Evidence map›Paper›PMID 38194163›Full record

Trial reportTargeted oncology2024

Exploratory Biomarker Analysis Using Plasma Angiogenesis-Related Factors and Cell-Free DNA in the TRUSTY Study: A Randomized, Phase II/III Study of Trifluridine/Tipiracil Plus Bevacizumab as Second-Line Treatment for Metastatic Colorectal Cancer.

Yu Sunakawa, Yasutoshi Kuboki, Jun Watanabe, Tetsuji Terazawa, Hisato Kawakami, Mitsuru Yokota, Masato Nakamura, Masahito Kotaka, Naotoshi Sugimoto, Hitoshi Ojima and 14 more

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

Trial report in Targeted oncology, 2024. 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
1.1field-weighted citation impact, top 21% 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, 4 citations in OpenAlex.

  1. Trial
  2. Review
  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

24 authors at 20 institutions in 1 country.

Yu SunakawaDepartment of Clinical Oncology, St. Marianna University School of Medicine, 2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511, Japan. y.sunakawa@marianna-u.ac.jp.ORCID 0000-0002-0163-7543
Yasutoshi KubokiDepartment of Experimental Therapeutics, National Cancer Center Hospital East, Kashiwa, Japan.ORCID 0000-0003-3675-953X
Jun WatanabeDepartment of Surgery, Gastroenterological Center, Yokohama City University Medical Center, Yokohama, Japan.ORCID 0000-0002-7187-3664
Tetsuji TerazawaCancer Chemotherapy Center, Osaka Medical and Pharmaceutical University, Takatsuki, Japan.
Hisato KawakamiDepartment of Medical Oncology, Kindai University Faculty of Medicine Hospital, Osaka-Sayama, Japan.ORCID 0000-0002-3280-4850
Mitsuru YokotaDepartment of General Surgery, Kurashiki Central Hospital, Kurashiki, Japan.
Masato NakamuraAizawa Comprehensive Cancer Center, Aizawa Hospital, Matsumoto, Japan.
Masahito KotakaGastrointestinal Cancer Center, Sano Hospital, Kobe, Japan.
Naotoshi SugimotoDepartment of Genetic Oncology, Osaka International Cancer Institute, Osaka, Japan.
Hitoshi OjimaDepartment of Gastroenterological Surgery, Gunma Prefectural Cancer Center, Ota, Japan.ORCID 0000-0003-3551-9796
Eiji OkiDepartment of Surgery and Science, Graduate School of Medical Science, Kyushu University, Fukuoka, Japan.ORCID 0000-0002-9763-9366
Takeshi KajiwaraDepartment of Gastrointestinal Medical Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.ORCID 0000-0001-5337-9833
Yoshiyuki YamamotoDepartment of Gastroenterology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.
Yasushi TsujiDepartment of Medical Oncology, Tonan Hospital, Sapporo, Japan.
Tadamichi DendaDivision of Gastroenterology, Chiba Cancer Center, Chiba, Japan.
Takao TamuraDepartment of Medical Oncology, Kindai University Nara Hospital, Ikoma, Japan.
Soichiro IshiharaDepartment of Surgical Oncology, The University of Tokyo, Tokyo, Japan.
Hiroya TaniguchiDepartment of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.ORCID 0000-0003-1407-6682
Takako Eguchi NakajimaDepartment of Early Clinical Development, Kyoto University Graduate School of Medicine, Kyoto, Japan.ORCID 0000-0002-4589-2335
Satoshi MoritaDepartment of Biomedical Statistics and Bioinformatics, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
Kuniaki ShiraoFaculty of Medicine, Oita University, Yufu, Japan.
Naruhito TakenakaClinical Development and Medical Affairs Division, Taiho Pharmaceutical Co., Ltd, Tokyo, Japan.ORCID 0009-0000-7746-6982
Daisuke OzawaClinical Development and Medical Affairs Division, Taiho Pharmaceutical Co., Ltd, Tokyo, Japan.
Takayuki YoshinoDepartment of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.ORCID 0000-0002-0489-4756
Kyoto University · JPNational Cancer Center Hospital East · JPTaiho Pharmaceutical (Japan) · JPAichi Cancer Center · JPAizawa Hospital · JPChiba Cancer Center · JPHyogo Prefectural Cancer Center · JPKindai University Hospital · JPKurashiki Central Hospital · JPKyushu University · JPNara Medical University Hospital · JPOita University · JPOsaka International Cancer Institute · JPOsaka University of Pharmaceutical Sciences · JPShikoku Cancer Center · JPSt. Marianna University School of Medicine · JPThe University of Tokyo · JPTonan Hospital · JPUniversity of Tsukuba · JPYokohama City University Medical Center · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe TRUSTY study evaluated the efficacy of second-line trifluridine/tipiracil (FTD/TPI) plus bevacizumab in metastatic colorectal cancer (mCRC).

objectiveThis exploratory biomarker analysis of TRUSTY investigated the relationship between baseline plasma concentrations of angiogenesis-related factors and cell-free DNA (cfDNA), and the efficacy of FTD/TPI plus bevacizumab in patients with mCRC. PATIENTS AND

methodsThe disease control rate (DCR) and progression-free survival (PFS) were compared between baseline plasma samples of patients with high and low plasma concentrations (based on the median value) of angiogenesis-related factors. Correlations between cfDNA concentrations and PFS were assessed.

resultsBaseline characteristics (n = 65) were as follows: male/female, 35/30; median age, 64 (range 25-84) years; and RAS status wild-type/mutant, 29/36. Patients in the hepatocyte growth factor (HGF)-low and interleukin (IL)-8-low groups had a significantly higher DCR (risk ratio [95% confidence intervals {CIs}]) than patients in the HGF-high (1.83 [1.12-2.98]) and IL-8-high (1.70 [1.02-2.82]) groups. PFS (hazard ratio {HR} [95% CI]) was significantly longer in patients in the HGF-low (0.33 [0.14-0.79]), IL-8-low (0.31 [0.14-0.70]), IL-6-low (0.19 [0.07-0.50]), osteopontin-low (0.39 [0.17-0.88]), thrombospondin-2-low (0.42 [0.18-0.98]), and tissue inhibitor of metalloproteinase-1-low (0.26 [0.10-0.67]) groups versus those having corresponding high plasma concentrations of these angiogenesis-related factors. No correlation was observed between cfDNA concentration and PFS.

conclusionLow baseline plasma concentrations of HGF and IL-8 may predict better DCR and PFS in patients with mCRC receiving FTD/TPI plus bevacizumab, however further studies are warranted. CLINICAL TRIAL REGISTRATION NUMBER: jRCTs031180122.

Indexed as

Cell-Free Nucleic AcidsColonic NeoplasmsColorectal NeoplasmsFrontotemporal DementiaPyrrolidinesThymineAdultAgedAged, 80 and overAngiogenesisAntineoplastic Combined Chemotherapy ProtocolsBevacizumabBiomarkersFemaleHumansInterleukin-8BevacizumabBiomarkersCell-Free Nucleic AcidsInterleukin-8PyrrolidinesThyminetipiracilTissue Inhibitor of Metalloproteinase-1TrifluridineUracil

Identifiers

PMID38194163
PMCPMC10830797
OpenAlexW4390769788

What OpenQuestion holds

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LicenceCC BY-NC
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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.