Evidence map›Paper›PMID 37480384›Full record

Trial reportBreast cancer research and treatment2023

Phase II trial of biweekly administration with eribulin after three cycles of induction therapy in hormone receptor-positive, HER2-negative metastatic breast cancer (JACCRO BC-03).

Kokoro Kobayashi, Norikazu Masuda, Toshiro Mizuno, Kayo Miura, Yutaka Tokuda, Tetsuhiro Yoshinami, Hidetoshi Kawaguchi, Shoichiro Ohtani, Toshiaki Saeki, Masakazu Toi and 2 more

Abstract readClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in Breast cancer research and treatment, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Article
  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

12 authors.

Kokoro KobayashiDepartment of Breast Medical Oncology, Cancer Institute Hospital of JFCR, Tokyo, Japan. kokorok-medicaloncology@memoad.jp.ORCID http://orcid.org/0000-0001-6639-0468
Norikazu MasudaDepartment of Breast and Endocrine Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.
Toshiro MizunoDepartment of Medical Oncology, Mie University Hospital, Tsu, Japan.
Kayo MiuraDepartment of Respiratory Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.
Yutaka TokudaBreast Center, Seirei Yokohama Hospital, Yokohama, Japan.
Tetsuhiro YoshinamiDepartment of Breast and Endocrine Surgery, Graduate School of Medicine, Osaka University, Suita, Japan.
Hidetoshi KawaguchiDepartment of Breast Surgery, Matsuyama Red Cross Hospital, Matsuyama, Japan.
Shoichiro OhtaniDepartment of Breast Surgery, Hiroshima City Hiroshima Citizens Hospital, Hiroshima, Japan.
Toshiaki SaekiDepartment of Breast Oncology, Saitama Medical University International Medical Center, Hidaka, Japan.
Masakazu ToiDepartment of Breast Surgery, Graduate School of Medicine, Kyoto University Hospital, Kyoto, Japan.
Masahiro TakeuchiGraduate School of Mathematical Sciences, The University of Tokyo, Tokyo, Japan.
Yoshinori ItoDepartment of Breast Medical Oncology, Cancer Institute Hospital of JFCR, Tokyo, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeMetastatic breast cancer (MBC) is usually incurable; treatment aims to maximize patients' function and quality of life (QOL). Eribulin is a standard treatment in patients with MBC pretreated with anthracycline and taxane; however, the best administration schedule is unknown.

methodsIn this prospective phase II trial of patients with luminal MBC, we administered biweekly eribulin to patients who completed a three-cycle induction treatment.

resultsSixty patients with hormone-receptor-positive and HER2-negative MBC were enrolled; 40 obtained stable disease (SD) or better efficacy after induction therapy, after which they were switched to biweekly maintenance administration. The median progression-free survival (PFS) in patients who switched to maintenance therapy was 15.21 weeks (95% CI 9.71-22.14), starting on the first day of maintenance therapy. Overall survival (OS) in patients who switched to maintenance therapy was 21.39 months (95% CI 18.89-32.89). PFS and OS in the whole population starting from the registration date were 19.00 weeks (95% CI 17.00-25.00) and 21.52 months (95% CI 16.23-24.25), respectively. PFS from the enrollment date for patients who received maintenance therapy was 25.29 weeks (95% CI 19.14-32.14). Patients who achieved complete response or partial response during induction therapy had significantly longer PFS compared to patients with SD.

conclusionThe efficacy of biweekly administration of eribulin at maintenance was nonsignificant. However, less frequent visits are convenient, and reduced dose intensity improves safety. Biweekly administration, besides dose reduction, could be an acceptable option for patients who are unable to maintain a standard regimen.

Indexed as

Breast NeoplasmsQuality of LifeFemaleFuransHumansInduction ChemotherapyKetonesPolyether PolyketidesProspective StudieseribulinFuransKetonesPolyether PolyketidesBiweeklyEribulinHR-positive HER2-negativeLuminalMetastatic breast cancer

Identifiers

PMID37480384

What OpenQuestion holds

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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.