Evidence map›Paper›PMID 31619197›Full record

Trial reportBMC cancer2019

Multicentre, phase II study of eribulin in combination with S-1 in patients with advanced breast cancer.

Tsutomu Iwasa, Junji Tsurutani, Satomi Watanabe, Ryoji Kato, Yutaka Mizuno, Yasuyuki Kojima, Tsutomu Takashima, Nobuki Matsunami, Takashi Morimoto, Jun Yamamura and 6 more

Abstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC cancer, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. 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

16 authors.

Tsutomu IwasaDepartment of Medical Oncology, Kindai University Faculty of Medicine, Osakasayam, Japan.
Junji TsurutaniAdvanced Cancer Translational Research Institute, Showa University, 1-5-8 Hatanodai, Shinagawa-ku, Tokyo, 142-8555, Japan. tsurutaj@med.showa-u.ac.jp.ORCID http://orcid.org/0000-0002-6260-6943
Satomi WatanabeDepartment of Medical Oncology, Kindai University Faculty of Medicine, Osakasayam, Japan.
Ryoji KatoDepartment of Medical Oncology, Kindai University Faculty of Medicine, Osakasayam, Japan.
Yutaka MizunoDepartment of Breast Surgery, Yokkaichi Municipal Hospital, Osakasayam, Japan.
Yasuyuki KojimaDivision of Breast and Endocrine Surgery, Department of Surgery, St. Marianna University School of Medicine, Osakasayam, Japan.
Tsutomu TakashimaDepartment of Surgical Oncology, Osaka City University Graduate School of Medicine, Yokkaichi, Japan.
Nobuki MatsunamiDepartment of Breast Surgery, Osaka Rosai Hospital, Kawasaki, Japan.
Takashi MorimotoDepartment of Breast Surgery, Yao Municipal Hospital, Osaka, Japan.
Jun YamamuraDepartment of Surgery, Breast Oncology, Sakai City Medical Center, Sakai, Japan.
Shoichiro OhtaniDepartment of Breast Surgery, Hiroshima City Hiroshima Citizens Hospital, Sakai, Japan.
Yuko TanabeDepartment of Medical Oncology, Toranomon Hospital, Sakai, Japan.
Tetsuhiro YoshinamiDepartment of Breast and Endocrine Surgery, Graduate school of medicine Osaka University, Hiroshima, Japan.
Toshimi TakanoDepartment of Medical Oncology, Toranomon Hospital, Sakai, Japan.
Yoshifumi KomoikeDepartment of Breast and Endocrine Surgery, Kindai University Faculty of Medicine, Tokyo, Japan.
Kazuhiko NakagawaDepartment of Medical Oncology, Kindai University Faculty of Medicine, Osakasayam, Japan.

Funding

Eisai not applicable
6 · The paper itself

Abstract

backgroundWe previously reported the synergistic effect of S-1 and eribulin in preclinical models. In addition, our phase I study revealed the recommended dose for the phase II study of the combination therapy in advanced breast cancer (ABC) patients pre-treated with anthracycline and taxane. Our current study reports on the efficacy and safety of the combined use of eribulin and S-1 in patients with ABC and poor prognosis.

methodsPatients with breast cancer who received prior anthracycline- and/or taxane-based therapy were assigned to receive a combination therapy of eribulin (1.4 mg/m

resultsThis study enrolled 33 patients. Confirmed ORR was 33.3% (95% CI: 17.3 to 52.8). Median PFS was 7.5 months (95% CI: 4.0 to 14.3). Median OS time was not reached during the current experimental periods. The most common grade 3/4 adverse event was neutropenia (68.8%).

conclusionsThe combination of eribulin and S-1 is safe and effective for treatment in patients with ABC and poor prognosis.

trial registrationCurrent Controlled Trials UMIN000015049 , date of registration: September 5th 2014.

Indexed as

AdultAgedAnthracyclinesAntimetabolites, AntineoplasticAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsBridged-Ring CompoundsDisease-Free SurvivalDrug CombinationsErb-b2 Receptor Tyrosine KinasesFemaleFuransHumansKetonesMiddle AgedOxonic AcidAnthracyclinesAntimetabolites, AntineoplasticBridged-Ring CompoundsDrug CombinationsERBB2 protein, humanErb-b2 Receptor Tyrosine KinaseseribulinFuransKetonesOxonic AcidPolyether PolyketidesReceptors, EstrogenS 1 (combination)taxaneTaxoidsTegafurBreast cancerEribulinPhase II studyS-1TNBC

Identifiers

PMID31619197
PMCPMC6796350

What OpenQuestion holds

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LicenceCC BY
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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.