Evidence map›Paper›PMID 20142595›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2010

Phase II, randomized, open-label study of pegfilgrastim-supported VDC/IE chemotherapy in pediatric sarcoma patients.

Sheri L Spunt, Helen Irving, Jami Frost, Leonard Sender, Matthew Guo, Bing-Bing Yang, Lyndah Dreiling, Victor M Santana

Open access · bronzeAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
1.4field-weighted citation impact, top 20% 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

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

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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

8 authors at 3 institutions in 2 countries.

Sheri L SpuntDepartment of Oncology, St Jude Children's Research Hospita, Universityof Tennessee Health Sciences Center, Memphis, TN 38105-3678, USA. sheri.spunt@stjude.org
Helen Irving
Jami Frost
Leonard Sender
Matthew Guo
Bing-Bing Yang
Lyndah Dreiling
Victor M Santana
Royal Children's Hospital · AUSt. Jude Children's Research Hospital · USLovelace Health System · US

Funding

Viral Vector Technology (VVTSR)P30CA021765 · NCI · ST. JUDE CHILDREN'S RESEARCH HOSPITAL · PI SUZANNE J. BAKER · 1985 to 2026
$166.9M
XENOGRAFT STUDIESP01CA023099 · NCI · ST. JUDE CHILDREN'S RESEARCH HOSPITAL · PI STEWART, CLINTON F · 1985 to 2011
$22.4M
NCI NIH HHS CA23099NCI NIH HHS P01 CA023099NCI NIH HHS P30 CA021765NCI NIH HHS P30 CA21765
6 · The paper itself

Abstract

purposeThis multicenter, randomized, open-label study evaluated the efficacy, safety, and pharmacokinetics of a single subcutaneous pegfilgrastim injection with daily subcutaneous filgrastim administration in pediatric patients receiving myelosuppressive chemotherapy for sarcoma. PATIENTS AND METHODS Forty-four patients with previously untreated, biopsy-proven sarcoma stratified into three age groups (0-5, 6-11, and 12-21 years) were randomly assigned in a 6:1 randomization ratio to receive a single pegfilgrastim dose of 100 microg/kg (n = 38) or daily filgrastim doses of 5 microg/kg (n = 6) after chemotherapy (cycles 1 and 3: vincristine-doxorubicin-cyclophosphamide; cycles 2 and 4: ifosfamide-etoposide). The duration of grade 4 neutropenia, time to neutrophil recovery, incidence of febrile neutropenia, and adverse events were recorded. Results Pegfilgrastim and filgrastim were similar for all efficacy and safety end points, and their pharmacokinetic profiles were consistent with those in adults. Younger children experienced more protracted neutropenia and had higher median pegfilgrastim exposure than older children. CONCLUSION A single dose of pegfilgrastim at 100 microg/kg administered once per chemotherapy cycle is comparable to daily injections of filgrastim at 5 microg/kg for pediatric sarcoma patients receiving myelosuppressive chemotherapy.

Indexed as

AdolescentAntineoplastic Combined Chemotherapy ProtocolsAustraliaChildChild, PreschoolDrug Administration ScheduleDrug-Related Side Effects and Adverse ReactionsFilgrastimGranulocyte Colony-Stimulating FactorHumansInfantInfant, NewbornInjections, SubcutaneousNeutropeniaPolyethylene GlycolsRecombinant ProteinsFilgrastimGranulocyte Colony-Stimulating FactorpegfilgrastimPolyethylene GlycolsRecombinant Proteins

Identifiers

PMID20142595
PMCPMC2834494
OpenAlexW2030045357

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.