Evidence map›Paper›PMID 34050432›Full record

Observational studyGastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association2021

A post-marketing observational study of ramucirumab in patients with gastric cancer in Japan.

Yucherng Chen, Taeko Katayose, Soshi Nagaoka, Yongzhe Piao, Kensei Yamaguchi, Hiroya Asou

Open access · hybridAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.7field-weighted citation impact, top 28% 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

3 citing papers in PubMed, 5 citations in OpenAlex.

  1. Article
  2. Article
  3. 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

6 authors at 2 institutions in 1 country.

Yucherng Chen, Eli Lilly Japan K.K., Lilly Plaza One Building, 5-1-28 Isogamidori, Chuo-Ku, Kobe, Hyogo, 651-0086, Japan. chen_yucherng@lilly.com.ORCID http://orcid.org/0000-0002-2755-0147
Taeko Katayose, Eli Lilly Japan K.K., Lilly Plaza One Building, 5-1-28 Isogamidori, Chuo-Ku, Kobe, Hyogo, 651-0086, Japan.
Soshi Nagaoka, Eli Lilly Japan K.K., Lilly Plaza One Building, 5-1-28 Isogamidori, Chuo-Ku, Kobe, Hyogo, 651-0086, Japan.
Yongzhe Piao, Eli Lilly Japan K.K., Lilly Plaza One Building, 5-1-28 Isogamidori, Chuo-Ku, Kobe, Hyogo, 651-0086, Japan.
Kensei YamaguchiDepartment of Gastroenterological Chemotherapy, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.
Hiroya Asou, Eli Lilly Japan K.K., Lilly Plaza One Building, 5-1-28 Isogamidori, Chuo-Ku, Kobe, Hyogo, 651-0086, Japan.
Eli Lilly (Japan) · JPSaitama Cancer Center · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis study evaluated the safety and effectiveness of ramucirumab monotherapy and combination therapy for advanced gastric cancer in the real-world setting.

methodsThis single-arm, prospective, multicenter, non-interventional, observational, post-marketing study was conducted in Japan from August 2015 to March 2019. Patients with unresectable advanced or recurrent gastric cancer and newly prescribed ramucirumab were followed for up to 12 months after first treatment. Data on adverse events and survival were collected via Electronic Data Capture.

resultsOf 687 enrolled patients, 658 were eligible for analysis. Most patients received either ramucirumab monotherapy (123/658; 18.7%) or ramucirumab plus paclitaxel combination therapy (528/658; 80.2%). The majority of patients reported ≥ 1 adverse events in both the combination therapy (any grade, 479/528; 90.7%; ≥ Grade 3, 321/528; 60.8%) and monotherapy groups (any grade, 77/123; 62.6%; ≥ Grade 3, 42/123; 34.2%). The most common any grade adverse events were neutropenia (combination: 49.6%; monotherapy: 8.9%), fatigue (combination: 19.5%; monotherapy: 13.8%), and decreased appetite (combination: 18.2%; monotherapy: 10.6%). Grade 5 adverse events were reported in 4 patients, including metastases to meninges, pneumonia aspiration, death, and gastric perforation; of these, gastric perforation was deemed treatment-related. Median survival time was 5.7 months (95% confidence interval: 4.1-6.8 months) following monotherapy and 11.0 months (95% confidence interval: 9.8-12.2 months) following combination therapy.

conclusionsThis analysis adds to the limited data available on ramucirumab use in a real-world setting, demonstrating similar safety and effectiveness for ramucirumab in treating advanced gastric cancer in routine clinical practice in Japan to that of global clinical trials.

Indexed as

Adverse Drug Reaction Reporting SystemsAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsFemaleHumansJapanMaleMiddle AgedPaclitaxelProspective StudiesRamucirumabStomach NeoplasmsAntibodies, Monoclonal, HumanizedAntineoplastic AgentsPaclitaxelRamucirumabGastric cancerPost-marketing surveillanceRamucirumab

Identifiers

PMID34050432
PMCPMC8502135
OpenAlexW3165545980

What OpenQuestion holds

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LicenceCC BY
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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.