Evidence map›Paper›PMID 32068351›Full record

Trial reportThoracic cancer2020

Severe hepatotoxicity due to osimertinib after nivolumab therapy in patients with non-small cell lung cancer harboring EGFR mutation.

Ou Yamaguchi, Kyoichi Kaira, Tomonori Kawasaki, Atsuto Mouri, Kosuke Hashimoto, Ayako Shiono, Shun Shinomiya, Yu Miura, Fuyumi Nishihara, Yoshitake Murayama and 3 more

Open access · goldAbstract readClinical Trial
In one paragraph

Trial report in Thoracic cancer, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
1.8field-weighted citation impact, top 13% 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

19 citing papers in PubMed, 40 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

13 authors at 2 institutions in 1 country.

Ou YamaguchiDepartment of Respiratory Medicine, Comprehensive Cancer Center, Saitama Medical University International Medical Center, Saitama, Japan.ORCID 0000-0001-7194-6459
Kyoichi KairaDepartment of Respiratory Medicine, Comprehensive Cancer Center, Saitama Medical University International Medical Center, Saitama, Japan.ORCID 0000-0001-5548-7686
Tomonori KawasakiDepartment of Pathology, Saitama Medical University International Medical Center, Saitama, Japan.
Atsuto MouriDepartment of Respiratory Medicine, Comprehensive Cancer Center, Saitama Medical University International Medical Center, Saitama, Japan.
Kosuke HashimotoDepartment of Respiratory Medicine, Comprehensive Cancer Center, Saitama Medical University International Medical Center, Saitama, Japan.
Ayako ShionoDepartment of Respiratory Medicine, Comprehensive Cancer Center, Saitama Medical University International Medical Center, Saitama, Japan.
Shun ShinomiyaDepartment of Respiratory Medicine, Comprehensive Cancer Center, Saitama Medical University International Medical Center, Saitama, Japan.
Yu MiuraDepartment of Respiratory Medicine, Comprehensive Cancer Center, Saitama Medical University International Medical Center, Saitama, Japan.
Fuyumi NishiharaDepartment of Respiratory Medicine, Comprehensive Cancer Center, Saitama Medical University International Medical Center, Saitama, Japan.
Yoshitake MurayamaDepartment of Respiratory Medicine, Comprehensive Cancer Center, Saitama Medical University International Medical Center, Saitama, Japan.
Kunihiko KobayashiDepartment of Respiratory Medicine, Comprehensive Cancer Center, Saitama Medical University International Medical Center, Saitama, Japan.
Satoshi MochidaDepartment of Gastroenterology and Hepatology, Faculty of Medicine, Saitama Medical University, Saitama, Japan.
Hiroshi KagamuDepartment of Respiratory Medicine, Comprehensive Cancer Center, Saitama Medical University International Medical Center, Saitama, Japan.
Saitama International Medical Center · JPSaitama Medical University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOsimertinib is the most promising treatment option for patients with epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC) with acquired T790M resistance. However, recent studies have suggested that osimertinib could increase the frequency of serious adverse events (AEs) if administered immediately after immune checkpoint inhibitor (ICI) treatment.

methodsIn this single-institution retrospective study conducted from May 2016 to January 2019, osimertinib was administered to 47 patients with pretreated advanced NSCLC harboring the EGFR mutation.

resultsOf the 47 patients, 20 (42.6%) were men and 27 (57.4%) were women. The median age was 71 years (range 37-83 years). A total of 19 patients (40.4%) had a smoking history. Furthermore, seven patients (14.9%) received osimertinib immediately after nivolumab therapy, while 40 patients (85.1%) were treated with osimertinib after treatment with drugs other than nivolumab. The frequency of grade 3 or 4 hepatotoxicity was significantly higher in patients with nivolumab prior to osimertinib (4/7; 57.1%) than in those treated with drugs other than nivolumab prior to osimertinib (2/40; 5.0%) (P = 0.0026). Liver biopsies were performed in two patients who received osimertinib immediately after nivolumab. In both patients, CD-8-positive T cell infiltration was predominantly observed in the liver tissues.

conclusionsThe use of osimertinib immediately after nivolumab significantly increased the frequency of grade 3 or higher hepatotoxicity in patients with advanced NSCLC harboring EGFR mutation acquired T790M resistance.

Indexed as

MutationAcrylamidesAdultAgedAged, 80 and overAniline CompoundsAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Non-Small-Cell LungCase-Control StudiesChemical and Drug Induced Liver InjuryErbB ReceptorsFemaleFollow-Up StudiesHumansIndolesLung NeoplasmsAcrylamidesAniline CompoundsEGFR protein, humanErbB ReceptorsIndolesNivolumabosimertinibPyrimidinesHepatotoxicityimmune checkpoint inhibitornivolumabnon-small-cell lung cancerosimertinib

Identifiers

PMID32068351
PMCPMC7113047
OpenAlexW3007051114

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.