Evidence map›Paper›PMID 36669140›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2023

Randomized Phase III Trial of Ganitumab With Interval-Compressed Chemotherapy for Patients With Newly Diagnosed Metastatic Ewing Sarcoma: A Report From the Children's Oncology Group.

Steven G DuBois, Mark D Krailo, Julia Glade-Bender, Allen Buxton, Nadia Laack, R Lor Randall, Helen X Chen, Nita L Seibel, Matthew Boron, Stephanie Terezakis and 15 more

Open access · greenAbstract readRandomized Controlled TrialClinical Trial, Phase III
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 56 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
56citing papers in PubMed, 1 pooled it
19.4field-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.

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

56 citing papers in PubMed, 1 synthesis or guideline pooled it, 79 citations in OpenAlex.

  1. Biological Sample Collection to Advance Research and Treatment: A Fight Osteosarcoma Through European Research and Euro Ewing Consortium Statement.Clinical cancer research : an official journal of the American Association for Cancer Research · 2024
    Guideline
  2. Trial
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  4. Trial
  5. Review
  6. Article
  7. Review
  8. Review
  9. Article
  10. Long-Term Analysis of Patients With Ewing Sarcoma Included in the Euro-EWING99 Study.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2026
    Article
  11. Sarcomas in Adolescents and Young Adults.Current oncology reports · 2026
    Review
  12. Article
  13. Review
  14. Article
  15. Article
  16. Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

25 authors at 19 institutions in 1 country.

Steven G DuBoisDana-Farber/Boston Children's Cancer and Blood Disorders Center, Harvard Medical School, Boston, MA.ORCID 0000-0003-0882-738X
Mark D KrailoDepartment of Population and Public Health Sciences, University of Southern California, Los Angeles, CA.
Julia Glade-BenderDepartment of Pediatrics, Memorial Sloan Kettering Cancer Center, New York, NY.ORCID 0000-0001-5316-6440
Allen BuxtonChildren's Oncology Group Statistics and Data Center, Monrovia, CA.
Nadia LaackDepartment of Radiation Oncology, Mayo Clinic, Rochester, MN.ORCID 0000-0002-4385-6349
R Lor RandallDepartment of Orthopedic Surgery, UC Davis Medical Center, Sacramento, CA.ORCID 0000-0002-3660-774X
Helen X ChenCancer Therapy Evaluation Program, National Cancer Institute, Bethesda, MD.
Nita L SeibelCancer Therapy Evaluation Program, National Cancer Institute, Bethesda, MD.ORCID 0000-0001-6259-7955
Matthew BoronCancer Therapy Evaluation Program, National Cancer Institute, Bethesda, MD.
Stephanie TerezakisDepartment of Radiation Oncology, University of Minnesota Medical School, Minneapolis, MN.ORCID 0000-0002-8125-3987
Christine Hill-KayserDepartment of Radiation Oncology, University of Pennsylvania Perelman School of Medicine and Children's Hospital of Philadelphia, Philadelphia, PA.
Andrea HayesDepartment of Surgery, Howard University College of Medicine, Washington, DC.
Joel M ReidDepartment of Oncology, Mayo Clinic, Rochester, MN.ORCID 0000-0003-2872-3123
Lisa TeotDepartment of Pathology, Boston Children's Hospital, Harvard Medical School, Boston, MA.
Dinesh RakhejaDepartment of Pathology, University of Texas Southwestern Medical Center, Dallas, TX.ORCID 0000-0001-6888-7902
Richard WomerDepartment of Pediatrics, University of Pennsylvania Perelman School of Medicine and Children's Hospital of Philadelphia, Philadelphia, PA.ORCID 0000-0002-4405-1200
Carola ArndtPediatric and Adolescent Medicine, Mayo Clinic, Rochester, MN.
Stephen L LessnickCenter for Childhood Cancer and Blood Diseases, Abigail Wexner Research Institute, Nationwide Children's Hospital, Columbus, OH.ORCID 0000-0001-9645-4434
Brian D CromptonDana-Farber/Boston Children's Cancer and Blood Disorders Center, Harvard Medical School, Boston, MA.ORCID 0000-0001-9404-6621
E Anders KolbDepartment of Radiology, Stanford University School of Medicine, Palo Alto, CA.ORCID 0000-0003-2854-9014
Heike Daldrup-LinkDepartment of Radiology, Stanford University School of Medicine, Palo Alto, CA.
Eric EutslerDepartment of Radiology, Washington University School of Medicine, St Louis, MO.
Damon R ReedDepartment of Individualized Cancer Management, Moffitt Cancer Center, Tampa, FL.ORCID 0000-0002-8238-2465
Katherine A JanewayDana-Farber/Boston Children's Cancer and Blood Disorders Center, Harvard Medical School, Boston, MA.ORCID 0000-0001-6000-3594
Richard G GorlickDepartment of Pediatrics, MD Anderson Cancer Center, Houston, TX.ORCID 0000-0001-8995-2929
National Cancer Institute · USChildren's Hospital of Philadelphia · USHarvard University · USMayo Clinic in Arizona · USStanford University · USBoston Children's Hospital · USBroad Institute · USChildren's Oncology Group · USHoward University · USMayo Clinic in Florida · USMemorial Sloan Kettering Cancer Center · USMoffitt Cancer Center · USNationwide Children's Hospital · USThe University of Texas MD Anderson Cancer Center · USThe University of Texas Southwestern Medical Center · USUniversity of California Davis Medical Center · USUniversity of Minnesota Medical Center · USUniversity of Southern California · USWashington University in St. Louis · US

