Evidence map›Paper›PMID 35489010›Full record

Observational studyInternational journal of clinical oncology2022

Real-world effectiveness of third- or later-line treatment in Japanese patients with HER2-positive, unresectable, recurrent or metastatic gastric cancer: a retrospective observational study.

Daisuke Sakai, Takeshi Omori, Soichi Fumita, Junya Fujita, Ryohei Kawabata, Jin Matsuyama, Hisateru Yasui, Motohiro Hirao, Tomono Kawase, Kentaro Kishi and 12 more

Open access · hybridAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in International journal of clinical oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 4 pooled it
2.7field-weighted citation impact, top 9% 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

14 citing papers in PubMed, 4 syntheses or guidelines pooled it, 18 citations in OpenAlex.

  1. Pooled it
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  9. Real-world effectiveness and safety of trastuzumab-deruxtecan in Japanese patients with HER2-positive advanced gastric cancer (EN-DEAVOR study).Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2025
    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

22 authors at 14 institutions in 1 country.

Daisuke SakaiOsaka University Graduate School of Medicine, Suita, Japan. dsakai@cfs.med.osaka-u.ac.jp.ORCID http://orcid.org/0000-0002-9436-7553
Takeshi OmoriOsaka International Cancer Institute, Osaka, Japan.
Soichi FumitaKindai University, Osakasayama, Japan.
Junya FujitaSakai City Medical Center, Sakai, Japan.
Ryohei KawabataOsaka Rosai Hospital, Sakai, Japan.
Jin MatsuyamaHigashiosaka City Medical Center, Higashiosaka, Japan.
Hisateru YasuiKobe City Medical Center General Hospital, Kobe, Japan.
Motohiro HiraoNational Hospital Organization Osaka National Hospital, Osaka, Japan.
Tomono KawaseToyonaka Municipal Hospital, Toyonaka, Japan.
Kentaro KishiOsaka Police Hospital, Osaka, Japan.
Yoshiki TaniguchiSaiseikai Senri Hospital, Suita, Japan.
Yasuhiro MiyazakiOsaka General Medical Center, Osaka, Japan.
Junji KawadaYao Municipal Hospital, Yao, Japan.
Hironaga SatakeKansai Medical University, Hirakata, Japan.
Tomoko MiuraDaiichi Sankyo Co., Ltd., Tokyo, Japan.
Akimitsu MiyakeOsaka University Hospital, Suita, Japan.
Yukinori KurokawaOsaka University Graduate School of Medicine, Suita, Japan.
Makoto YamasakiOsaka University Graduate School of Medicine, Suita, Japan.
Tomomi YamadaOsaka University Hospital, Suita, Japan.
Taroh SatohOsaka University Graduate School of Medicine, Suita, Japan.
Hidetoshi EguchiOsaka University Graduate School of Medicine, Suita, Japan.
Yuichiro DokiOsaka University Graduate School of Medicine, Suita, Japan.
The University of Osaka · JPKansai Medical University · JPSakai Municipal Hospital · JPDaiichi-Sankyo (Japan) · JPKindai University · JPKobe City Medical Center General Hospital · JPOsaka International Cancer Institute · JPOsaka National Hospital · JPOsaka Police Hospital · JPOsaka Prefectural Medical Center · JPOsaka University Hospital · JPSaiseikaisenri Hospital · JPTohoku University · JPToyonaka Municipal Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundReal-world evidence on the preference for and effectiveness of third- or later-line (3L +) monotherapy for HER2-positive gastric cancer is limited in Japan. This study evaluated the utility of nivolumab, irinotecan, and trifluridine/tipiracil (FTD/TPI) monotherapy as 3L + treatment in Japanese patients with HER2-positive gastric/gastroesophageal junction (G/GEJ) cancer who were previously treated with trastuzumab.

methodsIn this multicenter, retrospective, observational study (20 centers), data of eligible patients were extracted from medical records (September 22, 2017-March 31, 2020), with follow-up until June 30, 2020. Outcomes included overall survival (OS), real-world progression-free survival (rwPFS), time to treatment failure (TTF), objective response rate (ORR; complete response [CR] + partial response [PR]), and disease control rate (DCR).

resultsOf 127 enrolled patients, the overall analysis population comprised 117 patients (median [range] age, 71 [38-89] years). The most commonly prescribed 3L + monotherapy was nivolumab (n = 100), followed by irinotecan (n = 12) and FTD/TPI (n = 5). The median (95% confidence interval [CI]) OS, rwPFS, and TTF were 6.2 (4.5-8.0), 1.9 (1.5-2.3), and 1.8 (1.5-2.2) months, respectively, at median (range) 150 (25-1007) days of follow-up. The ORR (CR + PR) and DCR were 9.0% (1% + 8%) and 32.0%, respectively. Factors such as higher neutrophil-lymphocyte ratio (≥ 2.54), Glasgow prognostic score (≥ 1), Eastern Cooperative Oncology Group performance status (ECOG PS; ≥ 2), and hepatic metastasis significantly impacted OS.

conclusionsThe observed OS in this study for HER2-positive G/GEJ cancer was shorter than that reported previously, suggesting that the effectiveness of nivolumab, irinotecan, or FTD/TPI as 3L + therapy may be limited.

Indexed as

Frontotemporal DementiaStomach NeoplasmsAgedAntineoplastic Combined Chemotherapy ProtocolsHumansIrinotecanJapanNivolumabRetrospective StudiesIrinotecanNivolumabGastric cancerHER2 +JapanNivolumabThird- or later-line treatment

Identifiers

PMID35489010
PMCPMC9209345
OpenAlexW4225164052

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.