Clinical features of serous retinopathy observed with cobimetinib in patients with BRAF-mutated melanoma treated in the randomized coBRIM study
Identifieur interne : 000F81 ( Main/Exploration ); précédent : 000F80; suivant : 000F82Clinical features of serous retinopathy observed with cobimetinib in patients with BRAF-mutated melanoma treated in the randomized coBRIM study
Auteurs : Luis De La Cruz-Merino [Espagne] ; Lorenza Di Guardo [Italie] ; Jean-Jacques Grob [France] ; Alfredo Venosa [Italie] ; James Larkin [Royaume-Uni] ; Grant A. Mcarthur ; Antoni Ribas [États-Unis] ; Paolo A. Ascierto [Italie] ; Jeffrey T. R. Evans [Royaume-Uni] ; Antonio Gomez-Escobar [Espagne] ; Giulio Barteselli [États-Unis] ; Susan Eng [États-Unis] ; Jessie J. Hsu [États-Unis] ; Anne Uyei [États-Unis] ; Brigitte Dréno [France]Source :
- Journal of Translational Medicine [ 1479-5876 ] ; 2017.
Abstract
Serous chorioretinopathy has been associated with MEK inhibitors, including cobimetinib. We describe the clinical features of serous retinopathy observed with cobimetinib in patients with
In 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.
Eighty-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).
Cobimetinib treatment was associated with serous retinopathy in patients with
The online version of this article (doi:10.1186/s12967-017-1246-0) contains supplementary material, which is available to authorized users.
Url:
DOI: 10.1186/s12967-017-1246-0
PubMed: 28646893
PubMed Central: 5483259
Affiliations:
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Le document en format XML
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South San Francisco, CA USA</nlm:aff>
<country>États-Unis</country>
<placeName><region type="state">Californie</region>
</placeName>
<wicri:cityArea>South San Francisco</wicri:cityArea>
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</author>
<author><name sortKey="Eng, Susan" sort="Eng, Susan" uniqKey="Eng S" first="Susan" last="Eng">Susan Eng</name>
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<institution-id institution-id-type="GRID">grid.418158.1</institution-id>
<institution></institution>
<institution>Genentech, Inc.,</institution>
</institution-wrap>
South San Francisco, CA USA</nlm:aff>
<country>États-Unis</country>
<placeName><region type="state">Californie</region>
</placeName>
<wicri:cityArea>South San Francisco</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Hsu, Jessie J" sort="Hsu, Jessie J" uniqKey="Hsu J" first="Jessie J." last="Hsu">Jessie J. Hsu</name>
<affiliation wicri:level="2"><nlm:aff id="Aff11"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0534 4718</institution-id>
<institution-id institution-id-type="GRID">grid.418158.1</institution-id>
<institution></institution>
<institution>Genentech, Inc.,</institution>
</institution-wrap>
South San Francisco, CA USA</nlm:aff>
<country>États-Unis</country>
<placeName><region type="state">Californie</region>
</placeName>
<wicri:cityArea>South San Francisco</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Uyei, Anne" sort="Uyei, Anne" uniqKey="Uyei A" first="Anne" last="Uyei">Anne Uyei</name>
<affiliation wicri:level="2"><nlm:aff id="Aff11"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0534 4718</institution-id>
<institution-id institution-id-type="GRID">grid.418158.1</institution-id>
<institution></institution>
<institution>Genentech, Inc.,</institution>
</institution-wrap>
South San Francisco, CA USA</nlm:aff>
<country>États-Unis</country>
<placeName><region type="state">Californie</region>
</placeName>
<wicri:cityArea>South San Francisco</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Dreno, Brigitte" sort="Dreno, Brigitte" uniqKey="Dreno B" first="Brigitte" last="Dréno">Brigitte Dréno</name>
<affiliation wicri:level="1"><nlm:aff id="Aff12"><institution-wrap><institution-id institution-id-type="GRID">grid.4817.a</institution-id>
<institution></institution>
<institution>Nantes University,</institution>
</institution-wrap>
Nantes, France</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea>Nantes</wicri:regionArea>
</affiliation>
</author>
</analytic>
<series><title level="j">Journal of Translational Medicine</title>
<idno type="eISSN">1479-5876</idno>
<imprint><date when="2017">2017</date>
</imprint>
</series>
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<front><div type="abstract" xml:lang="en"><sec><title>Background</title>
<p id="Par1">Serous chorioretinopathy has been associated with MEK inhibitors, including cobimetinib. We describe the clinical features of serous retinopathy observed with cobimetinib in patients with <italic>BRAF</italic>
<sup>V600</sup>
-mutated melanoma treated in the Phase III coBRIM study.</p>
</sec>
<sec><title>Methods</title>
<p id="Par2">In 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.</p>
</sec>
<sec><title>Results</title>
<p id="Par3">Eighty-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).</p>
</sec>
<sec><title>Conclusions</title>
<p id="Par4">Cobimetinib treatment was associated with serous retinopathy in patients with <italic>BRAF</italic>
<sup>V600</sup>
-mutated melanoma. Retinopathy was generally asymptomatic or mild. Periodic ophthalmologic evaluations at regular intervals and at the manifestation of any visual disturbance are recommended to facilitate early detection and resolution of serous retinopathy while patients are taking cobimetinib.</p>
<p id="Par5"><italic>Trial Registration</italic>
Clinicaltrials.gov (NCT01689519). First received: September 18, 2012</p>
</sec>
<sec><title>Electronic supplementary material</title>
<p>The online version of this article (doi:10.1186/s12967-017-1246-0) contains supplementary material, which is available to authorized users.</p>
</sec>
</div>
</front>
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