Evidence map›Paper›PMID 37610516›Full record

Observational studyTargeted oncology2023

Clinical Efficacy and Safety of First- or Second-Generation EGFR-TKIs after Osimertinib Resistance for EGFR Mutated Lung Cancer: A Prospective Exploratory Study.

Kenji Morimoto, Tadaaki Yamada, Takayuki Takeda, Shinsuke Shiotsu, Koji Date, Nobuyo Tamiya, Yasuhiro Goto, Hibiki Kanda, Yusuke Chihara, Yusuke Kunimatsu and 4 more

Abstract readObservational StudyMulticenter Study
PubMed Publisher
In one paragraph

Observational study in Targeted oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
2.1field-weighted citation impact, top 12% 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

10 citing papers in PubMed, 8 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 7 institutions in 1 country.

Kenji MorimotoDepartment of Pulmonary Medicine, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kajii-cho, Kamigyo-ku, Kyoto, Japan.
Tadaaki YamadaDepartment of Pulmonary Medicine, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kajii-cho, Kamigyo-ku, Kyoto, Japan. tayamada@koto.kpu-m.ac.jp.ORCID 0000-0002-6945-281X
Takayuki TakedaDepartment of Respiratory Medicine, Japanese Red Cross Kyoto Daini Hospital, Kyoto, Japan.
Shinsuke ShiotsuDepartment of Respiratory Medicine, Japanese Red Cross Kyoto Daiichi Hospital, Kyoto, Japan.
Koji DateDepartment of Pulmonary Medicine, Kyoto Chubu Medical Center, Kyoto, Japan.
Nobuyo TamiyaDepartment of Pulmonary Medicine, Rakuwakai Otowa Hospital, Kyoto, Japan.
Yasuhiro GotoDepartment of Respiratory Medicine, Fujita Health University School of Medicine, Aichi, Japan.
Hibiki KandaDepartment of Respiratory Medicine, Omi Medical Center, Shiga, Japan.
Yusuke ChiharaDepartment of Respiratory Medicine, Uji-Tokushukai Medical Center, Kyoto, Japan.
Yusuke KunimatsuDepartment of Respiratory Medicine, Japanese Red Cross Kyoto Daini Hospital, Kyoto, Japan.
Yuki KatayamaDepartment of Pulmonary Medicine, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kajii-cho, Kamigyo-ku, Kyoto, Japan.
Masahiro IwasakuDepartment of Pulmonary Medicine, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kajii-cho, Kamigyo-ku, Kyoto, Japan.
Shinsaku TokudaDepartment of Pulmonary Medicine, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kajii-cho, Kamigyo-ku, Kyoto, Japan.
Koichi TakayamaDepartment of Pulmonary Medicine, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kajii-cho, Kamigyo-ku, Kyoto, Japan.
Kyoto Prefectural University of Medicine · JPJapanese Red Cross Society Kyoto Daini Hospital · JPFujita Health University · JPKyoto first Red Cross hospital · JPKyoto Medical Center · JPRakuwakai Otowa Hospital · JPShiga Medical Center · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOsimertinib monotherapy is a common treatment for epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer (NSCLC); however, standard treatment strategies for acquired resistance to this drug have not been established. In addition, the clinical significance of first-generation (1G) or second-generation (2G) EGFR-tyrosine kinase inhibitors (TKI) in patients with EGFR-mutant NSCLC and osimertinib resistance has not yet been fully evaluated.

objectiveWe aimed to conduct a prospective multicenter observational study to evaluate the efficacy and safety of 1G and 2G EGFR-TKIs after the development of osimertinib resistance.

methodsPatients with EGFR-mutant NSCLC who received 1G or 2G EGFR-TKIs after developing resistance to osimertinib monotherapy were prospectively assessed at eight institutions in Japan. The primary endpoint was progression-free survival (PFS).

resultsA total of 29 patients with advanced or recurrent EGFR-mutant NSCLC were analyzed. The objective response and disease control rates were 6.9% (2/29) and 58.6% (17/29), respectively. The median PFS was 1.9 months [95% confidence interval (CI): 1.3-5.3]. There was no significant difference in PFS between the 1G and 2G EGFR-TKI groups (3.7 versus 1.5 months, log-rank test p = 0.20). However, patients with normal cytokeratin 19 fragment (CYFRA 21-1) and pro-gastrin-releasing peptide (ProGRP) levels experienced longer PFS than those with elevated CYFRA 21-1 and/or ProGRP (5.5 versus 1.3 months, log-rank test p < 0.001).

conclusionAdministration of 1G or 2G EGFR-TKIs after the development of osimertinib resistance has limited efficacy in patients with EGFR-mutant NSCLC. Moreover, normal CYFRA 21-1 and ProGRP levels could be promising indicators for 1G and 2G EGFR-TKI administration after osimertinib resistance development. TRIAL REGISTRATION NUMBER: UMIN000044049.

Indexed as

Carcinoma, Non-Small-Cell LungLung NeoplasmsAcrylamidesAniline CompoundsAntigens, NeoplasmErbB ReceptorsHumansIndolesKeratin-19MutationNeoplasm Recurrence, LocalProspective StudiesProtein Kinase InhibitorsPyrimidinesTreatment OutcomeAcrylamidesAniline Compoundsantigen CYFRA21.1Antigens, NeoplasmEGFR protein, humanErbB ReceptorsIndolesKeratin-19osimertinibProtein Kinase InhibitorsPyrimidines

Identifiers

PMID37610516
OpenAlexW4386083792

What OpenQuestion holds

Textmetadata
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.