Evidence map›Paper›PMID 24762958›Full record

Trial reportBritish journal of cancer2014

Randomised proof-of-concept phase II trial comparing targeted therapy based on tumour molecular profiling vs conventional therapy in patients with refractory cancer: results of the feasibility part of the SHIVA trial.

C Le Tourneau, X Paoletti, N Servant, I Bièche, D Gentien, T Rio Frio, A Vincent-Salomon, V Servois, J Romejon, O Mariani and 22 more

Abstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in British journal of cancer, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 38 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed, 2 pooled it
–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

38 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
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  6. Review
  7. Article
  8. Article
  9. Quo vadis precision oncology?Journal of cancer research and clinical oncology · 2023
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  18. Statistical controversies in clinical research: basket trials, umbrella trials, and other master protocols: a review and examples.Annals of oncology : official journal of the European Society for Medical Oncology · 2017
    Review
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  20. 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

32 authors.

C Le Tourneau1] Institut Curie, Paris, France [2] Unité INSERM/Institut Curie U900, Paris, France [3] Institut Curie, Saint-Cloud, France.
X Paoletti1] Institut Curie, Paris, France [2] Unité INSERM/Institut Curie U900, Paris, France.
N Servant1] Institut Curie, Paris, France [2] Unité INSERM/Institut Curie U900, Paris, France.
I BiècheInstitut Curie, Paris, France.
D GentienInstitut Curie, Paris, France.
T Rio FrioInstitut Curie, Paris, France.
A Vincent-SalomonInstitut Curie, Paris, France.
V ServoisInstitut Curie, Paris, France.
J Romejon1] Institut Curie, Paris, France [2] Unité INSERM/Institut Curie U900, Paris, France.
O MarianiInstitut Curie, Paris, France.
V BernardInstitut Curie, Paris, France.
P Huppe1] Institut Curie, Paris, France [2] Unité INSERM/Institut Curie U900, Paris, France.
G PierronInstitut Curie, Paris, France.
F MulotInstitut Curie, Paris, France.
C CallensInstitut Curie, Paris, France.
J WongInstitut Curie, Paris, France.
C MauborgneInstitut Curie, Paris, France.
E RouleauInstitut Curie, Paris, France.
C ReyesInstitut Curie, Paris, France.
E HenryInstitut Curie, Paris, France.
Q LeroyInstitut Curie, Paris, France.
P Gestraud1] Institut Curie, Paris, France [2] Unité INSERM/Institut Curie U900, Paris, France.
P La Rosa1] Institut Curie, Paris, France [2] Unité INSERM/Institut Curie U900, Paris, France.
L EscalupInstitut Curie, Paris, France.
E MitryInstitut Curie, Saint-Cloud, France.
O TrédanCentre Léon Bérard, Lyon, France.
J-P DelordInstitut Claudius Régaud, Toulouse, France.
M CamponeCentre René Gauducheau, Nantes, France.
A GoncalvesInstitut Paoli-Calmettes, Marseille, France.
N IsambertCentre Georges-François Leclerc, Dijon, France.
C GavoilleCentre Alexis Vautrin, Nancy, France.
M KamalInstitut Curie, Paris, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe SHIVA trial is a multicentric randomised proof-of-concept phase II trial comparing molecularly targeted therapy based on tumour molecular profiling vs conventional therapy in patients with any type of refractory cancer. RESULTS of the feasibility study on the first 100 enrolled patients are presented.

methodsAdult patients with any type of metastatic cancer who failed standard therapy were eligible for the study. The molecular profile was performed on a mandatory biopsy, and included mutations and gene copy number alteration analyses using high-throughput technologies, as well as the determination of oestrogen, progesterone, and androgen receptors by immunohistochemistry (IHC).

resultsBiopsy was safely performed in 95 of the first 100 included patients. Median time between the biopsy and the therapeutic decision taken during a weekly molecular biology board was 26 days. Mutations, gene copy number alterations, and IHC analyses were successful in 63 (66%), 65 (68%), and 87 (92%) patients, respectively. A druggable molecular abnormality was present in 38 patients (40%).

conclusionsThe establishment of a comprehensive tumour molecular profile was safe, feasible, and compatible with clinical practice in refractory cancer patients.

Indexed as

AdultAgedAged, 80 and overAlgorithmsDNA Mutational AnalysisFemaleGene DosageHumansImmunohistochemistryMaleMiddle AgedMolecular Targeted TherapyNeoplasmsPrecision Medicine

Identifiers

PMID24762958
PMCPMC4090722

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.