Evidence map›Paper›PMID 21908574›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2011

Phase II study of oral capsular 4-hydroxyphenylretinamide (4-HPR/fenretinide) in pediatric patients with refractory or recurrent neuroblastoma: a report from the Children's Oncology Group.

Judith G Villablanca, Wendy B London, Arlene Naranjo, Patrick McGrady, Matthew M Ames, Joel M Reid, Renee M McGovern, Sarah A Buhrow, Hollie Jackson, Enno Stranzinger and 7 more

Open access · bronzeAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 52 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
52citing papers in PubMed, 2 pooled it
5.1field-weighted citation impact, top 4% 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

52 citing papers in PubMed, 2 syntheses or guidelines pooled it, 93 citations in OpenAlex.

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  20. Combining peptide TNIIIA2 with all-American journal of cancer research · 2019
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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

17 authors at 5 institutions in 2 countries.

Judith G VillablancaChildren's Hospital Los Angeles, Department of Pediatrics, Keck School of Medicine, University of Southern California, Los Angeles, California 90027, USA. jvillablanca@chla.usc.edu
Wendy B London
Arlene Naranjo
Patrick McGrady
Matthew M Ames
Joel M Reid
Renee M McGovern
Sarah A Buhrow
Hollie Jackson
Enno Stranzinger
Brenda J Kitchen
Paul M Sondel
Marguerite T Parisi
Barry Shulkin
Gregory A Yanik
Susan L Cohn
C Patrick Reynolds
Mayo Clinic in Florida · USChildren's Oncology Group · CHTexas Tech University · USUniversity Children’s Hospital Bern · CHUniversity of Southern California · US

Funding

COG FOREIGN ACCRUALU10CA098543 · NCI · NATIONAL CHILDHOOD CANCER FOUNDATION · PI ADAMSON, PETER C. · 2003 to 2013
$335.5M
Women's Cancer ProgramP30CA015083 · NCI · MAYO CLINIC ROCHESTER · PI Felicity Enders · 1985 to 2026
$151.3M
Children's Oncology Group Statistics &Data Center GrantU10CA098413 · NCI · UNIVERSITY OF NEBRASKA MEDICAL CENTER · PI ANDERSON, JAMES R · 2003 to 2013
$67.5M
ENHANCING ACTIVITY OF ALKYLATING AGENTS IN NEUROBLASTOMAR01CA082830 · NCI · TEXAS TECH UNIVERSITY HEALTH SCIS CENTER · PI REYNOLDS, CHARLES PATRICK · 1999 to 2011
$1.7M
NCI NIH HHS CA82830NCI NIH HHS P30 CA015083NCI NIH HHS P30 CA15083NCI NIH HHS R01 CA082830NCI NIH HHS U10 CA098413NCI NIH HHS U10 CA098543NCI NIH HHS U10 CA98413NCI NIH HHS U10 CA98543
6 · The paper itself

Abstract

purposeTo determine the response rate to oral capsular fenretinide in children with recurrent or biopsy proven refractory high-risk neuroblastoma. EXPERIMENTAL

designPatients received 7 days of fenretinide: 2,475 mg/m(2)/d divided TID (<18 years) or 1,800 mg/m(2)/d divided BID (≥18 years) every 21 days for a maximum of 30 courses. Patients with stable or responding disease after course 30 could request additional compassionate courses. Best response by course 8 was evaluated in stratum 1 (measurable disease on CT/MRI ± bone marrow and/or MIBG avid sites) and stratum 2 (bone marrow and/or MIBG avid sites only).

resultsSixty-two eligible patients, median age 5 years (range 0.6-19.9), were treated in stratum 1 (n = 38) and stratum 2 (n = 24). One partial response (PR) was seen in stratum 2 (n = 24 evaluable). No responses were seen in stratum 1 (n = 35 evaluable). Prolonged stable disease (SD) was seen in 7 patients in stratum 1 and 6 patients in stratum 2 for 4 to 45+ (median 15) courses. Median time to progression was 40 days (range 17-506) for stratum 1 and 48 days (range 17-892) for stratum 2. Mean 4-HPR steady-state trough plasma concentrations were 7.25 μmol/L (coefficient of variation 40-56%) at day 7 course 1. Toxicities were mild and reversible.

conclusionsAlthough neither stratum met protocol criteria for efficacy, 1 PR + 13 prolonged SD occurred in 14/59 (24%) of evaluable patients. Low bioavailability may have limited fenretinide activity. Novel fenretinide formulations with improved bioavailability are currently in pediatric phase I studies.

Indexed as

3-IodobenzylguanidineAdministration, OralAdolescentAntineoplastic AgentsCapsulesChildChild, PreschoolDisease-Free SurvivalFemaleFenretinideHumansInfantIodine RadioisotopesMagnetic Resonance ImagingMaleNeoplasm Recurrence, Local3-IodobenzylguanidineAntineoplastic AgentsCapsulesFenretinideIodine RadioisotopesRadiopharmaceuticals

Identifiers

PMID21908574
PMCPMC3207022
OpenAlexW2139201146

What OpenQuestion holds

Textmetadata
LicenceTDM
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.