clinical Trial of ABX-EGF Monotherapy in Subjects With Metastatic Colorectal Cancer Following Treatment With Fluoropyrimidine, Irinotecan, and Oxaliplatin Chemotherapy

TypeinterventionalSponsorAmgenRan2004 to 2008Enrolled185ConditionsColorectal Cancer, Metastatic CancerArmsPanitumumab
NCT00089635 phase2completednot on this map

A Phase 2 Multicenter Single Arm Clinical Trial of ABX-EGF Monotherapy in Subjects With Metastatic Colorectal Cancer Whose Tumors Express Low or Negative EGFr Levels of Immunohistochemistry Following Treatment With Fluoropyrimidine, Irinotecan, and Oxaliplatin Chemotherapy

TypeinterventionalSponsorAmgenRan2004 to 2008Enrolled203ConditionsColorectal Cancer, MetastasesArmsPanitumumab
NCT00113763 phase3completednot on this map

An Open-label, Randomized, Phase 3 Clinical Trial of ABX-EGF Plus Best Supportive Care Versus Best Supportive Care in Subjects With Metastatic Colorectal Cancer

TypeinterventionalSponsorAmgenRan2004 to 2009Enrolled463ConditionsColorectal Cancer, MetastasesArmsBest supportive care, Panitumumab
3 · Its place in the literature

Who cites it

0 citing papers in PubMed, 1 citations in OpenAlex.

No citing paper in PubMed yet.

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

4 authors at 2 institutions in 2 countries.

Michael Z LiaoClinical Pharmacology, Modeling and Simulation, Amgen Inc, 1120 Veterans Boulevard, South San Francisco, CA, 94080, USA.
Hans PrenenAntwerp University Hospital, Edegem, Belgium.
Sandeep DuttaClinical Pharmacology, Modeling and Simulation, Amgen Inc, Thousand Oaks, CA, USA.
Vijay V UpretiClinical Pharmacology, Modeling and Simulation, Amgen Inc, 1120 Veterans Boulevard, South San Francisco, CA, 94080, USA. vupreti@amgen.com.ORCID 0000-0003-1018-7166
Amgen (United States) · USAntwerp University Hospital · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposePanitumumab is a human monoclonal antibody targeting the epidermal growth factor receptor for the treatment of wild-type RAS metastatic colorectal cancer (mCRC). Currently, no dedicated clinical studies have evaluated the effect of organ impairment on the pharmacokinetics of panitumumab. Here, we present data from late phase studies of panitumumab in patients with mCRC and analyses of the effect of hepatic or renal impairment on the exposure of panitumumab.

methodsFrom three multicenter, open-label, phase 2 and phase 3 studies, 349 and 351 patients were included in hepatic and renal function subgroup analyses, respectively. Patients who received IV panitumumab and serum exposures were compared to patients with varying degrees of hepatic and renal organ dysfunction.

resultsThe C

conclusionsMild-to-moderate hepatic or renal dysfunction had no clinically meaningful impact on the pharmacokinetics of panitumumab in patients with mCRC. No dose adjustments for panitumumab are warranted in patients with mCRC with mild-to-moderate hepatic or renal dysfunction.

trial registrationClinicalTrials.gov; NCT00083616, NCT00089635, NCT00113763.

Indexed as

Administration, IntravenousAgedAntineoplastic Agents, ImmunologicalClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicColorectal NeoplasmsFemaleHumansKidney DiseasesLiver DiseasesMaleMiddle AgedPanitumumabRandomized Controlled Trials as Topicras ProteinsSeverity of Illness IndexAntineoplastic Agents, ImmunologicalPanitumumabras ProteinsDose adjustmentHepatic impairmentPanitumumabPharmacokineticsRAS wild-typeRenal impairment

Identifiers

PMID34213592
PMCPMC8367910
OpenAlexW3175159278

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.