Background and Importance Clinical trials show that recurrence-free survival (RFS) is significantly improved in melanoma patients treated adjuvantly with immune checkpoint inhibition (ICI) and targeted therapy (TT).The Stage of disease is an important factor in risk assessment of RFS and also influences theclinician’s decision.The adjuvant therapy in melanoma BRAF V600 mutated involves two treatment strategies: anti-PD-1 (nivolumab or pembrolizumab) and BRAF- MEK inhibitors (dabrafenib and trametinib).

Aim and Objectives Real World Data were collected from 01/08/2019 to 31/03/2021 in an Italian Oncological Hospital, in order to observe the time of RFS and toxicities.

Material and Methods 168 patients were included (11 stage IIIa,19 IIIB, 64 IIIC, 12 IIID, 5-V), of which 65 were women and 103 men (median age: 56). In particular, 76 patients received nivolumab (6 patients V600E mutated, 2 mut-NRAS, 3 mut-V600K), 28 pembrolizumab (1 pts mut-V600k and pK6001E, 1 pts mut-V600E) while 64 received TT.

Results Among the 64 pts treated with TT, 9 of them discontinued therapy, of which 5 for toxicity and 4 for progression disease (PD).In the nivolumab setting, 9 patients discontinued therapy, 6 because of toxicity (1undifferentiated arthritis) and 3 for PD. In the pembrolizumab setting only 1 patient discontinued for toxicity and 1 for PD. In 33 pts with recurrence, the median time from start of adjuvant treatment to 1st recurrence was18 months in TT (10), 14 months in nivolumab chort (19), 8 months in pembrolizumab chort (4). IIIC was the stage of disease that manifested the greatest risk of recurrence both among the cohort of patients treated with TT and in ICI. However, the number of patients going into PD was greater among those treated with ICI. Duration of therapy was the highest in pts treated with Nivolumab.

Conclusion and Relevance Based on our findings, TT and ICI therapies are comparable to pivotal studies in terms of duration, safety, and reasons for treatment discontinuation. In patient mut-BRAF, TT seems to show a better RFS when compared to ICI. However this could be due to the different stages of disease; stage IV (visceral involvement) is eligible only for ICI therapy and this can lead to a worse prognosis.

Conflict of Interest No conflict of interest