Clinical features of serous retinopathy observed with cobimetinib in patients with BRAF-mutated melanoma treated in the randomized coBRIM study.
Identifieur interne : 000F90 ( PubMed/Checkpoint ); précédent : 000F89; suivant : 000F91Clinical 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 [Australie] ; 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 BRAF (V600)-mutated melanoma treated in the Phase III coBRIM study.
DOI: 10.1186/s12967-017-1246-0
PubMed: 28646893
Affiliations:
- Australie, Espagne, France, Italie, Royaume-Uni, États-Unis
- Angleterre, Californie, Grand Londres, Lombardie, Pays de la Loire, Provence-Alpes-Côte d'Azur, Écosse
- Glasgow, Londres, Marseille, Milan, Nantes
- Université de Glasgow
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Mcarthur</name><affiliation wicri:level="1"><nlm:affiliation>Peter MacCallum Cancer Centre, East Melbourne, VIC, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Peter MacCallum Cancer Centre, East Melbourne, VIC</wicri:regionArea><wicri:noRegion>VIC</wicri:noRegion></affiliation></author><author><name sortKey="Ribas, Antoni" sort="Ribas, Antoni" uniqKey="Ribas A" first="Antoni" last="Ribas">Antoni Ribas</name><affiliation wicri:level="2"><nlm:affiliation>Jonsson Comprehensive Cancer Center at the University of California, Los Angeles, CA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Jonsson Comprehensive Cancer Center at the University of California, Los Angeles, CA</wicri:regionArea><placeName><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Ascierto, Paolo A" sort="Ascierto, Paolo A" uniqKey="Ascierto P" first="Paolo A" last="Ascierto">Paolo A. Ascierto</name><affiliation wicri:level="1"><nlm:affiliation>Istituto Nazionale Tumori Fondazione G. Pascale, Naples, Italy.</nlm:affiliation><country xml:lang="fr">Italie</country><wicri:regionArea>Istituto Nazionale Tumori Fondazione G. Pascale, Naples</wicri:regionArea><wicri:noRegion>Naples</wicri:noRegion></affiliation></author><author><name sortKey="Evans, Jeffrey T R" sort="Evans, Jeffrey T R" uniqKey="Evans J" first="Jeffrey T R" last="Evans">Jeffrey T R. Evans</name><affiliation wicri:level="4"><nlm:affiliation>Beatson West of Scotland Cancer Centre, University of Glasgow, Glasgow, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Beatson West of Scotland Cancer Centre, University of Glasgow, Glasgow</wicri:regionArea><orgName type="university">Université de Glasgow</orgName><placeName><settlement type="city">Glasgow</settlement><region type="country">Écosse</region></placeName></affiliation></author><author><name sortKey="Gomez Escobar, Antonio" sort="Gomez Escobar, Antonio" uniqKey="Gomez Escobar A" first="Antonio" last="Gomez-Escobar">Antonio Gomez-Escobar</name><affiliation wicri:level="1"><nlm:affiliation>Servicio de Oncología Médica, Hospital Universitario Virgen Macarena, Avenida Doctor Fedriani 3, 41071, Seville, Spain.</nlm:affiliation><country xml:lang="fr">Espagne</country><wicri:regionArea>Servicio de Oncología Médica, Hospital Universitario Virgen Macarena, Avenida Doctor Fedriani 3, 41071, Seville</wicri:regionArea><wicri:noRegion>Seville</wicri:noRegion></affiliation></author><author><name sortKey="Barteselli, Giulio" sort="Barteselli, Giulio" uniqKey="Barteselli G" first="Giulio" last="Barteselli">Giulio Barteselli</name><affiliation wicri:level="2"><nlm:affiliation>Genentech, Inc., South San Francisco, CA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Genentech, Inc., South San Francisco, CA</wicri:regionArea><placeName><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Eng, Susan" sort="Eng, Susan" uniqKey="Eng S" first="Susan" last="Eng">Susan Eng</name><affiliation wicri:level="2"><nlm:affiliation>Genentech, Inc., South San Francisco, CA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Genentech, Inc., South San Francisco, CA</wicri:regionArea><placeName><region type="state">Californie</region></placeName></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:affiliation>Genentech, Inc., South San Francisco, CA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Genentech, Inc., South