P. Guitera,,, G. Fogarty,,,, A. Hong,P. Soyer, M. Foote, J. Kelly, V. Mar,, J. Ruben, E. Paton, A. Economides
Background: Lentigo Maligna (LM) is a superﬁcial type of melanoma, common in the sun-exposed regions, most often occurring later in life. Currently, Radiotherapy is recommended and Imiquimod is used as alternate treatments for (LM) when staged surgical excision with 1 mm margins is not possible, is refused, or fails, however no class I evidence supports the use of either. This randomised prospective multicentre trial will evaluate which treatment is superior.
Methods: The ANZMTG are conducting a Multi-centre, open label, stratiﬁed, 2-arm parallel phase III trial, to recruit a total of 266 patients over 5 years. Primary endpoint is treatment failure at month 12 and is deﬁned as the presence of LM cells conﬁrmed by histopathology. Secondary objectives include: proportion of patients experiencing LM treatment failure (6 and 24 months), patient reported outcomes, cosmetic outcome and difference in the cumulative incidence of invasive melanoma within the treatment ﬁeld.
Discussion: We will discuss:
• Literature review on imiquimod and radiotherapy efﬁcacy,
• Practical recommendations for management of these treatments
• Recruitment strategies and issues in a clinical trial
Direct evidence of efﬁcacy of medical treatments for Lentigo Maligna is currently lacking. The results from this study are valuable and will inform international treatment guidelines for Lentigo Maligna.