Evidence map›Paper›PMID 36905787›Full record

Trial reportESMO open2023

A single-arm, multicenter, phase II trial of osimertinib in patients with epidermal growth factor receptor exon 18 G719X, exon 20 S768I, or exon 21 L861Q mutations.

L C Villaruz, X Wang, E M Bertino, L Gu, S J Antonia, T F Burns, J Clarke, J Crawford, T L Evans, D M Friedland and 4 more

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

Trial report in ESMO open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
6.5field-weighted citation impact, top 3% 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

15 citing papers in PubMed, 25 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

14 authors at 5 institutions in 1 country.

L C VillaruzUPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh.
X WangDepartment of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham.
E M BertinoDivision of Medical Oncology, The Ohio State University James Comprehensive Cancer Center, Columbus.
L GuDepartment of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham.
S J AntoniaDuke Cancer Institute, Durham, USA.
T F BurnsUPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh.
J ClarkeDuke Cancer Institute, Durham, USA.
J CrawfordDuke Cancer Institute, Durham, USA.
T L EvansUPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh.
D M FriedlandUPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh.
G A OttersonDivision of Medical Oncology, The Ohio State University James Comprehensive Cancer Center, Columbus.
N E ReadyDuke Cancer Institute, Durham, USA.
A J WozniakUPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh.
T E StinchcombeDuke Cancer Institute, Durham, USA. Electronic address: Thomas.stinchcombe@duke.edu.
UPMC Hillman Cancer Center · USDuke Institute for Health Innovation · USDuke University · USThe Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute · USDuke Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFor patients with stage IV non-small-cell lung cancer with epidermal growth factor receptor (EGFR) exon 19 deletions and exon 21 L858R mutations, osimertinib is the standard of care. Investigating the activity and safety of osimertinib in patients with EGFR exon 18 G719X, exon 20 S768I, or exon 21 L861Q mutations is of clinical interest. PATIENTS AND

methodsPatients with stage IV non-small-cell lung cancer with confirmed EGFR exon 18 G719X, exon 20 S768I, or exon 21 L861Q mutations were eligible. Patients were required to have measurable disease, an Eastern Cooperative Oncology Group performance status of 0 or 1, and adequate organ function. Patients were required to be EGFR tyrosine kinase inhibitor-naive. The primary objective was objective response rate, and secondary objectives were progression-free survival, safety, and overall survival. The study used a two-stage design with a plan to enroll 17 patients in the first stage, and the study was terminated after the first stage due to slow accrual.

resultsBetween May 2018 and March 2020, 17 patients were enrolled and received study therapy. The median age of patients was 70 years (interquartile range 62-76), the majority were female (n = 11), had a performance status of 1 (n = 10), and five patients had brain metastases at baseline. The objective response rate was 47% [95% confidence interval (CI) 23% to 72%], and the radiographic responses observed were partial response (n = 8), stable disease (n = 8), and progressive disease (n = 1). The median progression-free survival was 10.5 months (95% CI 5.0-15.2 months), and the median OS was 13.8 months (95% CI 7.3-29.2 months). The median duration on treatment was 6.1 months (range 3.6-11.9 months), and the most common adverse events (regardless of attribution) were diarrhea, fatigue, anorexia, weight loss, and dyspnea.

conclusionsThis trial suggests osimertinib has activity in patients with these uncommon EGFR mutations.

Indexed as

Carcinoma, Non-Small-Cell LungLung NeoplasmsAcrylamidesAgedAniline CompoundsErbB ReceptorsExonsFemaleHumansIndolesMaleMutationProtein Kinase InhibitorsPyrimidinesAcrylamidesAniline CompoundsErbB ReceptorsIndolesosimertinibProtein Kinase InhibitorsPyrimidinesepidermal growth factor receptor mutationnon-small-cell lung cancerosimertinibtargeted therapyuncommon EGFR mutations

Identifiers

PMID36905787
PMCPMC10163152
OpenAlexW4323870463

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.