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Adverse events associated with encorafenib plus binimetinib in the COLUMBUS study: incidence, course and management
HJ. Gogas, KT. Flaherty, R. Dummer, PA. Ascierto, A. Arance, M. Mandala, G. Liszkay, C. Garbe, D. Schadendorf, I. Krajsova, R. Gutzmer, VC. Sileni, C. Dutriaux, JWB. de Groot, N. Yamazaki, C. Loquai, A. Gollerkeri, MD. Pickard, C. Robert,
Jazyk angličtina Země Velká Británie
Typ dokumentu klinické zkoušky, fáze III, časopisecké články, multicentrická studie, randomizované kontrolované studie, práce podpořená grantem
- MeSH
- benzimidazoly aplikace a dávkování škodlivé účinky MeSH
- incidence MeSH
- inhibitory proteinkinas aplikace a dávkování škodlivé účinky terapeutické užití MeSH
- karbamáty aplikace a dávkování škodlivé účinky MeSH
- lidé středního věku MeSH
- lidé MeSH
- melanom farmakoterapie genetika metabolismus MeSH
- mitogenem aktivované proteinkinasy antagonisté a inhibitory metabolismus MeSH
- mutace MeSH
- nádory kůže farmakoterapie genetika metabolismus MeSH
- nauzea chemicky indukované epidemiologie MeSH
- protokoly protinádorové kombinované chemoterapie aplikace a dávkování škodlivé účinky terapeutické užití MeSH
- protoonkogenní proteiny B-raf antagonisté a inhibitory genetika metabolismus MeSH
- sulfonamidy aplikace a dávkování škodlivé účinky MeSH
- únava chemicky indukované epidemiologie MeSH
- vemurafenib aplikace a dávkování škodlivé účinky MeSH
- zvracení chemicky indukované epidemiologie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
BACKGROUND: Dual inhibition of the mitogen-activated protein kinase pathway with BRAF/MEK inhibitor (BRAFi/MEKi) therapy is a standard treatment for BRAFV600-mutant metastatic melanoma and has historically been associated with grade III pyrexia or photosensitivity depending on the combination used. The objective of this study was to fully describe adverse events from the COLUMBUS study evaluating the most recent BRAF/MEK inhibitor combination encorafenib+binimetinib. PATIENTS AND METHODS: Patients with locally advanced, unresectable or metastatic BRAFV600-mutant melanoma were randomised to receive encorafenib 450 mg once daily plus binimetinib 45 mg twice daily, encorafenib 300 mg once daily or vemurafenib 960 mg twice daily. Adverse events that represent known effects of available BRAFi and/or MEKi were evaluated. RESULTS: The safety population included a total of 570 patients (encorafenib+binimetinib = 192; encorafenib = 192; vemurafenib = 186). Median duration of exposure was longer with encorafenib+binimetinib (51 weeks) than with encorafenib (31 weeks) or vemurafenib (27 weeks). Common BRAFi/MEKi toxicities with encorafenib+binimetinib were generally manageable, reversible and infrequently associated with discontinuation. Pyrexia was less frequent with encorafenib+binimetinib (18%) and encorafenib (16%) than with vemurafenib (30%) and occurred later in the course of therapy with encorafenib+binimetinib (median time to first onset: 85 days versus 2.5 days and 19 days, respectively). The incidence of photosensitivity was lower with encorafenib+binimetinib (5%) and encorafenib (4%) than with vemurafenib (30%). The incidence of serous retinopathy was higher with encorafenib+binimetinib (20%) than with encorafenib (2%) or vemurafenib (2%), but no patients discontinued encorafenib+binimetinib because of this event. CONCLUSION: Encorafenib+binimetinib is generally well tolerated and has a low discontinuation rate in patients with BRAFV600-mutant melanoma, with a distinct safety profile as compared with other anti-BRAF/MEK targeted therapies. TRIAL REGISTRATION: ClinicalTrials.gov (Identifier: NCT01909453) and with EudraCT (number 2013-001176-38).
Array BioPharma Inc Boulder CO USA
Cancer Center Massachusetts General Hospital Boston MA USA
Department of Dermatologic Oncology National Cancer Center Hospital Tokyo Japan
Department of Dermatology National Institute of Oncology Budapest Hungary
Department of Dermatology University Hospital Tuebingen Tuebingen Germany
Department of Dermatology University Medical Center Mainz Mainz Germany
Department of Medical Oncology Hospital Clinic of Barcelona Barcelona Spain
Department of Medical Oncology Isala Zwolle Netherlands
Department of Oncology and Haematology Papa Giovanni XXIII Cancer Center Hospital Bergamo Italy
Melanoma Cancer Unit Oncology Institute of Veneto IRCCS Padua Italy
Citace poskytuje Crossref.org
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- $a Gogas, Helen J $u Department of Internal Medicine, National and Kapodistrian University of Athens, Laikon Hospital, Athens, Greece. Electronic address: helgogas@gmail.com.
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- $a BACKGROUND: Dual inhibition of the mitogen-activated protein kinase pathway with BRAF/MEK inhibitor (BRAFi/MEKi) therapy is a standard treatment for BRAFV600-mutant metastatic melanoma and has historically been associated with grade III pyrexia or photosensitivity depending on the combination used. The objective of this study was to fully describe adverse events from the COLUMBUS study evaluating the most recent BRAF/MEK inhibitor combination encorafenib+binimetinib. PATIENTS AND METHODS: Patients with locally advanced, unresectable or metastatic BRAFV600-mutant melanoma were randomised to receive encorafenib 450 mg once daily plus binimetinib 45 mg twice daily, encorafenib 300 mg once daily or vemurafenib 960 mg twice daily. Adverse events that represent known effects of available BRAFi and/or MEKi were evaluated. RESULTS: The safety population included a total of 570 patients (encorafenib+binimetinib = 192; encorafenib = 192; vemurafenib = 186). Median duration of exposure was longer with encorafenib+binimetinib (51 weeks) than with encorafenib (31 weeks) or vemurafenib (27 weeks). Common BRAFi/MEKi toxicities with encorafenib+binimetinib were generally manageable, reversible and infrequently associated with discontinuation. Pyrexia was less frequent with encorafenib+binimetinib (18%) and encorafenib (16%) than with vemurafenib (30%) and occurred later in the course of therapy with encorafenib+binimetinib (median time to first onset: 85 days versus 2.5 days and 19 days, respectively). The incidence of photosensitivity was lower with encorafenib+binimetinib (5%) and encorafenib (4%) than with vemurafenib (30%). The incidence of serous retinopathy was higher with encorafenib+binimetinib (20%) than with encorafenib (2%) or vemurafenib (2%), but no patients discontinued encorafenib+binimetinib because of this event. CONCLUSION: Encorafenib+binimetinib is generally well tolerated and has a low discontinuation rate in patients with BRAFV600-mutant melanoma, with a distinct safety profile as compared with other anti-BRAF/MEK targeted therapies. TRIAL REGISTRATION: ClinicalTrials.gov (Identifier: NCT01909453) and with EudraCT (number 2013-001176-38).
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