Evidence map›Paper›PMID 27502712›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2016

Prospective assessment of a gene signature potentially predictive of clinical benefit in metastatic melanoma patients following MAGE-A3 immunotherapeutic (PREDICT).

P Saiag, R Gutzmer, P A Ascierto, M Maio, J-J Grob, P Murawa, B Dreno, M Ross, J Weber, A Hauschild and 10 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00942162 (GSK2132231A Antigen-Specific Cancer Immunotherapeutic as First-line Treatment of Patients With Unresectable Metastatic Melanoma), 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
–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.

NCT00942162 phase2completednot on this map

GSK2132231A Antigen-Specific Cancer Immunotherapeutic as First-line Treatment of Patients With Unresectable Metastatic Melanoma

TypeinterventionalSponsorGlaxoSmithKlineRan2009 to 2015Enrolled125ConditionsMelanomaArmsImmunotherapeutic GSK2132231A
3 · Its place in the literature

Who cites it

10 citing papers in PubMed.

  1. Trial
  2. Article
  3. Review
  4. Article
  5. Review
  6. Article
  7. Article
  8. Review
  9. Review
  10. 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

20 authors.

P SaiagGeneral Dermatology and Oncology Service, Ambroise-Paré Hospital, AP-HP, University of Versailles-Saint-Quentin-en-Yvelines, Boulogne, France philippe.saiag@uvsq.fr.
R GutzmerSkin Cancer Center Hannover, Hannover Medical School, Hannover, Germany.
P A AsciertoNational Institute for Tumors Foundation 'G. Pascale', Napoli.
M MaioMedical Oncology and Immunotherapy, Department of Oncology, University Hospital of Siena, Istituto Toscano Tumori, Siena, Italy.
J-J GrobDepartment of Dermatology and Skin Cancers, La Timone APHM Hospital, Aix-Marseille University, Marseille, France.
P MurawaDepartment of Biochemistry and Molecular Biology, Poznań University of Medical Sciences, Poznań, Poland.
B DrenoDermatology Clinic, Hôtel-Dieu Hospital, CHU Nantes, Nantes, France.
M RossDepartment of Surgical Oncology, UTMD Anderson Cancer Center, Houston.
J WeberMoffitt Cancer Center, Tampa, USA.
A HauschildDepartment of Dermatology, University Hospital Schleswig-Holstein, Kiel, Germany.
P RutkowskiDepartment of Soft Tissue/Bone Sarcoma and Melanoma, Maria Sklodowska-Curie Memorial Center and Institute of Oncology, Warsaw, Poland.
A TestoriMelanoma and Soft Tissue Sarcoma Division, European Institute of Oncology, Milan, Italy.
E LevchenkoPetrov Research Institute of Oncology, St Petersburg, Russian Federation.
A EnkDepartment of Dermatology, University of Heidelberg, Heidelberg, Germany.
L MiseryDepartment of Dermatology, University Hospital of Brest, Brest, France.
C Vanden AbeeleGSK Vaccines, Rixensart, Belgium.
I VojtekGSK Vaccines, Rixensart, Belgium.
O PeetersGSK Vaccines, Rixensart, Belgium.
V G BrichardGSK Vaccines, Rixensart, Belgium.
P TherasseGSK Vaccines, Rixensart, Belgium.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundGenomic profiling of tumor tissue may aid in identifying predictive or prognostic gene signatures (GS) in some cancers. Retrospective gene expression profiling of melanoma and non-small-cell lung cancer led to the characterization of a GS associated with clinical benefit, including improved overall survival (OS), following immunization with the MAGE-A3 immunotherapeutic. The goal of the present study was to prospectively evaluate the predictive value of the previously characterized GS. PATIENTS AND

methodsAn open-label prospective phase II trial ('PREDICT') in patients with MAGE-A3-positive unresectable stage IIIB-C/IV-M1a melanoma.

resultsOf 123 subjects who received the MAGE-A3 immunotherapeutic, 71 (58.7%) displayed the predictive GS (GS+). The 1-year OS rate was 83.1%/83.3% in the GS+/GS- populations. The rate of progression-free survival at 12 months was 5.8%/4.1% in GS+/GS- patients. The median time-to-treatment failure was 2.7/2.4 months (GS+/GS-). There was one complete response (GS-) and two partial responses (GS+). The MAGE-A3 immunotherapeutic was similarly immunogenic in both populations and had a clinically acceptable safety profile.

conclusionTreatment of patients with MAGE-A3-positive unresectable stage IIIB-C/IV-M1a melanoma with the MAGE-A3 immunotherapeutic demonstrated an overall 1-year OS rate of 83.5%. GS- and GS+ patients had similar 1-year OS rates, indicating that in this study, GS was not predictive of outcome. Unexpectedly, the objective response rate was lower in this study than in other studies carried out in the same setting with the MAGE-A3 immunotherapeutic. Investigation of a GS to predict clinical benefit to adjuvant MAGE-A3 immunotherapeutic treatment is ongoing in another melanoma study.This study is registered at www.clinicatrials.gov NCT00942162.

Indexed as

AdultAgedAged, 80 and overAntigens, NeoplasmDisease-Free SurvivalFemaleGene Expression Regulation, NeoplasticGenomicsHumansImmunotherapyMaleMelanomaMiddle AgedNeoplasm ProteinsNeoplasm StagingTranscriptomeAntigens, NeoplasmMAGEA3 protein, humanNeoplasm Proteinsgene signatureimmunotherapyMAGE-A3 antigenmelanomapredictive biomarkers

Identifiers

PMID27502712
PMCPMC5035794

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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.