Evidence map›Paper›PMID 24696052›Full record

Trial reportJournal of neuro-oncology2014

Results of nimotuzumab and vinorelbine, radiation and re-irradiation for diffuse pontine glioma in childhood.

Maura Massimino, Veronica Biassoni, Rosalba Miceli, Elisabetta Schiavello, Monika Warmuth-Metz, Piergiorgio Modena, Michela Casanova, Emilia Pecori, Felice Giangaspero, Manila Antonelli and 13 more

Erratum issued 2 registry-linked trialsAbstract readClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in Journal of neuro-oncology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 59 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
59citing papers in PubMed, 5 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.

NCT03620032 phase2unknown statusnot on this mapstarted 2015, after this paper: background citation

Phase 2 Randomized Study of RT and Reirradiation at Relapse vs Multiple Elective RT Courses With Same Concomitant CT for Newly Diagnosed

TypeinterventionalSponsorFondazione IRCCS Istituto Nazionale dei Tumori, MilanoRan2015 to 2024Enrolled54ConditionsDiffuse Intrinsic Pontine GliomaArmsNimotuzumab, Vinorelbine, Radiotherapy
NCT03841435 nacompletednot on this mapstarted 2018, after this paper: background citation

Feasibility Study of Hypofractionated Radiotherapy in the Setting of Recurrent Diffuse Intrinsic Pontine Glioma

TypeinterventionalSponsorUniversity of CincinnatiRan2018 to 2023Enrolled5ConditionsRecurrent Diffuse Intrinsic Pontine GliomaArmsHypofractionated Radiotherapy
3 · Its place in the literature

Who cites it

59 citing papers in PubMed, 5 syntheses or guidelines pooled it.

  1. Diagnostic challenges and treatment barriers in the management of diffuse intrinsic pontine glioma in low- and lower-middle-income countries: a systematic review.Child's nervous system : ChNS : official journal of the International Society for Pediatric Neurosurgery · 2026
    Pooled it
  2. Pooled it
  3. Pooled it
  4. Reirradiation for diffuse intrinsic pontine glioma: a systematic review and meta-analysis.Child's nervous system : ChNS : official journal of the International Society for Pediatric Neurosurgery · 2019
    Pooled it
  5. Pooled it
  6. Trial
  7. Review
  8. Radiological complete response in diffuse intrinsic pontine glioma: a case report.Child's nervous system : ChNS : official journal of the International Society for Pediatric Neurosurgery · 2026
    Article
  9. Re-irradiation in progressive diffuse infiltrative pontine glioma in children and young adults.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2025
    Article
  10. Review
  11. Article
  12. Article
  13. Advances in Treatment of Diffuse Midline Gliomas.Current neurology and neuroscience reports · 2023
    Review
  14. Article
  15. Review
  16. Review
  17. Article
  18. Review
  19. Article
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

23 authors.

