Evidence map›Paper›PMID 28667408›Full record

Trial reportInternational journal of clinical oncology2017

Randomized phase II study of daily and alternate-day administration of S-1 for advanced gastric cancer (JFMC43-1003).

Hiroaki Tanaka, Mitsuro Kanda, Satoshi Morita, Masataka Taguri, Kazuhiro Nishikawa, Mitsuo Shimada, Kazuya Muguruma, Keisuke Koeda, Masazumi Takahashi, Mikihito Nakamori and 12 more

Abstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International journal of clinical oncology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

5 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. 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

22 authors.

Hiroaki TanakaDepartment of Surgical Oncology, Osaka City University Graduate School of Medicine, 1-4-3 Asahimachi, Abenoku, Osaka, 545-8585, Japan. hiroakitan@medosaka-cu.ac.jp.
Mitsuro KandaDepartment of Gastroenterological Surgery (Surgery II), Nagoya University Graduate School of Medicine, Nagoya, Japan.
Satoshi MoritaDepartment of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Masataka TaguriDepartment of Biostatistics, Yokohama City University Graduate School of Medicine, Yokohama, Japan.
Kazuhiro NishikawaDepartment of Surgery, Osaka National Hospital, Osaka, Japan.
Mitsuo ShimadaDepartment of Surgery, Tokushima University, Tokushima, Japan.
Kazuya MugurumaDepartment of Surgical Oncology, Osaka City University Graduate School of Medicine, 1-4-3 Asahimachi, Abenoku, Osaka, 545-8585, Japan.
Keisuke KoedaDepartment of Surgery, Iwate Medical University, Morioka, Japan.
Masazumi TakahashiDepartment of Gastrointestinal Surgery, Yokohama Municipal Citizen's Hospital, Yokohama, Japan.
Mikihito NakamoriSecond Department of Surgery, Wakayama Medical University, Wakayama, Japan.
Hiroyuki KonnoHamamatsu University School of Medicine, Hamamatsu, Japan.
Akihito TsujiClinical Oncology, Faculty of Medicine, Kagawa University, Takamatsu, Japan.
Yoshinori HosoyaDepartment of Gastrointestinal Surgery, Jichi Medical University, Shimotsuke, Japan.
Tetsuhiko ShirasakaTokushima University, Kitasato University, Tokushima, Japan.
Susumu YamamitsuSapporo Tsukisamu Hospital, Sapporo, Japan.
Michio SowaHistory of Yukioka School of Allied Health Professions, Osaka, Japan.
Masaki KitajimaInternational University of Health and Welfare, Otawara, Japan.
Masazumi OkajimaDepartment of Surgery, Hiroshima City Hiroshima Citizens Hospital, Hiroshima, Japan.
Michiya KobayashiCancer Treatment Center, Kochi Medical School Hospital, Kochi, Japan.
Junichi SakamotoJapanese Foundation for Multidisciplinary Treatment of Cancer, Tokyo, Japan.
Shigetoyo SajiJapanese Foundation for Multidisciplinary Treatment of Cancer, Tokyo, Japan.
Kosei HirakawaOsaka City University Hospital, Osaka, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeAlthough S-1 based chemotherapy for patients with advanced gastric cancer has generally been accepted in Japan, discontinuations of treatment have been reported due to grade 3 or more adverse events. The present randomized phase II study was conducted to test whether alternate-day administration of S-1 would be comparably efficient and reduce adverse events compared with conventional daily administration in the first-line chemotherapy for advanced gastric cancer.

methods132 patients with advanced gastric cancer were randomly assigned to 1:2 ratios to receive treatment with daily at a standard dose of 80 mg/m

resultsThe 6-month PFS rate of the alternate-day administration group was 20.9% and failed to show significant difference from the pre-specified threshold at 15% (p = 0.117), whereas that of the daily administration group was 39.1% and significantly higher than the threshold (p = 0.001). The hazard ratio of the alternate-day administration group compared with the daily administration group was 1.753 (95% confidence interval (CI) 1.15-2.68, p = 0.010). With regard to OS, the hazard ratio of the alternate-day administration group compared with the daily administration group was 1.487 (95% CI 0.97-2.29, p = 0.072). The median TTF were 4.2 and 2.8 months in the daily and alternate-day administration group, respectively (p = 0.007).

conclusionThe alternate-day administration of S-1 was not recommended as the first-line therapy for patients with advanced gastric cancer.

Indexed as

AdultAgedAged, 80 and overAntimetabolites, AntineoplasticDisease-Free SurvivalDrug Administration ScheduleDrug CombinationsFemaleHumansJapanMaleMiddle AgedOxonic AcidStomach NeoplasmsTegafurTreatment OutcomeAntimetabolites, AntineoplasticDrug CombinationsOxonic AcidS 1 (combination)TegafurChemotherapyGastric cancerRandomized phase II studyS-1

Identifiers

PMID28667408
PMCPMC5677054

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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.