Evidence map›Paper›PMID 23117071›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2013

Growth modulation index as metric of clinical benefit assessment among advanced soft tissue sarcoma patients receiving trabectedin as a salvage therapy.

N Penel, G D Demetri, J Y Blay, S Cousin, R G Maki, S P Chawla, I Judson, M von Mehren, P Schöffski, J Verweij and 9 more

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

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed
1.7field-weighted citation impact, top 14% 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

28 citing papers in PubMed, 50 citations in OpenAlex.

  1. Trial
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  7. Phase IB Study of Selinexor, a First-in-Class Inhibitor of Nuclear Export, in Patients With Advanced Refractory Bone or Soft Tissue Sarcoma.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2016
    Trial
  8. Trial
  9. Article
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  11. Observational
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  16. Efficacy of second and third lines of treatment in advanced soft tissue sarcomas: a real-world study.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2023
    Article
  17. Article
  18. Review
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  20. Bevacizumab in recurrent ovarian cancer: could it be particularly effective in patients with clear cell carcinoma?Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 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

19 authors at 13 institutions in 7 countries.

N PenelMedical Oncology Department, Centre Oscar Lambret, Lille, France. Electronic address: n-penel@o-lambret.fr.
G D DemetriMedical Oncology Department, Ludwig Center at Dana-Farber Cancer Institute, Boston, USA.
J Y BlayMedical Oncology Department, Centre Léon Bérard, Lyon, France.
S CousinMedical Oncology Department, Centre Oscar Lambret, Lille, France.
R G MakiMedical Oncology Department,Mount Sinai School of Medicine, New York.
S P ChawlaMedical Oncology Department, Santa Monica Oncology Center Santa Monica, USA.
I JudsonMedical Oncology Department, Royal Marsden Hospital, London, UK.
M von MehrenMedical Oncology Department, Fox Chase Cancer Center, Philadelphia, USA.
P SchöffskiMedical Oncology Department, University Hospital Gasthuisberg, Leuven, Belgium.
J VerweijMedical Oncology Department, Erasmus University Medical Center, Rotterdam, The Netherlands.
P CasaliMedical Oncology Department, Istituto Nazionale Tumori, Milan, Italy.
S RodenhuisMedical Oncology Department, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
H J SchütteMedical Oncology Department, Marien Hospital, Dûsseldorf, Deutschland.
A CassarScientific liaison office, Novex Pharma, Levallois-Perret, France.
J GomezStatistics Department & Medical affairs, Pharmamar, Madrid, Spain.
A NietoStatistics Department & Medical affairs, Pharmamar, Madrid, Spain.
P ZintlStatistics Department & Medical affairs, Pharmamar, Madrid, Spain.
M J PontesStatistics Department & Medical affairs, Pharmamar, Madrid, Spain.
A Le CesneMedical Oncology Department, Institut Gustave Roussy, Villejuif, France.
PharmaMar (Spain) · ESCentre Oscar Lambret · FRCentre Léon Bérard · FRDana-Farber Cancer Institute · USErasmus MC · NLFondazione IRCCS Istituto Nazionale dei Tumori · ITFox Chase Cancer Center · USIcahn School of Medicine at Mount Sinai · USInstitut Gustave Roussy · FRMarien Hospital Düsseldorf · DERoyal Marsden Hospital · GBSarcoma Oncology Center · USThe Netherlands Cancer Institute · NL

Funding

Tissue and Pathology ResourcesP50CA127003 · NCI · DANA-FARBER CANCER INST · PI EL-BARDEESY, NABEEL, SELLERS, WILLIAM R · 2007 to 2023
$33.2M
NCI NIH HHS P50 CA127003
6 · The paper itself

Abstract

backgroundThe growth modulation index (GMI) is the ratio of time to progression with the nth line (TTP(n)) of therapy to the TTP(n)(-1) with the n-1th line. GMI >1.33 is considered as a sign of activity in phase II trials. PATIENTS AND

methodsThis retrospective analysis evaluated the concordance between the GMI and the efficacy outcomes in 279 patients with advanced soft tissue sarcoma (ASTS) treated with trabectedin 1.5 mg/m² (24-h infusion every 3 weeks) in four phase II trials.

resultsOne hundred and forty-two (51%) patients received one prior line and 137 ≥ 2 lines. The median TTP(n) was 2.8 months (range 0.2-26.8), whereas the median TTP(n)(-1) was 4.0 months (0.3-79.5). The median GMI was 0.6 (0.0-14.4). Overall, 177 patients (63%) had a GMI <1; 21 (8%) a GMI equal to 1-1.33 and 81 (29%) a GMI >1.33, which correlated with the median overall survival in those patients (9.1, 13.9 and 23.8 months, respectively, P = 0.0005). A high concordance rate between the GMI and response rate (P < 0.0001) and progression-free survival (PFS, P < 0.0001) was observed. Good performance status (PS) was the only factor associated with GMI >1.33 (PS = 0; P < 0.04).

conclusionsA high GMI was associated with favorable efficacy outcomes in patients treated with trabectedin. Further research is needed to assess GMI as an indicator in this setting.

Indexed as

AdultAgedAged, 80 and overAntibiotics, AntineoplasticAntineoplastic Agents, AlkylatingCell ProliferationDioxolesDisease-Free SurvivalDoxorubicinFemaleHumansMaleMiddle AgedRetrospective StudiesSalvage TherapySarcomaAntibiotics, AntineoplasticAntineoplastic Agents, AlkylatingDioxolesDoxorubicinTetrahydroisoquinolinesTrabectedin

Identifiers

PMID23117071
PMCPMC4271084
OpenAlexW2108003570

What OpenQuestion holds

Textmetadata
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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.