دورية أكاديمية
Encorafenib plus binimetinib versus vemurafenib or encorafenib in patients with BRAF-mutant melanoma (COLUMBUS): a multicentre, open-label, randomised phase 3 trial
| العنوان: | Encorafenib plus binimetinib versus vemurafenib or encorafenib in patients with BRAF-mutant melanoma (COLUMBUS): a multicentre, open-label, randomised phase 3 trial |
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| المؤلفون: | Dummer, Reinhard, Ascierto, Paolo A, Gogas, Helen J, Arance, Ana, Mandala, Mario, Liszkay, Gabriella, Garbe, Claus, Schadendorf, Dirk, Krajsova, Ivana, Gutzmer, Ralf, Chiarion-Sileni, Vanna, Dutriaux, Caroline, de Groot, Jan Willem B, Yamazaki, Naoya, Loquai, Carmen, Moutouh-de Parseval, Laure A, Pickard, Michael D, Sandor, Victor, Robert, Caroline, Flaherty, Keith T |
| المصدر: | Dummer, Reinhard; Ascierto, Paolo A; Gogas, Helen J; Arance, Ana; Mandala, Mario; Liszkay, Gabriella; Garbe, Claus; Schadendorf, Dirk; Krajsova, Ivana; Gutzmer, Ralf; Chiarion-Sileni, Vanna; Dutriaux, Caroline; de Groot, Jan Willem B; Yamazaki, Naoya; Loquai, Carmen; Moutouh-de Parseval, Laure A; Pickard, Michael D; Sandor, Victor; Robert, Caroline; Flaherty, Keith T (2018). Encorafenib plus binimetinib versus vemurafenib or encorafenib in patients with BRAF-mutant melanoma (COLUMBUS): a multicentre, open-label, randomised phase 3 trial. Lancet Oncology, 19(5):603-615. |
| بيانات النشر: | Elsevier |
| سنة النشر: | 2018 |
| المجموعة: | University of Zurich (UZH): ZORA (Zurich Open Repository and Archive |
| مصطلحات موضوعية: | Dermatology Clinic, 610 Medicine & health |
| الوصف: | BACKGROUND Combined BRAF-MEK inhibitor therapy is the standard of care for BRAF-mutant advanced melanoma. We investigated encorafenib, a BRAF inhibitor with unique target-binding properties, alone or in combination with the MEK inhibitor binimetinib, versus vemurafenib in patients with advanced BRAF-mutant melanoma. METHODS COLUMBUS was conducted as a two-part, randomised, open-label phase 3 study at 162 hospitals in 28 countries. Eligible patients were aged 18 years or older and had histologically confirmed locally advanced (American Joint Committee on Cancer [AJCC] stage IIIB, IIIC, or IV), unresectable or metastatic cutaneous melanoma, or unknown primary melanoma; a BRAF or BRAF mutation; an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; and were treatment naive or had progressed on or after previous first-line immunotherapy. In part 1 of the study, patients were randomly assigned (1:1:1) via interactive response technology to receive either oral encorafenib 450 mg once daily plus oral binimetinib 45 mg twice daily (encorafenib plus binimetinib group), oral encorafenib 300 mg once daily (encorafenib group), or oral vemurafenib 960 mg twice daily (vemurafenib group). The primary endpoint was progression-free survival by blinded independent central review for encorafenib plus binimetinib versus vemurafenib. Efficacy analyses were by intention-to-treat. Safety was analysed in patients who received at least one dose of study drug and one postbaseline safety assessment. The results of part 2 will be published separately. This study is registered with ClinicalTrials.gov, number NCT01909453, and EudraCT, number 2013-001176-38. FINDINGS Between Dec 30, 2013, and April 10, 2015, 577 of 1345 screened patients were randomly assigned to either the encorafenib plus binimetinib group (n=192), the encorafenib group (n=194), or the vemurafenib group (n=191). With a median follow-up of 16·6 months (95% CI 14·8-16·9), median progression-free survival was 14·9 months (95% CI 11·0-18·5) in the ... |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | application/pdf |
| اللغة: | English |
| تدمد: | 1470-2045 |
| العلاقة: | https://www.zora.uzh.ch/id/eprint/151962/1/747_Dummer_R._et_al._Encorafenib_plus_binimetinib_versus_vemurafenib_or_encorafenib_in_patients_Lancet_Oncology_2018.pdfTest; https://www.zora.uzh.ch/id/eprint/151962/8/Dummer_et_al_Lancet_Oncology_13.12.17.pdfTest; info:pmid/29573941; urn:issn:1470-2045 |
| DOI: | 10.5167/uzh-151962 |
| DOI: | 10.1016/S1470-2045(18)30142-6 |
| الإتاحة: | https://doi.org/10.5167/uzh-15196210.1016/S1470-2045Test(18)30142-6 https://www.zora.uzh.ch/id/eprint/151962Test/ https://www.zora.uzh.ch/id/eprint/151962/1/747_Dummer_R._et_al._Encorafenib_plus_binimetinib_versus_vemurafenib_or_encorafenib_in_patients_Lancet_Oncology_2018.pdfTest https://www.zora.uzh.ch/id/eprint/151962/8/Dummer_et_al_Lancet_Oncology_13.12.17.pdfTest |
| حقوق: | info:eu-repo/semantics/openAccess ; Creative Commons: Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0) ; http://creativecommons.org/licenses/by-nc-nd/4.0Test/ |
| رقم الانضمام: | edsbas.3D00A124 |
| قاعدة البيانات: | BASE |
| تدمد: | 14702045 |
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| DOI: | 10.5167/uzh-151962 |