Evidence map›Paper›PMID 39789369›Full record

Observational studyInvestigational new drugs2025

Stage-specific efficacy of osimertinib in treatment-naïve EGFR-mutant non-small cell lung cancer according to baseline genetic alterations in circulating tumor DNA.

Yoshihiko Taniguchi, Akihiro Tamiya, Mitsuo Osuga, Shun-Ichi Isa, Keiichi Nakamura, Yasuyuki Mizumori, Tsutomu Shinohara, Hidetoshi Yanai, Katsumi Nakatomi, Masahide Oki and 6 more

Abstract readMulticenter StudyObservational Study
PubMed Publisher
In one paragraph

Observational study in Investigational new drugs, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the 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
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

0 citing papers in PubMed.

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

16 authors.

Yoshihiko TaniguchiDepartment of Internal Medicine, NHO Kinki Chuo Chest Medical Center, 1180 Nagasone-cho, Kita-ku, Sakai City, Osaka, 591-8555, Japan. taniguchi.yoshihiko.ny@mail.hosp.go.jp.ORCID 0000-0001-6387-3683
Akihiro TamiyaDepartment of Internal Medicine, NHO Kinki Chuo Chest Medical Center, 1180 Nagasone-cho, Kita-ku, Sakai City, Osaka, 591-8555, Japan.
Mitsuo OsugaCenter for Biomedical Sciences, Wakayama Medical University, Wakayama, Japan.
Shun-Ichi IsaClinical Research Center, NHO Kinki Chuo Chest Medical Center, Sakai, Osaka, Japan.
Keiichi NakamuraDepartment of Respiratory Medicine, NHO Asahikawa Medical Center, Asahikawa, Hokkaido, Japan.
Yasuyuki MizumoriDepartment of Respiratory Medicine, NHO Himeji Medical Center, Himeji, Hyogo, Japan.
Tsutomu ShinoharaDepartment of Respiratory Medicine, NHO Kochi Hospital, Kochi, Japan.
Hidetoshi YanaiDepartment of Respiratory Medicine, NHO Mito Medical Center, Ibaraki, Japan.
Katsumi NakatomiDepartment of Respiratory Medicine, NHO Ureshino Medical Center, Ureshino, Saga, Japan.
Masahide OkiDepartment of Respiratory Medicine, NHO Nagoya Medical Center, Nagoya, Aichi, Japan.
Masahide MoriDepartment of Thoracic Oncology, NHO Osaka Toneyama Medical Center, Toyonaka, Osaka, Japan.
Tomohito KuwakoDepartment of Respiratory Medicine, NHO Shibukawa Medical Center, Shibukawa, Gunma, Japan.
Koji YamazakiDepartment of Thoracic Surgery, NHO Kyushu Medical Center, Fukuoka, Kyushu, Japan.
Masahiro ShimadaDepartment of Respiratory Medicine, NHO Tokyo National Hospital, Tokyo, Japan.
Masahiko AndoDepartment of Advanced Medicine, Nagoya University Hospital, Aichi, Japan.
Yasuhiro KohCenter for Biomedical Sciences, Wakayama Medical University, Wakayama, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The impact of clinical stage on the effectiveness of osimertinib for epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC) remains unexamined. We investigated osimertinib therapeutic efficacy variation between stage IVA or lower and stage IVB EGFR mutation-positive lung cancers, focusing on differences in pretreatment co-occurring genetic alterations in circulating tumor DNA. This was a secondary analysis of the ELUCIDATOR study, a multicenter prospective observational study in Japan that assessed the mechanisms underlying resistance to osimertinib as a first-line treatment for advanced NSCLC with EGFR mutations. We compared the progression-free survival (PFS), overall survival (OS), and pretreatment co-occurring genetic alterations detected in plasma between patients with stages IVA (n = 83) and IVB disease (n = 84). Multivariate analysis of PFS and OS revealed that stage IVB was associated with a poor prognosis (hazard ratio [HR]: 2.03, 95% confidence interval [CI]: 1.36-3.04, p < 0.001, HR: 2.35, 95% CI: 1.45-3.90, p < 0.001, respectively). Pre-osimertinib treatment, significantly more TP53- (52.4% vs. 27.7%, p = 0.002), EGFR amplification- (58.3% vs. 23.2%, p < 0.001), and MET amplification-positive cases (22.6% vs. 7.2%, p = 0.008) were found among stage IVB than among stage IVA or lower cases. Patients with EGFR-positive NSCLC in stage IVB exhibited significantly shorter PFS and OS than those in earlier stages when treated with first-line osimertinib. The prevalence of baseline TP53 mutations, EGFR amplification, and MET amplification in plasma were significantly higher in stage IVB cases, implicating them in the worse outcomes of this group.

Indexed as

AcrylamidesAniline CompoundsAntineoplastic AgentsCarcinoma, Non-Small-Cell LungCirculating Tumor DNALung NeoplasmsProtein Kinase InhibitorsAdultAgedAged, 80 and overErbB ReceptorsFemaleHumansIndolesMaleMiddle AgedAcrylamidesAniline CompoundsAntineoplastic AgentsCirculating Tumor DNAEGFR protein, humanErbB ReceptorsIndolesosimertinibProtein Kinase InhibitorsPyrimidinesCirculating tumor DNAEpidermal growth factor receptor mutationNon-small cell lung cancerOsimertinibSurvival

Identifiers

PMID39789369

What OpenQuestion holds

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Registered trials

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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.