An open-label, multicentre safety study of vemurafenib in patients with BRAF

Aged Antineoplastic Agents / therapeutic use Brain Neoplasms / drug therapy Female Follow-Up Studies Humans Lymphatic Metastasis Male Melanoma / drug therapy Mutation Nomograms Prognosis Proto-Oncogene Proteins B-raf / genetics Survival Rate Validation Studies as Topic Vemurafenib / therapeutic use

BRAF(V600) mutation Metastatic melanoma Prognostic scoring system Safety Vemurafenib

Journal

European journal of cancer (Oxford, England : 1990)

ISSN: 1879-0852

Titre abrégé: Eur J Cancer

Pays: England

ID NLM: 9005373

Informations de publication

Date de publication:
01 2019

Historique:

received: 22 08 2018

revised: 31 10 2018

accepted: 16 11 2018

pubmed: 24 12 2018

medline: 6 5 2020

entrez: 24 12 2018

Statut: ppublish

Résumé

The oncogenic BRAF inhibitor vemurafenib improves outcomes for patients with advanced BRAF In this open-label, multicentre study, patients with previously treated or untreated melanoma and the BRAF Between March 2011 and January 2013, 3224 patients were enrolled, and 3219 patients received ≥1 dose of vemurafenib (safety population); median follow-up time was 33.4 months. Vemurafenib's long-term benefits were confirmed, and no new safety signals identified. The prognostic index showed between-group differences in OS, with tight, non-overlapping confidence intervals. Validation in a pooled group of 666 vemurafenib-treated clinical trial patients revealed a similar pattern; the pattern was similar in 280 patients treated with vemurafenib plus cobimetinib. Final results from the vemurafenib safety study confirm vemurafenib's tolerability in BRAF

Sections du résumé

BACKGROUND

The oncogenic BRAF inhibitor vemurafenib improves outcomes for patients with advanced BRAF

PATIENTS AND METHODS

In this open-label, multicentre study, patients with previously treated or untreated melanoma and the BRAF

RESULTS

Between March 2011 and January 2013, 3224 patients were enrolled, and 3219 patients received ≥1 dose of vemurafenib (safety population); median follow-up time was 33.4 months. Vemurafenib's long-term benefits were confirmed, and no new safety signals identified. The prognostic index showed between-group differences in OS, with tight, non-overlapping confidence intervals. Validation in a pooled group of 666 vemurafenib-treated clinical trial patients revealed a similar pattern; the pattern was similar in 280 patients treated with vemurafenib plus cobimetinib.

CONCLUSIONS

Final results from the vemurafenib safety study confirm vemurafenib's tolerability in BRAF

Identifiants

DOI: 10.1016/j.ejca.2018.11.018 PMID: 30580112

pubmed: 30580112

pii: S0959-8049(18)31516-8

doi: 10.1016/j.ejca.2018.11.018

pii:

doi:

Substances chimiques

Antineoplastic Agents 0

Vemurafenib 207SMY3FQT

BRAF protein, human EC 2.7.11.1

Proto-Oncogene Proteins B-raf EC 2.7.11.1

Banques de données

ClinicalTrials.gov

['NCT01307397']

Types de publication

Journal Article Multicenter Study Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

Pagination

175-185