Evidence map›Paper›PMID 32159882›Full record

Trial reportCancer science2020

Safety and efficacy of first-line dacomitinib in Japanese patients with advanced non-small cell lung cancer.

Makoto Nishio, Terufumi Kato, Seiji Niho, Noboru Yamamoto, Toshiaki Takahashi, Naoyuki Nogami, Hiroyasu Kaneda, Yuka Fujita, Keith Wilner, Mizuki Yoshida and 4 more

Open access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Cancer science, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 2 pooled it
2.8field-weighted citation impact, top 7% 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

22 citing papers in PubMed, 2 syntheses or guidelines pooled it, 30 citations in OpenAlex.

  1. Pooled it
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  8. J-REGISTER: real-world study of Japanese patients withFuture oncology (London, England) · 2025
    Observational
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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 12 institutions in 2 countries.

Makoto NishioDepartment of Thoracic Medical Oncology, The Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.ORCID https://orcid.org/0000-0003-4969-4165
Terufumi KatoDepartment of Thoracic Oncology, Kanagawa Cancer Center, Kanagawa, Japan.ORCID https://orcid.org/0000-0002-5853-1424
Seiji NihoDepartment of Thoracic Oncology, National Cancer Center Hospital East, Chiba, Japan.
Noboru YamamotoDepartment of Experimental Therapeutics, National Cancer Center Hospital, Tokyo, Japan.ORCID https://orcid.org/0000-0002-0787-2851
Toshiaki TakahashiDivision of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka, Japan.
Naoyuki NogamiDepartment of Thoracic Oncology, National Hospital Organization Shikoku Cancer Center, Ehime, Japan.
Hiroyasu KanedaDepartment of Clinical Oncology, Graduate School of Medicine, Osaka City University, Osaka, Japan.
Yuka FujitaDepartment of Respiratory Medicine, National Hospital Organization Asahikawa Medical Center, Asahikawa, Japan.
Keith WilnerPfizer Oncology, La Jolla, CA, USA.
Mizuki YoshidaPfizer R&D Japan, Tokyo, Japan.
Mitsuhiro IsozakiPfizer R&D Japan, Tokyo, Japan.
Shinsuke WadaPfizer R&D Japan, Tokyo, Japan.
Fumito TsujiSFJ Pharma Japan, Osaka, Japan.
Kazuhiko NakagawaDepartment of Medical Oncology, Kindai University Faculty of Medicine, Osaka, Japan.ORCID https://orcid.org/0000-0003-1284-9776
Pfizer (Japan) · JPAsahikawa Medical University · JPKanagawa Prefectural Hospital Organization · JPKindai University · JPNational Cancer Center Hospital East · JPOsaka City University · JPOsaka Nishi Clinic · JPPfizer (United States) · USShikoku Cancer Center · JPShizuoka Cancer Center · JPThe Cancer Institute Hospital · JPTokyo National Hospital · JP

Funding

Pfizer, Inc.
6 · The paper itself

Abstract

In a subgroup of Japanese patients in the ARCHER 1050 randomized phase 3 trial, we evaluated the efficacy and safety and determined the effects of dose modifications on adverse events (AE) and therapy management of first-line oral dacomitinib 45 mg compared with oral gefitinib 250 mg, each once daily in 28-d cycles, in patients with EGFR-activating mutation-positive (EGFR-positive; exon 19 deletion or exon 21 L858R substitution mutations) advanced non-small cell lung cancer (NSCLC). The primary endpoint was progression-free survival (PFS; RECIST, version 1.1, by blinded independent review). In 81 Japanese patients (40 dacomitinib, 41 gefitinib), PFS was longer with dacomitinib compared with gefitinib (hazard ratio [HR], 0.544 [95% confidence interval {CI}, 0.307-0.961]; 2-sided P = .0327; median 18.2 for dacomitinib [95% CI, 11.0-31.3] mo, 9.3 [95% CI, 7.4-14.7] mo for gefitinib). The most common Grade 3 AEs were dermatitis acneiform with dacomitinib (27.5%) and increased alanine aminotransferase with gefitinib (12.2%). A higher proportion of patients receiving dacomitinib (85.0%) compared with gefitinib (24.4%) had AEs leading to dose reduction. Incidence and severity of diarrhea, dermatitis acneiform, stomatitis and paronychia were generally reduced after dacomitinib dose reductions and dacomitinib treatment duration was generally longer in patients with a dose reduction in comparison with those without a dose reduction. Our results confirmed the efficacy and safety of first-line dacomitinib in Japanese patients with EGFR-positive advanced NSCLC.

Indexed as

AdultAgedAged, 80 and overAntineoplastic AgentsCarcinoma, Non-Small-Cell LungDose-Response Relationship, DrugDrug-Related Side Effects and Adverse ReactionsErbB ReceptorsFemaleGefitinibHumansJapanLung NeoplasmsMaleMiddle AgedMutationAntineoplastic AgentsdacomitinibEGFR protein, humanErbB ReceptorsGefitinibProtein Kinase InhibitorsQuinazolinonesdacomitinibepidermal growth factor receptorJapanesenon-small cell lung cancertyrosine kinase inhibitor

Identifiers

PMID32159882
PMCPMC7226281
OpenAlexW3011524920

What OpenQuestion holds

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LicenceCC BY-NC
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.