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

Background: Serous chorioretinopathy has been associated with MEK inhibitors, including cobimetinib. We describe the clinical features of serous retinopathy observed with cobimetinib in patients with BRAFV600-mutated melanoma treated in the Phase III coBRIM study. Methods: In the coBRIM study, 493 p...

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Autores: Cruz Merino, Luis de la, Di Guardo, Lorenza, Grob, Jean Jacques, Venosa, Alfredo, Larkin, James, McArthur, Grant A., Dreno, Brigitte
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2017
País:España
Institución:Universidad de Sevilla (US)
Repositorio:idUS. Depósito de Investigación de la Universidad de Sevilla
OAI Identifier:oai:idus.us.es:11441/156164
Acceso en línea:https://hdl.handle.net/11441/156164
https://doi.org/10.1186/s12967-017-1246-0
Access Level:acceso abierto
Palabra clave:Cobimetinib
MEK inhibition
Melanoma
Serous retinopathy
Visual disturbance
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spelling Clinical features of serous retinopathy observed with cobimetinib in patients with BRAF‑mutated melanoma treated in the randomized coBRIM studyCruz Merino, Luis de laDi Guardo, LorenzaGrob, Jean JacquesVenosa, AlfredoLarkin, JamesMcArthur, Grant A.Dreno, BrigitteCobimetinibMEK inhibitionMelanomaSerous retinopathyVisual disturbanceBackground: Serous chorioretinopathy has been associated with MEK inhibitors, including cobimetinib. We describe the clinical features of serous retinopathy observed with cobimetinib in patients with BRAFV600-mutated melanoma treated in the Phase III coBRIM study. Methods: 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 identifed in the study database using a group of relevant and synonymous adverse event terms. Results: Eighty-six serous retinopathy events were reported in 70 patients (79 events in 63 cobimetinib and vemu‑ rafenib-treated patients vs seven events in seven vemurafenib-treated patients). Most patients with serous retinopa‑ thy identifed 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 cobi‑ metinib and vemurafenib treatment; median time to onset was 1.0 month. Most events were managed by observa‑ tion and continuation of cobimetinib without dose modifcation and resolved or were resolving by the data cutof date (19 Sept 2014). Conclusions: Cobimetinib treatment was associated with serous retinopathy in patients with BRAFV600-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.Biomed Central LTDMedicinaCTS151: Bioquímica médica2017info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfapplication/pdfhttps://hdl.handle.net/11441/156164https://doi.org/10.1186/s12967-017-1246-0reponame:idUS. Depósito de Investigación de la Universidad de Sevillainstname:Universidad de Sevilla (US)InglésJournal of Translational Medicine, 15 (1), 1-9.https://translational-medicine.biomedcentral.com/articles/10.1186/s12967-017-1246-0info:eu-repo/semantics/openAccessoai:idus.us.es:11441/1561642026-06-17T12:51:07Z
dc.title.none.fl_str_mv Clinical features of serous retinopathy observed with cobimetinib in patients with BRAF‑mutated melanoma treated in the randomized coBRIM study
title Clinical features of serous retinopathy observed with cobimetinib in patients with BRAF‑mutated melanoma treated in the randomized coBRIM study
spellingShingle Clinical features of serous retinopathy observed with cobimetinib in patients with BRAF‑mutated melanoma treated in the randomized coBRIM study
Cruz Merino, Luis de la
Cobimetinib
MEK inhibition
Melanoma
Serous retinopathy
Visual disturbance
title_short Clinical features of serous retinopathy observed with cobimetinib in patients with BRAF‑mutated melanoma treated in the randomized coBRIM study
title_full Clinical features of serous retinopathy observed with cobimetinib in patients with BRAF‑mutated melanoma treated in the randomized coBRIM study
title_fullStr Clinical features of serous retinopathy observed with cobimetinib in patients with BRAF‑mutated melanoma treated in the randomized coBRIM study
title_full_unstemmed Clinical features of serous retinopathy observed with cobimetinib in patients with BRAF‑mutated melanoma treated in the randomized coBRIM study
title_sort Clinical features of serous retinopathy observed with cobimetinib in patients with BRAF‑mutated melanoma treated in the randomized coBRIM study
dc.creator.none.fl_str_mv Cruz Merino, Luis de la
Di Guardo, Lorenza
Grob, Jean Jacques
Venosa, Alfredo
Larkin, James
McArthur, Grant A.
Dreno, Brigitte
author Cruz Merino, Luis de la
author_facet Cruz Merino, Luis de la
Di Guardo, Lorenza
Grob, Jean Jacques
Venosa, Alfredo
Larkin, James
McArthur, Grant A.
Dreno, Brigitte
author_role author
author2 Di Guardo, Lorenza
Grob, Jean Jacques
Venosa, Alfredo
Larkin, James
McArthur, Grant A.
Dreno, Brigitte
author2_role author
author
author
author
author
author
dc.contributor.none.fl_str_mv Medicina
CTS151: Bioquímica médica
dc.subject.none.fl_str_mv Cobimetinib
MEK inhibition
Melanoma
Serous retinopathy
Visual disturbance
topic Cobimetinib
MEK inhibition
Melanoma
Serous retinopathy
Visual disturbance
description Background: Serous chorioretinopathy has been associated with MEK inhibitors, including cobimetinib. We describe the clinical features of serous retinopathy observed with cobimetinib in patients with BRAFV600-mutated melanoma treated in the Phase III coBRIM study. Methods: 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 identifed in the study database using a group of relevant and synonymous adverse event terms. Results: Eighty-six serous retinopathy events were reported in 70 patients (79 events in 63 cobimetinib and vemu‑ rafenib-treated patients vs seven events in seven vemurafenib-treated patients). Most patients with serous retinopa‑ thy identifed 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 cobi‑ metinib and vemurafenib treatment; median time to onset was 1.0 month. Most events were managed by observa‑ tion and continuation of cobimetinib without dose modifcation and resolved or were resolving by the data cutof date (19 Sept 2014). Conclusions: Cobimetinib treatment was associated with serous retinopathy in patients with BRAFV600-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.
publishDate 2017
dc.date.none.fl_str_mv 2017
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://hdl.handle.net/11441/156164
https://doi.org/10.1186/s12967-017-1246-0
url https://hdl.handle.net/11441/156164
https://doi.org/10.1186/s12967-017-1246-0
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Journal of Translational Medicine, 15 (1), 1-9.
https://translational-medicine.biomedcentral.com/articles/10.1186/s12967-017-1246-0
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv Biomed Central LTD
publisher.none.fl_str_mv Biomed Central LTD
dc.source.none.fl_str_mv reponame:idUS. Depósito de Investigación de la Universidad de Sevilla
instname:Universidad de Sevilla (US)
instname_str Universidad de Sevilla (US)
reponame_str idUS. Depósito de Investigación de la Universidad de Sevilla
collection idUS. Depósito de Investigación de la Universidad de Sevilla
repository.name.fl_str_mv
repository.mail.fl_str_mv
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