Evidence map›Paper›PMID 20576718›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2010

Inhaled granulocyte-macrophage colony stimulating factor for first pulmonary recurrence of osteosarcoma: effects on disease-free survival and immunomodulation. a report from the Children's Oncology Group.

Carola A S Arndt, Nadya V Koshkina, Carrie Y Inwards, Douglas S Hawkins, Mark D Krailo, Doojduen Villaluna, Peter M Anderson, Allen M Goorin, Martin L Blakely, Mark Bernstein and 5 more

2 registry-linked trialsOpen access · bronzeAbstract readClinical Trial
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 38 papers.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed
2.3field-weighted citation impact, top 11% 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.

NCT00066365 phase2completednot on this map

A Phase II Study of Aerosolized GM-CSF (NSC# 613795, IND# 11042) in Patients With First Pulmonary Recurrence of Osteosarcoma

TypeinterventionalSponsorChildren's Oncology GroupRan2004 to 2013Enrolled49ConditionsMetastatic Cancer, SarcomaArmssargramostim, conventional surgery
NCT04569877 phase2completednot on this mapstarted 2020, after this paper: background citation

Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) Inhalation to Prevent ARDS in COVID-19 Pneumonia (GI-COVID)

TypeinterventionalSponsorUniversity of GiessenRan2020 to 2022Enrolled63ConditionsSevere Acute Respiratory Syndrome (SARS) Pneumonia, COVID-19 PneumoniaArmsMolgramostim nebuliser solution, Placebo nebuliser solution
3 · Its place in the literature

Who cites it

38 citing papers in PubMed, 80 citations in OpenAlex.

  1. Trial
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  11. Recent and Ongoing Research into Metastatic Osteosarcoma Treatments.International journal of molecular sciences · 2022
    Review
  12. Advancing therapy for osteosarcoma.Nature reviews. Clinical oncology · 2021
    Review
  13. Review
  14. Article
  15. Review
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  17. Review
  18. Article
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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

15 authors at 9 institutions in 2 countries.

Carola A S ArndtMayo Clinic, 200 First Street SW, Rochester, MN 55905, USA. carndt@mayo.edu
Nadya V Koshkina
Carrie Y Inwards
Douglas S Hawkins
Mark D Krailo
Doojduen Villaluna
Peter M Anderson
Allen M Goorin
Martin L Blakely
Mark Bernstein
Sharon A Bell
Kaylee Ray
Darryl C Grendahl
Neyssa Marina
Eugenie S Kleinerman
Seattle Children's Hospital · USArcadia · USIzaak Walton Killam Health Centre · CAThe University of Texas MD Anderson Cancer Center · USChildren's Oncology Group · USDana-Farber Cancer Institute · USStanford Medicine · USStanford University · USUniversity of Tennessee Health Science Center · US

Funding

COG FOREIGN ACCRUALU10CA098543 · NCI · NATIONAL CHILDHOOD CANCER FOUNDATION · PI ADAMSON, PETER C. · 2003 to 2013
$335.5M
Children's Oncology Group Statistics &Data Center GrantU10CA098413 · NCI · UNIVERSITY OF NEBRASKA MEDICAL CENTER · PI ANDERSON, JAMES R · 2003 to 2013
$67.5M
NCI NIH HHS U10 CA098413NCI NIH HHS U10 CA098543NCI NIH HHS U10 CA98413NCI NIH HHS U10 CA98543
6 · The paper itself

Abstract

purposeOsteosarcoma most commonly recurs in the lung. Based on preliminary data on the antitumor effects of granulocyte-macrophage colony stimulating factor (GM-CSF) in animal models, and promising phase I trials, we embarked on a feasibility study of inhaled GM-CSF in patients with first isolated pulmonary recurrence of osteosarcoma. EXPERIMENTAL

designForty-three eligible patients received inhaled GM-CSF at doses from 250 to 1,750 microg twice daily on alternate weeks. Following two cycles, patients underwent thoracotomy to resect tumor and analyze pulmonary nodules for expression of Fas/Fas ligand (Fas/FasL), and the presence of dendritic cells by immunostaining for CD1a, clusterin, and S100. Following surgery, patients received 12 additional cycles of therapy on alternating weeks or until progression. Event-free survival and survival, and feasibility of therapy delivery were evaluated.

resultsDose escalation to 1,750 microg twice daily was feasible with no dose-limiting toxicity. Mean scores for Fas/FasL in nodules from patients with bilateral recurrence who underwent unilateral thoracotomy pretreatment (using a scoring system of 0-3) were 1.3 and 0.88, respectively, compared with 0.78 and 0.62 in nodules resected following two cycles of therapy. Only 11 of 30 nodules postinhalation were positive for CD1a, 4 of 30 for S100, and 6 of 30 for clusterin. Event-free and overall survival at 3 years were 7.8% and 35.4%, respectively.

conclusionsInhalation of GM-CSF at doses from 250 to 1,750 microg twice daily on alternate weeks was feasible with low toxicity. However, no detectable immunostimulatory effect in pulmonary metastases or improved outcome postrelapse was seen.

Indexed as

Administration, InhalationAdolescentAdultAntineoplastic AgentsBone NeoplasmsChildDisease-Free SurvivalFeasibility StudiesFemaleGranulocyte-Macrophage Colony-Stimulating FactorHumansImmunomodulationKaplan-Meier EstimateLung NeoplasmsMaleOsteosarcomaAntineoplastic AgentsGranulocyte-Macrophage Colony-Stimulating Factor

Identifiers

PMID20576718
PMCPMC2989183
OpenAlexW2100378516

What OpenQuestion holds

Textmetadata
LicenceTDM
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.