Evidence map›Paper›PMID 32567817›Full record

ArticlePharmacology research & perspectives2020

A multicenter, phase I, pharmacokinetic study of osimertinib in cancer patients with normal renal function or severe renal impairment.

Karthick Vishwanathan, Inmaculada Sanchez-Simon, Bhumsuk Keam, Nicolas Penel, Maria de Miguel-Luken, Doris Weilert, Andrew Mills, Marcelo Marotti, Martin Johnson, Alain Ravaud

Open access · goldAbstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in Pharmacology research & perspectives, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 24% 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

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 13 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. Article
  5. 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

10 authors at 8 institutions in 5 countries.

Karthick VishwanathanClinical Pharmacology and Safety Science, R&D, AstraZeneca, Boston, MA, USA.
Inmaculada Sanchez-SimonDepartamento de Oncología, Hospital Universitario Virgen del Rocío, Seville, Spain.
Bhumsuk KeamDepartment of Internal Medicine, Seoul National University Hospital, Seoul, South Korea.
Nicolas PenelDepartment of Medicine, Centre Oscar Lambret and Lille University (Univ. Lille), Lille, France.
Maria de Miguel-LukenSTART Madrid-Centro Integral Oncológico Clara Campal, Sanchinarro University Hospital, Madrid, Spain.
Doris WeilertIQVIA, Overland Park, KS, USA.
Andrew MillsBiometrics and Information Sciences, AstraZeneca, Cambridge, UK.
Marcelo MarottiBiometrics and Information Sciences, AstraZeneca, Cambridge, UK.
Martin JohnsonClinical Pharmacology and Safety Science, R&D, AstraZeneca, Cambridge, UK.
Alain RavaudMedical Oncology Department, Bordeaux University Hospital, Saint-André Hospital, Bordeaux, France.
AstraZeneca (United Kingdom) · GBAstraZeneca (United States) · USCentre Oscar Lambret · FRHôpital Saint-André · FRHospital Universitario HM Sanchinarro · ESHospital Universitario Virgen del Rocío · ESIQVIA (United States) · USSeoul National University Hospital · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Osimertinib is a third-generation, irreversible, oral epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI) that potently and selectively inhibits both EGFR-TKI sensitizing and EGFR T790M and has demonstrated efficacy in non-small cell lung cancer (NSCLC) central nervous system metastases. In this phase I study, we assessed the effects of normal renal function (NRF) and severe renal impairment (SRI) on the pharmacokinetics (PK) of osimertinib in patients with solid tumors. Part A: patients with NRF (creatinine clearance [CrCL] ≥90 mL/min), and SRI, (CrCL <30 mL/min), received a single 80-mg oral dose of osimertinib and standard PK measures were assessed. Part B: patients with SRI were treated for 3 months to obtain safety data, if deemed clinically appropriate. The geometric mean osimertinib plasma concentrations were higher in patients with SRI (n = 7) vs NRF (n = 8) and were highly variable. Osimertinib exposure based on C

Indexed as

AcrylamidesAdministration, OralAgedAged, 80 and overAniline CompoundsAntineoplastic AgentsArea Under CurveFemaleHepatic InsufficiencyHumansIndolesKidney Function TestsMaleMiddle AgedNeoplasmsProtein Kinase InhibitorsAcrylamidesAniline CompoundsAntineoplastic AgentsIndolesosimertinibProtein Kinase InhibitorsPyrimidinesepidermal growth factor receptorskidneynon-small cell lung cancerosimertinibpharmacokineticsrenal dispositiontyrosine kinase inhibitors

Identifiers

PMID32567817
PMCPMC7307240
OpenAlexW3036840384

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.