An open-label, multicentre safety study of vemurafenib in patients with BRAF(V600)-mutant metastatic melanoma: final analysis and a validated prognostic scoring system
Identifikátory výsledku
Kód výsledku v IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064165%3A_____%2F19%3A10396070" target="_blank" >RIV/00064165:_____/19:10396070 - isvavai.cz</a>
Nalezeny alternativní kódy
RIV/00216208:11110/19:10396070
Výsledek na webu
<a href="https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=TQnuGSOPql" target="_blank" >https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=TQnuGSOPql</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1016/j.ejca.2018.11.018" target="_blank" >10.1016/j.ejca.2018.11.018</a>
Alternativní jazyky
Jazyk výsledku
angličtina
Název v původním jazyce
An open-label, multicentre safety study of vemurafenib in patients with BRAF(V600)-mutant metastatic melanoma: final analysis and a validated prognostic scoring system
Popis výsledku v původním jazyce
Background: The oncogenic BRAF inhibitor vemurafenib improves outcomes for patients with advanced BRAF(V600) mutation-positive melanoma compared with cytotoxic chemotherapy. Vemurafenib is now approved for use in this patient population. Patients and methods: In this open-label, multicentre study, patients with previously treated or untreated melanoma and the BRAF(V600) mutation received vemurafenib 960 mg twice daily. The primary endpoint was safety. In a post hoc analysis, overall survival (OS) was analysed according to a prognostic scoring system developed using Eastern Cooperative Oncology Group performance status, existence of brain metastases and baseline serum lactate dehydrogenase level. The index was validated using data from patients treated with vemurafenib or dacarbazine in three clinical trials and data from patients treated with vemurafenib plus cobimetinib in two studies. The study is registered with ClinicalTrials.gov (NCT01307397). 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(V600) mutation-positive patients and resemble those seen in real-world clinical practice. This index may be useful in patients on combination therapy and as a basis for further work.
Název v anglickém jazyce
An open-label, multicentre safety study of vemurafenib in patients with BRAF(V600)-mutant metastatic melanoma: final analysis and a validated prognostic scoring system
Popis výsledku anglicky
Background: The oncogenic BRAF inhibitor vemurafenib improves outcomes for patients with advanced BRAF(V600) mutation-positive melanoma compared with cytotoxic chemotherapy. Vemurafenib is now approved for use in this patient population. Patients and methods: In this open-label, multicentre study, patients with previously treated or untreated melanoma and the BRAF(V600) mutation received vemurafenib 960 mg twice daily. The primary endpoint was safety. In a post hoc analysis, overall survival (OS) was analysed according to a prognostic scoring system developed using Eastern Cooperative Oncology Group performance status, existence of brain metastases and baseline serum lactate dehydrogenase level. The index was validated using data from patients treated with vemurafenib or dacarbazine in three clinical trials and data from patients treated with vemurafenib plus cobimetinib in two studies. The study is registered with ClinicalTrials.gov (NCT01307397). 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(V600) mutation-positive patients and resemble those seen in real-world clinical practice. This index may be useful in patients on combination therapy and as a basis for further work.
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
2019
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
107
Číslo periodika v rámci svazku
January
Stát vydavatele periodika
GB - Spojené království Velké Británie a Severního Irska
Počet stran výsledku
11
Strana od-do
175-185
Kód UT WoS článku
000454908700021
EID výsledku v databázi Scopus
2-s2.0-85058680214