An open-label, multicentre safety study of vemurafenib in patients with BRAF(V600)-mutant metastatic melanoma: final analysis and a validated prognostic scoring system
The result's identifiers
Result code in 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>
Alternative codes found
RIV/00216208:11110/19:10396070
Result on the web
<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>
Alternative languages
Result language
angličtina
Original language name
An open-label, multicentre safety study of vemurafenib in patients with BRAF(V600)-mutant metastatic melanoma: final analysis and a validated prognostic scoring system
Original language description
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.
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - 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
Result continuities
Project
—
Continuities
N - Vyzkumna aktivita podporovana z neverejnych zdroju
Others
Publication year
2019
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
European Journal of Cancer
ISSN
0959-8049
e-ISSN
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Volume of the periodical
107
Issue of the periodical within the volume
January
Country of publishing house
GB - UNITED KINGDOM
Number of pages
11
Pages from-to
175-185
UT code for WoS article
000454908700021
EID of the result in the Scopus database
2-s2.0-85058680214