Evidence map›Paper›PMID 34755009›Full record

ArticleAnnals of gastroenterological surgery2021

Effects of an oral elemental nutritional supplement in gastric cancer patients with adjuvant S-1 chemotherapy after gastrectomy: A multicenter, open-label, single-arm, prospective phase II study (OGSG1108).

Hiroshi Imamura, Jin Matsuyama, Kazuhiro Nishikawa, Shunji Endo, Tomono Kawase, Yutaka Kimura, Junichi Fukui, Junji Kawada, Yukinori Kurokawa, Kazumasa Fujitani and 8 more

Open access · goldAbstract read
In one paragraph

Article in Annals of gastroenterological surgery, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
3.4field-weighted citation impact, top 7% 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

13 citing papers in PubMed, 24 citations in OpenAlex.

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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

18 authors at 9 institutions in 1 country.

Hiroshi ImamuraDepartment of Surgery Toyonaka Municipal Hospital Toyonaka Japan.ORCID https://orcid.org/0000-0002-4294-6289
Jin MatsuyamaDepartment of Gastroenterological Surgery Higashiosaka City Medical Center Higashiosaka Japan.
Kazuhiro NishikawaDepartment of Surgery National Hospital Organization Osaka National Hospital Osaka Japan.
Shunji EndoDepartment of Digestive Surgery Kawasaki Medical School Okayama Japan.
Tomono KawaseDepartment of Surgery Toyonaka Municipal Hospital Toyonaka Japan.
Yutaka KimuraDepartment of Surgery Kindai University Faculty of Medicine Osaka-Sayama Japan.ORCID https://orcid.org/0000-0002-0188-0586
Junichi FukuiDepartment of Surgery Katano Hospital Katano Japan.
Junji KawadaDepartment of Surgery Osaka general medical center Osaka Japan.
Yukinori KurokawaDepartment of Gastroenterological Surgery Osaka University Graduate School of Medicine Suita Japan.ORCID https://orcid.org/0000-0002-2883-0132
Kazumasa FujitaniDepartment of Surgery Osaka general medical center Osaka Japan.
Daisuke SakaiDepartment of Frontier Science for Cancer and Chemotherapy Osaka University Graduate School of Medicine Suita Japan.
Hisato KawakamiDepartment of Medical Oncology Kindai University Faculty of Medicine Osaka-Sayama Japan.ORCID https://orcid.org/0000-0002-3280-4850
Toshimasa TsujinakaDepartment of Surgery Izumi City General Hospital Izumi Japan.
Toshio ShimokawaClinical Study Support Center Wakayama Medical University Hospital Wakayama Japan.
Yoshihiro MatsubaraBiostatistical Research Association Toyonaka Japan.
Taroh SatohDepartment of Frontier Science for Cancer and Chemotherapy Osaka University Graduate School of Medicine Suita Japan.
Hiroshi FurukawaDepartment of Surgery Kindai University Faculty of Medicine Osaka-Sayama Japan.
Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)
The University of Osaka · JPKindai University · JPToyonaka Municipal Hospital · JPIzumi City General Hospital · JPKawasaki Medical School · JPKindai University Hospital · JPOsaka City General Hospital · JPOsaka National Hospital · JPWakayama Medical University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimPost-surgical weight loss influences chemotherapy compliance and may be a risk factor for survival. Intake of an oral elemental nutritional supplement (OENS) can reduce weight loss after gastric cancer (GC) surgery. We assessed whether therapy completion levels would increase in patients receiving postoperative adjuvant chemotherapy in combination with an OENS.

methodsThis was a multicenter, open-label, single-arm, phase II study in GC patients who underwent curative total or distal gastrectomy (TG/DG) and received adjuvant S-1 chemotherapy. The primary endpoint was the S-1 completion rate for 1 year with a relative performance (RP) value of ≥70%; secondary endpoints included factors affecting the completion rate of S-1, RP value after eight S-1 courses, S-1 and OENS persistence rates, nutritional index, OENS compliance, and safety.

resultsIn 71 efficacy-evaluable patients, the S-1 completion rate was 69.0% (TG, 68.0%; DG, 69.6%) and the RP value was 87.5 (TG, 89.1; DG, 87.5). Over eight treatment courses, median persistence rates were 89.0% for S-1 and 93.8% for the OENS. The mean OENS compliance was 81.8% at the fourth S-1 course and 52.9% at the eighth course. The incidence of Grade 3 or 4 adverse events was 27.2%, most commonly neutropenia (12.3%).

conclusionsThe completion rate of S-1 for 1 year in patients who could take the OENS exceeded the pre-defined threshold level. Randomized controlled trials are warranted to confirm the role of OENS in adjuvant chemotherapy.

Indexed as

adjuvant chemotherapygastrectomygastric cancersupplemental nutrition

Identifiers

PMID34755009
PMCPMC8560593
OpenAlexW3187058611

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.