Evidence map›Paper›PMID 38470405›Full record

Trial reportCancer2024

Outcome of patients with relapsed or refractory nonrhabdomyosarcoma soft tissue sarcomas enrolled in phase 2 cooperative group clinical trials: A report from the Children's Oncology Group.

Sapna Oberoi, Amira Qumseya, Wei Xue, Rajkumar Venkatramani, Aaron R Weiss

Abstract readClinical Trial, Phase II
In one paragraph

Trial report in Cancer, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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

2 citing papers in PubMed.

  1. Article
  2. Review
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

5 authors.

Sapna OberoiDepartment of Pediatrics and Child Health, University of Manitoba, Winnipeg, Manitoba, Canada.ORCID https://orcid.org/0000-0002-6071-0042
Amira QumseyaDepartment of Biostatistics, College of Public Health and Health Professions College of Medicine, University of Florida, Gainesville, Florida, USA.
Wei XueDepartment of Biostatistics, College of Public Health and Health Professions College of Medicine, University of Florida, Gainesville, Florida, USA.
Rajkumar VenkatramaniDivision of Hematology/Oncology, Department of Pediatrics, Texas Children's Cancer Center, Texas Children's Hospital, Baylor College of Medicine, Houston, Texas, USA.
Aaron R WeissDivision of Pediatric Hematology-Oncology, Department of Pediatrics, Maine Medical Center, Portland, Maine, USA.ORCID https://orcid.org/0000-0001-8352-3963

Funding

NCTN BIQSFP ANBL1531 (NRT)U10CA180886 · NCI · PUBLIC HEALTH INSTITUTE · PI Douglas S. Hawkins · 2014 to 2026
$390.6M
COG SDMC - Statistics CoreU10CA180899 · NCI · UNIVERSITY OF SOUTHERN CALIFORNIA · PI TODD A ALONZO · 2014 to 2026
$132.8M
MaineHealth Cancer Care Network (MHCCN) and NCORP Activities across the LifespanUG1CA239771 · NCI · MAINEHEALTH · PI Leslie Bradford, Christine Lu-Emerson · 2019 to 2026
$7.9M
National Clinical Trials Network Operations Center U10CA180886National Clinical Trials Network Statistics & Data Center U10CA180899NCI NIH HHS U10 CA180886NCI NIH HHS U10 CA180899NCI NIH HHS UG1 CA239771St. Baldrick's FoundationTakeda
6 · The paper itself

Abstract

backgroundThe aim of this study was to estimate the event-free survival (EFS) of children and young adults with relapsed or refractory nonrhabdomyosarcoma soft tissue sarcoma (NRSTS) treated in nonrandomized phase 2 studies conducted by the Children's Oncology Group (COG) and predecessor groups to establish a benchmark EFS for future phase 2 NRSTS trials evaluating the activity of novel agents.

methodsA retrospective analysis of patients with recurrent or refractory NRSTS prospectively enrolled in nonrandomized phase 2 COG and predecessor group trials between 1994 and 2015 was conducted. EFS was defined as disease progression/relapse or death and calculated via the Kaplan-Meier method. The log-rank test and relative risk regression were used to compare EFS distribution by age at enrollment, sex, race, NRSTS histology, prior lines of therapy, calendar year of trial, and type of radiographic response.

resultsIn total, 137 patients were enrolled in 13 phase 2 trials. All trials used radiographic response rate as a primary outcome, and none of the agents used were considered active on the basis of trial-specified thresholds. The estimated median EFS and 6-month EFS of the entire study cohort was 1.5 months (95% confidence interval [CI], 1.3-1.8 months) and 19.4% (95% CI, 12.7%-26%), respectively. No difference in EFS was observed by age at enrollment, sex, race, NRSTS histology subtype, prior lines of therapies, and trial initiation year. EFS significantly differed by radiographic response.

conclusionsThe EFS for children and young adults with relapsed or refractory NRSTS remains suboptimal. Established EFS can be referenced as a benchmark for future single-agent phase 2 trials incorporating potentially active novel agents in this population.

Indexed as

Clinical Trials, Phase II as TopicNeoplasm Recurrence, LocalSarcomaAdolescentAdultChildChild, PreschoolFemaleHumansInfantKaplan-Meier EstimateMaleProgression-Free SurvivalRetrospective StudiesTreatment OutcomeYoung Adultchildhoodrefractoryrelapsesoft tissue sarcomasurvivalyoung adults

Identifiers

PMID38470405
PMCPMC11214599

What OpenQuestion holds

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Registered trials

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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.