Open-label, multicentre safety study of vemurafenib in 3219 patients with BRAFV600 mutation-positive metastatic melanoma: 2-year follow-up data and long-term responders' analysis

European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)
C BlankMichael P Brown

Abstract

The orally available BRAF kinase inhibitor vemurafenib is an effective and tolerable treatment option for patients with metastatic melanoma harbouring BRAFV600 mutations. We assessed the safety of vemurafenib in a large population of patients with few alternative treatment options; we report updated 2-year safety. 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® 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). 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 lik...Continue Reading

Citations

Apr 9, 2019·Journal of the National Comprehensive Cancer Network : JNCCN·Daniel G CoitAnita M Engh
Oct 5, 2019·International Journal of Cancer. Journal International Du Cancer·Mark P van OpijnenEllen H W Kapiteijn
Feb 10, 2018·Oncotarget·Haixiu YangDesi Shang
Nov 28, 2018·High-throughput·Theodoros G SoldatosDavid B Jackson
Oct 22, 2020·Cancers·Martin SalzmannJessica C Hassel
Nov 9, 2020·Critical Reviews in Oncology/hematology·Camille HouronCosmin Sebastian Voican
Oct 26, 2020·European Journal of Nuclear Medicine and Molecular Imaging·Joyce van SluisRonald Boellaard
Oct 7, 2020·Experimental Biology and Medicine·Jeff OwsleyAri VanderWalde

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