Evidence map›Paper›PMID 26041763›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2015

Aplidin in patients with advanced dedifferentiated liposarcomas: a French Sarcoma Group Single-Arm Phase II study.

M Toulmonde, A Le Cesne, S Piperno-Neumann, N Penel, C Chevreau, F Duffaud, C Bellera, A Italiano

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01876043 (Efficacy and Safety of Plitidepsin in Patients With Advanced Unresectable or Metastatic, Relapsed/Refractory, Dedifferentiated Liposarcoma), which is not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
1.2field-weighted citation impact, top 19% 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.

NCT01876043 phase2terminatednot on this map

Efficacy and Safety of Plitidepsin in Patients With Advanced Unresectable or Metastatic, Relapsed/Refractory, Dedifferentiated Liposarcoma (DLPS): an Exploratory Phase II Multicenter Trial

TypeinterventionalSponsorInstitut BergoniéRan2012 to 2015Enrolled24ConditionsAdult Patients With Unresectable Locally Advanced or Metastatic, Relapsed/Refractory Dedifferentiated LiposarcomaArmsplitidepsin
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 17 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Review
  5. Article
  6. Review
  7. Review
  8. Review
  9. Plitidepsin: design, development, and potential place in therapy.Drug design, development and therapy · 2017
    Review
  10. Prognostic value of HMGA2, CDK4, and JUN amplification in well-differentiated and dedifferentiated liposarcomas.Modern pathology : an official journal of the United States and Canadian Academy of Pathology, Inc · 2015
    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 6 institutions in 1 country.

M ToulmondeDepartment of Medical Oncology, Institut Bergonié, Bordeaux.
A Le CesneDepartment of Medicine, Institut Gustave Roussy, Villejuif.
S Piperno-NeumannDepartment of Medicine, Institut Curie, Paris.
N PenelDepartment of Medicine, Centre Oscar Lambret, Lille.
C ChevreauDepartment of Medicine, Institut Claudius Regaud, Toulouse.
F DuffaudDepartment of Medical Oncology, Hôpital La Timone, Marseille.
C BelleraClinical and Epidemiological Research Unit, Institut Bergonié, Bordeaux Data Center for Cancer Clinical Trials, CTD-INCa, Bordeaux, France.
A ItalianoDepartment of Medical Oncology, Institut Bergonié, Bordeaux a.italiano@bordeaux.unicancer.fr.
Institut Bergonié · FRCentre Oscar Lambret · FRHôpital de la Timone · FRInstitut Claudius Regaud · FRInstitut Curie · FRInstitut Gustave Roussy · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPreclinical data have suggested a therapeutic role of JUN pathway activation in dedifferentiated liposarcoma (DDLPS) tumorigenesis. Aplidin is a drug inducing apoptosis through a strong, sustained activation of c-Jun NH2-terminal kinase.

methodsThis phase II trial included patients with progressive advanced DDLPS. They received Aplidin 5 mg/m(2) days 1-15, 28-day cycle until disease progression or unacceptable toxicity. The primary end point was the 3-month nonprogression rate (PFS3) defined as the proportion of patients with nonprogressive disease at 3 months. A PFS3 of 40% considered as a reasonable objective to claim drug efficacy.

resultsBetween August 2012 and May 2013, 24 patients were included. Sixteen had received prior chemotherapy. Twenty-two were assessable for efficacy. The PFS3 was 9.1% [95% confidence interval (CI) 1.1-29.2]. Median progression-free and overall survivals were 1.6 months (95% CI 1.4-2.6) and 9.2 months (95% CI 6.6-). The most frequent adverse events of any grade were nausea, fatigue, anorexia, vomiting and diarrhea.

conclusionAplidin did not meet the primary end point of this trial and do not deserve further investigation in DDLPS. CLINICALTRIALSGOV IDENTIFIER: NCT01876043.

Indexed as

AgedAged, 80 and overDepsipeptidesDisease ProgressionFemaleFollow-Up StudiesHumansLiposarcomaMaleMiddle AgedNeoplasm MetastasisNeoplasm StagingPeptides, CyclicPrognosisSurvival RateDepsipeptidesPeptides, CyclicplitidepsinAplidindedifferentiated liposarcomaJUNplitidepsintreatment

Identifiers

PMID26041763
PMCPMC4478976
OpenAlexW2130560812

What OpenQuestion holds

Textmetadata
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.