Evidence map›Paper›PMID 32391579›Full record

Trial reportInternational journal of cancer2020

A subset analysis of a phase II trial evaluating the use of DFMO as maintenance therapy for high-risk neuroblastoma.

Elizabeth C Lewis, Jacqueline M Kraveka, William Ferguson, Don Eslin, Valerie I Brown, Genevieve Bergendahl, William Roberts, Randal K Wada, Javier Oesterheld, Deanna Mitchell and 8 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIComparative Study
In one paragraph

Trial report in International journal of cancer, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05594563 (TArgeting Type 1 Diabetes Using POLyamines), which is not on this map. Cited by 41 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
41citing papers in PubMed, 1 pooled it
3.1field-weighted citation impact, top 6% 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.

NCT05594563 phase2active not recruitingnot on this mapstarted 2023, after this paper: background citation

TArgeting Type 1 Diabetes Using POLyamines (TADPOL): A Randomized, Double-Masked, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of Difluoromethylornithine (DFMO) to Preserve Insulin Production in Type 1 Diabetes

TypeinterventionalSponsorEmily K. SimsRan2023 to 2027Enrolled74ConditionsType 1 DiabetesArmsDFMO, Placebo
3 · Its place in the literature

Who cites it

41 citing papers in PubMed, 1 synthesis or guideline pooled it, 64 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. 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
  4. Trial
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Antitumor potential of polyamines in cancer.Acta biochimica et biophysica Sinica · 2025
    Review
  12. Article
  13. Review
  14. Article
  15. Review
  16. Article
  17. Bachmann-Bupp syndrome and treatment.Developmental medicine and child neurology · 2024
    Review
  18. Article
  19. Review
  20. Article
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 11 institutions in 1 country.

Elizabeth C LewisHelen DeVos Children's Hospital at Spectrum Health, Grand Rapids, Michigan, USA.ORCID 0000-0001-6663-6333
Jacqueline M KravekaMedical University of South Carolina, Charleston, South Carolina, USA.
William FergusonSt. Louis University School of Medicine, St. Louis, Missouri, USA.
Don EslinArnold Palmer Hospital for Children, Orlando, Florida, USA.
Valerie I BrownPenn State Health Children's Hospital at the Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania, USA.
Genevieve BergendahlHelen DeVos Children's Hospital at Spectrum Health, Grand Rapids, Michigan, USA.
William RobertsRady Children's Hospital-San Diego and UC San Diego School of Medicine, San Diego, California, USA.
Randal K WadaKapiolani Medical Center for Women and Children, Honolulu, Hawaii, USA.
Javier OesterheldLevine Children's Hospital, Charlotte, North Carolina, USA.
Deanna MitchellHelen DeVos Children's Hospital at Spectrum Health, Grand Rapids, Michigan, USA.
Jessica FoleyHelen DeVos Children's Hospital at Spectrum Health, Grand Rapids, Michigan, USA.
Peter ZageRady Children's Hospital-San Diego and UC San Diego School of Medicine, San Diego, California, USA.
Jawhar RawwasChildren's Hospitals and Clinics of Minnesota, Minneapolis, Minnesota, USA.
Maria RichHelen DeVos Children's Hospital at Spectrum Health, Grand Rapids, Michigan, USA.
Elizabeth LorenziBerry Consultants, LLC, Austin, Texas, USA.
Kristine BroglioBerry Consultants, LLC, Austin, Texas, USA.
Donald BerryBerry Consultants, LLC, Austin, Texas, USA.
Giselle L Saulnier ShollerHelen DeVos Children's Hospital at Spectrum Health, Grand Rapids, Michigan, USA.
Spectrum Health · USBerry & Associates (United States) · USGrand Rapids Community College · USUniversity of California San Diego · USArnold Palmer Hospital for Children · USChildren's Minnesota · USKapiolani Medical Center for Women and Children · USLevine Children's Hospital · USMedical University of South Carolina · USPenn State Milton S. Hershey Medical Center · USUniversity of Missouri–St. Louis · US

Funding

Convalescent Plasma to Limit Coronavirus Associated ComplicationsUL1TR003167 · NCATS · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI KARP, DANIEL D, MCPHERSON, DAVID D · 2019 to 2023
$45.3M
NCATS NIH HHS UL1 TR003167
6 · The paper itself

Abstract

Neuroblastoma is a sympathetic nervous system tumor, primarily presenting in children under 6 years of age. The long-term prognosis for patients with high-risk neuroblastoma (HRNB) remains poor despite aggressive multimodal therapy. This report provides an update to a phase II trial evaluating DFMO as maintenance therapy in HRNB. Event-free survival (EFS) and overall survival (OS) of 81 subjects with HRNB treated with standard COG induction, consolidation and immunotherapy followed by 2 years of DFMO on the NMTRC003/003b Phase II trial were compared to a historical cohort of 76 HRNB patients treated at Beat Childhood Cancer Research Consortium (BCC) hospitals who were disease-free after completion of standard upfront therapy and did not receive DFMO. The 2- and 5-year EFS were 86.4% [95% confidence interval (CI) 79.3%-94.2%] and 85.2% [77.8%-93.3%] for the NMTRC003/003b subset vs 78.3% [69.5%-88.3%] and 65.6% [55.5%-77.5%] for the historical control group. The 2- and 5-year OS were 98.8% [96.4-100%] and 95.1% [90.5%-99.9%] vs 94.4% [89.3%-99.9%] and 81.6% [73.0%-91.2%], respectively. DFMO maintenance for HRNB after completion of standard of care therapy was associated with improved EFS and OS relative to historical controls treated at the same institutions. These results support additional investigations into the potential role of DFMO in preventing relapse in HRNB.

Indexed as

Child, PreschoolDisease-Free SurvivalEflornithineFemaleHumansMaintenance ChemotherapyMaleNeuroblastomaPrognosisStandard of CareTreatment OutcomeEflornithineDFMOhigh-risk neuroblastomamaintenance

Identifiers

PMID32391579
PMCPMC7586843
OpenAlexW3023715425

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.