Maura MassiminoPediatric Unit, Fondazione IRCCS Istituto Nazionale dei Tumori (INT), Via Venezian 1, 20133, Milano, Italy. maura.massimino@istitutotumori.mi.it.
Veronica BiassoniPediatric Unit, Fondazione IRCCS Istituto Nazionale dei Tumori (INT), Via Venezian 1, 20133, Milano, Italy.
Rosalba MiceliMedical Statistics, Biometry and Bioinformatics Unit, Fondazione IRCCS Istituto Nazionale dei Tumori (INT), Via Venezian 1, 20133, Milano, Italy.
Elisabetta SchiavelloPediatric Unit, Fondazione IRCCS Istituto Nazionale dei Tumori (INT), Via Venezian 1, 20133, Milano, Italy.
Monika Warmuth-MetzDepartment of Neuroradiology, University of Würzburg, Josef-Schneider-Str.11, 97080, Wurzburg, Germany.
Piergiorgio ModenaGenetics Unit, Pathology Department, Ospedale S. Anna, San Fermo della Battaglia, 22100, Como, Italy.
Michela CasanovaPediatric Unit, Fondazione IRCCS Istituto Nazionale dei Tumori (INT), Via Venezian 1, 20133, Milano, Italy.
Emilia PecoriRadiotherapy Unit, Fondazione IRCCS Istituto Nazionale dei Tumori (INT), Via Venezian 1, 20133, Milano, Italy.
Felice GiangasperoRadiological and Oncological Sciences Department, Universita` Sapienza, Viale del Policlinico, 00151, Roma, Italy.
Manila AntonelliRadiological and Oncological Sciences Department, Universita` Sapienza, Viale del Policlinico, 00151, Roma, Italy.
Francesca Romana ButtarelliPathology Department, Universita` Sapienza, Viale del Policlinico, 00151, Roma, Italy.
Paolo PotepanRadiology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori (INT), Via Venezian 1, 20133, Milano, Italy.
Bianca PolloNeuropathology Unit, IRCCS Istituto Neurologico Carlo Besta, Via Celoria, 20133, Milano, Italy.
Raffaele NunziataNeuropathology Unit, IRCCS Istituto Neurologico Carlo Besta, Via Celoria, 20133, Milano, Italy.
Filippo SpreaficoPediatric Unit, Fondazione IRCCS Istituto Nazionale dei Tumori (INT), Via Venezian 1, 20133, Milano, Italy.
Marta PoddaPediatric Unit, Fondazione IRCCS Istituto Nazionale dei Tumori (INT), Via Venezian 1, 20133, Milano, Italy.
Andrea AnichiniHuman Tumor Immunobiology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori (INT), Via Venezian 1, 20133, Milano, Italy.
Carlo Alfredo ClericiPediatric Unit, Fondazione IRCCS Istituto Nazionale dei Tumori (INT), Via Venezian 1, 20133, Milano, Italy.
Iacopo SardiNeuro-Oncology Unit, Ospedale Meyer, Viale Pieraccini 24, 50139, Firenze, Italy.
Loris De CeccoMolecular Therapies Unit, Fondazione IRCCS Istituto Nazionale dei Tumori (INT), Via Venezian 1, 20133, Milano, Italy.
Udo BodeDepartment of Pediatric Hematology/Oncology, University of Bonn Medical School, Bonn, Germany.
Ferdinand BachOncoscience AG, Hafenstraße 32, 22880, Wedel, Germany.
Lorenza GandolaRadiotherapy Unit, Fondazione IRCCS Istituto Nazionale dei Tumori (INT), Via Venezian 1, 20133, Milano, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Radiotherapy is the only treatment definitely indicated for diffuse pontine gliomas (DIPG). Findings on the role of EGFR signaling in the onset of childhood DIPG prompted the use of nimotuzumab, an anti-EGFR monoclonal antibody. Assuming a potential synergy with both radiotherapy and vinorelbine, a pilot phase 2 protocol was launched that combined nimotuzumab with concomitant radiation and vinorelbine. An amendment in July 2011 introduced re-irradiation at relapse. The primary endpoint for first-line treatment was objective response rate (CR + PR + SD) according to the RECIST. This report concerns the outcome of this strategy as a whole. Vinorelbine 20 mg/m(2) was administered weekly, with nimotuzumab 150 mg/m(2) in the first 12 weeks of treatment; radiotherapy was delivered from weeks 3 to 9, for a total dose of 54 Gy. Vinorelbine 25 mg/m(2) and nimotuzumab were given every other week thereafter until the tumor progressed or for up to 2 years. Re-irradiation consisted of 19.8 Gy, fractionated over 11 days. Baseline and latest MRIs were assessed blindly by an outside neuroradiologist. Twenty five children (mean age 7.4 years) were enrolled as of August 2009 (median follow-up 29 months). A response was observed in 24/25 patients (96 %). The nimotuzumab/vinorelbine combination was very well tolerated, with no acute side-effects. Eleven of 16 locally-relapsing patients were re-irradiated. One-year PFS and OS rates were 30 ± 10 % and 76 ± 9 %, respectively; 2-year OS was 27 ± 9 %; the median PFS and OS were 8.5 and 15 months, respectively. This strategy generated interesting results and warrants further investigation.

Indexed as

ChemoradiotherapyAdolescentAntibodies, Monoclonal, HumanizedAntineoplastic Agents, PhytogenicBrain Stem NeoplasmsChildChild, PreschoolDrug Therapy, CombinationFemaleFollow-Up StudiesGliomaHumansImmunologic FactorsMagnetic Resonance ImagingMaleNeoplasm Recurrence, LocalAntibodies, Monoclonal, HumanizedAntineoplastic Agents, PhytogenicImmunologic FactorsnimotuzumabVinblastineVinorelbine

Identifiers

What OpenQuestion holds

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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.