Evaluation of Patient Tolerability Associated with Vemurafenib Treatment of Advanced or Metastatic Melanoma

Trial description: Vemurafenib is an oral BRAF inhibitor that is indicated for the treatment of patients with unresectable or metastatic melanoma with BRAFV600E mutation as detected by an FDA-approved test. Commonly reported adverse events (AEs) in trials of patients treated with vemurafenib included skin toxicities, such as photosensitivity and cutaneous squamous cell carcinoma, arthralgia, and fatigue. Reports from clinical trials of subjects treated with vemaurafenib suggest that many of these AEs were reported as grade 1 or 2, and therefore, may not be perceived as clinically important by treating physicians. However, physicians’ and patients’ perceptions of the effect on quality of life (QoL) of AEs may be different. The results from previous oncology studies suggest that when compared to patient ratings, physicians tended to underestimate the frequency and severity of AEs associated with cancer treatments. The primary objective of this study is to measure the effect of skin-related patient-reported outcomes (PROs) among patients treated with vemurafenib. The secondary objectives are to measure the effect of vemurafenib treatment on overall PROs and PROs pertaining to arthralgia- or fatigue‐related AEs; to measure the impact of AEs on patients’ self‐reported utilization, persistence (time to discontinuation of vemurafenib treatment), and treatment modifications (whether there is a dose change or treatment interruption); and to assess the psychometric validity of the PRO instruments in a population with treated unresectable or metastatic melanoma. The primary hypothesis for this study is that vemurafenib treatment is associated with a decrement in QoL as measured by a lower Skindex-29 score at baseline versus week 4 (higher scores indicating lower levels of quality of life).This will be a prospective, observational, single‐arm study.