San Francisco, CA</wicri:regionArea><placeName><region type="state">Californie</region></placeName></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:affiliation>Genentech, Inc., South San Francisco, CA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Genentech, Inc., South San Francisco, CA</wicri:regionArea><placeName><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Dreno, Brigitte" sort="Dreno, Brigitte" uniqKey="Dreno B" first="Brigitte" last="Dréno">Brigitte Dréno</name><affiliation wicri:level="3"><nlm:affiliation>Nantes University, Nantes, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Nantes University, Nantes</wicri:regionArea><placeName><region type="region">Pays de la Loire</region><region type="old region">Pays de la Loire</region><settlement type="city">Nantes</settlement></placeName></affiliation></author></analytic><series><title level="j">Journal of translational medicine</title><idno type="eISSN">1479-5876</idno><imprint><date when="2017" type="published">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">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.</div></front></TEI><pubmed><MedlineCitation Status="In-Process" Owner="NLM"><PMID Version="1">28646893</PMID><DateCreated><Year>2017</Year><Month>06</Month><Day>25</Day></DateCreated><DateRevised><Year>2017</Year><Month>06</Month><Day>28</Day></DateRevised><Article PubModel="Electronic"><Journal><ISSN IssnType="Electronic">1479-5876</ISSN><JournalIssue CitedMedium="Internet"><Volume>15</Volume><Issue>1</Issue><PubDate><Year>2017</Year><Month>Jun</Month><Day>24</Day></PubDate></JournalIssue><Title>Journal of translational medicine</Title><ISOAbbreviation>J Transl Med</ISOAbbreviation></Journal><ArticleTitle>Clinical features of serous retinopathy observed with cobimetinib in patients with BRAF-mutated melanoma treated in the randomized coBRIM study.</ArticleTitle><Pagination><MedlinePgn>146</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1186/s12967-017-1246-0</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="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 BRAF (V600)-mutated melanoma treated in the Phase III coBRIM study.</AbstractText><AbstractText Label="METHODS" NlmCategory="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.</AbstractText><AbstractText Label="RESULTS" NlmCategory="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).</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="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.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>de la Cruz-Merino</LastName><ForeName>Luis</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Servicio de Oncología Médica, Hospital Universitario Virgen Macarena, Avenida Doctor Fedriani 3, 41071, Seville, Spain. lucme12@yahoo.es.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Di Guardo</LastName><ForeName>Lorenza</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Grob</LastName><ForeName>Jean-Jacques</ForeName><Initials>JJ</Initials><AffiliationInfo><Affiliation>Aix-Marseille University, Hôpital de la Timone, Marseille, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Venosa</LastName><ForeName>Alfredo</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Ospedale Monaldi, Naples, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Larkin</LastName><ForeName>James</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Royal Marsden NHS Foundation Trust, London, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>McArthur</LastName><ForeName>Grant A</ForeName><Initials>GA</Initials><AffiliationInfo><Affiliation>Peter MacCallum Cancer Centre, East Melbourne, VIC, Australia.