Christina H Choe1, Grant A McArthur2, Ivor Caro3, John H Kempen4, Ravi K Amaravadi5. 1. Departments of Ophthalmology and the Scheie Eye Institute, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania. 2. Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia. 3. Genentech, South San Francisco, California. 4. Departments of Ophthalmology and the Scheie Eye Institute, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania; Center for Clinical Epidemiology and Biostatistics and Department of Biostatistics and Epidemiology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania. 5. Department of Medicine, Abramson Cancer Center, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania. Electronic address: ravi.amaravadi@uphs.upenn.edu.
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.
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.
Authors: Christopher D Conrady; Marissa Larochelle; Paula Pecen; Alan Palestine; Akbar Shakoor; Ajay Singh Journal: Graefes Arch Clin Exp Ophthalmol Date: 2017-10-27 Impact factor: 3.117
Authors: Harpal S Sandhu; Anton M Kolomeyer; Marisa K Lau; Carol L Shields; Lynn M Schuchter; Charles W Nichols; Tomas S Aleman Journal: Retin Cases Brief Rep Date: 2019 Spring
Authors: Akosua A Nti; Leona W Serrano; Harpal S Sandhu; Katherine E Uyhazi; Ilaina D Edelstein; Elaine J Zhou; Scott Bowman; Delu Song; Tara C Gangadhar; Lynn M Schuchter; Sheryl Mitnick; Alexander Huang; Charles W Nichols; Ravi K Amaravadi; Benjamin J Kim; Tomas S Aleman Journal: Retina Date: 2019-03 Impact factor: 4.256