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 pat...
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Autor*in:	de la Cruz-Merino, Luis [verfasserIn] Di Guardo, Lorenza Grob, Jean-Jacques Venosa, Alfredo Larkin, James McArthur, Grant A. Ribas, Antoni Ascierto, Paolo A. Evans, Jeffrey T. R. Gomez-Escobar, Antonio Barteselli, Giulio Eng, Susan Hsu, Jessie J. Uyei, Anne Dréno, Brigitte

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2017

Schlagwörter:	Cobimetinib MEK inhibition Melanoma Serous retinopathy Visual disturbance

Anmerkung:	© The Author(s) 2017

Übergeordnetes Werk:	Enthalten in: Journal of translational medicine - London : BioMed Central, 2003, 15(2017), 1 vom: 24. Juni
Übergeordnetes Werk:	volume:15 ; year:2017 ; number:1 ; day:24 ; month:06

Links:	Volltext

DOI / URN:	10.1186/s12967-017-1246-0

Katalog-ID:	SPR028964594

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520			\|a 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 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 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. Trial Registration Clinicaltrials.gov (NCT01689519). First received: September 18, 2012
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allfields	10.1186/s12967-017-1246-0 doi (DE-627)SPR028964594 (SPR)s12967-017-1246-0-e DE-627 ger DE-627 rakwb eng de la Cruz-Merino, Luis verfasserin aut Clinical features of serous retinopathy observed with cobimetinib in patients with BRAF-mutated melanoma treated in the randomized coBRIM study 2017 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2017 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 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 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. Trial Registration Clinicaltrials.gov (NCT01689519). First received: September 18, 2012 Cobimetinib (dpeaa)DE-He213 MEK inhibition (dpeaa)DE-He213 Melanoma (dpeaa)DE-He213 Serous retinopathy (dpeaa)DE-He213 Visual disturbance (dpeaa)DE-He213 Di Guardo, Lorenza aut Grob, Jean-Jacques aut Venosa, Alfredo aut Larkin, James aut McArthur, Grant A. aut Ribas, Antoni aut Ascierto, Paolo A. aut Evans, Jeffrey T. R. aut Gomez-Escobar, Antonio aut Barteselli, Giulio aut Eng, Susan aut Hsu, Jessie J. aut Uyei, Anne aut Dréno, Brigitte aut Enthalten in Journal of translational medicine London : BioMed Central, 2003 15(2017), 1 vom: 24. Juni (DE-627)369084136 (DE-600)2118570-0 1479-5876 nnns volume:15 year:2017 number:1 day:24 month:06 https://dx.doi.org/10.1186/s12967-017-1246-0 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 15 2017 1 24 06
spelling	10.1186/s12967-017-1246-0 doi (DE-627)SPR028964594 (SPR)s12967-017-1246-0-e DE-627 ger DE-627 rakwb eng de la Cruz-Merino, Luis verfasserin aut Clinical features of serous retinopathy observed with cobimetinib in patients with BRAF-mutated melanoma treated in the randomized coBRIM study 2017 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2017 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 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 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. Trial Registration Clinicaltrials.gov (NCT01689519). First received: September 18, 2012 Cobimetinib (dpeaa)DE-He213 MEK inhibition (dpeaa)DE-He213 Melanoma (dpeaa)DE-He213 Serous retinopathy (dpeaa)DE-He213 Visual disturbance (dpeaa)DE-He213 Di Guardo, Lorenza aut Grob, Jean-Jacques aut Venosa, Alfredo aut Larkin, James aut McArthur, Grant A. aut Ribas, Antoni aut Ascierto, Paolo A. aut Evans, Jeffrey T. R. aut Gomez-Escobar, Antonio aut Barteselli, Giulio aut Eng, Susan aut Hsu, Jessie J. aut Uyei, Anne aut Dréno, Brigitte aut Enthalten in Journal of translational medicine London : BioMed Central, 2003 15(2017), 1 vom: 24. Juni (DE-627)369084136 (DE-600)2118570-0 1479-5876 nnns volume:15 year:2017 number:1 day:24 month:06 https://dx.doi.org/10.1186/s12967-017-1246-0 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 15 2017 1 24 06
