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dc.contributor.authorde la Cruz-Merino, L
dc.contributor.authorDi Guardo, L
dc.contributor.authorGrob, J-J
dc.contributor.authorVenosa, A
dc.contributor.authorLarkin, J
dc.contributor.authorMcArthur, GA
dc.contributor.authorRibas, A
dc.contributor.authorAscierto, PA
dc.contributor.authorEvans, JTR
dc.contributor.authorGomez-Escobar, A
dc.contributor.authorBarteselli, G
dc.contributor.authorEng, S
dc.contributor.authorHsu, JJ
dc.contributor.authorUyei, A
dc.contributor.authorDréno, B
dc.date.accessioned2018-02-19T10:56:43Z
dc.date.issued2017-06-24
dc.identifier.citationJournal of translational medicine, 2017, 15 (1), pp. 146 - ?
dc.identifier.issn1479-5876
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/1256
dc.identifier.eissn1479-5876
dc.identifier.doi10.1186/s12967-017-1246-0
dc.description.abstractBackground Serous chorioretinopathy has been associated with MEK inhibitors, including cobimetinib. We describe the clinical features of serous retinopathy observed with cobimetinib in patients with BRAF V600 -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 identified 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 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).Conclusions Cobimetinib treatment was associated with serous retinopathy in patients with BRAF V600 -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. Trial Registration Clinicaltrials.gov (NCT01689519). First received: September 18, 2012.
dc.formatElectronic
dc.format.extent146 - ?
dc.languageeng
dc.language.isoeng
dc.rights.urihttps://creativecommons.org/licenses/by/4.0
dc.subjectHumans
dc.subjectMelanoma
dc.subjectSkin Neoplasms
dc.subjectRecurrence
dc.subjectSulfonamides
dc.subjectAzetidines
dc.subjectPiperidines
dc.subjectIndoles
dc.subjectProto-Oncogene Proteins B-raf
dc.subjectMutation
dc.subjectTime Factors
dc.subjectAdult
dc.subjectAged
dc.subjectMiddle Aged
dc.subjectFemale
dc.subjectMale
dc.subjectCentral Serous Chorioretinopathy
dc.subjectVemurafenib
dc.titleClinical features of serous retinopathy observed with cobimetinib in patients with BRAF-mutated melanoma treated in the randomized coBRIM study.
dc.typeJournal Article
dcterms.dateAccepted2017-06-15
rioxxterms.versionofrecord10.1186/s12967-017-1246-0
rioxxterms.licenseref.urihttps://creativecommons.org/licenses/by/4.0
rioxxterms.licenseref.startdate2017-06-24
rioxxterms.typeJournal Article/Review
dc.relation.isPartOfJournal of translational medicine
pubs.issue1
pubs.notesNot known
pubs.organisational-group/ICR
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Melanoma and Kidney Cancer
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Melanoma and Kidney Cancer/Melanoma and Kidney Cancer (hon.)
pubs.organisational-group/ICR/Primary Group/Royal Marsden Clinical Units
pubs.organisational-group/ICR
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Melanoma and Kidney Cancer
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Melanoma and Kidney Cancer/Melanoma and Kidney Cancer (hon.)
pubs.organisational-group/ICR/Primary Group/Royal Marsden Clinical Units
pubs.publication-statusPublished
pubs.volume15
pubs.embargo.termsNot known
icr.researchteamMelanoma and Kidney Canceren_US
dc.contributor.icrauthorLarkin, Jamesen
dc.contributor.icrauthorMarsden,en


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