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Ocular toxicity in BRAF mutant cutaneous melanoma patients treated with vemurafenib
Christina H Choe1, Grant A McArthur2, Ivor Caro3
1Departments of Ophthalmology and the Scheie Eye Institute, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania.
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.
Insights
Vemurafenib treatment for melanoma can cause ocular side effects in over 20% of patients, including uveitis and dry eyes. These effects are manageable, allowing continued vemurafenib therapy.
Area of Science:
- Ophthalmology
- Oncology
- Pharmacology
Background:
- Metastatic cutaneous melanoma is a serious diagnosis.
- BRAF(V600) mutation-positive melanoma is a target for specific therapies like vemurafenib.
Purpose of the Study:
- To determine the frequency of ocular adverse effects associated with vemurafenib (PLX4032) treatment for metastatic cutaneous melanoma.
Main Methods:
- Retrospective review of clinical study reports from vemurafenib trials (Phase 1-3).
- Analysis of data from 855 patients with unresectable, BRAF(V600)-positive melanoma (568 on vemurafenib, 287 on dacarbazine).
Main Results:
- Ocular adverse effects occurred in 22% of patients treated with vemurafenib.
- Most common ocular effects included uveitis (4.0%), conjunctivitis (2.8%), and dry eyes (2.0%).
- All ocular events were successfully managed without interrupting vemurafenib therapy.
Conclusions:
- Ocular adverse events are common in vemurafenib-treated patients.
- Vemurafenib can be safely continued during management of ocular symptoms.
- Further research is needed to understand the pathogenesis of these ocular side effects.
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