Evidence map›Paper›PMID 32343642›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2020

Irinotecan, Temozolomide, and Dinutuximab With GM-CSF in Children With Refractory or Relapsed Neuroblastoma: A Report From the Children's Oncology Group.

Rajen Mody, Alice L Yu, Arlene Naranjo, Fan F Zhang, Wendy B London, Barry L Shulkin, Marguerite T Parisi, Sabah-E-Noor Servaes, Mitchell B Diccianni, Jacquelyn A Hank and 9 more

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

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2020. 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 118 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
118citing papers in PubMed, 3 pooled it
8.7field-weighted citation impact, top 2% 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

118 citing papers in PubMed, 3 syntheses or guidelines pooled it, 184 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. 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
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  13. Long-Term Follow-up of a Phase III Study of ch14.18 (Dinutuximab) + Cytokine Immunotherapy in Children with High-Risk Neuroblastoma: COG Study ANBL0032.Clinical cancer research : an official journal of the American Association for Cancer Research · 2021
    Trial
  14. Article
  15. Development of novel GPC2-directed radiotheranostics and CAR T cell therapy for neuroblastoma.Molecular therapy : the journal of the American Society of Gene Therapy · 2026
    Article
  16. Review
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  19. Article
  20. Article

58 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 2 countries.

Rajen ModyC.S. Mott Children's Hospital, University of Michigan, Ann Arbor, MI.
Alice L YuUniversity of California San Diego, San Diego, CA.
Arlene NaranjoChildren's Oncology Group Statistics and Data Center, University of Florida, Gainesville, FL.
Fan F ZhangChildren's Oncology Group Statistics and Data Center, Monrovia, CA.
Wendy B LondonDana-Farber Cancer Institute and Harvard Medical School, Boston, MA.
Barry L ShulkinSt Jude Children's Research Hospital and University of Tennessee Health Science Center, Memphis, TN.
Marguerite T ParisiSeattle Children's Hospital and University of Washington, Seattle, WA.
Sabah-E-Noor ServaesChildren's Hospital of Philadelphia and University of Pennsylvania, Philadelphia, PA.
Mitchell B DiccianniUniversity of California San Diego, San Diego, CA.
Jacquelyn A HankUniversity of Wisconsin, Madison, WI.
Mildred FelderUniversity of Wisconsin, Madison, WI.
Jennifer BirstlerUniversity of Wisconsin, Madison, WI.
Paul M SondelUniversity of Wisconsin, Madison, WI.
Shahab AsgharzadehChildren's Hospital of Los Angeles and University of Southern California, Los Angeles, CA.
Julia Glade-BenderMemorial Sloan Kettering Cancer Center, New York, NY.
Howard KatzensteinNemour's Children's Clinic, Jacksonville, FL.
John M MarisChildren's Hospital of Philadelphia and University of Pennsylvania, Philadelphia, PA.
Julie R ParkSeattle Children's Hospital and University of Washington, Seattle, WA.
Rochelle BagatellChildren's Hospital of Philadelphia and University of Pennsylvania, Philadelphia, PA.
University of Wisconsin–Madison · USChildren's Oncology Group · USUniversity of California, San Diego · USUniversity of Pennsylvania · USUniversity of Washington · USChildren's Hospital of Philadelphia · USC. S. Mott Children's Hospital · USDana-Farber Cancer Institute · USMemorial Sloan Kettering Cancer Center · USNemours Children’s Clinic · USSt. Jude Children's Research Hospital · USUniversity of Southern California · 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 Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
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
NCI NIH HHS P30 CA008748NCI 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

purposeThe combination of irinotecan, temozolomide, dintuximab, and granulocyte-macrophage colony-stimulating factor (I/T/DIN/GM-CSF) demonstrated activity in patients with relapsed/refractory neuroblastoma in the randomized Children's Oncology Group ANBL1221 trial. To more accurately assess response rate and toxicity, an expanded cohort was nonrandomly assigned to I/T/DIN/GM-CSF. PATIENTS AND

methodsPatients were eligible at first relapse or first designation of refractory disease. Oral T and intravenous (IV) irinotecan were administered on days 1 to 5 of 21-day cycles. DIN was administered IV (days 2-5), and GM-CSF was administered subcutaneously (days 6-12). The primary end point was objective response, analyzed on an intent-to-treat basis per the International Neuroblastoma Response Criteria.

resultsSeventeen eligible patients were randomly assigned to I/T/DIN/GM-CSF (February 2013 to March 2015); 36 additional patients were nonrandomly assigned to I/T/DIN/GM-CSF (August 2016 to May 2017). Objective (complete or partial) responses were observed in nine (52.9%) of 17 randomly assigned patients (95% CI, 29.2% to 76.7%) and 13 (36.1%) of 36 expansion patients (95% CI, 20.4% to 51.8%). Objective responses were seen in 22 (41.5%) of 53 patients overall (95% CI, 28.2% to 54.8%); stable disease was also observed in 22 of 53. One-year progression-free and overall survival for all patients receiving I/T/DIN/GM-CSF were 67.9% ± 6.4% (95% CI, 55.4% to 80.5%) and 84.9% ± 4.9% (95% CI, 75.3% to 94.6%), respectively. Two patients did not receive protocol therapy and were evaluable for response but not toxicity. Common grade ≥ 3 toxicities were fever/infection (18 [35.3%] of 51), neutropenia (17 [33.3%] of 51), pain (15 [29.4%] of 51), and diarrhea (10 [19.6%] of 51). One patient met protocol-defined criteria for unacceptable toxicity (grade 4 hypoxia). Higher DIN trough levels were associated with response.

conclusionI/T/DIN/GM-CSF has significant antitumor activity in patients with relapsed/refractory neuroblastoma. Study of chemoimmunotherapy in the frontline setting is indicated, as is further evaluation of predictive biomarkers.

Indexed as

AdolescentAntibodies, MonoclonalAntineoplastic Combined Chemotherapy ProtocolsChildChild, PreschoolFemaleGranulocyte-Macrophage Colony-Stimulating FactorHumansImmunotherapyInfantIrinotecanMaleNeuroblastomaSurvival AnalysisTemozolomideAntibodies, MonoclonaldinutuximabGranulocyte-Macrophage Colony-Stimulating FactorIrinotecanTemozolomide

Identifiers

PMID32343642
PMCPMC7325366
OpenAlexW3018670999

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.