Evidence map›Paper›PMID 39908698›Full record

Trial reportESMO open2025

Efficacy, safety, and pharmacokinetics of eribulin as monotherapy or in combination with irinotecan for patients with pediatric rhabdomyosarcoma, non-rhabdomyosarcoma soft tissue sarcoma, or Ewing sarcoma.

M Casanova, C M Albert, F Bautista, S C Borinstein, S Bradfield, A Bukowinski, Q Campbell-Hewson, D S Hawkins, A Kim, G M Milano and 10 more

Abstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in ESMO open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

20 authors.

M CasanovaPediatric Oncology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy. Electronic address: Michela.Casanova@istitutotumori.mi.it.
C M AlbertDivision of Hematology, Oncology, Bone Marrow Transplant and Cellular Therapy, Seattle Children's Hospital, Seattle; Department of Pediatrics, University of Washington School of Medicine, Seattle, USA.
F BautistaHospital del Niño Jesús, Madrid, Spain.
S C BorinsteinDepartment of Pediatrics, Vanderbilt University Medical Center, Nashville.
S BradfieldDivision of Pediatric Hematology/Oncology, Nemours Children's Health, Jacksonville.
A BukowinskiDepartment of Hematology/Oncology, UPMC Children's Hospital of Pittsburgh, Pittsburgh, USA.
Q Campbell-HewsonThe Great North Children's Hospital, Royal Victoria Infirmary, Newcastle Upon Tyne, UK.
D S HawkinsDivision of Hematology, Oncology, Bone Marrow Transplant and Cellular Therapy, Seattle Children's Hospital, Seattle; Department of Pediatrics, University of Washington School of Medicine, Seattle, USA.
A KimCenter for Cancer and Blood Disorders, Children's National Hospital, Washington, USA.
G M MilanoDivision of Pediatric Hematology and Oncology, Gene and Cellular Therapy, IRCCS Ospedale Pediatrico Bambino Gesù, Rome, Italy.
L V MarshallChildren and Young People's Unit, The Royal Marsden Hospital, and Divisions of Clinical Studies and Cancer Therapeutics, The Institute of Cancer Research, London, UK.
N PintoChildren's Hospital Colorado, Aurora.
C A PratilasDepartment of Oncology, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, USA.
A Rubio-San-SimónDepartment of Pediatric Oncology and Hematology, Hospital del Niño Jesús, Madrid, Spain.
R WindsorChildren and Young People's Cancer Service, University College London Hospitals NHS Foundation Trust, London.
O MajidEisai Ltd., Hatfield, UK.
R ScottEisai Ltd., Hatfield, UK.
Y JiaEisai Inc., Nutley, USA.
C PaolettiEisai Inc., Nutley, USA.
U KontnyDivision of Pediatric Hematology, Oncology and Stem Cell Transplantation, University Hospital Aachen, Aachen, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn this report, we present results from studies of eribulin as monotherapy (Study 223) and in combination with irinotecan (the phase II part of Study 213) for patients with relapsed/refractory pediatric rhabdomyosarcoma (RMS), non-rhabdomyosarcoma soft tissue sarcoma (NRSTS), or Ewing sarcoma (EWS). PATIENTS AND

methodsStudies 223 and 213 were phase II multicenter trials that enrolled pediatric patients with histologically confirmed disease. Treatment comprised 21-day cycles of eribulin mesylate 1.4 mg/m

resultsIn Study 223, 21 patients (RMS, n = 8; NRSTS, n = 8; EWS, n = 5) were enrolled and treated. No responses were observed, resulting in early termination of enrollment. By the data cut-off date (22 February 2021), six patients (RMS, n = 3; NRSTS, n = 1; EWS, n = 2) had stable disease for ≥5 weeks. All patients had one or more treatment-emergent adverse event (TEAE), most commonly neutrophil count decreased (71.4%). In Study 213 (phase II part), 27 patients (RMS, n = 9; NRSTS, n = 9; EWS, n = 9) were enrolled/treated. By the data cut-off date (9 July 2021), three patients (one in each cohort) had had a response, resulting in an ORR of 11.1% and DORs of 2.9 (RMS), 1.4 (NRSTS), and 15.4 (EWS) months. All patients had one or more TEAE, most commonly diarrhea and neutrophil count decreased (51.9% each).

conclusionsEribulin, as monotherapy or combination therapy, exhibited a safety profile consistent with that observed previously in adult populations; however, efficacy in both studies was not considered adequate to advance investigation in these disease areas.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsFuransIrinotecanKetonesSarcomaAdolescentCamptothecinChildChild, PreschoolFemaleHumansMalePolyether PolyketidesRhabdomyosarcomaSarcoma, EwingTreatment OutcomeCamptothecineribulinFuransIrinotecanKetonesPolyether PolyketideseribulinEwing sarcomapediatricpharmacokineticssoft tissue sarcoma

Identifiers

PMID39908698
PMCPMC11847257

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LicenceCC BY-NC-ND
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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.