Funding

NCTN BIQSFP ANBL1531 (NRT)U10CA180886 · NCI · PUBLIC HEALTH INSTITUTE · PI Douglas S. Hawkins · 2014 to 2026
$390.6M
X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI SELWYN M VICKERS · 1985 to 2026
$347.4M
Women's Cancer ProgramP30CA015083 · NCI · MAYO CLINIC ROCHESTER · PI Lila J. Rutten · 1985 to 2026
$151.3M
COG SDMC - Statistics CoreU10CA180899 · NCI · UNIVERSITY OF SOUTHERN CALIFORNIA · PI TODD A ALONZO · 2014 to 2026
$132.8M
NCI NIH HHS P30 CA008748NCI NIH HHS P30 CA015083NCI NIH HHS U10 CA180886NCI NIH HHS U10 CA180899
6 · The paper itself

Abstract

purposeMonoclonal antibodies directed against insulin-like growth factor-1 receptor (IGF-1R) have shown activity in patients with relapsed Ewing sarcoma. The primary objective of Children's Oncology Group trial AEWS1221 was to determine if the addition of the IGF-1R monoclonal antibody ganitumab to interval-compressed chemotherapy improves event-free survival (EFS) in patients with newly diagnosed metastatic Ewing sarcoma.

methodsPatients were randomly assigned 1:1 at enrollment to standard arm (interval-compressed vincristine/doxorubicin/cyclophosphamide alternating once every 2 weeks with ifosfamide/etoposide = VDC/IE) or to experimental arm (VDC/IE with ganitumab at cycle starts and as monotherapy once every 3 weeks for 6 months after conventional therapy). A planned sample size of 300 patients was projected to provide 81% power to detect an EFS hazard ratio of 0.67 or smaller for the experimental arm compared with the standard arm with a one-sided α of .025.

resultsTwo hundred ninety-eight eligible patients enrolled (148 in standard arm; 150 in experimental arm). The 3-year EFS estimates were 37.4% (95% CI, 29.3 to 45.5) for the standard arm and 39.1% (95% CI, 31.3 to 46.7) for the experimental arm (stratified EFS-event hazard ratio for experimental arm 1.00; 95% CI, 0.76 to 1.33; 1-sided,

conclusionGanitumab added to interval-compressed chemotherapy did not significantly reduce the risk of EFS event in patients with newly diagnosed metastatic Ewing sarcoma, with outcomes similar to prior trials without IGF-1R inhibition or interval compression. The addition of ganitumab may be associated with increased toxicity.

Indexed as

Bone NeoplasmsSarcoma, EwingAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsChildCyclophosphamideDisease-Free SurvivalDoxorubicinEtoposideHumansNeoplasm Recurrence, LocalVincristineAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedCyclophosphamideDoxorubicinEtoposideganitumabVincristine

Identifiers

PMID36669140
PMCPMC10082251
OpenAlexW4317565671

What OpenQuestion holds

Textmetadata
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.