Powering a prospective melanoma chemoprevention trial in high‐risk cohorts

Abstract

Dear Editor, Although daily sunscreen use can reduce melanoma risk, there is considerable interest in developing chemoprevention strategies that could be used as an adjunct to sunscreen. While several agents have shown promise in early phase trials, no prospective randomized trial with melanoma as the endpoint has been performed. Testing candidate agents is problematic given the latency of melanoma development and its relatively low incidence which may require long monitoring times and large numbers of subjects depending on their melanoma risk. However, examining a high-risk population with a higher individual risk of melanoma would allow for a smaller number of subjects to be required in such a chemoprevention trial. Designing a prospective randomized controlled chemoprevention trial with melanoma as the endpoint thus requires a reasonable estimation of melanoma risk (i.e. rate of melanoma development per person per year) in the proposed study group. We reviewed the literature and found several studies that describe the rate of melanoma development in high-risk cohorts (Table 1). However, there is significant disparity in the observed melanoma rate among studies that is likely related to the