Evidence map›Paper›PMID 40632416›Full record

Observational studyGastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association2025

An observational study of the effectiveness and safety of nivolumab plus chemotherapy for untreated advanced or recurrent gastric cancer in Japanese real-world settings: the G-KNIGHT study.

Shigenori Kadowaki, Tomoyuki Otsuka, Keiko Minashi, Shinichi Nishina, Hiroshi Yabusaki, Chiaki Inagaki, Tomohiro Nishina, Hisateru Yasui, Hiroshi Matsuoka, Nozomu Machida and 10 more

Erratum issuedAbstract readObservational StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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

6 citing papers in PubMed.

  1. Article
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors.

Shigenori KadowakiDepartment of Clinical Oncology, Aichi Cancer Center Hospital, Aichi, Japan. skadowaki@aichi-cc.jp.
Tomoyuki OtsukaDepartment of Medical Oncology, Osaka International Cancer Institute, Osaka, Japan.
Keiko MinashiClinical Trial Promotion Department, Chiba Cancer Center, Chiba, Japan.
Shinichi NishinaDepartment of Medical Oncology, Kurashiki Central Hospital, Okayama, Japan.
Hiroshi YabusakiDepartment of Gastroenterological Surgery, Niigata Cancer Center Hospital, Niigata, Japan.
Chiaki InagakiDepartment of Medical Oncology, Faculty of Medicine, Kindai University, Osaka, Japan.
Tomohiro NishinaDepartment of Gastrointestinal Medical Oncology, NHO Shikoku Cancer Center, Ehime, Japan.
Hisateru YasuiDepartment of Medical Oncology, Kobe City Medical Center General Hospital, Hyogo, Japan.
Hiroshi MatsuokaDepartment of Surgery, Fujita Health University, Aichi, Japan.
Nozomu MachidaDepartment of Gastroenterology, Kanagawa Cancer Center, Kanagawa, Japan.
Masahiro TsudaDepartment of Gastroenterological Oncology, Hyogo Cancer Center, Hyogo, Japan.
Fumio NagashimaDepartment of Medical Oncology, Faculty of Medicine, Kyorin University, Tokyo, Japan.
Hisashi HosakaDepartment of Gastroenterology, Gunma Prefectural Cancer Center, Gunma, Japan.
Junichi MatsubaraDepartment of Medical Oncology, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Hiroyuki AraiDepartment of Clinical Oncology, St. Marianna University School of Medicine, Kanagawa, Japan.
Satoshi IdaDepartment of Gastroenterological Surgery, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.
Yuya KimijimaOncology Medical, Bristol Myers Squibb, Tokyo, Japan.
Yuko MatsudaMedical Affairs, Ono Pharmaceutical Co. Ltd, Osaka, Japan.
Manabu MutoDepartment of Medical Oncology, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Kei MuroDepartment of Clinical Oncology, Aichi Cancer Center Hospital, Aichi, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNivolumab plus chemotherapy has shown efficacy in clinical trials for advanced or recurrent gastric cancer (GC). However, real-world utilization data are limited. In this study, we aimed to assess the effectiveness, safety, and treatment status of first line nivolumab plus chemotherapy in Japanese patients with treatment-naïve advanced or recurrent GC.

methodsUntreated patients with advanced or recurrent GC who initiated nivolumab plus chemotherapy as first line treatment from November 2021 to June 2023 across 23 Japanese sites were enrolled in this observational study (G-KNIGHT). This report focused on the objective response rate (ORR), real-world progression-free survival (rwPFS), and the treatment-related adverse event (TRAE) incidence. Furthermore, subgroup analyses for ORR and rwPFS were conducted for patients stratified by various factors including age and the programmed cell death ligand 1 (PD-L1) combined positive score (CPS).

resultsAmong 527 patients (median age, 70.3 years; 25.2% aged ≥ 75 years; 65.5% male; 84.3% with advanced GC), the median follow-up period was 10.4 (interquartile range, 6.7-15.2) months. The ORR was 65.6% (95% confidence interval [CI], 59.9-70.9%). The median rwPFS (months, 95% CI) was 6.9 (6.2-7.6); by subgroups: age < 75 years, 6.7 (6.0-7.5); age ≥ 75 years, 7.4 (6.2-8.6); PD-L1 CPS < 1, 7.5 (6.5-9.0); CPS 1-5, 6.2 (5.5-8.0); and CPS ≥ 5, 7.0 (6.2-8.2). TRAEs occurred in 91.3% of patients, with 40.4% experiencing grade ≥ 3 events.

conclusionsThis large-scale real-world study supports the effectiveness and safety of nivolumab plus chemotherapy in untreated Japanese patients with advanced or recurrent GC.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsNeoplasm Recurrence, LocalNivolumabStomach NeoplasmsAdultAgedAged, 80 and overEast Asian PeopleFemaleHumansJapanMaleMiddle AgedProgression-Free SurvivalSurvival RateNivolumabJapanNivolumabObservational studyStomach neoplasms

Identifiers

PMID40632416
PMCPMC12378153

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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.