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>University of Melbourne, Parkville, VIC, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ribas</LastName><ForeName>Antoni</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Jonsson Comprehensive Cancer Center at the University of California, Los Angeles, CA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ascierto</LastName><ForeName>Paolo A</ForeName><Initials>PA</Initials><AffiliationInfo><Affiliation>Istituto Nazionale Tumori Fondazione G. Pascale, Naples, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Evans</LastName><ForeName>Jeffrey T R</ForeName><Initials>JTR</Initials><AffiliationInfo><Affiliation>Beatson West of Scotland Cancer Centre, University of Glasgow, Glasgow, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Gomez-Escobar</LastName><ForeName>Antonio</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Servicio de Oncología Médica, Hospital Universitario Virgen Macarena, Avenida Doctor Fedriani 3, 41071, Seville, Spain.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Barteselli</LastName><ForeName>Giulio</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>Genentech, Inc., South San Francisco, CA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Eng</LastName><ForeName>Susan</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Genentech, Inc., South San Francisco, CA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hsu</LastName><ForeName>Jessie J</ForeName><Initials>JJ</Initials><AffiliationInfo><Affiliation>Genentech, Inc., South San Francisco, CA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Uyei</LastName><ForeName>Anne</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Genentech, Inc., South San Francisco, CA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Dréno</LastName><ForeName>Brigitte</ForeName><Initials>B</Initials><AffiliationInfo><Affiliation>Nantes University, Nantes, France.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT01689519</AccessionNumber></AccessionNumberList></DataBank></DataBankList><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2017</Year><Month>06</Month><Day>24</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>J Transl Med</MedlineTA><NlmUniqueID>101190741</NlmUniqueID><ISSNLinking>1479-5876</ISSNLinking></MedlineJournalInfo><CommentsCorrectionsList><CommentsCorrections RefType="Cites"><RefSource>N Engl J Med. 2015 Jan 1;372(1):30-9</RefSource><PMID Version="1">25399551</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Cancer Treat Rev. 2013 Oct;39(6):664-72</RefSource><PMID Version="1">23434072</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Lancet Oncol. 2014 Aug;15(9):954-65</RefSource><PMID Version="1">25037139</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Case Rep Ophthalmol Med. 2013;2013:673796</RefSource><PMID Version="1">23555064</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Nature. 2002 Jun 27;417(6892):949-54</RefSource><PMID Version="1">12068308</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Clin Cancer Res. 2013 Mar 1;19(5):1232-43</RefSource><PMID Version="1">23434733</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>N Engl J Med. 2005 Nov 17;353(20):2135-47</RefSource><PMID Version="1">16291983</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>N Engl J Med. 2014 Nov 13;371(20):1877-88</RefSource><PMID Version="1">25265492</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Lancet. 2015 Aug 1;386(9992):444-51</RefSource><PMID Version="1">26037941</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Surv Ophthalmol. 2013 Mar-Apr;58(2):103-26</RefSource><PMID Version="1">23410821</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Ann Oncol. 2014 Jul;25(7):1437-41</RefSource><PMID Version="1">24864047</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Eye (Lond). 2015 Aug;29(8):1003-12</RefSource><PMID Version="1">26043707</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>JAMA Ophthalmol. 2014 Aug;132(8):1005-9</RefSource><PMID Version="1">24852144</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Int J Mol Med. 2009 Jun;23(6):771-7</RefSource><PMID Version="1">19424603</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>N Engl J Med. 2014 Nov 13;371(20):1867-76</RefSource><PMID Version="1">25265494</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Nat Rev Clin Oncol. 2014 Jul;11(7):385-400</RefSource><PMID Version="1">24840079</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Methods Mol Biol. 2011;686:133-48</RefSource><PMID Version="1">21082369</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Lancet Oncol. 