COLUMBUS 5-Year Update: A Randomized, Open-Label, Phase III Trial of Encorafenib Plus Binimetinib Versus Vemurafenib or Encorafenib in Patients With
Journal
Journal of clinical oncology : official journal of the American Society of Clinical Oncology
ISSN: 1527-7755
Titre abrégé: J Clin Oncol
Pays: United States
ID NLM: 8309333
Informations de publication
Date de publication:
20 12 2022
20 12 2022
Historique:
pubmed:
22
7
2022
medline:
20
12
2022
entrez:
21
7
2022
Statut:
ppublish
Résumé
Combination treatment with BRAF and MEK inhibitors has demonstrated benefits on progression-free survival (PFS) and overall survival (OS) and is a standard of care for the treatment of advanced Patients with locally advanced unresectable or metastatic Five hundred seventy-seven patients were randomly assigned: 192 to encorafenib plus binimetinib, 191 to vemurafenib, and 194 to encorafenib. The 5-year PFS and OS rates with encorafenib plus binimetinib were 23% and 35% overall and 31% and 45% in those with normal lactate dehydrogenase levels, respectively. In comparison, the 5-year PFS and OS rates with vemurafenib were 10% and 21% overall and 12% and 28% in those with normal lactate dehydrogenase levels, respectively. The median duration of response with encorafenib plus binimetinib was 18.6 months, with disease control achieved in 92.2% of patients. In comparison, the median duration of response with vemurafenib was 12.3 months, with disease control achieved in 81.2% of patients. Long-term follow-up showed no new safety concerns, and results were consistent with the known tolerability profile of encorafenib plus binimetinib. Interactive visualization of the data presented in this article is available at COLUMBUS dashboard. In this 5-year update of part 1 of the COLUMBUS trial, encorafenib plus binimetinib treatment demonstrated continued long-term benefits and a consistent safety profile in patients with
Identifiants
pubmed: 35862871
doi: 10.1200/JCO.21.02659
pmc: PMC9916040
doi:
Substances chimiques
Vemurafenib
207SMY3FQT
binimetinib
181R97MR71
encorafenib
8L7891MRB6
Proto-Oncogene Proteins B-raf
EC 2.7.11.1
Lactate Dehydrogenases
EC 1.1.-
BRAF protein, human
EC 2.7.11.1
Banques de données
ClinicalTrials.gov
['NCT01909453']
Types de publication
Randomized Controlled Trial
Clinical Trial, Phase III
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
4178-4188Commentaires et corrections
Type : CommentIn
Type : ErratumIn
Type : CommentIn
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