Ocular toxicity in BRAF mutant cutaneous melanoma patients treated with vemurafenib.

Abstract:

PURPOSE:To determine the frequency of ocular adverse effects associated with vemurafenib (PLX4032) treatment for metastatic cutaneous melanoma. DESIGN:Retrospective review of the clinical study reports from the clinical pharmacology, phase 1, phase 2, and phase 3 trials of vemurafenib. METHODS:The vemurafenib clinical trials were a multicenter series involving adult patients with histologically confirmed, BRAF(V600) mutation-positive, unresectable, stage IIIC or IV melanoma. A total of 855 patients were enrolled in the trials: 568 patients were treated with vemurafenib and 287 patients were treated with dacarbazine. RESULTS:Among the 568 patients treated with vemurafenib, ocular adverse effects developed in 22% (95% confidence interval [CI], 18.5-25.6). The most common ocular diagnosis was uveitis (4.0%; 95% CI, 2.6-6.0), followed by conjunctivitis (2.8%; 95% CI, 1.6-4.5) and dry eyes (2.0%; 95% CI, 1.1-3.7). All were successfully managed while vemurafenib therapy was continued. CONCLUSIONS:Ocular adverse events and symptoms may be seen in more than one-fifth of patients being treated with vemurafenib. However, vemurafenib can be continued while the ocular symptoms are being managed. The pathogenesis of ocular symptoms in this patient population is unclear; additional studies are necessary.

journal_name

Am J Ophthalmol

authors

Choe CH,McArthur GA,Caro I,Kempen JH,Amaravadi RK

doi

10.1016/j.ajo.2014.07.003

subject

Has Abstract

pub_date

2014-10-01 00:00:00

pages

831-837.e2

issue

4

eissn

0002-9394

issn

1879-1891

pii

S0002-9394(14)00394-8

journal_volume

158

pub_type

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