Evidence map›Paper›PMID 33185928›Full record

Trial reportCancer science2021

Tumor mutation burden as a biomarker for lung cancer patients treated with pemetrexed and cisplatin (the JIPANG-TR).

Kazuko Sakai, Masahiro Tsuboi, Hirotsugu Kenmotsu, Takeharu Yamanaka, Toshiaki Takahashi, Koichi Goto, Haruko Daga, Tatsuo Ohira, Tsuyoshi Ueno, Tadashi Aoki and 18 more

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

Trial report in Cancer science, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 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

15 citing papers in PubMed, 1 synthesis or guideline pooled it, 26 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

28 authors at 20 institutions in 1 country.

Kazuko SakaiDepartment of Genome Biology, Kindai University Faculty of Medicine, Osaka-sayama, Japan.ORCID https://orcid.org/0000-0003-1822-2720
Masahiro TsuboiDivision of Thoracic Surgery, National Cancer Center Hospital East, Kashiwa, Japan.
Hirotsugu KenmotsuDivision of Thoracic Oncology, Shizuoka Cancer Center, Nagaizumi-cho Sunto-gun, Japan.ORCID https://orcid.org/0000-0003-0590-9259
Takeharu YamanakaDepartment of Biostatistics, Yokohama City University School of Medicine, Yokohama, Japan.
Toshiaki TakahashiDivision of Thoracic Oncology, Shizuoka Cancer Center, Nagaizumi-cho Sunto-gun, Japan.
Koichi GotoDepartment of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa, Japan.ORCID https://orcid.org/0000-0002-3023-2510
Haruko DagaDepartment of Medical Oncology, Osaka City General Hospital, Osaka, Japan.
Tatsuo OhiraDepartment of Surgery, Tokyo Medical University, Tokyo, Japan.
Tsuyoshi UenoDepartment of Thoracic Surgery, National Hospital Organization, Shikoku Cancer Center, Matsuyama, Japan.
Tadashi AokiDepartment of Chest Surgery, Niigata Cancer Center Hospital, Niigata, Japan.
Kazuhiko NakagawaDepartment of Medical Oncology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan.
Koji YamazakiDepartment of Thoracic Surgery, Kyushu Medical Center, Clinical Research Institute, National Hospital Organization, Fukuoka, Japan.
Yukio HosomiDepartment of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan.
Koji KawaguchiDepartment of Thoracic Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.
Norihito OkumuraDepartment of Thoracic Surgery, Kurashiki Central Hospital, Kurashiki, Japan.ORCID https://orcid.org/0000-0001-6850-6284
Yuichi TakiguchiDepartment of Medical Oncology, Chiba University Hospital, Chiba, Japan.ORCID https://orcid.org/0000-0001-6059-7476
Akimasa SekineDepartment of Respiratory Medicine, Kanagawa Cardiovascular and Respiratory Center, Yokohama, Japan.
Tomohiro HarukiDivision of General Thoracic Surgery, Department of Surgery, Faculty of Medicine, Tottori University, Tottori, Japan.
Hiromasa YamamotoDepartment of General Thoracic Surgery, Breast and Endocrinological Surgery, Okayama University Hospital, Okayama, Japan.ORCID https://orcid.org/0000-0002-5330-5460
Yuki SatoDepartment of Respiratory Medicine, Kobe City Medical Center General Hospital, Kobe, Japan.
Hiroaki AkamatsuInternal Medicine III, Wakayama Medical University, Wakayama, Japan.
Takashi SetoDepartment of Thoracic Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.
Sho SaekiDepartment of Respiratory Medicine, Kumamoto University Hospital, Kumamoto, Japan.
Kenji SugioDepartment of Thoracic and Breast Surgery, Oita University, Oita, Japan.
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
Kazunori OkabeDepartment of Thoracic Surgery, National Hospital Organization Yamaguchi Ube Medical Center, Yamaguchi, Japan.
Nobuyuki YamamotoInternal Medicine III, Wakayama Medical University, Wakayama, Japan.
Kazuto NishioDepartment of Genome Biology, Kindai University Faculty of Medicine, Osaka-sayama, Japan.ORCID https://orcid.org/0000-0002-8275-0846
Kindai University · JPNational Cancer Center Hospital East · JPShizuoka Cancer Center · JPWakayama Medical University · JPChiba University Hospital · JPKanagawa Cardiovascular and Respiratory Center · JPKindai University Hospital · JPKobe City Medical Center General Hospital · JPKumamoto University Hospital · JPKurashiki Central Hospital · JPNagoya University · JPNational Hospital Organization Kyushu Cancer Center · JPNational Kyushu Medical Center · JPNational Sanyo Hospital · JPNiigata Cancer Center Hospital · JPOita University · JPOkayama University Hospital · JPOsaka City General Hospital · JPShikoku Cancer Center · JPThe Cancer Institute Hospital · JP

Funding

Kindai University
6 · The paper itself

Abstract

The JIPANG study is a randomized phase III study of pemetrexed/cisplatin (Pem/Cis) versus vinorelbine/cisplatin (Vnr/Cis) for completely resected stage II-IIIA non-squamous non-small cell lung cancer (Ns-NSCLC). This study did not meet the primary endpoint (recurrence-free survival, RFS) but Pem/Cis had a similar efficacy to Vnr/Cis with a better tolerability. Tumor mutation burden (TMB) is thought to have a predictive value of immune checkpoint inhibitors. However, the relevance of TMB to cytotoxic chemotherapy remains unknown. This exploratory study investigates the relationship between tumor mutation profiles and clinical outcome of Pem/Cis. Formalin-fixed, paraffin-embedded tumor tissues (n = 389) were obtained from the patients. Mutation status of tissue DNA was analyzed by targeted deep sequencing. Epidermal growth factor receptor (EGFR) mutations were detected frequently in Ns-NSCLC (139/374). Patients without any EGFR mutations experienced longer RFS in the Pem/Cis arm versus Vnr/Cis arms. Pem/Cis in patients with high TMB (≥12-16 mut/Mb) tended to have improved survival. In patients with wild-type EGFR, TMB ≥ 12 mut/Mb was significantly associated with improved RFS with Pem/Cis versus Vnr/Cis (not reached vs 52.5 months; hazard ratio (HR) 0.477). It could be proposed that TMB was predictive of RFS benefit with Pem/Cis versus Vnr/Cis in Ns-NSCLC. Further investigation is required to determine whether TMB combined with EGFR mutation status could be used as a predictive biomarker.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorCarcinoma, Non-Small-Cell LungCisplatinDNA Mutational AnalysisErbB ReceptorsFemaleHumansLung NeoplasmsMaleMiddle AgedMutationPemetrexedTreatment OutcomeBiomarkers, TumorCisplatinEGFR protein, humanErbB ReceptorsPemetrexedadjuvant chemotherapynext-generation sequencingnon-squamous non-small cell lung cancerpemetrexedtumor mutation burden (TMB)

Identifiers

PMID33185928
PMCPMC7780021
OpenAlexW3104451825

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

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.