Evidence map›Paper›PMID 23782513›Full record

Trial reportBMC cancer2013

Radiotherapy plus nimotuzumab or placebo in the treatment of high grade glioma patients: results from a randomized, double blind trial.

Maria Teresa Solomón, Julio César Selva, Javier Figueredo, José Vaquer, Carolina Toledo, Nelson Quintanal, Silvia Salva, Rafael Domíngez, José Alert, Jorge Juan Marinello and 8 more

Open access · goldAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC cancer, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 38 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed, 4 pooled it
5.5field-weighted citation impact, top 3% 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

38 citing papers in PubMed, 4 syntheses or guidelines pooled it, 78 citations in OpenAlex.

  1. Pooled it
  2. Anti-epidermal growth factor receptor therapy for glioblastoma in adults.The Cochrane database of systematic reviews · 2020
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  5. The relation of EGFR expression by immunohistochemical staining and clinical response of combination treatment of nimotuzumab and chemotherapy in esophageal squamous cell carcinoma.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2016
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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

18 authors at 9 institutions in 3 countries.

Maria Teresa SolomónCalixto García Hospital, Havana, Cuba.
Julio César Selva
Javier Figueredo
José Vaquer
Carolina Toledo
Nelson Quintanal
Silvia Salva
Rafael Domíngez
José Alert
Jorge Juan Marinello
Mauricio Catalá
Martha González Griego
Juan Antonio Martell
Patricia Lorenzo Luaces
Javier Ballesteros
Niurys de-Castro
Ferdinand Bach
Tania Crombet
Hospital Oncológico Docente "Conrado Benítez García" · CUCenter of Molecular Immunology (Cuba) · CUCuban Neuroscience Center · CUInstituto de Oncología y Radiobiología · CUHermanos Ameijeiras Hospital · CUInstituto de Nutricion e Higiene de los Alimentos · CUOncoscience (Germany) · DEUniversity of Holguín · CUUniversity of the Basque Country · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe prognosis of patients bearing high grade glioma remains dismal. Epidermal Growth Factor Receptor (EGFR) is well validated as a primary contributor of glioma initiation and progression. Nimotuzumab is a humanized monoclonal antibody that recognizes the EGFR extracellular domain and reaches Central Nervous System tumors, in nonclinical and clinical setting. While it has similar activity when compared to other anti-EGFR antibodies, it does not induce skin toxicity or hypomagnesemia.

methodsA randomized, double blind, multicentric clinical trial was conducted in high grade glioma patients (41 anaplastic astrocytoma and 29 glioblastoma multiforme) that received radiotherapy plus nimotuzumab or placebo. Treatment and placebo groups were well-balanced for the most important prognostic variables. Patients received 6 weekly doses of 200 mg nimotuzumab or placebo together with irradiation as induction therapy. Maintenance treatment was given for 1 year with subsequent doses administered every 3 weeks. The objectives of this study were to assess the comparative overall survival, progression free survival, response rate, immunogenicity and safety.

resultsThe median cumulative dose was 3200 mg of nimotuzumab given over a median number of 16 doses. The combination of nimotuzumab and RT was well-tolerated. The most prevalent related adverse reactions included nausea, fever, tremors, anorexia and hepatic test alteration. No anti-idiotypic response was detected, confirming the antibody low immunogenicity. The mean and median survival time for subjects treated with nimotuzumab was 31.06 and 17.76 vs. 21.07 and 12.63 months for the control group.

conclusionsIn this randomized trial, nimotuzumab showed an excellent safety profile and significant survival benefit in combination with irradiation.

trial registrationCuban National Register for clinical trials (No. 1745) (http://registroclinico.sld.cu/ensayos).

Indexed as

AdultAntibodies, Monoclonal, HumanizedAntineoplastic AgentsBrain NeoplasmsChemoradiotherapyDouble-Blind MethodFemaleGliomaHumansKaplan-Meier EstimateMaleMiddle AgedNeoplasm GradingAntibodies, Monoclonal, HumanizedAntineoplastic Agentsnimotuzumab

Identifiers

PMID23782513
PMCPMC3691625
OpenAlexW1990736053

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.