Details

Autor(en) / Beteiligte

• Choe, Christina H
• McArthur, Grant A
• Caro, Ivor
• Kempen, John H
• Amaravadi, Ravi K

Titel

Ocular Toxicity in BRAF Mutant Cutaneous Melanoma Patients Treated With Vemurafenib

Ist Teil von

• American journal of ophthalmology, 2014-10, Vol.158 (4), p.831-837.e2

Ort / Verlag

United States: Elsevier Inc

Erscheinungsjahr

2014

Quelle

MEDLINE

Beschreibungen/Notizen

• 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, BRAFV600 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.