Evidence map›Paper›PMID 28646893›Full record

Trial reportJournal of translational medicine2017

Clinical features of serous retinopathy observed with cobimetinib in patients with BRAF-mutated melanoma treated in the randomized coBRIM study.

Luis de la Cruz-Merino, Lorenza Di Guardo, Jean-Jacques Grob, Alfredo Venosa, James Larkin, Grant A McArthur, Antoni Ribas, Paolo A Ascierto, Jeffrey T R Evans, Antonio Gomez-Escobar and 5 more

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of translational medicine, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 2 pooled it
2.0field-weighted citation impact, top 13% 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

22 citing papers in PubMed, 2 syntheses or guidelines pooled it, 44 citations in OpenAlex.

  1. Comparing treatment outcomes in randomized controlled trials of central serous chorioretinopathy.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2023
    Pooled it
  2. Pooled it
  3. Trial
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  9. Challenges in posterior uveitis-tips and tricks for the retina specialist.Journal of ophthalmic inflammation and infection · 2023
    Review
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  13. Review
  14. ERK Inhibitor LY3214996-Based Treatment Strategies forMolecular cancer therapeutics · 2021
    Article
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  18. [Cobimetinib/vemurafenib-associated bilateral serous retinopathy: a case report].Der Ophthalmologe : Zeitschrift der Deutschen Ophthalmologischen Gesellschaft · 2019
    Article
  19. Review
  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

15 authors at 10 institutions in 6 countries.

Luis de la Cruz-MerinoServicio de Oncología Médica, Hospital Universitario Virgen Macarena, Avenida Doctor Fedriani 3, 41071, Seville, Spain. lucme12@yahoo.es.
Lorenza Di GuardoFondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Jean-Jacques GrobAix-Marseille University, Hôpital de la Timone, Marseille, France.
Alfredo VenosaOspedale Monaldi, Naples, Italy.
James LarkinRoyal Marsden NHS Foundation Trust, London, UK.
Grant A McArthurPeter MacCallum Cancer Centre, East Melbourne, VIC, Australia.
Antoni RibasJonsson Comprehensive Cancer Center at the University of California, Los Angeles, CA, USA.
Paolo A AsciertoIstituto Nazionale Tumori Fondazione G. Pascale, Naples, Italy.
Jeffrey T R EvansBeatson West of Scotland Cancer Centre, University of Glasgow, Glasgow, UK.
Antonio Gomez-EscobarServicio de Oncología Médica, Hospital Universitario Virgen Macarena, Avenida Doctor Fedriani 3, 41071, Seville, Spain.
Giulio BarteselliGenentech, Inc., South San Francisco, CA, USA.
Susan EngGenentech, Inc., South San Francisco, CA, USA.
Jessie J HsuGenentech, Inc., South San Francisco, CA, USA.
Anne UyeiGenentech, Inc., South San Francisco, CA, USA.
Brigitte DrénoNantes University, Nantes, France.
Aix-Marseille Université · FRBeatson West of Scotland Cancer Centre · GBFondazione IRCCS Istituto Nazionale dei Tumori · ITHospital Universitario Virgen Macarena · ESIstituto Nazionale Tumori IRCCS "Fondazione G. Pascale" · ITNantes Université · FROspedale Monaldi · ITRoyal Marsden NHS Foundation Trust · GBUniversity of California, Los Angeles · USUniversity of Melbourne · AU

Funding

Cancer Research UK 11650Cancer Research UK 12946Cancer Research UK 20409
6 · The paper itself

Abstract

backgroundSerous chorioretinopathy has been associated with MEK inhibitors, including cobimetinib. We describe the clinical features of serous retinopathy observed with cobimetinib in patients with BRAF

methodsIn the coBRIM study, 493 patients were treated in two randomly assigned treatment groups: cobimetinib and vemurafenib (n = 247) or vemurafenib (n = 246). All patients underwent prospective ophthalmic examinations at screening, at regular intervals during the study, and whenever ocular symptoms developed. Patients with serous retinopathy were identified in the study database using a group of relevant and synonymous adverse event terms.

resultsEighty-six serous retinopathy events were reported in 70 patients (79 events in 63 cobimetinib and vemurafenib-treated patients vs seven events in seven vemurafenib-treated patients). Most patients with serous retinopathy identified by ophthalmic examination had no symptoms or had mild symptoms, among them reduced visual acuity, blurred vision, dyschromatopsia, and photophobia. Serous retinopathy usually occurred early during cobimetinib and vemurafenib treatment; median time to onset was 1.0 month. Most events were managed by observation and continuation of cobimetinib without dose modification and resolved or were resolving by the data cutoff date (19 Sept 2014).

conclusionsCobimetinib treatment was associated with serous retinopathy in patients with BRAF

Indexed as

AdultAgedAzetidinesCentral Serous ChorioretinopathyFemaleHumansIndolesMaleMelanomaMiddle AgedMutationPiperidinesProto-Oncogene Proteins B-rafRecurrenceSkin NeoplasmsSulfonamidesAzetidinescobimetinibIndolesPiperidinesProto-Oncogene Proteins B-rafSulfonamidesVemurafenibCobimetinibMEK inhibitionMelanomaSerous retinopathyVisual disturbance

Identifiers

PMID28646893
PMCPMC5483259
OpenAlexW2660763961

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.