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dc.contributor.authorBlank, CUen_US
dc.contributor.authorLarkin, Jen_US
dc.contributor.authorArance, AMen_US
dc.contributor.authorHauschild, Aen_US
dc.contributor.authorQueirolo, Pen_US
dc.contributor.authorDel Vecchio, Men_US
dc.contributor.authorAscierto, PAen_US
dc.contributor.authorKrajsova, Ien_US
dc.contributor.authorSchachter, Jen_US
dc.contributor.authorNeyns, Ben_US
dc.contributor.authorGarbe, Cen_US
dc.contributor.authorChiarion Sileni, Ven_US
dc.contributor.authorMandalà, Men_US
dc.contributor.authorGogas, Hen_US
dc.contributor.authorEspinosa, Een_US
dc.contributor.authorHospers, GAPen_US
dc.contributor.authorMiller, WHen_US
dc.contributor.authorRobson, Sen_US
dc.contributor.authorMakrutzki, Men_US
dc.contributor.authorAntic, Ven_US
dc.contributor.authorBrown, MPen_US
dc.coverage.spatialEnglanden_US
dc.date.accessioned2018-02-15T14:40:30Z
dc.date.issued2017-07en_US
dc.identifierhttps://www.ncbi.nlm.nih.gov/pubmed/28501764en_US
dc.identifierS0959-8049(17)30884-5en_US
dc.identifier.citationEur J Cancer, 2017, 79 pp. 176 - 184en_US
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/1123
dc.identifier.eissn1879-0852en_US
dc.identifier.doi10.1016/j.ejca.2017.04.007en_US
dc.description.abstractBACKGROUND: The orally available BRAF kinase inhibitor vemurafenib is an effective and tolerable treatment option for patients with metastatic melanoma harbouring BRAFV600 mutations. We assessed the safety of vemurafenib in a large population of patients with few alternative treatment options; we report updated 2-year safety. METHODS: This was an open-label, multicentre study of vemurafenib (960 mg bid) in patients with previously treated or untreated BRAF mutation-positive metastatic melanoma (cobas® 4800 BRAF V600 Mutation Test). The primary end-point was safety; efficacy end-points were secondary. An exploratory analysis was performed to assess safety outcomes in patients with long duration of response (DOR) (≥12 or ≥24 months). RESULTS: After a median follow-up of 32.2 months (95% CI, 31.1-33.2 months), 3079/3219 patients (96%) had discontinued treatment. Adverse events (AEs) were largely consistent with previous reports; the most common all-grade treatment-related AEs were arthralgia (37%), alopecia (25%) and hyperkeratosis (23%); the most common grade 3/4 treatment-related AEs were squamous cell carcinoma of the skin (8%) and keratoacanthoma (8%). In the exploratory analysis, patients with DOR ≥12 months (n = 287) or ≥24 months (n = 133) were more likely to experience grade 3/4 AEs than the overall population. No new specific safety signals were observed with longer vemurafenib exposure. CONCLUSIONS: After 2 years' follow-up, safety was maintained in this large group of patients with BRAFV600 mutation-positive metastatic melanoma who are more representative of routine clinical practice than typical clinical trial populations. These data suggest that long-term vemurafenib treatment is effective and tolerable without the development of new safety signals.en_US
dc.format.extent176 - 184en_US
dc.languageengen_US
dc.language.isoengen_US
dc.subjectBRAF(V600) mutationen_US
dc.subjectMetastatic melanomaen_US
dc.subjectSafetyen_US
dc.subjectVemurafeniben_US
dc.subjectAdulten_US
dc.subjectAgeden_US
dc.subjectAntineoplastic Agentsen_US
dc.subjectBrain Neoplasmsen_US
dc.subjectDisease Progressionen_US
dc.subjectDisease-Free Survivalen_US
dc.subjectFemaleen_US
dc.subjectFollow-Up Studiesen_US
dc.subjectHumansen_US
dc.subjectIndolesen_US
dc.subjectMaleen_US
dc.subjectMelanomaen_US
dc.subjectMiddle Ageden_US
dc.subjectMutationen_US
dc.subjectProto-Oncogene Proteins B-rafen_US
dc.subjectSkin Neoplasmsen_US
dc.subjectSulfonamidesen_US
dc.subjectTreatment Outcomeen_US
dc.subjectVemurafeniben_US
dc.titleOpen-label, multicentre safety study of vemurafenib in 3219 patients with BRAFV600 mutation-positive metastatic melanoma: 2-year follow-up data and long-term responders' analysis.en_US
dc.typeJournal Article
dcterms.dateAccepted2017-04-07en_US
rioxxterms.versionofrecord10.1016/j.ejca.2017.04.007en_US
rioxxterms.licenseref.startdate2017-07en_US
rioxxterms.typeJournal Article/Reviewen_US
dc.relation.isPartOfEur J Canceren_US
pubs.notesNot knownen_US
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-statusPublisheden_US
pubs.volume79en_US
pubs.embargo.termsNot knownen_US
icr.researchteamMelanoma and Kidney Canceren_US
dc.contributor.icrauthorLarkin, Jamesen_US
dc.contributor.icrauthorMarsden,en_US


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