Background: The risk for malignant melanoma is higher than expected in Parkinson's disease (PD). The National Institutes of Health (NIH) Exploratory Trials in PD (NET-PD) Long-term Study 1 (LS-1) trial is a contemporary phase 3 study of subjects with early, treated PD. The objective of this work was to assess the incidence of malignant melanoma in a PD cohort.
Methods: Incident melanoma cases were identified from the adverse events log. The expected number of cases was calculated, using the expected incidence rates and the number of person-years.
Results: A total of 618 females and 1119 males were followed for 6452 person-years; 19 new melanoma cases were observed. The expected number was 5.29. The standardized event ratio compared to the general population was 3.6 (95% confidence interval, 2.2-5.6).
Conclusions: The risk for developing melanoma was higher than expected in the NET-PD LS-1 cohort and was similar to the risk reported in earlier comparable clinical trial cohorts. Dermatologic screening may be useful in Parkinson's disease to identify melanoma at an early stage.
Keywords: Parkinson's disease; clinical trial; malignant melanoma; standardized event ratio.
© 2013 Movement Disorder Society.