Evidence map›Paper›PMID 30506519›Full record

Trial reportGastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association2019

A subanalysis of Japanese patients in a randomized, double-blind, placebo-controlled, phase 3 trial of nivolumab for patients with advanced gastric or gastro-esophageal junction cancer refractory to, or intolerant of, at least two previous chemotherapy regimens (ONO-4538-12, ATTRACTION-2).

Ken Kato, Taroh Satoh, Kei Muro, Takaki Yoshikawa, Takao Tamura, Yasuo Hamamoto, Keisho Chin, Keiko Minashi, Masahiro Tsuda, Kensei Yamaguchi and 21 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04563975 (Toripalimab Combined With Docetaxel or Nab-paclitaxel in the Treatment of Advanced Gastric Cancer), which is not on this map. Cited by 55 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
55citing papers in PubMed, 9 pooled it
3.2field-weighted citation impact, top 6% 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.

NCT04563975 phase2unknown statusnot on this mapstarted 2020, after this paper: background citation

Toripalimab Combined With Docetaxel or Nab-paclitaxel in the Treatment of Advanced Gastric Cancer : a Single-arm, Open Label, Prospective Phase II Clinical Trial

TypeinterventionalSponsorTao ZhangRan2020 to 2023Enrolled54ConditionsGastric Cancer Stage IVArmsToripalimab, Docetaxel, nab-paclitaxel
3 · Its place in the literature

Who cites it

55 citing papers in PubMed, 9 syntheses or guidelines pooled it, 72 citations in OpenAlex.

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  10. Efficacy and safety of irinotecan-based therapy in elderly patients with advanced gastric cancer receiving third-line or later chemotherapy: post-hoc age-subgroup analysis of the rindberg trial.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2026
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  12. Phase II Study of the Liposomal Formulation of Eribulin (E7389-LF) in Combination with Nivolumab: Results from the Gastric Cancer Cohort.Clinical cancer research : an official journal of the American Association for Cancer Research · 2024
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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

31 authors at 20 institutions in 3 countries.

