Evidence map›Paper›PMID 32926507›Full record

Trial reportCancer science2020

First-line pembrolizumab vs chemotherapy in metastatic non-small-cell lung cancer: KEYNOTE-024 Japan subset.

Miyako Satouchi, Kaname Nosaki, Toshiaki Takahashi, Kazuhiko Nakagawa, Keisuke Aoe, Takayasu Kurata, Akimasa Sekine, Atsushi Horiike, Tatsuro Fukuhara, Shunichi Sugawara and 16 more

Retracted Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized 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. It has been retracted, and should not be counted. It is linked to trial NCT02142738 (A Randomized Open-Label Phase III Trial of Pembrolizumab Versus Platinum Based Chemotherapy in 1L Subjects With PD-L1 Strong Metastatic Non-Small Cell Lung Cancer), which is not on this map. Cited by 18 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 4 pooled it
2.0field-weighted citation impact, top 11% 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.

NCT02142738 phase3completednot on this map

A Randomized Open-Label Phase III Trial of Pembrolizumab Versus Platinum Based Chemotherapy in 1L Subjects With PD-L1 Strong Metastatic Non-Small Cell Lung Cancer

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2014 to 2021Enrolled305ConditionsNon-Small Cell Lung CarcinomaArmsPembrolizumab, Paclitaxel, Carboplatin, Pemetrexed, Cisplatin
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 4 syntheses or guidelines pooled it, 29 citations in OpenAlex.

  1. Pooled it
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  11. PD-L1: expression regulation.Blood science (Baltimore, Md.) · 2023
    Review
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  16. Retraction.Cancer science · 2021
    Article
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

26 authors at 20 institutions in 2 countries.

Miyako SatouchiDepartment of Thoracic Oncology, Hyogo Cancer Center, Akashi, Japan.ORCID https://orcid.org/0000-0003-0613-9487
Kaname NosakiDepartment of Thoracic Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.
Toshiaki TakahashiDivision of Thoracic Oncology, Shizuoka Cancer Center, Shuntougun, Japan.
Kazuhiko NakagawaDepartment of Medical Oncology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan.
Keisuke AoeDepartment of Medical Oncology, National Hospital Organization Yamaguchi Ube Medical Center, Ube, Japan.
Takayasu KurataDepartment of Thoracic Oncology, Kansai Medical University, Osaka, Japan.
Akimasa SekineDepartment of Respiratory Medicine, Kanagawa Cardiovascular and Respiratory Center, Kanagawa, Japan.
Atsushi HoriikeDepartment of Thoracic Medical Oncology, The Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan.
Tatsuro FukuharaDepartment of Respiratory Medicine, Miyagi Cancer Center, Natori, Japan.
Shunichi SugawaraDepartment of Pulmonary Medicine, Sendai Kousei Hospital, Miyagi, Japan.ORCID https://orcid.org/0000-0002-3427-4558
Shigeki UmemuraDepartment of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
Hideo SakaDepartment of Respiratory Medicine and Medical Oncology, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.
Isamu OkamotoResearch Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.ORCID https://orcid.org/0000-0002-7587-6096
Nobuyuki YamamotoInternal Medicine III, Wakayama Medical University, Wakayama, Japan.
Hiroshi SakaiDepartment of Thoracic Oncology, Saitama Cancer Center, Saitama, Japan.
Kazuma KishiDepartment of Respiratory Medicine, Respiratory Center, Totanomon Hospital, Tokyo, Japan.
Nobuyuki KatakamiDivision of Integrated Oncology, Institute of Biomedical Research and Innovation Hospital, Kobe, Japan.
Hidehito HorinouchiDepartment of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.ORCID https://orcid.org/0000-0001-9090-801X
Toyoaki HidaDepartment of Thoracic Oncology, Aichi Cancer Center, Aichi, Japan.ORCID https://orcid.org/0000-0003-3537-0020
Hiroaki OkamotoDepartment of Respiratory Medicine and Medical Oncology, Yokohama Municipal Citizen's Hospital, Yokohama, Japan.
Shinji AtagiDepartment of Thoracic Oncology, National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai, Japan.
Tatsuo OhiraDepartment of Surgery, Tokyo Medical University, Tokyo, Japan.
Shi Rong HanMSD K.K., Tokyo, Japan.
Kazuo NoguchiMSD K.K., Tokyo, Japan.
Victoria EbianaMerck & Co., Inc., Kenilworth, NJ, USA.
Katsuyuki HottaCenter for Innovative Clinical Medicine, Okayama University Hospital, Okayama, Japan.ORCID https://orcid.org/0000-0002-0112-0843
MSD K.K. (Japan) · JPAichi Cancer Center · JPFoundation for Biomedical Research and Innovation · JPHyogo Prefectural Cancer Center · JPKanagawa Cardiovascular and Respiratory Center · JPKansai Medical University · JPKindai University Hospital · JPKyushu University · JPMerck & Co., Inc., Rahway, NJ, USA (United States) · USMiyagi Prefectural Hospital Organization · JPNational Cancer Center Hospital East · JPNational Hospital Organization · JPNational Hospital Organization Kyushu Cancer Center · JPNational Sanyo Hospital · JPNHO Kinki Chuo Chest Medical Center · JPOkayama University Hospital · JPSaitama Cancer Center · JPSendai Kousei Hospital · JPShizuoka Cancer Center · JPThe Cancer Institute Hospital · JP

