Open-label, multicentre safety study of vemurafenib in 3219 patients with BRAF(V600) mutation-positive metastatic melanoma: 2-year follow-up data and long-term responders' analysis

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064165%3A_____%2F17%3A10363978" target="_blank" >RIV/00064165:_____/17:10363978 - isvavai.cz</a>

Result on the web

<a href="http://dx.doi.org/10.1016/j.ejca.2017.04.007" target="_blank" >http://dx.doi.org/10.1016/j.ejca.2017.04.007</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/j.ejca.2017.04.007" target="_blank" >10.1016/j.ejca.2017.04.007</a>

Result language

angličtina

Original language name

Open-label, multicentre safety study of vemurafenib in 3219 patients with BRAF(V600) mutation-positive metastatic melanoma: 2-year follow-up data and long-term responders' analysis

Original language description

Background: The orally available BRAF kinase inhibitor vemurafenib is an effective and tolerable treatment option for patients with metastatic melanoma harbouring BRAF(V600) 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 (R) 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) (&gt;= 12 or &gt;= 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 &gt;= 12 months (n = 287) or &gt;= 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&apos; follow-up, safety was maintained in this large group of patients with BRAF(V600) mutation-positive metastatic melanoma who are more representative of routine clinical practice than typical clinical trial populations. These data suggest that longterm vemurafenib treatment is effective and tolerable without the development of new safety signals.

Czech name

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Czech description

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Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

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OECD FORD branch

30216 - Dermatology and venereal diseases

Project

—

Continuities

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Publication year

2017

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

European Journal of Cancer

ISSN

0959-8049

e-ISSN

—

Volume of the periodical

79

Issue of the periodical within the volume

July

Country of publishing house

GB - UNITED KINGDOM

Number of pages

9

Pages from-to

176-184

UT code for WoS article

000402872000020

EID of the result in the Scopus database

2-s2.0-85019142254