Evidence map›Paper›PMID 30536780›Full record

Observational studyThoracic cancer2019

Prospective exosome-focused translational research for afatinib study of non-small cell lung cancer patients expressing EGFR (EXTRA study).

Yusuke Okuma, Kei Morikawa, Hisashi Tanaka, Takuma Yokoyama, Hidetoshi Itani, Kazuya Horiuchi, Hideyuki Nakagawa, Nobumasa Takahashi, Akihiro Bessho, Kenzo Soejima and 7 more

Abstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Thoracic cancer, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–field-weighted citation impact
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

8 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. Review
  5. Cutaneous Thermal Injury Modulates Blood and Skin Metabolomes Differently in a Murine Model.Journal of burn care & research : official publication of the American Burn Association · 2021
    Article
  6. Review
  7. Review
  8. Review
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

17 authors.

Yusuke OkumaDepartments of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Tokyo, Japan.ORCID 0000-0001-5743-0149
Kei MorikawaDepartment of Internal Medicine, Division of Respiratory Medicine, St. Marianna University School of Medicine, Kanagawa, Japan.
Hisashi TanakaDepartment of Respiratory Medicine, Hirosaki University Graduate School of Medicine, Aomori, Japan.
Takuma YokoyamaDepartment of Respiratory Medicine, Kyorin University School of Medicine, Kyorin University Hospital, Tokyo, Japan.
Hidetoshi ItaniDepartment of Respiratory Medicine, Ise Red Cross Hospital, Mie, Japan.
Kazuya HoriuchiRespiratory Disease Center, Showa University Northern Yokohama Hospital, Kanagawa, Japan.
Hideyuki NakagawaDepartment of Respiratory Medicine, National Hospital Organization, Hirosaki Hospital, Aomori, Japan.
Nobumasa TakahashiDepartment of General Thoracic Surgery, Saitama Cardiovascular and Respiratory Center, Saitama, Japan.
Akihiro BesshoDepartment of Respiratory Medicine, Japanese Red Cross Okayama Hospital, Okayama, Japan.
Kenzo SoejimaClinical and Translational Research Center, Keio University Hospital, Tokyo, Japan.
Kazuma KishiDepartment of Respiratory Medicine, Respiratory Center, Toranomon Hospital, Tokyo, Japan.
Akira TogashiNippon Boehringer Ingelheim Co., Ltd., Tokyo, Japan.
Yae KanaiDepartment of Pathology, Keio University School of Medicine, Tokyo, Japan.
Koji UedaProject for Realization of Personalized Cancer Medicine, Cancer Precision Medicine Center, Japanese Foundation for Cancer Research, Tokyo, Japan.
Katsuhisa HorimotoMolecular Profiling Research Center for Drug Discovery, National Institute of Advanced Industrial Science and Technology (AIST), Tokyo, Japan.
Noriyuki MatsutaniDepartment of Surgery, Teikyo University School of Medicine, Tokyo, Japan.
Nobuhiko SekiDivision of Medical Oncology, Department of Internal Medicine, Teikyo University School of Medicine, Tokyo, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Patients with EGFR-mutated non-small cell lung cancer (NSCLC) exhibit resistance to EGFR-tyrosine kinase inhibitors (TKIs) within 9-14 months of therapy. Recently, EGFR-mutated NSCLC has demonstrated the potential for heterogeneity; therefore, the manner of clonal heterogeneity may impact the duration of progression-free and overall survival and other parameters affecting EGFR-TKI treatment efficacy. However no predictive biomarker of these favorable treatment efficacies has been identified to date. The exosome-focused translational research for afatinib (EXTRA) study aims to identify a novel predictive biomarker and a resistance marker for afatinib by analyzing data from association studies of the clinical efficacy of afatinib and four "OMICs" (genomics, proteomics, epigenomics, and metabolomics) using peripheral blood from patients treated with afatinib. This study aims to: (i) conduct comprehensive multi-OMIC analyses in a prospective clinical trial, and (ii) focus on both sera/plasma and exosome as a source for OMIC analyses to identify a novel predictor of the efficacy of a specific drug. To eliminate the carryover bias of prior treatment, systemic treatment-naïve patients were enrolled. The candidates to be screened for biomarkers comprise a discovery cohort of 60 patients and an independent validation cohort of 40 patients. The EXTRA study is the first trial to screen novel biomarkers of longer treatment efficacy of EGFR-TKIs using four-OMICs analyses, focusing on both "naked or free" molecules and "capsulated" exosomal components in serially collected peripheral blood.

Indexed as

MutationResearch DesignTranslational Research, BiomedicalAdultAfatinibAgedAged, 80 and overCarcinoma, Non-Small-Cell LungEpigenomicsErbB ReceptorsExosomesFollow-Up StudiesHumansLung NeoplasmsMetabolomeMiddle AgedAfatinibEGFR protein, humanErbB ReceptorsProtein Kinase InhibitorsAfatinibepidermal growth factor receptorexosomeOMICtranslational research

Identifiers

PMID30536780
PMCPMC6360199

What OpenQuestion holds

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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.