Evidence map›Paper›PMID 38295160›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2024

Phase II Study of the Liposomal Formulation of Eribulin (E7389-LF) in Combination with Nivolumab: Results from the Gastric Cancer Cohort.

Akihito Kawazoe, Noboru Yamamoto, Naotoshi Sugimoto, Hisato Kawakami, Takashi Oshima, Kensei Yamaguchi, Kaori Hino, Motohiro Hirao, Yukinori Kurokawa, Takeshi Kawakami and 10 more

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

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 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
1.3field-weighted citation impact, top 22% 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, 3 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors at 15 institutions in 1 country.

Akihito KawazoeNational Cancer Hospital East, Kashiwa, Japan.ORCID 0000-0001-8632-3748
Noboru YamamotoNational Cancer Center Hospital, Tokyo, Japan.ORCID 0000-0002-0787-2851
Naotoshi SugimotoOsaka International Cancer Institute, Osaka, Japan.ORCID 0000-0001-9579-690X
Hisato KawakamiKindai University Faculty of Medicine, Osakasayama, Japan.ORCID 0000-0002-3280-4850
Takashi OshimaKanagawa Cancer Center, Yokohama, Japan.ORCID 0000-0001-5818-8649
Kensei YamaguchiThe Cancer Institute Hospital of Japanese Foundation for Cancer, Tokyo, Japan.ORCID 0000-0001-6887-5709
Kaori HinoNHO Shikoku Cancer Center, Ehime, Japan.ORCID 0000-0001-9046-253X
Motohiro HiraoNational Hospital Organization Osaka National Hospital, Osaka, Japan.ORCID 0000-0002-6509-6416
Yukinori KurokawaOsaka University Graduate School of Medicine, Suita, Japan.ORCID 0000-0002-2883-0132
Takeshi KawakamiShizuoka Cancer Center, Shizuoka, Japan.ORCID 0000-0001-9385-9516
Masahiro TsudaHyogo Cancer Center, Hyogo, Japan.ORCID 0000-0001-6442-9250
Hiroki HaraSaitama Cancer Center, Saitama, Japan.ORCID 0000-0003-3881-9815
Shota KanameOno Pharmaceutical Co., Ltd., Osaka, Japan.ORCID 0009-0008-4436-6027
Daiko MatsuokaEisai Co., Ltd., Tokyo, Japan.ORCID 0000-0001-8250-7603
Yohei OtakeEisai Co., Ltd., Tokyo, Japan.ORCID 0000-0001-5056-403X
Keisuke YasudaEisai Co., Ltd., Tokyo, Japan.ORCID 0009-0005-8324-272X
Takao TakaseEisai Co., Ltd., Tokyo, Japan.ORCID 0000-0002-4556-5035
Shuya TakashimaEisai Co., Ltd., Tokyo, Japan.ORCID 0009-0004-7148-9250
Taro SembaEisai Co., Ltd., Ibaraki, Japan.ORCID 0000-0003-0432-1138
Kei MuroAichi Cancer Center Hospital, Nagoya, Japan.ORCID 0000-0002-5572-743X
Koei Chemical (Japan) · JPAichi Cancer Center · JPHyogo Prefectural Cancer Center · JPJapanese Foundation For Cancer Research · JPKanagawa Prefectural Hospital Organization · JPKindai University · JPNational Cancer Center Hospital East · JPOno Pharmaceutical (Japan) · JPOsaka International Cancer Institute · JPOsaka National Hospital · JPSaitama Cancer Center · JPShikoku Cancer Center · JPShizuoka Cancer Center · JPSoka University · JPTokyo National Hospital · JP

Funding

Eisai
6 · The paper itself

Abstract

purposeE7389-LF is a liposomal formulation of the microtubule dynamics inhibitor eribulin and has shown preliminary efficacy in the treatment of gastric cancer. Study 120, a phase Ib/II open-label study, assessed efficacy and safety of E7389-LF in combination with nivolumab, a programmed cell death (PD)-1 inhibitor. This report focuses on the gastric cancer cohort within the expansion phase. PATIENTS AND

methodsEligible patients had unresectable, measurable gastric cancer, progression following a platinum drug plus fluoropyrimidine (1L), and a taxane-containing regimen (2L). The primary objective of the expansion phase was objective response rate, secondary objectives included safety and PFS, and exploratory objectives included overall survival and biomarker evaluation. Patients received E7389-LF 2.1 mg/m2 in combination with nivolumab 360 mg every 3 weeks, both as intravenous infusions. Tumor responses were assessed every 6 weeks by the investigators per RECIST v1.1. Plasma and tumor biomarkers were assessed.

resultsIn the 31 patients who received E7389-LF in combination with nivolumab, the objective response rate was 25.8% [confidence interval (CI), 11.9-44.6]. The median progression-free survival was 2.69 months (95% CI, 1.91-2.99) and median overall survival was 7.85 months (95% CI, 4.47-not estimable). The most common treatment-related TEAE of any grade were neutropenia (77.4%), leukopenia (74.2%), and decreased appetite (51.6%). E7389-LF in combination with nivolumab significantly increased CD8-positive cells at C2D1 (P = 0.039), and six of seven vascular markers and four IFNγ-related markers showed increases from C1D1.

conclusionsPromising antitumor activity was observed with E7389-LF in combination with nivolumab in patients with gastric cancer, and no new safety signals were observed, compared with either monotherapy.

Indexed as

NivolumabPolyether PolyketidesStomach NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsFuransHumansKetonesTubulin ModulatorseribulinFuransKetonesNivolumabPolyether PolyketidesTubulin Modulators

Identifiers

PMID38295160
PMCPMC10982638
OpenAlexW4391380740

What OpenQuestion holds

Textmetadata
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.