2012 Aug;13(8):773-81</RefSource><PMID Version="1">22805291</PMID></CommentsCorrections></CommentsCorrectionsList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">Cobimetinib</Keyword><Keyword MajorTopicYN="N">MEK inhibition</Keyword><Keyword MajorTopicYN="N">Melanoma</Keyword><Keyword MajorTopicYN="N">Serous retinopathy</Keyword><Keyword MajorTopicYN="N">Visual disturbance</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2017</Year><Month>03</Month><Day>24</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2017</Year><Month>06</Month><Day>15</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2017</Year><Month>6</Month><Day>26</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2017</Year><Month>6</Month><Day>26</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2017</Year><Month>6</Month><Day>26</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>epublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">28646893</ArticleId><ArticleId IdType="doi">10.1186/s12967-017-1246-0</ArticleId><ArticleId IdType="pii">10.1186/s12967-017-1246-0</ArticleId><ArticleId IdType="pmc">PMC5483259</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>Australie</li><li>Espagne</li><li>France</li><li>Italie</li><li>Royaume-Uni</li><li>États-Unis</li></country><region><li>Angleterre</li><li>Californie</li><li>Grand Londres</li><li>Lombardie</li><li>Pays de la Loire</li><li>Provence-Alpes-Côte d'Azur</li><li>Écosse</li></region><settlement><li>Glasgow</li><li>Londres</li><li>Marseille</li><li>Milan</li><li>Nantes</li></settlement><orgName><li>Université de Glasgow</li></orgName></list><tree><country name="Espagne"><noRegion><name sortKey="De La Cruz Merino, Luis" sort="De La Cruz Merino, Luis" uniqKey="De La Cruz Merino L" first="Luis" last="De La Cruz-Merino">Luis De La Cruz-Merino</name></noRegion><name sortKey="Gomez Escobar, Antonio" sort="Gomez Escobar, Antonio" uniqKey="Gomez Escobar A" first="Antonio" last="Gomez-Escobar">Antonio Gomez-Escobar</name></country><country name="Italie"><region name="Lombardie"><name sortKey="Di Guardo, Lorenza" sort="Di Guardo, Lorenza" uniqKey="Di Guardo L" first="Lorenza" last="Di Guardo">Lorenza Di Guardo</name></region><name sortKey="Ascierto, Paolo A" sort="Ascierto, Paolo A" uniqKey="Ascierto P" first="Paolo A" last="Ascierto">Paolo A. Ascierto</name><name sortKey="Venosa, Alfredo" sort="Venosa, Alfredo" uniqKey="Venosa A" first="Alfredo" last="Venosa">Alfredo Venosa</name></country><country name="France"><region name="Provence-Alpes-Côte d'Azur"><name sortKey="Grob, Jean Jacques" sort="Grob, Jean Jacques" uniqKey="Grob J" first="Jean-Jacques" last="Grob">Jean-Jacques Grob</name></region><name sortKey="Dreno, Brigitte" sort="Dreno, Brigitte" uniqKey="Dreno B" first="Brigitte" last="Dréno">Brigitte Dréno</name></country><country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Larkin, James" sort="Larkin, James" uniqKey="Larkin J" first="James" last="Larkin">James Larkin</name></region><name sortKey="Evans, Jeffrey T R" sort="Evans, Jeffrey T R" uniqKey="Evans J" first="Jeffrey T R" last="Evans">Jeffrey T R. Evans</name></country><country name="Australie"><noRegion><name sortKey="Mcarthur, Grant A" sort="Mcarthur, Grant A" uniqKey="Mcarthur G" first="Grant A" last="Mcarthur">Grant A. Mcarthur</name></noRegion></country><country name="États-Unis"><region name="Californie"><name sortKey="Ribas, Antoni" sort="Ribas, Antoni" uniqKey="Ribas A" first="Antoni" last="Ribas">Antoni Ribas</name></region><name sortKey="Barteselli, Giulio" sort="Barteselli, Giulio" uniqKey="Barteselli G" first="Giulio" last="Barteselli">Giulio Barteselli</name><name sortKey="Eng, Susan" sort="Eng, Susan" uniqKey="Eng S" first="Susan" last="Eng">Susan Eng</name><name sortKey="Hsu, Jessie J" sort="Hsu, Jessie J" uniqKey="Hsu J" first="Jessie J" last="Hsu">Jessie J. Hsu</name><name sortKey="Uyei, Anne" sort="Uyei, Anne" uniqKey="Uyei A" first="Anne" last="Uyei">Anne Uyei</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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