Evidence map›Paper›PMID 28915798›Full record

ArticleBMC cancer2017

Vemurafenib plus cobimetinib in unresectable stage IIIc or stage IV melanoma: response monitoring and resistance prediction with positron emission tomography and tumor characteristics (REPOSIT): study protocol of a phase II, open-label, multicenter study.

Bernies van der Hiel, John B A G Haanen, Marcel P M Stokkel, Daniel S Peeper, Connie R Jimenez, Jos H Beijnen, Bart A van de Wiel, Ronald Boellaard, Alfons J M van den Eertwegh, REPOSIT study group

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in BMC cancer, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02414750 (A Phase II, Open-Label, Multicenter Study of Vemurafenib Plus Cobimetinib), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.0field-weighted citation impact, top 24% 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.

NCT02414750 phase2terminatednot on this map

A Phase II, Open-Label, Multicenter Study of Vemurafenib Plus Cobimetinib (GDC-0973) in Unresectable Stage IIIc or Stage IV Melanoma; Response Monitoring and Resistance Prediction With Positron Emission Tomography and Tumor Characteristics

TypeinterventionalSponsorNetherlands Working Group on Immunotherapy of OncologyRan2014 to 2020Enrolled78ConditionsMetastatic MelanomaArmsVemurafenib plus cobimetinib, Positron Emission Tomography, Tissue sampling, Blood sampling
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 16 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. Utility of PET/CT in patients with stage I-III melanoma.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2020
    Article
  5. Article
  6. Article
  7. Article
  8. 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

10 authors at 3 institutions in 1 country.

Bernies van der HielDepartment of Nuclear Medicine, Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, PO Box 90203, 1006, BE, Amsterdam, The Netherlands. b.vd.hiel@nki.nl.ORCID http://orcid.org/0000-0001-8158-405X
John B A G HaanenDepartment of Medical Oncology, Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands.
Marcel P M StokkelDepartment of Nuclear Medicine, Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, PO Box 90203, 1006, BE, Amsterdam, The Netherlands.
Daniel S PeeperDepartment of Molecular Oncology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
Connie R JimenezOncoproteomics Laboratory, Department of Medical Oncology, VU University Medical Center, Amsterdam, the Netherlands.
Jos H BeijnenDepartment of Pharmacy and Pharmacology, The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands.
Bart A van de WielDepartment of Pathology, The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands.
Ronald BoellaardDepartment of Nuclear Medicine and Molecular Imaging, University Medical Center Groningen, Groningen, The Netherlands.
Alfons J M van den EertweghDepartment of Medical Oncology, VU University Medical Center, Amsterdam, the Netherlands.
REPOSIT study group
The Netherlands Cancer Institute · NLUniversity Medical Center Groningen · NLAmsterdam UMC Location Vrije Universiteit Amsterdam · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn patients with BRAFV600 mutated unresectable stage IIIc or metastatic melanoma, molecular targeted therapy with combined BRAF/MEK-inhibitor vemurafenib plus cobimetinib has shown a significantly improved progression-free survival and overall survival compared to treatment with vemurafenib alone. Nevertheless, the majority of BRAFV600 mutation-positive melanoma patients will eventually develop resistance to treatment. Molecular imaging with

methodsThis phase II, open-label, multicenter study evaluates whether metabolic response to treatment with vemurafenib plus cobimetinib in the first 7 weeks as assessed by 18F-FDG/18F-FLT PET can predict progression-free survival and whether early changes in 18F-FDG/18F-FLT can be used for early detection of treatment response compared to standard response assessment with RECISTv1.1 ceCT at 7 weeks. Ninety patients with BRAFV600E/K mutated unresectable stage IIIc/IV melanoma will be included. Prior to and during treatment all patients will undergo DISCUSSION: The results of this study will help in linking PET measured metabolic alterations induced by targeted therapy of BRAFV600 mutated melanoma to molecular changes within the tumor. We will be able to correlate both

trial registrationClinicaltrials.gov identifier: NCT02414750. Registered 10 April 2015, retrospectively registered.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsAzetidinesClinical Trials, Phase II as TopicDisease-Free SurvivalDrug Resistance, NeoplasmHumansIndolesMelanomaMulticenter Studies as TopicNeoplasm StagingPiperidinesPositron-Emission TomographyResearch DesignSkin NeoplasmsSulfonamidesTreatment OutcomeAzetidinescobimetinibIndolesPiperidinesSulfonamidesVemurafenib18F-FDG18F-FLTBRAF inhibitorMEK inhibitorPET/CTResistanceStage IIIc/IV melanoma

Identifiers

PMID28915798
PMCPMC5603097
OpenAlexW2755757666

What OpenQuestion holds

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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.