Ken KatoDivision of Gastrointestinal Medical Oncology, National Cancer Center Hospital, 5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.
Taroh SatohDepartment of Frontier Science for Cancer and Chemotherapy, Osaka University Graduate School of Medicine, Suita, Japan.
Kei MuroDepartment of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.
Takaki YoshikawaDepartment of Gastrointestinal Surgery, Kanagawa Cancer Center, Yokohama, Japan.
Takao TamuraDepartment of Medical Oncology, Kindai University, Faculty of Medicine, Osaka, Japan.
Yasuo HamamotoKeio Cancer Center, School of Medicine, Keio University, Tokyo, Japan.
Keisho ChinDepartment of Gastroenterology, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan.
Keiko MinashiClinical Trial Promotion Department, Chiba Cancer Center, Chiba, Japan.
Masahiro TsudaDepartment of Gastroenterological Oncology, Hyogo Cancer Center, Akashi, Japan.
Kensei YamaguchiDepartment of Gastroenterology, Saitama Cancer Center, Saitama, Japan.
Nozomu MachidaDivision of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan.
Taito EsakiDepartment of Gastrointestinal and Medical Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.
Masahiro GotoCancer Chemotherapy Center, Osaka Medical College Hospital, Takatsuki, Japan.
Yoshito KomatsuDivision of Cancer Chemotherapy, Hokkaido University Hospital Cancer Center, Sapporo, Japan.
Takako Eguchi NakajimaDepartment of Clinical Oncology, St. Marianna University School of Medicine, Kawasaki, Japan.
Naotoshi SugimotoDepartment of Medical Oncology, Osaka International Cancer Institute, Osaka, Japan.
Kazuhiro YoshidaDepartment of Surgical Oncology, Gifu University Graduate School of Medicine, Gifu, Japan.
Eiji OkiDepartment of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Tomohiro NishinaDepartment of Gastrointestinal Medical Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.
Akihito TsujiDepartment of Medical Oncology, Kobe City Medical Center General Hospital, Kobe, Japan.
Hirofumi FujiiDepartment of Clinical Oncology, Cancer Center Jichi Medical University Hospital, Shimotsuke, Japan.
Kenji KuniedaDepartment of Medical Oncology, Saku Central Hospital Advanced Care Center, Saku, Japan.
Soh SaitohInternal Medicine, Misawa City Hospital, Misawa, Japan.
Yasushi OmuroDepartment of Medical Oncology, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan.
Mizutomo AzumaDepartment of Gastroenterology, Kitasato University School of Medicine, Sagamihara, Japan.
Yasuo IwamotoMedical Oncology, Hiroshima City Hiroshima Citizens Hospital, Hiroshima, Japan.
Keisei TakuMedical Oncology, Shizuoka General Hospital, Shizuoka, Japan.
Sachio FushidaGastroenterological Surgery, Kanazawa University Hospital, Kanazawa, Japan.
Li-Tzong ChenNational Institute of Cancer Research, National Health Research Institutes, Tainan, Taiwan, Republic of China.
Yoon-Koo KangDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
Narikazu BokuDivision of Gastrointestinal Medical Oncology, National Cancer Center Hospital, 5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan. nboku@ncc.go.jp.
Aichi Cancer Center · JPChiba Cancer Center · JPGifu University · JPHiroshima City Asa Citizens Hospital · JPHokkaido University Hospital · JPHyogo Prefectural Cancer Center · JPJapanese Foundation For Cancer Research · JPJichi Medical University · JPKanazawa University Hospital · JPKeio University · JPKindai University · JPKitasato University · JPKobe City Medical Center General Hospital · JPKyushu University · JPMisawa City Hospital · JPNational Cheng Kung University Hospital · TWNational Hospital Organization Kyushu Cancer Center · JPOsaka Medical and Pharmaceutical University · JPOsaka Medical Center for Cancer and Cardiovascular Diseases · JPOsaka University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNivolumab, an anti-programmed death-1 agent, showed survival benefits in Asian patients, including Japanese, with gastric/gastro-esophageal junction (G/GEJ) cancer. We report the analysis of the Japanese subpopulation from ATTRACTION-2 that evaluated nivolumab versus placebo in unresectable advanced or recurrent G/GEJ cancer after ≥ 2 chemotherapy regimens.

methodsData from the Japanese subpopulation in the randomized, double-blind, placebo-controlled, phase 3 trial were analyzed (data cutoff, February 25, 2017). Primary endpoint was overall survival (OS); secondary endpoints included progression-free survival (PFS) and objective response rate (ORR).

resultsAmong the overall study population of 493 patients, 226 (nivolumab 152; placebo 74) were enrolled from 28 sites in Japan. In the Japanese subset, median OS was longer with nivolumab versus placebo (5.4 months, 95% CI 4.6-7.4 versus 3.6 months, 95% CI 2.8-5.0). The risk of death was lower in the nivolumab versus placebo group (hazard ratio 0.58, 95% CI 0.42-0.78; p = 0.0002). Incidences of serious adverse events were 23% (35/152) and 25% (18/72) in the nivolumab and placebo groups, respectively. In the Japanese ITT population, 22% of nivolumab-treated and 28% of placebo-treated patients received prior ramucirumab treatment. Overall, clinical activity of nivolumab was observed regardless of prior ramucirumab use. In the nivolumab group, ORR and PFS were numerically higher in patients with prior ramucirumab use than in those without.

conclusionsIn the Japanese subpopulation, patients receiving nivolumab had longer OS, similar to the overall population, with a manageable safety profile. The interaction between nivolumab and ramucirumab will be clarified in ongoing clinical trials.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Agents, ImmunologicalAsian PeopleDouble-Blind MethodDrug Resistance, NeoplasmEsophagogastric JunctionFemaleHumansMaleMiddle AgedNivolumabProgression-Free SurvivalSalvage TherapyStomach NeoplasmsAntineoplastic Agents, ImmunologicalNivolumabGastric cancerGastro-esophageal junction cancerJapanNivolumab

Identifiers

PMID30506519
PMCPMC6394726
OpenAlexW2903127846

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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.