Evidence map›Paper›PMID 27125669›Full record

Trial reportBreast cancer research and treatment2016

Phase II clinical study of eribulin monotherapy in Japanese patients with metastatic breast cancer who had well-defined taxane resistance.

Kenichi Inoue, Tsuyoshi Saito, Katsuhiko Okubo, Kei Kimizuka, Hirofumi Yamada, Takashi Sakurai, Kazuo Ishizuna, Satoshi Hata, Toshihiro Kai, Masafumi Kurosumi

Open access · hybridAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Breast cancer research and treatment, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 1 pooled it
3.9field-weighted citation impact, top 5% 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

20 citing papers in PubMed, 1 synthesis or guideline pooled it, 44 citations in OpenAlex.

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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

10 authors at 7 institutions in 1 country.

Kenichi InoueDivision of Breast Oncology, Saitama Cancer Center, 780 Komuro, Ina-machi, Kita-adachi-gun, Saitama, 362-0806, Japan. ino.bad.ken@gmail.com.
Tsuyoshi SaitoDepartment of Breast Surgery, Saitama Red Cross Hospital, Saitama, Japan.
Katsuhiko OkuboDepartment of Breast Unit, Toda Central General Hospital, Saitama, Japan.
Kei KimizukaDepartment of Breast Surgery, Kasukabe Municipal Hospital, Saitama, Japan.
Hirofumi YamadaDepartment of Surgery, Sekishindo Hospital, Saitama, Japan.
Takashi SakuraiDivision of Surgery, JCHO Saitama Medical Center, Saitama, Japan.
Kazuo IshizunaBreast Center, Dokkyo Medical University Koshigaya Hospital, Saitama, Japan.
Satoshi HataBreast Center, Mitsui Hospital, Saitama, Japan.
Toshihiro KaiShintoshin Ladies' Mammo Clinic, Saitama, Japan.
Masafumi KurosumiDepartment of Pathology, Saitama Cancer Center, Saitama, Japan.
Saitama Cancer Center · JPDokkyo Medical University Saitama Medical Center · JPHakodate Central General Hospital · JPMitsui (Japan) · JPSaitama Municipal Hospital · JPSaitama Red Cross Hospital · JPSocial Insurance Saitama Chuo Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

No clinical evidence on the efficacy and safety of eribulin monotherapy has been obtained by a prospective clinical study in patients with metastatic breast cancer (MBC) who had well-defined taxane resistance. The present Phase II, multicenter, single-arm, open-label study aimed to obtain the evidence. Japanese female patients, aged 33-74 years who had the metastasis of taxane-resistant and histopathologically confirmed breast cancer, received eribulin mesylate 1.4 mg/m(2) (equivalent to eribulin 1.23 mg/m(2) [expressed as free base]) as a 2- to 5-min intravenous infusion on days 1 and 8 of each 21-day cycle. The primary endpoint was the clinical benefit rate (CBR) [complete response (CR), partial response (PR), and long-term stable disease (LSD) ≥24 weeks]. A total of 51 patients underwent chemotherapy cycles (median 4; range 1-42 cycles). The CBR was 39.2 % (CR 2.0 %; PR 23.5 %; and LSD 13.7 %), and the rate of progressive disease was 49.0 %. The median progression-free survival and the median overall survival were 3.6 months [95 % confidence interval (CI) 2.6-4.6 months] and 11.7 months (95 % CI 9.2-14.2 months), respectively. Grade 3 or greater adverse events were leukopenia (23.5 %), neutropenia (35.3 %), anemia (5.9 %), and febrile neutropenia (7.8 %). The incidences of grade 3 and 4 peripheral sensory neuropathy were 2.0 and 0 %, respectively. Eribulin showed a clinically manageable tolerability profile by dose adjustments or symptomatic treatment. Eribulin was effective and well tolerated in heavily pretreated patients with MBC who had well-defined taxane resistance, thus providing a potential therapeutic option in the clinical settings.

Indexed as

AdultAgedAntineoplastic AgentsBreast NeoplasmsDisease-Free SurvivalDrug Administration ScheduleFemaleFuransHumansInfusions, IntravenousJapanKetonesMiddle AgedNeoplasm MetastasisPolyether PolyketidesProspective StudiesAntineoplastic AgentseribulinFuransKetonesPolyether PolyketidesEribulin mesylateEstrogen receptorHuman epidermal growth factor receptor 2-negativeMetastatic breast cancerTaxane resistanceTriple-negative

Identifiers

PMID27125669
PMCPMC4875050
OpenAlexW2343566398

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.