Background and Importance Background and importance: Melanoma is a malignant tumour that originates from melanocytes of the skin and mucous membranes or rarely from melanocytes located in extracutaneous sites. In 2020 in Europe, approximately 50.972 females and 55.397 males are diagnosed with melanoma, and 9.457 males and 7.031 females died because of it. 45–50% of melanomas have a mutation in the BRAF gene and the most frequent is V600E.Oncogenic mutations of BRAF lead to constitutive activation of the RAS/RAF/MEK/ERK pathway. Target therapies are the most appropriate to obtain an effective therapeutic action.

Aim and Objectives We analysed the 2 most prescribed oral associated therapies in our centre for the treatment of mutated BRAF metastatic melanoma with the aim of identifying which is the most tolerated and highlighting the types of toxicity that emerged from real life data bases.

Material and Methods The data were extrapolated from our prescription software and from the electronic medical records of the investigated patients.

Results In the period 2019–2022 we considered 36 patients treated with Dabrafenib 75 mg + Trametinib 2 mg or Encorafenib 75 mg + Binimetinib 15 mg, 50% treated with both therapies. 33 patients started the combination therapy of Dabrafenib + Trametinib and of these only 7 (20%) did not show any severe toxicity leading to discontinuation of treatment. The most frequent toxicity was pyrexia (40%), followed by skin toxicity (25%), gastrointestinal toxicity (12.5%), asthenia (8%). Patients who discontinued treatment for progression disease were 9 (28%). Owing to unacceptable toxicity, 14 patients (43%) switched to Encorafenib + Binimetinib: only 2 of these patients showed toxicity (G1-G3 asthenia, G2 nausea) upon discontinuing treatment. 3 patients of analysed population started therapy with Encorafenib + Binimetinib as first-line treatment, without toxicity to discontinue therapy.

Conclusion and Relevance These data point out that the first choice is a combination therapy Dabrafenib + Trametinib associated with better patient compliance, thanks to more easily manageable number of tablets to take daily. However, the toxicity appears to be higher. For this reason, the therapy with a lower compliance is actually the best tolerated and prolonged therapy with fewer suspensions, ensuring better continuity of care and therapeutic efficacy.

References and/or Acknowledgements 1. (https://ecis.jrc.ec.europa.eu/pdf/factsheets/Melanoma_cancer_en.pdf)

2. https://www.aiom.it/linee-guida-aiom/

Conflict of Interest No conflict of interest.