Evidence map›Paper›PMID 29071414›Full record

Trial reportCancer chemotherapy and pharmacology2017

A non-randomized, open-label, single-arm, Phase 2 study of emibetuzumab in Asian patients with MET diagnostic positive, advanced gastric cancer.

Daisuke Sakai, Hyun Cheol Chung, Do-Youn Oh, Se Hoon Park, Shigenori Kadowaki, Yeul Hong Kim, Akihito Tsuji, Yoshito Komatsu, Yoon-Koo Kang, Kazunori Uenaka and 5 more

Open access · hybridAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Cancer chemotherapy and pharmacology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
1.9field-weighted citation impact, top 14% 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

17 citing papers in PubMed, 1 synthesis or guideline pooled it, 30 citations in OpenAlex.

  1. Pooled it
  2. A Phase Ib/II Study of Ramucirumab in Combination with Emibetuzumab in Patients with Advanced Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2019
    Trial
  3. Review
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  14. Comprehensive review of targeted therapy for colorectal cancer.Signal transduction and targeted therapy · 2020
    Review
  15. Journal of experimental pharmacology · 2020
    Review
  16. HGF/c-Met Axis: The Advanced Development in Digestive System Cancer.Frontiers in cell and developmental biology · 2020
    Review
  17. Review
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

15 authors at 12 institutions in 3 countries.

Daisuke SakaiOsaka University Hospital, Osaka, 565-0871, Japan.
Hyun Cheol ChungYonsei Cancer Center, Yonsei University College of Medicine, Seoul, 03722, South Korea.
Do-Youn OhSeoul National University Hospital, Seoul, 03080, South Korea.
Se Hoon ParkSungkyunkwan University Samsung Medical Center, Seoul, 06351, South Korea.
Shigenori KadowakiAichi Cancer Center Hospital, Nagoya, 464-8681, Japan.
Yeul Hong KimKorea University College of Medicine, Seoul, 02841, South Korea.
Akihito TsujiDepartment of Clinical Oncology, Faculty of Medicine, Kagawa University, Kita, 761-0793, Japan.
Yoshito KomatsuCancer Center, Hokkaido University Hospital, Sapporo, 060-8648, Japan.
Yoon-Koo KangAsan Medical Center, University of Ulsan College of Medicine, Seoul, 138-736, South Korea.
Kazunori UenakaEli Lilly Japan K.K., Kobe, 651-0086, Japan.
Sameera R WijayawardanaEli Lilly and Company, Indianapolis, IN, 46285, USA.
Volker WacheckEli Lilly and Company, Indianapolis, IN, 46285, USA.
Xuejing WangEli Lilly and Company, Indianapolis, IN, 46285, USA.
Ayuko YamamuraEli Lilly Japan K.K., Kobe, 651-0086, Japan.
Toshihiko DoiNational Cancer Center Hospital East, 5-1, Kashiwanoha 6-chome, Kashiwa, Chiba, 277-8577, Japan. tdoi@east.ncc.go.jp.
Eli Lilly (United States) · USEli Lilly (Japan) · JPAichi Cancer Center · JPHokkaido University Hospital · JPKagawa University · JPKorea University · KRNational Cancer Center Hospital East · JPOsaka University Hospital · JPSamsung Medical Center · KRSeoul National University Hospital · KRUniversity of Ulsan · KRYonsei University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeMesenchymal-epithelial transition factor (MET) is expressed in gastric cancer and associated with poor clinical outcomes. We assessed activity, safety, and pharmacokinetics of emibetuzumab, a bivalent monoclonal anti-MET antibody that blocks ligand-dependent and ligand-independent MET signaling.

methodsThis non-randomized, single-arm, Phase 2 study enrolled Asian patients with MET diagnostic positive advanced gastric adenocarcinoma. Emibetuzumab (2000 mg, intravenous) was given on days 1 and 15 (28-day cycle). The primary endpoint was 8-week progression-free survival rate. Secondary objectives included safety, pharmacokinetics, overall survival, and change in tumor size.

resultsTumors from 65 patients were immunohistochemically screened to enroll 15 MET diagnostic positive patients (23% positivity; 8 Japanese, 7 Korean; 10 male). Eight-week progression-free survival rate was 0.47 (70% CI, 0.33-0.59). Disease control rate was 40% (target lesion decreases, three patients; no complete/partial responses according to RECIST). Median overall survival was 17.1 weeks (95% CI, 6.3-not achievable). No serious emibetuzumab-related adverse events or new safety signals emerged. Grade ≥ 3 possibly drug-related adverse events were hyperkalemia, hyponatremia, and hyperuricemia (one each). Emibetuzumab's pharmacokinetics profile was similar to that observed previously. MET expression and clinical outcomes were not obviously associated.

conclusionEmibetuzumab was well tolerated with limited single-agent activity in advanced gastric adenocarcinoma.

Indexed as

AdultAgedAntibodies, BispecificAntibodies, Monoclonal, HumanizedAsian PeopleDisease-Free SurvivalFemaleHumansMaleMiddle AgedStomach NeoplasmsAntibodies, BispecificAntibodies, Monoclonal, HumanizedemicizumabAntibodies, monoclonal, humanizedClinical trialLY2875358MET protein, humanPhase IIStomach neoplasms

Identifiers

PMID29071414
PMCPMC5686250
OpenAlexW2765207681

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.