Funding

Merck Sharp & Dohme Corp.
6 · The paper itself

Abstract

This prespecified subanalysis of the global, randomized controlled phase III KEYNOTE-024 study of pembrolizumab vs chemotherapy in previously untreated metastatic non-small-cell lung cancer without EGFR/ALK alterations and a programmed death ligand 1 (PD-L1) tumor proportion score of 50% or higher evaluated clinical outcomes among patients enrolled in Japan. Treatment consisted of pembrolizumab 200 mg every 3 weeks (35 cycles) or platinum-based chemotherapy (four to six cycles). The primary end-point was progression-free survival; secondary end-points included overall survival and safety. Of 305 patients randomized in KEYNOTE-024 overall, 40 patients were enrolled in Japan (all received treatment: pembrolizumab, n = 21; chemotherapy, n = 19). Median progression-free survival was 41.4 (95% confidence interval [CI], 4.2-42.5) months with pembrolizumab and 4.1 (95% CI, 2.8-8.3) months with chemotherapy (hazard ratio [HR], 0.27 [95% CI, 0.11-0.65]; one-sided, nominal P = .001). Median overall survival was not reached (NR) (95% CI, 22.9-NR) and 21.5 (95% CI, 5.2-35.0) months, respectively (HR, 0.39 [95% CI, 0.17-0.91]; one-sided, nominal P = .012). Treatment-related adverse events occurred in 21/21 (100%) pembrolizumab-treated and 18/19 (95%) chemotherapy-treated patients; eight patients (38%) and nine patients (47%), respectively, had grade 3-5 events. Immune-mediated adverse events and infusion reactions occurred in 11 pembrolizumab-treated patients (52%) and four chemotherapy-treated patients (21%), respectively; four patients (19%) and one patient (5%), respectively, had grade 3-5 events. Consistent with results from KEYNOTE-024 overall, first-line pembrolizumab improved progression-free survival and overall survival vs chemotherapy with manageable safety among Japanese patients with metastatic non-small-cell lung cancer without EGFR/ALK alterations and a PD-L1 tumor proportion score of 50% or higher. The trial is registered with Clinicaltrials.gov: NCT02142738.

Indexed as

AdultAgedAged, 80 and overAnaplastic Lymphoma KinaseAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalAntineoplastic Combined Chemotherapy ProtocolsB7-H1 AntigenCarboplatinCarcinoma, Non-Small-Cell LungCarcinoma, Squamous CellCisplatinConfidence IntervalsCross-Over StudiesDeoxycytidineDrug Administration ScheduleALK protein, humanAnaplastic Lymphoma KinaseAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalB7-H1 AntigenCarboplatinCisplatinDeoxycytidineGemcitabinePaclitaxelpembrolizumabPemetrexedProgrammed Cell Death 1 ReceptorJapannon-small-cell lung carcinomaPD-L1 proteinpembrolizumabtreatment outcome

Identifiers

PMID32926507
PMCPMC7734005
OpenAlexW3087482818

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

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.