Evidence map›Paper›PMID 33743073›Full record

Trial reportJournal of cancer research and clinical oncology2021

Phase II study of metronomic treatment with daily oral vinorelbine as first-line chemotherapy in patients with advanced/metastatic HR+/HER2- breast cancer resistant to endocrine therapy: VinoMetro-AGO-B-046.

Slavomir Krajnak, Thomas Decker, Lukas Schollenberger, Christian Rosé, Christian Ruckes, Tanja Fehm, Christoph Thomssen, Nadia Harbeck, Marcus Schmidt

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Journal of cancer research and clinical oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03007992 (Phase II Study of Metronomic Treatment With Daily Oral Vinorelbine as First-line Chemotherapy in Patients With Advanced/Metastatic HR+/HER2- Breast Cancer Resistant to Endocrine Therapy), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.6field-weighted citation impact, top 30% 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.

NCT03007992 phase2completednot on this map

Phase II Study of Metronomic Treatment With Daily Oral Vinorelbine as First-line Chemotherapy in Patients With Advanced/Metastatic HR+/HER2- Breast Cancer Resistant to Endocrine Therapy

TypeinterventionalSponsorJohannes Gutenberg University MainzRan2016 to 2019Enrolled9ConditionsMetastatic Breast CancerArmsVinorelbine
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 8 citations in OpenAlex.

  1. Trial
  2. Metronomic Chemotherapy in Elderly Patients.Current oncology reports · 2024
    Review
  3. Review
  4. Article
  5. Review
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

9 authors at 5 institutions in 1 country.

Slavomir KrajnakDepartment of Gynaecology and Obstetrics, University Medical Centre, Mainz, Germany.
Thomas DeckerHaematology and Oncology Outpatient Clinic, Ravensburg, Germany.
Lukas SchollenbergerInterdisciplinary Centre for Clinical Trials, University Medical Centre, Mainz, Germany.
Christian RoséPierre-Fabre GmbH, Freiburg, Germany.
Christian RuckesInterdisciplinary Centre for Clinical Trials, University Medical Centre, Mainz, Germany.
Tanja FehmDepartment of Gynaecology and Obstetrics, University Medical Centre, Düsseldorf, Germany.
Christoph ThomssenDepartment of Gynaecology, University Medical Centre, Halle (Saale), Germany.
Nadia HarbeckBreast Centre, Department of Gynaecology and Obstetrics and CCC Munich LMU, University Hospital, LMU Munich, Munich, Germany.
Marcus SchmidtDepartment of Gynaecology and Obstetrics, University Medical Centre, Mainz, Germany. marcus.schmidt@unimedizin-mainz.de.ORCID http://orcid.org/0000-0003-1365-2414
Johannes Gutenberg University Mainz · DEDüsseldorf University Hospital · DELudwig-Maximilians-Universität München · DEPierre Fabre (Germany) · DEUniversity Medical Centre Mannheim · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeMetronomic chemotherapy (MCT) is an increasingly used treatment option in hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) advanced/metastatic breast cancer (MBC) after failure of endocrine-based therapies.

methodsVinoMetro was a multicentre, open-label, single-arm, phase II study of metronomic oral vinorelbine (VRL; 30 mg/day) as a first-line chemotherapy (CT) in patients with HR+/HER2- MBC after endocrine failure. The primary endpoint was the clinical benefit rate (CBR) at 24 weeks.

resultsBetween January 2017 and April 2019, nine patients were enrolled. The CBR was 22.2% (90% confidence interval [CI] 4.1-55.0), p = 0.211. The median progression-free survival (PFS) was 12.0 weeks (95% CI 11.3-12.7). Grade 3-4 adverse events (AEs) occurred in 22.2% of patients. One patient died of febrile neutropenia.

conclusionVinoMetro (AGO-B-046) was closed early after nine patients and occurrence of one grade 5 toxicity in agreement with the lead institutional review board (IRB). Metronomic dosing of oral VRL in HR+/HER2- MBC as first-line CT after failure of endocrine therapies showed only limited benefit in this population. TRIAL REGISTRATION NUMBER AND DATE OF REGISTRATION: ClinicalTrials.gov Identifier: NCT03007992; December 15, 2016.

Indexed as

Administration, MetronomicAdministration, OralAgedAntineoplastic Agents, PhytogenicBreast NeoplasmsDrug Resistance, NeoplasmErb-b2 Receptor Tyrosine KinasesFemaleHumansMiddle AgedNeoplasm MetastasisNeoplasm StagingProgression-Free SurvivalReceptors, EstrogenReceptors, SteroidVinorelbineAntineoplastic Agents, PhytogenicERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesReceptors, EstrogenReceptors, SteroidVinorelbineClinical benefit rateDaily oral vinorelbineMetastatic breast cancerMetronomic chemotherapy

Identifiers

PMID33743073
PMCPMC8484172
OpenAlexW3137422322

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.