Evidence map›Paper›PMID 37555463›Full record

Observational studyThe oncologist2023

Incidence and Resolution of Eribulin-Induced Peripheral Neuropathy (IRENE) in Locally Advanced or Metastatic Breast Cancer: Prospective Cohort Study.

Hans-Joachim Lück, Marcus Schmidt, Tobias Hesse, Oliver Hoffmann, Bernhard J Heinrich, Tjoung-Won Park-Simon, Eva-Maria Grischke, Rudolf Weide, Harald Müller-Huesmann, Kerstin Lüdtke-Heckenkamp and 7 more

Open access · goldAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in The oncologist, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.7field-weighted citation impact, top 23% 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

3 citing papers in PubMed, 3 citations in OpenAlex.

  1. Trial
  2. Article
  3. 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

17 authors at 14 institutions in 2 countries.

Hans-Joachim LückGynecologic Oncology, Gynäkologisch-Onkologische Praxis am Pelikanplatz, Hannover, Germany.
Marcus SchmidtDepartment of Obstetrics and Gynecology, University Medical Center Mainz, Mainz, Germany.
Tobias HesseDepartment of Gynecology, Agaplesion Diakonieklinikum Rotenburg gGmbH, Rotenburg (Wuemme), Germany.
Oliver HoffmannDepartment of Gynecology and Obstetrics, Universitätsklinikum Essen, Essen, Germany.
Bernhard J HeinrichHematology/Oncology, Praxis Heinrich/Bangerter, Augsburg, Germany.
Tjoung-Won Park-SimonDepartment of Obstetrics and Gynecology, MHH Hannover, Hannover, Germany.
Eva-Maria GrischkeOncology, Universitäts-Frauenklinik Tübingen, Tübingen, Germany.
Rudolf WeideOncological Outpatient Department, Praxis für Hämatologie und Onkologie Koblenz, Koblenz, Germany.
Harald Müller-HuesmannDepartment of Hematology/Oncology, Brüderkrankenhaus St. Josef Paderborn, Paderborn, Germany.
Kerstin Lüdtke-HeckenkampDepartment of Hematology/Oncology, Niels Stensen Clinics, Franziskus Hospital, Georgsmarienhütte, Germany.
Dorothea FischerDepartment of Gynaecology and Obstetrics, Hospital Ernst von Bergmann, Potsdam, Germany.
Cosima ZemlinDepartment for Gynecology, Obstetrics and Reproductive Medicine, Saarland University Medical Center, Homburg, Germany.
Matthias KögelKlinikum Worms Frauenklinik, Worms, Germany.
Jane WuBiostatistics, Eisai Inc., Nutley, NJ, USA.
Helga SchmitzMedical Department, Eisai GmbH, Frankfurt, Germany.
Christian EngelbrechtMedical Affairs, Eisai GmbH, Frankfurt, Germany.
Christian JackischDepartment of Obstetrics and Gynecology, Sana Klinikum Offenbach GmbH, Offenbach, Germany.ORCID 0000-0001-8537-3743
Eisai (Germany) · DEPraxis für Hämatologie und Onkologie · DEAgaplesion Diakonieklinikum Rotenburg · DEBrüderkrankenhaus St. Josef Paderborn · DEEisai (United States) · USEssen University Hospital · DEHannover Re (Germany) · DEJohannes Gutenberg University Mainz · DEKlinikum Ernst von Bergmann · DESaarland University · DESana Klinikum Offenbach · DESt. Franziskus Hospital · DEUniversitäts Frauenklinik · DEUniversity of Applied Sciences Worms · DE

Funding

Eisai GmbH, Frankfurt, GermanyEisai Inc., Nutley, NJ, USA
6 · The paper itself

Abstract

backgroundEribulin, a halichondrin-class microtubule dynamics inhibitor, is a preferred treatment option for patients with advanced breast cancer who have been pretreated with an anthracycline and a taxane. Peripheral neuropathy (PN) is a common side effect of chemotherapies for breast cancer and other tumors. The Incidence and Resolution of Eribulin-Induced Peripheral Neuropathy (IRENE) noninterventional postauthorization safety study assessed the incidence and severity of PN in patients with breast cancer treated with eribulin. PATIENTS AND

methodsIRENE is an ongoing observational, single-arm, prospective, multicenter, cohort study. Adult patients (≥18 years of age) with locally advanced or metastatic breast cancer and disease progression after 1-2 prior chemotherapeutic regimen(s) for advanced disease were treated with eribulin. Patients with eribulin-induced PN (new-onset PN or worsening of preexisting PN) were monitored until death or resolution of PN. Primary endpoints included the incidence, severity, and time to resolution of eribulin-induced PN. Secondary endpoints included time to disease progression and safety.

resultsIn this interim analysis (data cutoff date: July 1, 2019), 67 (32.4%) patients experienced any grade eribulin-induced PN, and 12 (5.8%) patients experienced grade ≥3 eribulin-induced PN. Median time to resolution of eribulin-induced PN was not reached. Median time to disease progression was 4.6 months (95% CI, 4.0-6.5). Treatment-emergent adverse events (TEAEs) occurred in 195 (93.8%) patients and serious TEAEs occurred in 107 (51.4%) patients.

conclusionThe rates of any grade and grade ≥3 eribulin-induced PN observed in this real-world study were consistent with those observed in phase III randomized clinical trials. No new safety findings were observed.

Indexed as

Breast NeoplasmsPeripheral Nervous System DiseasesAdultCohort StudiesDisease ProgressionFemaleFuransHumansIncidenceKetonesPolyether PolyketidesProspective StudiesTreatment OutcomeTubulin ModulatorseribulinFuransKetonesPolyether PolyketidesTubulin Modulatorsbreast neoplasmscohort studieseribulinmedical oncologyperipheral nervous system diseasesprospective studies

Identifiers

PMID37555463
PMCPMC10712709
OpenAlexW4385684462

What OpenQuestion holds

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LicenceCC BY
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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.