allfields_unstemmed	10.1186/s12967-017-1246-0 doi (DE-627)SPR028964594 (SPR)s12967-017-1246-0-e DE-627 ger DE-627 rakwb eng de la Cruz-Merino, Luis verfasserin aut Clinical features of serous retinopathy observed with cobimetinib in patients with BRAF-mutated melanoma treated in the randomized coBRIM study 2017 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2017 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 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 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. Trial Registration Clinicaltrials.gov (NCT01689519). First received: September 18, 2012 Cobimetinib (dpeaa)DE-He213 MEK inhibition (dpeaa)DE-He213 Melanoma (dpeaa)DE-He213 Serous retinopathy (dpeaa)DE-He213 Visual disturbance (dpeaa)DE-He213 Di Guardo, Lorenza aut Grob, Jean-Jacques aut Venosa, Alfredo aut Larkin, James aut McArthur, Grant A. aut Ribas, Antoni aut Ascierto, Paolo A. aut Evans, Jeffrey T. R. aut Gomez-Escobar, Antonio aut Barteselli, Giulio aut Eng, Susan aut Hsu, Jessie J. aut Uyei, Anne aut Dréno, Brigitte aut Enthalten in Journal of translational medicine London : BioMed Central, 2003 15(2017), 1 vom: 24. Juni (DE-627)369084136 (DE-600)2118570-0 1479-5876 nnns volume:15 year:2017 number:1 day:24 month:06 https://dx.doi.org/10.1186/s12967-017-1246-0 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 15 2017 1 24 06
allfieldsGer	10.1186/s12967-017-1246-0 doi (DE-627)SPR028964594 (SPR)s12967-017-1246-0-e DE-627 ger DE-627 rakwb eng de la Cruz-Merino, Luis verfasserin aut Clinical features of serous retinopathy observed with cobimetinib in patients with BRAF-mutated melanoma treated in the randomized coBRIM study 2017 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2017 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 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 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. Trial Registration Clinicaltrials.gov (NCT01689519). First received: September 18, 2012 Cobimetinib (dpeaa)DE-He213 MEK inhibition (dpeaa)DE-He213 Melanoma (dpeaa)DE-He213 Serous retinopathy (dpeaa)DE-He213 Visual disturbance (dpeaa)DE-He213 Di Guardo, Lorenza aut Grob, Jean-Jacques aut Venosa, Alfredo aut Larkin, James aut McArthur, Grant A. aut Ribas, Antoni aut Ascierto, Paolo A. aut Evans, Jeffrey T. R. aut Gomez-Escobar, Antonio aut Barteselli, Giulio aut Eng, Susan aut Hsu, Jessie J. aut Uyei, Anne aut Dréno, Brigitte aut Enthalten in Journal of translational medicine London : BioMed Central, 2003 15(2017), 1 vom: 24. Juni (DE-627)369084136 (DE-600)2118570-0 1479-5876 nnns volume:15 year:2017 number:1 day:24 month:06 https://dx.doi.org/10.1186/s12967-017-1246-0 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 15 2017 1 24 06
allfieldsSound	10.1186/s12967-017-1246-0 doi (DE-627)SPR028964594 (SPR)s12967-017-1246-0-e DE-627 ger DE-627 rakwb eng de la Cruz-Merino, Luis verfasserin aut Clinical features of serous retinopathy observed with cobimetinib in patients with BRAF-mutated melanoma treated in the randomized coBRIM study 2017 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2017 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 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 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. Trial Registration Clinicaltrials.gov (NCT01689519). First received: September 18, 2012 Cobimetinib (dpeaa)DE-He213 MEK inhibition (dpeaa)DE-He213 Melanoma (dpeaa)DE-He213 Serous retinopathy (dpeaa)DE-He213 Visual disturbance (dpeaa)DE-He213 Di Guardo, Lorenza aut Grob, Jean-Jacques aut Venosa, Alfredo aut Larkin, James aut McArthur, Grant A. aut Ribas, Antoni aut Ascierto, Paolo A. aut Evans, Jeffrey T. R. aut Gomez-Escobar, Antonio aut Barteselli, Giulio aut Eng, Susan aut Hsu, Jessie J. aut Uyei, Anne aut Dréno, Brigitte aut Enthalten in Journal of translational medicine London : BioMed Central, 2003 15(2017), 1 vom: 24. Juni (DE-627)369084136 (DE-600)2118570-0 1479-5876 nnns volume:15 year:2017 number:1 day:24 month:06 https://dx.doi.org/10.1186/s12967-017-1246-0 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 15 2017 1 24 06
language	English
source	Enthalten in Journal of translational medicine 15(2017), 1 vom: 24. Juni volume:15 year:2017 number:1 day:24 month:06
sourceStr	Enthalten in Journal of translational medicine 15(2017), 1 vom: 24. Juni volume:15 year:2017 number:1 day:24 month:06
format_phy_str_mv	Article
institution	findex.gbv.de
topic_facet	Cobimetinib MEK inhibition Melanoma Serous retinopathy Visual disturbance
isfreeaccess_bool	true
container_title	Journal of translational medicine
