BACKGROUND:Advanced melanoma is an aggressive disease with a poor prognosis. Approved therapy is limited in the U.K. and, until recently, no treatment had improved survival over best supportive care. A deeper understanding of current clinical practice will help new agents find a place in future treatment pathways. OBJECTIVES:To document U.K. clinical practice for the treatment of patients with unresectable stage III/IV (advanced) melanoma. METHODS:MELODY (melanoma treatment patterns and outcomes among patients with unresectable stage III/IV disease: a retrospective longitudinal survey) compiled registries of consecutive patients with malignant melanoma (any stage) between 1 July 2005 and 30 June 2006 from France, Italy and the U.K. Patients with advanced melanoma and ≥ 2 months of follow-up were eligible for analysis. RESULTS:There were 220 eligible patients identified in the U.K., of whom 117 (53.2%) received systemic therapy outside of clinical trials. Over half of these patients received dacarbazine as first- or second-line therapy. Healthcare-resource utilization was extensive and patients had short survival times: 1- and 2-year survival rates after first-line systemic treatment were 45.5% [95% confidence interval (CI) 37.1-53.6] and 24.7% (95% CI 17.7-32.3), respectively. CONCLUSIONS:Systemic and palliative treatments used to manage advanced melanoma in the U.K. are associated with considerable healthcare resource utilization and poor short-term survival.

There are few treatments available for advanced melanoma and survival rates are low. While the incidence of the disease continues to rise, only two new treatments have come to the market recently: ipilimumab and vemurafenib. Ipilimumab is indicated in Europe for the treatment of advanced melanoma in adults who have received prior therapy. Ipilimumab has demonstrated a statistically significant improvement in overall survival in 2 Phase III RCTs. Prolonged survival (>2 years in some patients) has been shown (MDX020 & 024). Data from the MDX010-20 trial, which was conducted in previously treated patients with a maximum follow up duration of 55 months, was used to develop an economic model for health technology assessment in England & Wales. This model has been used to predict the conditional survival (CS) of patients treated with ipilimumab (based on both ipilimumab containing arms) compared to gp100 – the active control. The model used patient level Kaplan–Meier data for the first 18 months, parametric curves fitted to the patient level data from 18 months to 5 years, and published AJCC registry data beyond 5 years. The curves were a good fit to the MDX010-20 trial data (MAE 0.003) and consistent with published Phase II data (which provides a longer time horizon). Given an ipilimumab patient has survived 2 years, the modelled probability of being alive at 5 years is 67% (49%,79%) (gp100: 15% [9%,21%]) and at 10 years is 54% (39%, 63%) (gp100: 2% [1%,3%]). The model shows that a substantial proportion of patients treated with ipilimumab surviving to 2 years are likely to have sustained survival benefits: more than 50% of ipilimumab patients surviving to 2 years are alive at 10 years, with 29% remaining alive at 20 years. This level of sustained survival is not shown by gp100 patients.