Evidence map›Paper›PMID 30726533›Full record

Trial reportJournal of neuro-oncology2019

Multicenter, single arm, phase II trial on the efficacy of ortataxel in recurrent glioblastoma.

Antonio Silvani, Irene De Simone, Vittorio Fregoni, Elena Biagioli, Enrico Marchioni, Manuela Caroli, Andrea Salmaggi, Andrea Pace, Valter Torri, Paola Gaviani and 5 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Journal of neuro-oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01989884 (Multicenter, Single Arm, Open-Label Phase II Trial On The Efficacy Of Ortataxel In Recurrent Glioblastoma), which is not on this map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 pooled it
–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.

NCT01989884 phase2completednot on this map

Multicenter, Single Arm, Open-Label Phase II Trial On The Efficacy Of Ortataxel In Recurrent Glioblastoma

TypeinterventionalSponsorMario Negri Institute for Pharmacological ResearchRan2013 to 2016Enrolled45ConditionsGlioblastomaArmsOrtataxel
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Guideline
  3. Review
  4. Review
  5. Review
  6. Review
  7. Article
  8. Review
  9. Review
  10. 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

15 authors.

Antonio SilvaniFondazione Istituto Neurologico Carlo Besta, IRCCS, Milan, Italy.
Irene De SimoneIstituto di Ricerche Farmacologiche Mario Negri, IRCCS, Milan, Italy. irene.desimone@marionegri.it.ORCID http://orcid.org/0000-0002-4806-7904
Vittorio FregoniFondazione Salvatore Maugeri, IRCCS, Pavia, Italy.
Elena BiagioliIstituto di Ricerche Farmacologiche Mario Negri, IRCCS, Milan, Italy.
Enrico MarchioniFondazione Istituto Neurologico Nazionale Casimiro Mondino, IRCCS, Pavia, Italy.
Manuela CaroliFondazione Ca'Granda Ospedale Maggiore Policlinico, IRCCS, Milan, Italy.
Andrea SalmaggiOspedale A. Manzoni, Lecco, Italy.
Andrea PaceIstituto Nazionale Tumori Regina Elena, Roma, Italy.
Valter TorriIstituto di Ricerche Farmacologiche Mario Negri, IRCCS, Milan, Italy.
Paola GavianiFondazione Istituto Neurologico Carlo Besta, IRCCS, Milan, Italy.
Erica QuaquariniFondazione Salvatore Maugeri, IRCCS, Pavia, Italy.
Giorgia SimonettiFondazione Istituto Neurologico Carlo Besta, IRCCS, Milan, Italy.
Eliana RulliIstituto di Ricerche Farmacologiche Mario Negri, IRCCS, Milan, Italy.
Maurizio D'IncalciIstituto di Ricerche Farmacologiche Mario Negri, IRCCS, Milan, Italy.
Italian Association of Neuro-Oncology

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

background and purposeGlioblastoma (GBM) is the most aggressive and frequent subtype of all malignant gliomas. At the time of recurrence, therapeutic options are lacking. Ortataxel, a second-generation taxane was reported to be effective in pre-clinical and phase I clinical studies. The aim of this study was to evaluate a potential therapeutic activity of ortataxel in patients with GBM recurring after surgery and first line treatment.

methodsIn this phase II study, according to a two stage design, adult patients with histologically confirmed GBM in recurrence after surgery or biopsy, standard radiotherapy and chemotherapy with temozolomide were considered eligible. Patients included were treated with ortataxel 75 mg/m

resultsBetween Nov 26, 2013 and Dec 12, 2015, 40 patients were recruited across six centres. The number of patients alive and free from progression at 6 months after the enrollment, observed in the first stage was four (11.4%), out of 35 patients included in the analysis, below the minimum number of events (7 out of 33) required to continue the study with the second stage The most important toxicities were neutropenia and hepatotoxicity that occurred in 13.2% of patients and leukopenia that occurred in 15.8% of patients.

conclusionOverall ortataxel treatment fail to demonstrate a significant activity in recurrent GBM patients. However in a limited number of patients the drug produced a benefit that lasted for a long time.

trial registrationThis study is registered with ClinicalTrials.gov, number NCT01989884.

Indexed as

AdultAgedAntineoplastic AgentsBrain NeoplasmsBridged-Ring CompoundsFemaleFollow-Up StudiesGlioblastomaHumansMaleMiddle AgedNeoplasm Recurrence, LocalPrognosisSurvival RateTaxoidsAntineoplastic AgentsBridged-Ring CompoundsIDN 5109TaxoidsGlioblastomaOrtataxelRecurrenceTaxane

Identifiers

PMID30726533

What OpenQuestion holds

Textmetadata
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.