Evidence map›Paper›PMID 42658449›Full record

ArticleGastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association2026

Phase II study of mFOLFOX6 in advanced gastric cancer patients with severe peritoneal metastases (WJOG10517G), including an individual patient data comparison with JCOG1108/WJOG7312G.

Toshiki Masuishi, Hiroki Hara, Takayuki Ando, Takeshi Kawakami, Yoshiyuki Yamamoto, Naotoshi Sugimoto, Kazuhiro Shiraishi, Taito Esaki, Yuji Negoro, Takao Tsuzuki and 15 more

Abstract read
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In one paragraph

Article in Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Article
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

25 authors.

Toshiki MasuishiDepartment of Clinical Oncology, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi, 464-8681, Japan. tmasuishi@aichi-cc.jp.ORCID http://orcid.org/0000-0002-7521-1596
Hiroki HaraDepartment of Gastroenterology, Saitama Cancer Center, Saitama, Japan.ORCID http://orcid.org/0000-0003-3881-9815
Takayuki AndoThird Department of Internal Medicine, University of Toyama, Toyama, Japan.ORCID http://orcid.org/0000-0001-8369-8536
Takeshi KawakamiDivision of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan.ORCID http://orcid.org/0000-0001-9385-9516
Yoshiyuki YamamotoDepartment of Gastroenterology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.ORCID http://orcid.org/0000-0002-2932-5904
Naotoshi SugimotoDepartment of Genetic Oncology, Osaka International Cancer Institute, Osaka, Japan.ORCID http://orcid.org/0000-0001-9579-690X
Kazuhiro ShiraishiDepartment of Medical Oncology, NHO Nagoya Medical Center, Nagoya, Japan.ORCID http://orcid.org/0009-0004-3131-1829
Taito EsakiDepartment of Gastrointestinal and Medical Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.ORCID http://orcid.org/0000-0002-9169-8453
Yuji NegoroDepartment of Oncological Medicine, Kochi Health Sciences Center, Kochi, Japan.
Takao TsuzukiDepartment of Internal Medicine, Japanese Red Cross Society Himeji Hospital, Himeji, Japan.
Hiroaki SawaiDepartment of Gastroenterology, Takatsuki General Hospital, Takatsuki, Japan.
Masato NakamuraAizawa Comprehensive Cancer Center, Aizawa Hospital, Matsumoto, Japan.
Takashi InagakiDepartment of Medical Oncology and Hematology, Faculty of Medicine, Oita University, Oita, Japan.
Yudai ShinoharaDepartment of Hematology and Oncology, Japan Community Healthcare Organization Kyushu Hospital, Kitakyushu, Japan.
Kentaro KawakamiDepartment of Medical Oncology, Keiyukai Sapporo Hospital, Sapporo, Japan.
Seiichiro MitaniDepartment of Medical Oncology, Faculty of Medicine, Kindai University, Sakai, Japan.ORCID http://orcid.org/0000-0003-0033-8741
Kenji TsuchihashiDepartment of Hematology, Oncology and Cardiovascular Medicine, Kyushu University Hospital, Kyushu, Japan.ORCID http://orcid.org/0000-0002-9014-6382
Chihiro KondohDepartment of Medical Oncology, Toranomon Hospital, Tokyo, Japan.ORCID http://orcid.org/0000-0001-6189-4851
Hiroo KatsuyaDivision of Hematology, Respiratory Medicine and Oncology, Department of Internal Medicine, Faculty of Medicine, Saga University, Saga, Japan.ORCID http://orcid.org/0000-0003-1498-4357
Osamu MaedaDepartment of Clinical Oncology and Chemotherapy, Nagoya University Hospital, Nagoya, Japan.ORCID http://orcid.org/0000-0003-4700-6541
Yuriko FujitaDepartment of Gastroenterology, Yokohama Municipal Citizen's Hospital, Yokohama, Japan.
Kenichi YoshimuraInnovative Clinical Research Center (iCREK), Nagoya City University, Nagoya, Japan.
Masanori TerashimaDivision of Gastric Surgery, Shizuoka Cancer Center, Shizuoka, Japan.ORCID http://orcid.org/0000-0002-2967-8267
Takako Eguchi NakajimaDepartment of Early Clinical Development, Kyoto University Graduate School of Medicine, Kyoto, Japan.ORCID http://orcid.org/0000-0002-4589-2335
Kei MuroDepartment of Clinical Oncology, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi, 464-8681, Japan.ORCID http://orcid.org/0000-0002-5572-743X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAdvanced gastric cancer patients with severe peritoneal metastases, defined as massive ascites throughout the abdominal cavity and/or inadequate oral intake requiring intravenous infusion support, have been excluded from pivotal clinical trials.

methodsThis phase II trial evaluated mFOLFOX6 in HER2-negative, chemotherapy-naive advanced gastric cancer patients with severe peritoneal metastases. The primary endpoint was overall survival (OS); secondary endpoints included ascites response rate among patients with massive ascites and oral intake improvement rate. A sample size of 50 was planned to detect a median OS of 9 months, with a threshold of 6 months (one-sided α = 0.05; β = 0.2). A prespecified individual patient data comparative analysis was performed using data from patients treated with 5-fluorouracil/l-leucovorin (FL) or FL plus paclitaxel (FLTAX) in JCOG1108/WJOG7312G.

resultsAmong 51 patients, Eastern Cooperative Oncology Group performance status was 0/1/2 in 3/40/8 patients. Median OS and progression-free survival were 7.4 (lower limit of one-sided 95% confidence interval [CI], 6.5) and 3.8 months, respectively. Among 25 patients with massive ascites, the ascites response rate was 36%. Of 33 patients with inadequate oral intake, 46% achieved improved oral intake. The most frequent grade 3-4 adverse event was neutropenia (51%), and febrile neutropenia occurred in one patient (2%). No treatment-related deaths occurred. In propensity score-weighted analysis, OS hazard ratios with mFOLFOX6 versus FL and FLTAX were 0.76 (95% CI 0.56-1.03) and 0.87 (95% CI 0.64-1.18), respectively.

conclusionsmFOLFOX6 was tolerable and may be a treatment option for advanced gastric cancer patients with severe peritoneal metastases. CLINICAL

trial registrationjRCTs041180007.

Indexed as

FOLFOXGastric cancerInadequate oral intakeMassive ascitesSevere peritoneal metastases

Identifiers

PMID42658449

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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.