ANZMTG 02.12: A Phase III Trial of Imiquimod Topical Treatment Versus Radiotherapy (#337)
Question: Currently Radiotherapy is recommended and Imiquimod is used as alternate treatments for Lentigo Maligna (LM) when staged surgical excision with 5mm 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 investigators and the Australia and New Zealand Melanoma Trials Group (ANZMTG) have developed the protocol that has been designed to compare the rate of LM treatment failure following treatment with topical imiquimod 5% cream or radiotherapy as in patients who are unable to undergo surgery, refuse surgery or have failed surgery (incomplete excision or excision margins less than 1mm).The trial will utilise reflectance confocal microscopy to detect and exclude invasive melanoma and map the area to treat. Confocal microscopy will be used to detect treatment failure to minimise the need for biopsy and enable earlier identification of progression. The primary endpoint is treatment failure at months 12 and is defined as the presence of LM cells confirmed by histopathology. Secondary objectives include: proportion of patients experiencing LM treatment failure (at Months 6 and 24), patient reported outcomes, cosmetic outcome and difference in the cumulative incidence of invasive melanoma within the treatment field. A feasibility study is planned to commence in 2014 to recruit 80 participants.
Results: The protocol will be presented including inclusion and exclusion criteria as well as the results of the 2013 Feasibility Evaluation and funding application results. Timeline for study activation at multiple sites will be discussed.
Conclusion: 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.
Keywords: Lentigo Maligna, Lentigo Maligna Melanoma, Radiotherapy, Imiquimod, localised therapies, confocal microscopy, clinical trials.