authorswithroles_txt_mv	de la Cruz-Merino, Luis @@aut@@ Di Guardo, Lorenza @@aut@@ Grob, Jean-Jacques @@aut@@ Venosa, Alfredo @@aut@@ Larkin, James @@aut@@ McArthur, Grant A. @@aut@@ Ribas, Antoni @@aut@@ Ascierto, Paolo A. @@aut@@ Evans, Jeffrey T. R. @@aut@@ Gomez-Escobar, Antonio @@aut@@ Barteselli, Giulio @@aut@@ Eng, Susan @@aut@@ Hsu, Jessie J. @@aut@@ Uyei, Anne @@aut@@ Dréno, Brigitte @@aut@@
publishDateDaySort_date	2017-06-24T00:00:00Z
hierarchy_top_id	369084136
id	SPR028964594
language_de	englisch
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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 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. 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author	de la Cruz-Merino, Luis
spellingShingle	de la Cruz-Merino, Luis misc Cobimetinib misc MEK inhibition misc Melanoma misc Serous retinopathy misc Visual disturbance Clinical features of serous retinopathy observed with cobimetinib in patients with BRAF-mutated melanoma treated in the randomized coBRIM study
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topic_title	Clinical features of serous retinopathy observed with cobimetinib in patients with BRAF-mutated melanoma treated in the randomized coBRIM study Cobimetinib (dpeaa)DE-He213 MEK inhibition (dpeaa)DE-He213 Melanoma (dpeaa)DE-He213 Serous retinopathy (dpeaa)DE-He213 Visual disturbance (dpeaa)DE-He213
topic	misc Cobimetinib misc MEK inhibition misc Melanoma misc Serous retinopathy misc Visual disturbance
topic_unstemmed	misc Cobimetinib misc MEK inhibition misc Melanoma misc Serous retinopathy misc Visual disturbance
topic_browse	misc Cobimetinib misc MEK inhibition misc Melanoma misc Serous retinopathy misc Visual disturbance
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title	Clinical features of serous retinopathy observed with cobimetinib in patients with BRAF-mutated melanoma treated in the randomized coBRIM study
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title_full	Clinical features of serous retinopathy observed with cobimetinib in patients with BRAF-mutated melanoma treated in the randomized coBRIM study
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author_browse	de la Cruz-Merino, Luis Di Guardo, Lorenza Grob, Jean-Jacques Venosa, Alfredo Larkin, James McArthur, Grant A. Ribas, Antoni Ascierto, Paolo A. Evans, Jeffrey T. R. Gomez-Escobar, Antonio Barteselli, Giulio Eng, Susan Hsu, Jessie J. Uyei, Anne Dréno, Brigitte
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author-letter	de la Cruz-Merino, Luis
doi_str_mv	10.1186/s12967-017-1246-0
title_sort	clinical features of serous retinopathy observed with cobimetinib in patients with braf-mutated melanoma treated in the randomized cobrim study
title_auth	Clinical features of serous retinopathy observed with cobimetinib in patients with BRAF-mutated melanoma treated in the randomized coBRIM study
abstract	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 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 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. Trial Registration Clinicaltrials.gov (NCT01689519). First received: September 18, 2012 © The Author(s) 2017
abstractGer	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 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 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. Trial Registration Clinicaltrials.gov (NCT01689519). First received: September 18, 2012 © The Author(s) 2017
abstract_unstemmed	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 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 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. Trial Registration Clinicaltrials.gov (NCT01689519). First received: September 18, 2012 © The Author(s) 2017
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title_short	Clinical features of serous retinopathy observed with cobimetinib in patients with BRAF-mutated melanoma treated in the randomized coBRIM study
url	https://dx.doi.org/10.1186/s12967-017-1246-0
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author2	Di Guardo, Lorenza Grob, Jean-Jacques Venosa, Alfredo Larkin, James McArthur, Grant A. Ribas, Antoni Ascierto, Paolo A. Evans, Jeffrey T. R. Gomez-Escobar, Antonio Barteselli, Giulio Eng, Susan Hsu, Jessie J. Uyei, Anne Dréno, Brigitte
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