Evidence map›Paper›PMID 29143272›Full record

Trial reportJournal of neuro-oncology2018

Preliminary results of immune modulating antibody MDV9300 (pidilizumab) treatment in children with diffuse intrinsic pontine glioma.

Iris Fried, Alex Lossos, Tal Ben Ami, Rina Dvir, Helen Toledano, Myriam Weil Ben Arush, Sergei Postovski, Abed Abu Kuidar, Michal Yalon, Michael Weintraub and 1 more

Abstract readClinical Trial
PubMed Publisher
In one paragraph

Trial report in Journal of neuro-oncology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing 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.

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

23 citing papers in PubMed, 2 syntheses or guidelines 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

11 authors.

Iris FriedThe Department of Pediatric Hematology Oncology, Hadassah Medical Center, Jerusalem, Israel. Ishonet@gmail.com.
Alex LossosThe Gaffin Center for Neuro-Oncology, Sharett Institute of Oncology, Hadassah Medical Center, Jerusalem, Israel.
Tal Ben AmiThe Department of Pediatric Hematology Oncology, Hadassah Medical Center, Jerusalem, Israel.
Rina DvirPediatric Hematology Oncology Department, Sourasky Medical Center, Tel Aviv, Israel.
Helen ToledanoPediatric Hematology Oncology Department, Schneider Hospital, Petah Tikva, Israel.
Myriam Weil Ben ArushPediatric Hematology Oncology Department, Rambam Hospital, Haifa, Israel.
Sergei PostovskiPediatric Hematology Oncology Department, Rambam Hospital, Haifa, Israel.
Abed Abu KuidarPediatric Hematology Oncology Department, Soroka Hospital, Beersheba, Israel.
Michal YalonPediatric Hematology Oncology Department, Sheba Hospital, Ramat Gan, Israel.
Michael WeintraubThe Department of Pediatric Hematology Oncology, Hadassah Medical Center, Jerusalem, Israel.
Mony BeniflaPediatric Neurosurgery Unit, Hadassah Medical Center, Jerusalem, Israel.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Diffuse intrinsic pontine glioma (DIPG) is an incurable disease with a median overall survival of 10 months. Immune modulating antibodies have recently emerged as a highly promising treatment modality in multiple cancer types. We present results from the first study to evaluate the immune modulating antibody MDV9300 (pidilizumab) in pediatric patients with DIPG. All patients aged 3 years and older, diagnosed with DIPG between February 2014 and June 2015 in Israel, were offered to participate in the study. Enrolled patients were started on biweekly 6 mg/kg MDV9300 after radiation completion. Treatment was continued until disease progression on imaging. Patients were followed biweekly for the occurrence of neurological deficit toxicities and side effects. Secondary endpoints were event free survival and overall survival. Of 13 children diagnosed with DIPG during the study period, nine were enrolled in the study. The patients underwent radiotherapy and none had chemotherapy. A total of 83 cycles of MDV9300 (range 2-16) were applied. The main side effects were neutropenia (CTCAE grade 1-3), mild to moderate fatigue, and acute elevation of blood pressure. Four patients died within 1 year of the diagnosis, another three died within 2 years and two children are still alive nearly 30 months from diagnosis, with stable disease. The median event free survival is 9.3 months (range 6.8-24) and the median overall survival is 15.6 months (range 6.9-28). Preliminary results demonstrate that MDV9300 treatment is safe and may be effective in the treatment of children with DIPG.

Indexed as

AdolescentAntibodies, MonoclonalAntineoplastic Agents, ImmunologicalBrain Stem NeoplasmsChildChild, PreschoolCombined Modality TherapyDisease ProgressionFemaleGliomaHumansMaleProgression-Free SurvivalProspective StudiesSurvival AnalysisAntibodies, MonoclonalAntineoplastic Agents, ImmunologicalpidilizumabBrain stem gliomaImmunotherapyMDV9300Pediatric oncology

Identifiers

PMID29143272

What OpenQuestion holds

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Registered trials

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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.