Evidence map›Paper›PMID 34787778›Full record

ArticleJournal of neuro-oncology2021

Afatinib and radiotherapy, with or without temozolomide, in patients with newly diagnosed glioblastoma: results of a phase I trial.

Frank Saran, Liam Welsh, Allan James, Catherine McBain, Rao Gattamaneni, Sarah Jefferies, Fiona Harris, Karine Pemberton, Jennifer Schaible, Shaun Bender and 2 more

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

Article in Journal of neuro-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 NCT00977431 (Phase I, Open Label Trial to Explore Safety of Combining BIBW 2992 and Radiotherapy With or Without Temozolomide in Newly Diagnosed GBM), which is not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
1.8field-weighted citation impact, top 14% 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.

NCT00977431 phase1completednot on this map

Phase I, Open Label Trial to Explore Safety of Combining BIBW 2992 and Radiotherapy With or Without Temozolomide in Newly Diagnosed GBM

TypeinterventionalSponsorBoehringer IngelheimRan2009 to 2017Enrolled36ConditionsGlioblastomaArmsTemozolomide, Radiotherapy, BIBW2992
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 20 citations in OpenAlex.

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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

12 authors at 8 institutions in 4 countries.

Frank Saran *The Royal Marsden NHS Foundation Trust, London, UK. FSaran@adhb.govt.nz.ORCID http://orcid.org/0000-0002-3448-5064
Liam WelshThe Royal Marsden NHS Foundation Trust, London, UK.
Allan JamesThe Beatson West of Scotland Cancer Centre, Glasgow, UK.
Catherine McBainThe Christie NHS Foundation Trust, Manchester, UK.
Rao GattamaneniThe Christie NHS Foundation Trust, Manchester, UK.
Sarah JefferiesCambridge University Hospitals NHS Foundation Trust, Cambridge, UK.
Fiona HarrisCambridge University Hospitals NHS Foundation Trust, Cambridge, UK.
Karine PembertonBoehringer Ingelheim Ltd, Bracknell, UK.
Jennifer SchaibleBoehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.
Shaun BenderBoehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA.
Agnieszka CsehBoehringer Ingelheim International GmbH, Ingelheim, Germany.
Michael Brada *Clatterbridge Cancer Centre NHS Foundation Trust, Bebington, UK.
Boehringer Ingelheim (Germany) · DECambridge University Hospitals NHS Foundation Trust · GBRoyal Marsden NHS Foundation Trust · GBThe Christie NHS Foundation Trust · GBBeatson West of Scotland Cancer Centre · GBBoehringer Ingelheim (United Kingdom) · GBBoehringer Ingelheim (United States) · USClatterbridge Cancer Centre NHS Foundation Trust · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundGlioblastoma multiforme (GBM) is the most common primary malignant brain tumor in adults. Amplification or overexpression of the epidermal growth factor receptor gene, part of the ErbB family, occur in approximately 40% and 60% of patients with GBM, respectively. We present data from a dose-finding study of the ErbB inhibitor afatinib in combination with radiotherapy (RT), with or without temozolomide (TMZ), in patients with GBM.

methodsThis was a phase I, open-label, 3 + 3 dose-escalation trial in patients with newly-diagnosed, histologically-confirmed grade 4 malignant glioma and proven O

resultsFifty-five patients were enrolled; 36 received ≥ 1 dose of trial medication (regimen M, n = 20, regimen U, n = 16). Afatinib was discontinued by all patients during the study. Reasons for afatinib discontinuation (regimen M/U) included disease progression (45%/50%), dose-limiting toxicity (10%/0%), and other adverse events (AEs; 35%/38%). The most frequently reported AEs with either regimen were diarrhea and rash, with no new safety signals identified. The MTD was determined as afatinib 30 mg in combination with daily TMZ and RT, and afatinib 40 mg in combination with RT alone.

conclusionsThis study identified the MTD for afatinib in combination with RT, with and without TMZ, in patients with GBM. Further studies of afatinib in patients with GBM are warranted and should be based on appropriate biomarker-based preselection.

trial registrationNCT00977431 (first posted September 15, 2009).

Indexed as

Brain NeoplasmsGlioblastomaAdultAfatinibAntineoplastic Combined Chemotherapy ProtocolsDacarbazineHumansTemozolomideTreatment OutcomeAfatinibDacarbazineTemozolomideAfatinibDose-escalationGlioblastomaRadiotherapyTemozolomide

Identifiers

PMID34787778
PMCPMC8651574
OpenAlexW3211922006

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.