Evidence map›Paper›PMID 33504555›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2021

Long-Term Follow-up of a Phase III Study of ch14.18 (Dinutuximab) + Cytokine Immunotherapy in Children with High-Risk Neuroblastoma: COG Study ANBL0032.

Alice L Yu, Andrew L Gilman, M Fevzi Ozkaynak, Arlene Naranjo, Mitchell B Diccianni, Jacek Gan, Jacquelyn A Hank, Ayse Batova, Wendy B London, Sheena C Tenney and 9 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05421897 (RAPID Feasibility Study), which is not on this map. Cited by 133 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
133citing papers in PubMed, 4 pooled it
16.0field-weighted citation impact, top 1% 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.

NCT05421897 phase1active not recruitingnot on this mapstarted 2022, after this paper: background citation

RAPID Feasibility Study: A Pilot Study for the Rapid Infusion of Dinutuximab

TypeinterventionalSponsorChildren's Hospital Los AngelesRan2022 to 2026Enrolled11ConditionsNeuroblastomaArmsDinutuximab with Chemotherapy
3 · Its place in the literature

Who cites it

133 citing papers in PubMed, 4 syntheses or guidelines pooled it, 203 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Trial
  7. A Phase II Trial of Naxitamab plus Stepped-up Dosing of GM-CSF for Patients with High-Risk Neuroblastoma in First Complete Remission.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025
    Trial
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  11. Review
  12. Article
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  15. Article
  16. Review
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  18. Targeted therapies in pediatric oncology: A start.Molecular therapy. Oncology · 2026
    Review
  19. Review
  20. Article

73 more citing papers are in PubMed but not listed here.

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

19 authors at 12 institutions in 3 countries.

Alice L YuUniversity of California in San Diego, San Diego, California. a1yu@ucsd.edu pmsondel@humonc.wisc.edu.ORCID 0000-0003-2444-0505
Andrew L GilmanPRA Health Services, Raleigh, North Carolina.
M Fevzi OzkaynakNew York Medical College, Valhalla, New York.
Arlene NaranjoChildren's Oncology Group Statistics and Data Center, University of Florida, Gainesville, Florida.
Mitchell B DiccianniUniversity of California in San Diego, San Diego, California.
Jacek GanUniversity of Wisconsin Carbone Cancer Center, Madison, Wisconsin.
Jacquelyn A HankUniversity of Wisconsin Carbone Cancer Center, Madison, Wisconsin.ORCID 0000-0002-1402-3540
Ayse BatovaUniversity of California in San Diego, San Diego, California.
Wendy B LondonDana-Farber/Boston Children's Cancer and Blood Disorder Center, Harvard Medical School, Boston, Massachusetts.
Sheena C TenneyChildren's Oncology Group Statistics and Data Center, University of Florida, Gainesville, Florida.ORCID 0000-0002-3255-8450
Malcolm SmithNational Cancer Institute, Bethesda, Maryland.ORCID 0000-0001-9880-9876
Barry L ShulkinSaint Jude Children's Research Hospital, Memphis, Tennessee.ORCID 0000-0003-4784-7914
Marguerite ParisiSeattle Children's Hospital and University of Washington School of Medicine, Seattle, Washington.
Katherine K MatthayUniversity of California School of Medicine and UCSF Children's Hospital, San Francisco, California.
Susan L CohnUniversity of Chicago, Chicago, Illinois.ORCID 0000-0001-5749-7650
John M MarisChildren's Hospital of Philadelphia and University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania.ORCID 0000-0002-8088-7929
Rochelle BagatellChildren's Hospital of Philadelphia and University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania.ORCID 0000-0002-5729-8819
Julie R ParkSeattle Children's Hospital and University of Washington School of Medicine, Seattle, Washington.
Paul M SondelUniversity of Wisconsin Carbone Cancer Center, Madison, Wisconsin. a1yu@ucsd.edu pmsondel@humonc.wisc.edu.
University of San Diego · USUniversity of Wisconsin Carbone Cancer Center · USChildren's Hospital of Philadelphia · USChildren's Oncology Group · CHSeattle Children's Hospital · USDana-Farber/Boston Children's Cancer and Blood Disorders Center · USNational Cancer Institute · USNC Department of Health and Human Services · USNew York Medical College · USSt. Jude Children's Research Hospital · USUCSF Benioff Children's Hospital · USUniversity of Illinois Chicago · US

