The Impact Of Frailty On The Occurrence Of Immune-Related Adverse Events In Older Patients With Advanced Melanoma.

e24028 Background: Immune checkpoint inhibitors (ICIs) have changed the melanoma treatment landscape by inducing durable responses and significantly improving survival. ICI can cause immune-related adverse events (irAES) ranging from mild to life threatening. Clinical trials have not shown major increase of irAES in older patients when compared to younger patients. However, older patients have been underrepresented and were relatively fit in these trials. In this study, we assessed the occurrence of irAEs treated with systemic corticosteroids and/or leading to treatment discontinuation (relevant irAEs) in older patients with melanoma and, if relevant irAEs occurred more often in frail patients, as assessed with the Geriatric 8 (G8). Methods: Patients ≥70 years diagnosed with advanced melanoma, about to start with ICI, and screened with a G8, were enrolled in this prospective observational study. Patients were classified according to the G8 score as “fit” (G8 score >14) or “frail” (G8 score ≤14). Toxicity was scored according to CTCAE v4.03. Primary outcome was occurrence of relevant irAEs in “fit” and “frail” patients. Secondary outcomes were the occurrence of irAEs any grade and severe irAE (grade ≥3). Results: In total, 49 patients were included for statistical analyses. Thirty-three patients were classified fit according to the G8 and, 16 patients were frail. Relevant irAEs occurred statically significantly more often in in frail patients: 12 (75%) versus 15 patients (46%) ( p=0.05). In addition, more irAEs grade ≥3 were reported in frail patients, although not significant: 7 (44%) versus 8 patients (25%) ( p= 0.11). Conclusions: Frailty, classified by the G8, is associated with the occurrence of relevant irAEs in the older patient with advanced melanoma. These data need to be confirmed in larger series.