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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

Identifikátory výsledku

  • Kód výsledku v 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>

  • Výsledek na webu

    <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>

Alternativní jazyky

  • Jazyk výsledku

    angličtina

  • Název v původním jazyce

    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

  • Popis výsledku v původním jazyce

    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.

  • Název v anglickém jazyce

    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

  • Popis výsledku anglicky

    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.

Klasifikace

  • Druh

    J<sub>imp</sub> - Článek v periodiku v databázi Web of Science

  • CEP obor

  • OECD FORD obor

    30216 - Dermatology and venereal diseases

Návaznosti výsledku

  • Projekt

  • Návaznosti

    N - Vyzkumna aktivita podporovana z neverejnych zdroju

Ostatní

  • Rok uplatnění

    2017

  • Kód důvěrnosti údajů

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

Údaje specifické pro druh výsledku

  • Název periodika

    European Journal of Cancer

  • ISSN

    0959-8049

  • e-ISSN

  • Svazek periodika

    79

  • Číslo periodika v rámci svazku

    July

  • Stát vydavatele periodika

    GB - Spojené království Velké Británie a Severního Irska

  • Počet stran výsledku

    9

  • Strana od-do

    176-184

  • Kód UT WoS článku

    000402872000020

  • EID výsledku v databázi Scopus

    2-s2.0-85019142254