Funding

NCTN BIQSFP ANBL1531 (NRT)U10CA180886 · NCI · PUBLIC HEALTH INSTITUTE · PI Douglas S. Hawkins · 2014 to 2026
$390.6M
COG FOREIGN ACCRUALU10CA098543 · NCI · NATIONAL CHILDHOOD CANCER FOUNDATION · PI ADAMSON, PETER C. · 2003 to 2013
$335.5M
COG SDMC - Statistics CoreU10CA180899 · NCI · UNIVERSITY OF SOUTHERN CALIFORNIA · PI TODD A ALONZO · 2014 to 2026
$132.8M
Discovering mechanisms of neuroblastoma tumorigenesis to improve patient outcomesR35CA220500 · NCI · CHILDREN'S HOSP OF PHILADELPHIA · PI JOHN M MARIS · 2017 to 2026
$8.7M
Enhancing Antibody-directed Innate Immunity to Improve Cancer OutcomeR35CA197078 · NCI · UNIVERSITY OF WISCONSIN-MADISON · PI SONDEL, PAUL M · 2015 to 2021
$6.4M
IMMUNE MONITOR FOR COG TRIAL OF ANTI-GD2 IN NEUROBLASTOMAR01FD002319 · FDA · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI YU, ALICE L. · 2005 to 2009
$994k
Predicting toxicity and success of anti-GD2 immunotherapy of neuroblastomaR01CA164132 · NCI · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI YU, ALICE L. · 2012 to 2014
$936k
FDA HHS R01 FD002319NCI NIH HHS R01 CA164132NCI NIH HHS R35 CA197078NCI NIH HHS R35 CA220500NCI NIH HHS U10 CA098543NCI NIH HHS U10 CA180886NCI NIH HHS U10 CA180899
6 · The paper itself

Abstract

purposePreviously our randomized phase III trial demonstrated that immunotherapy including dinutuximab, a chimeric anti-GD2 mAb, GM-CSF, and IL2 improved survival for children with high-risk neuroblastoma that had responded to induction and consolidation therapy. These results served as the basis for FDA approval of dinutuximab. We now present long-term follow-up results and evaluation of predictive biomarkers. PATIENTS AND

methodsPatients recieved six cycles of isotretinoin with or without five cycles of immunotherapy which consists of dinutuximab with GM-CSF alternating with IL2. Accrual was discontinued early due to meeting the protocol-defined stopping rule for efficacy, as assessed by 2-year event-free survival (EFS). Plasma levels of dinutuximab, soluble IL2 receptor (sIL2R), and human anti-chimeric antibody (HACA) were assessed by ELISA. Fcγ receptor 2A and 3A genotypes were determined by PCR and direct sequencing.

resultsFor 226 eligible randomized patients, 5-year EFS was 56.6 ± 4.7% for patients randomized to immunotherapy (

conclusionsImmunotherapy with dinutuximab improved outcome for patients with high-risk neuroblastoma. Early stoppage for efficacy resulted in a smaller sample size than originally planned, yet clinically significant long-term differences in survival were observed.

Indexed as

AdolescentAntibodies, MonoclonalAntineoplastic Combined Chemotherapy ProtocolsChildChild, PreschoolFollow-Up StudiesHumansInfantInterleukin-2IsotretinoinMaleNeuroblastomaProgression-Free SurvivalRecombinant ProteinsAntibodies, MonoclonaldinutuximabIL2 protein, humanInterleukin-2IsotretinoinRecombinant Proteins

Identifiers

PMID33504555
PMCPMC8046731
OpenAlexW3123833440

What OpenQuestion holds

Textmetadata
LicenceTDM
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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.