Evidence map›Paper›PMID 33452711›Full record

SynthesisCancer medicine2021

Systematic review of phase-I/II trials enrolling refractory and recurrent Ewing sarcoma: Actual knowledge and future directions to optimize the research.

Arthur Felix, Pablo Berlanga, Maud Toulmonde, Judith Landman-Parker, Sarah Dumont, Gilles Vassal, Marie-Cécile Le Deley, Nathalie Gaspar

Open access · goldAbstract readSystematic Review
In one paragraph

Synthesis in Cancer medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
1.6field-weighted citation impact, top 16% 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

13 citing papers in PubMed, 1 synthesis or guideline pooled it, 19 citations in OpenAlex.

  1. Biological Sample Collection to Advance Research and Treatment: A Fight Osteosarcoma Through European Research and Euro Ewing Consortium Statement.Clinical cancer research : an official journal of the American Association for Cancer Research · 2024
    Guideline
  2. Trial
  3. Observational
  4. Article
  5. Article
  6. Review
  7. Article
  8. Article
  9. Article
  10. Article
  11. Review
  12. Review
  13. Bone sarcoma: success through interdisciplinary collaboration.Journal of children's orthopaedics · 2021
    Article
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 4 institutions in 1 country.

Arthur FelixDepartment of Oncology for Child and Adolescent, Gustave Roussy Cancer Campus, Villejuif cedex, France.ORCID 0000-0002-6034-6869
Pablo BerlangaDepartment of Oncology for Child and Adolescent, Gustave Roussy Cancer Campus, Villejuif cedex, France.
Maud ToulmondeMedical Oncology Department, Institut Bergonié, Bordeaux, France.ORCID 0000-0003-3896-9274
Judith Landman-ParkerService d'Hématologie et d'Oncologie Pédiatrique, Hôpital Armand Trousseau, Paris, France.
Sarah DumontDepartment of Medical Oncology, Gustave Roussy Cancer Campus, Villejuif, France.
Gilles VassalDepartment of Oncology for Child and Adolescent, Gustave Roussy Cancer Campus, Villejuif cedex, France.
Marie-Cécile Le DeleyDirection de la Recherche Clinique et de l'Innovation, Centre Oscar Lambret, Lille, France.
Nathalie GasparDepartment of Oncology for Child and Adolescent, Gustave Roussy Cancer Campus, Villejuif cedex, France.
Institut Gustave Roussy · FRCentre Oscar Lambret · FRInstitut Bergonié · FRSorbonne Université · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOptimal Phase-II design to evaluate new therapies in refractory/relapsed Ewing sarcomas (ES) remains imperfectly defined.

objectivesRecurrent/refractory ES phase-I/II trials analysis to improve trials design.

methodsComprehensive review of therapeutic trials registered on five databases (who.int/trialsearch, clinicaltrials.gov, clinicaltrialsregister.eu, e-cancer.fr, and umin.ac.jp) and/or published in PubMed/ASCO/ESMO websites, between 2005 and 2018, using the criterion: (Ewing sarcoma OR bone sarcoma OR sarcoma) AND (Phase-I or Phase-II).

resultsThe 146 trials identified (77 phase-I/II, 67 phase-II, and 2 phase-II/III) tested targeted (34%), chemo- (23%), immune therapies (19%), or combined therapies (24%). Twenty-three trials were ES specific and 48 had a specific ES stratum. Usually multicentric (88%), few trials were international (30%). Inclusion criteria cover the recurrent ES age range for only 12% of trials and allowed only accrual of measurable diseases (RECIST criteria). Single-arm design was the most frequent (88%) testing mainly single drugs (61%), only 5% were randomized. Primary efficacy outcome was response rate (RR=CR+PR; Complete+Partial response) (n = 116/146; 79%), rarely progression-free or overall survival (16% PFS and 3% OS). H0 and H1 hypotheses were variable (3%-25% and 20%-50%, respectively). The 62 published trials enrolled 827 ES patients. RR was poor (10%; 15 CR=1.7%, 68 PR=8.3%). Stable disease was the best response for 186 patients (25%). Median PFS/OS was of 1.9 (range 1.3-14.7) and 7.6 months (5-30), respectively. Eleven (18%) published trials were considered positive, with median RR/PFS/OS of 15% (7%-30%), 4.5 (1.3-10), and 16.6 months (6.9-30), respectively.

conclusionThis review supports the need to develop the international randomized phase-II trials across all age ranges with PFS as primary endpoint.

Indexed as

Antineoplastic AgentsBone NeoplasmsClinical Trials, Phase I as TopicClinical Trials, Phase II as TopicCombined Modality TherapyDatabases, FactualHumansImmunotherapyMolecular Targeted TherapyMulticenter Studies as TopicNeoplasm Recurrence, LocalProgression-Free SurvivalRandomized Controlled Trials as TopicResearch DesignResponse Evaluation Criteria in Solid TumorsSarcoma, EwingAntineoplastic AgentsEwing sarcomanew cancer therapiesphase-I/II trialstrial design

Identifiers

PMID33452711
PMCPMC7940237
OpenAlexW3125883930

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.