Evidence map›Paper›PMID 28861862›Full record

ArticleBreast cancer (Tokyo, Japan)2018

Phase I dose-finding study of eribulin and capecitabine for metastatic breast cancer: JBCRG-18 cape study.

Masaya Hattori, Hiroshi Ishiguro, Norikazu Masuda, Akiyo Yoshimura, Shoichiro Ohtani, Hiroyuki Yasojima, Satoshi Morita, Shinji Ohno, Hiroji Iwata

Erratum issuedAbstract readClinical Trial, Phase IMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Breast cancer (Tokyo, Japan), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–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

3 citing papers in PubMed.

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

Corrections and comments

5 · Who and what money

Authors and funding

9 authors.

Masaya HattoriDepartment of Breast Oncology, Aichi Cancer Center, 1-1 Kanokoden, Chikusa-ku, Nagoya, 464-8681, Japan.
Hiroshi IshiguroDepartment of Target Therapy Oncology, Graduate School of Medicine, Kyoto University, Kyoto, 606-8501, Japan.
Norikazu MasudaDepartment of Surgery, Breast Oncology, NHO Osaka National Hospital, Osaka, 540-0006, Japan.
Akiyo YoshimuraDepartment of Breast Oncology, Aichi Cancer Center, 1-1 Kanokoden, Chikusa-ku, Nagoya, 464-8681, Japan.
Shoichiro OhtaniDivision of Breast Surgery, Hiroshima City Hiroshima Citizens Hospital, Hiroshima, 730-8518, Japan.
Hiroyuki YasojimaDepartment of Surgery, Breast Oncology, NHO Osaka National Hospital, Osaka, 540-0006, Japan.
Satoshi MoritaDepartment of Biomedical Statistics and Bioinformatics, Graduate School of Medicine, Kyoto University, Kyoto, 606-8501, Japan.
Shinji OhnoBreast Oncology Center, Cancer Institute Hospital of JFCR, Tokyo, 135-8550, Japan.
Hiroji IwataDepartment of Breast Oncology, Aichi Cancer Center, 1-1 Kanokoden, Chikusa-ku, Nagoya, 464-8681, Japan. hiwata@aichi-cc.jp.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEribulin is a nontaxane microtubule inhibitor with activity in patients with metastatic breast cancer (MBC). We conducted a phase I dose-finding study of eribulin and capecitabine in patients with MBC pretreated with anthracycline and taxane.

methodsWomen with MBC aged ≤70 years were enrolled. A 3 + 3 dose escalation design was used: level 0 dosing, eribulin (1.4 mg/m

resultsNine women with MBC were enrolled; six at level 0, three at level 1. One patient had grade 4 DLTs at level 0 (serum creatinine 7.65 mg/dL and uric acid 13.4 mg/dL), considered associated with study drugs. Level 1 dosing was taken as the RD. Neutropenia was the most common ≥grade 3 toxicity. Pharmacokinetic parameters of eribulin were not influenced by co-administration of capecitabine. Of three patients in level 1, one achieved partial response and one had prolonged stable disease.

conclusionEribulin with capecitabine in the level 1 dosing schedule was associated with manageable toxicities and promising clinical activity. This combination is recommended for phase II investigation.

Indexed as

AdultAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCapecitabineDose-Response Relationship, DrugFemaleFollow-Up StudiesFuransHumansKetonesMaximum Tolerated DoseMiddle AgedNeoplasm InvasivenessNeoplasm MetastasisPolyether PolyketidesPrognosisCapecitabineeribulinFuransKetonesPolyether PolyketidesBreast cancerCapecitabineEribulinMetastasesPharmacokinetics

Identifiers

PMID28861862
PMCPMC5741785

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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.