Evidence map›Paper›PMID 35546669›Full record

Observational studyBMC cancer2022

Safety and effectiveness of eribulin in Japanese patients with soft tissue sarcoma including rare subtypes: a post-marketing observational study.

Akira Kawai, Hiroyuki Narahara, Shunji Takahashi, Tomoki Nakamura, Hiroshi Kobayashi, Yasunori Megumi, Toshiyuki Matsuoka, Eisuke Kobayashi

Registry-linked trialOpen access · goldAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in BMC cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03058406 (Special Use Investigation of HALAVEN), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
1.4field-weighted citation impact, top 19% 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.

NCT03058406 completednot on this map

Special Use Investigation of HALAVEN (HAL03T) - Study on Safety and Efficacy in Patients With Soft Tissue Sarcomas

TypeobservationalSponsorEisai Co., Ltd.Ran2016 to 2018Enrolled256ConditionsSarcoma, Soft TissueArmsEribulin mesylate
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 10 citations in OpenAlex.

  1. 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

8 authors at 5 institutions in 1 country.

Akira KawaiDepartment of Musculoskeletal Oncology and Rehabilitation Medicine, National Cancer Center Hospital, Rare Cancer Center, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan. akawai@ncc.go.jp.
Hiroyuki NaraharaDepartment of Medical Oncology, Hyogo Prefectural Nishinomiya Hospital, Nishinomiya, Japan.
Shunji TakahashiDepartment of Medical Oncology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.
Tomoki NakamuraDepartment of Orthopedic Surgery, Mie University Graduate School of Medicine, Tsu, Japan.
Hiroshi KobayashiDepartment of Orthopedic Surgery, Faculty of Medicine, The University of Tokyo, Tokyo, Japan.
Yasunori MegumiClinical Planning and Development Department, Medical Headquarters, Eisai Co., Ltd., Tokyo, Japan.
Toshiyuki MatsuokaClinical Planning and Development Department, Medical Headquarters, Eisai Co., Ltd., Tokyo, Japan.
Eisuke KobayashiDepartment of Musculoskeletal Oncology and Rehabilitation Medicine, National Cancer Center Hospital, Rare Cancer Center, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.
Eisai (Japan) · JPHyogo Prefectural Nishinomiya Hospital · JPMie University · JPThe Cancer Institute Hospital · JPThe University of Tokyo · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSoft tissue sarcomas (STSs) are a heterogeneous group of cancers with over 100 described subtypes. While these cancers are infrequent, the prognosis is quite poor, particularly for those with stage IV metastatic disease. Patients for whom curative resection is difficult or those with recurrent metastatic disease are treated with chemotherapy, although the options are very limited. Eribulin is an approved treatment of all STS subtypes in Japan. Efficacy and safety data for the treatment of rare STS subtypes other than liposarcoma and leiomyosarcoma (L-type sarcomas) are limited. This nationwide, multicenter, prospective, post-marketing observational study was conducted to assess the real-world effectiveness and safety of eribulin in Japanese patients with STS.

methodsPatients with all types of STS and who consented to eribulin treatment were eligible to participate. The observation period was 1 year, starting at treatment initiation, and clinical outcomes were followed up for 2 years after initiating treatment. The primary endpoint was overall survival (OS). Additional outcomes included time-to-treatment failure (TTF), objective response rate (ORR), disease control rate (DCR), and safety. ORR and DCR were evaluated using imaging findings. Effectiveness results were analyzed both for all patients and by STS subtype.

resultsA total of 256 patients were enrolled; 252 and 254 were included in the effectiveness and safety analysis set, respectively. Most patients (83.1%) received an initial eribulin dose of 1.4 mg/m

conclusionsEribulin demonstrated effectiveness and a manageable safety profile for patients with STS, although the effectiveness of eribulin was not demonstrated for some non-L-type subtypes.

trial registrationNCT03058406 ( ClinicalTrials.gov ).

Indexed as

SarcomaSoft Tissue NeoplasmsAgedFuransHumansJapanKetonesMarketingPolyether PolyketidesProspective StudiesTreatment OutcomeeribulinFuransKetonesPolyether PolyketidesEribulinJapanOverall survivalPost-marketing studySoft tissue sarcoma

Identifiers

PMID35546669
PMCPMC9092704
OpenAlexW4280524659

What OpenQuestion holds

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Registered trials

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.