Evidence map›Paper›PMID 31102009›Full record

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

Multicenter phase II study of trastuzumab with S-1 plus oxaliplatin for chemotherapy-naïve, HER2-positive advanced gastric cancer.

Daisuke Takahari, Keisho Chin, Naoki Ishizuka, Atsuo Takashima, Keiko Minashi, Shigenori Kadowaki, Tomohiro Nishina, Takako Eguchi Nakajima, Kenji Amagai, Nozomu Machida and 7 more

Open access · bronzeAbstract readClinical Trial, Phase IIMulticenter Study
PubMed 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. Cited by 37 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 1 pooled it
5.9field-weighted citation impact, top 3% 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

37 citing papers in PubMed, 1 synthesis or guideline pooled it, 54 citations in OpenAlex.

  1. Japanese gastric cancer treatment guidelines 2025 (7th edition).Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2026
    Guideline
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  11. Biomarker-oriented chemo-immunotherapy for advanced gastric cancer.International journal of clinical oncology · 2024
    Review
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  14. German, Austrian, and Swiss guidelines for systemic treatment of gastric cancer.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2024
    Article
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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

17 authors at 11 institutions in 1 country.

Daisuke TakahariDepartment of Gastroenterology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, 3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan. daisuke.takahari@jfcr.or.jp.ORCID 0000-0002-2492-6014
Keisho ChinDepartment of Gastroenterology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, 3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan.
Naoki IshizukaDepartment of Clinical Trial Planning and Management, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.
Atsuo TakashimaDepartment of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.
Keiko MinashiClinical Trial Promotion Department, Chiba Cancer Center, Chiba, Japan.
Shigenori KadowakiDepartment of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.
Tomohiro NishinaDepartment of Gastrointestinal Medical Oncology, Shikoku Cancer Center, Matsuyama, Japan.
Takako Eguchi NakajimaDepartment of Clinical Oncology, St Marianna University School of Medicine, Kawasaki, Japan.
Kenji AmagaiDepartment of Gastroenterology, Ibaraki Prefectural Central Hospital, Kasama, Japan.
Nozomu MachidaDepartment of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan.
Masahiro GotoDepartment of Cancer Chemotherapy Center, Osaka Medical College, Takatsuki, Japan.
Keisei TakuDepartment of Medical Oncology, Shizuoka General Hospital, Shizuoka, Japan.
Takeru WakatsukiDepartment of Gastroenterology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, 3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan.
Hirokazu ShojiDepartment of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.
Shuichi HironakaClinical Trial Promotion Department, Chiba Cancer Center, Chiba, Japan.
Narikazu BokuDepartment of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.
Kensei YamaguchiDepartment of Gastroenterology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, 3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan.
The Cancer Institute Hospital · JPNational Cancer Center Hospital East · JPAichi Cancer Center · JPChiba Cancer Center · JPIbaraki Prefectural Central Hospital · JPOita University · JPOsaka Medical and Pharmaceutical University · JPShikoku Cancer Center · JPShizuoka Cancer Center · JPShizuoka General Hospital · JPSt. Marianna University School of Medicine · JP

Funding

Japanese Foundation for Multidisciplinary Treatment of Cancer JMFC2015
6 · The paper itself

Abstract

backgroundTrastuzumab with cisplatin and fluoropyrimidines improves overall survival (OS) in patients with HER2-positive advanced gastric cancer (AGC). S-1 plus oxaliplatin (SOX) is one of the standard regimens for HER2-negative AGC in Japan. However, few studies have evaluated trastuzumab combined with SOX in patients with HER2-positive AGC.

methodsThis was a multicenter, phase II study conducted at 10 institutions in Japan. Patients with HER2-positive AGC received S-1 twice a day on days 1-14 and oxaliplatin and trastuzumab on day 1 of a 21-day cycle. The primary endpoint was the confirmed overall response rate (ORR), and the secondary endpoints were OS, progression-free survival (PFS), and safety. The sample size was 75 to have 90% power with an alpha error of 0.1 (one-sided), expecting an ORR of 65% and threshold of 50%.

resultsFrom June 2015 to January 2018, 75 patients were enrolled. The ORR was 70.7% [95% confidence interval (CI) 59.0-80.6]. The median OS and PFS were estimated as 18.1 months (95% CI 15.6-26.5) and 8.8 months (95% CI 7.4-12.2), respectively. The major grade 3 or 4 adverse events were sensory neuropathy (16.0%) and neutropenia (10.7%).

conclusionsTrastuzumab with SOX had promising activity with well-tolerated toxicities for patients with HER2-positive AGC. CLINICAL

trial registrationUMIN000017602.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsDrug CombinationsErb-b2 Receptor Tyrosine KinasesFemaleHumansJapanMaleMiddle AgedOxaliplatinOxonic AcidProgression-Free SurvivalProspective StudiesStomach NeoplasmsSurvival RateDrug CombinationsERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesOxaliplatinOxonic AcidS 1 (combination)TegafurTrastuzumabAdvanced gastric cancerHER2-positiveOxaliplatinS-1Trastuzumab

Identifiers

PMID31102009
OpenAlexW2945120766

What OpenQuestion holds

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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.