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) (>= 12 or >= 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 >= 12 months (n = 287) or >= 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' 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) (>= 12 or >= 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 >= 12 months (n = 287) or >= 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' 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