Evidence map›Paper›PMID 36309895›Full record

Observational studyJournal of neuro-oncology2022

Observational real-life study on regorafenib in recurrent glioblastoma: does dose reduction reduce toxicity while maintaining the efficacy?

Roberta Rudà, Francesco Bruno, Alessia Pellerino, Edoardo Pronello, Rosa Palmiero, Luca Bertero, Stefania Crasto, Valentina Polo, Roberta Vitaliani, Elena Trincia and 3 more

Registry-linked trialAbstract readObservational Study
PubMed Publisher
In one paragraph

Observational study in Journal of neuro-oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05958485 (Glioblastoma Multiforme Patients in Clinical Trials), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
2.4field-weighted citation impact, top 10% 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.

NCT05958485 not yet recruitingnot on this mapstarted 2024, after this paper: background citation

Glioblastoma Multiforme Patients in Clinical Trials: An Examination of Their Clinical Trial Experiences

TypeobservationalSponsorPower Life Sciences Inc.Ran2024 to 2026Enrolled500ConditionsGlioblastoma Multiforme
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 18 citations in OpenAlex.

  1. Pooled it
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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

13 authors at 5 institutions in 1 country.

Roberta Rudà *Division of Neuro-Oncology, Department of Neuroscience, University and City of Health and Science Hospital, Turin, Italy. rudarob@hotmail.com.
Francesco Bruno *Division of Neuro-Oncology, Department of Neuroscience, University and City of Health and Science Hospital, Turin, Italy.
Alessia PellerinoDivision of Neuro-Oncology, Department of Neuroscience, University and City of Health and Science Hospital, Turin, Italy.
Edoardo PronelloDivision of Neuro-Oncology, Department of Neuroscience, University and City of Health and Science Hospital, Turin, Italy.
Rosa PalmieroDivision of Neuro-Oncology, Department of Neuroscience, University and City of Health and Science Hospital, Turin, Italy.
Luca BerteroPathology Unit, Department of Medical Sciences, University of Turin, Turin, Italy.
Stefania CrastoLARC and RIBA MRI Services, Turin, Italy.
Valentina PoloOncology Unit, Azienda Unità Locale Socio-Sanitaria (AULSS 2) Marca Trevigiana, Cà Foncello Hospital, Treviso, Italy.
Roberta VitalianiDivision of Neurology, Cà Foncello Hospital, AULSS2 Marca Trevigiana, Treviso, Italy.
Elena TrinciaNeuroradiology Unit, Cà Foncello Hospital, AULSS2 Marca Trevigiana, Treviso, Italy.
Valeria InternòDivision of Medical Oncology, A.O.U. Consorziale Policlinico di Bari, Bari, Italy.
Camillo PortaDivision of Medical Oncology, A.O.U. Consorziale Policlinico di Bari, Bari, Italy.
Riccardo SoffiettiDivision of Neuro-Oncology, Department of Neuroscience, University and City of Health and Science Hospital, Turin, Italy.
Piedmont Reference Center for Epidemiology and Cancer Prevention · ITCa' Foncello Hospital · ITUniversità degli Studi del Piemonte Orientale “Amedeo Avogadro” · ITUniversity of Bari Aldo Moro · ITUniversity of Turin · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeIn the phase 2 REGOMA trial, regorafenib improved overall survival, as compared with lomustine, in glioblastoma (GBM) patients at first progression after chemoradiation. Recently, some real-life trials showed similar impact on survival but a higher rate of adverse events than in REGOMA, thus raising concerns over tolerability. The aim of this study was to assess the efficacy and tolerability of a lower intensity regorafenib regimen. PATIENTS AND

methodsRegorafenib daily dose was gradually increased from 80 to 160 mg across the first 2 cycles. Progression-free survival (PFS) and overall survival (OS) were defined as time from regorafenib initiation and disease progression or death.

resultsSixty-six GBM patients were included. Median age was 60.0 years. Median PFS and OS following regorafenib were 2.7 and 7.1 months, respectively. Best RANO response to regorafenib were partial response (PR) in 10 (15.1%), stable disease in 17 (25.8%), and progressive disease in 39 (59.1%) patients. Forty-six (69.7%) patients presented adverse events of any grade, and 21 (31.8%) grade 3-4 toxicity. In a multivariable analysis, higher age and absence of MGMTp methylation were significantly associated with poorer disease control after regorafenib.

conclusionsOur study is the largest observational real-life study on the use of regorafenib. Our lower intensity regimen proved as effective as the standard 160 mg daily schedule (mPFS and mOS being 2.7 vs 2.0 months and 7.1 vs 7.4 months in our study vs REGOMA, respectively). Moreover, we observed a higher rate of PRs as compared with REGOMA (15.0% vs 3.0%).

Indexed as

GlioblastomaDrug TaperingHumansMiddle AgedNeoplasm Recurrence, LocalPhenylurea CompoundsPyridinesPhenylurea CompoundsPyridinesregorafenibEfficacyGlioblastomaRecurrenceRegorafenibToxicity

Identifiers

PMID36309895
OpenAlexW4307658323

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.