Immunotherapy, Cell Therapy and Biobank, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola (FC), Italy
Francesco De Rosa , Laura Ridolfi , Enrica Teresa Tanda , Elena Marra , Jacopo Pigozzo , Riccardo Marconcini , Michele Guida , Giulia Gallizzi , Marcella Occelli , Laura Pala , Elisabetta Gambale , Melissa Bersanelli , Raffaele Conca , Alessio Cortellini , Francesca Morgese , Federica Zoratto , Luigia Stefania Stucci , Sabino Strippoli , Elisabetta Petracci , Massimo Guidoboni
Background: advanced age is associated with comorbidities and impairment of the immune system: these aspects may influence efficacy and tolerability of immune checkpoint inhibitors. Limited data suggest that anti-PD1 antibodies in advanced melanoma are equally effective in patients (pts) aged over 65 years; however, the information on late elderly pts ( > 75 years) is still lacking, as comorbidities and logistic reasons often exclude them from clinical trials. Methods: we retrospectively reviewed clinical records of late elderly advanced melanoma pts treated in any line with an anti-PD1 agent (nivolumab or pembrolizumab) at our institutions to investigate efficacy and toxicity in a real practice setting. Clinical response was assessed according to RECIST criteria; toxicity was assessed according to CTCAE 4.0. Survival was estimated according to Kaplan-Meier method. Results: we identified 161 pts fulfilling inclusion criteria (68 M, 93 F). Median age was 79 (range 75-93); 110 pts (68%) had multiple comorbidities including history of other cancers (25 pts) and autoimmune/inflammatory disorders (13 pts). Eighty-eight pts received nivolumab, 73 pembrolizumab; basal LDH was elevated in 76 pts (47.2%). Fourteen pts (8.7%) obtained a complete response and 44 (27.3%) a partial response; additional 30 patients (18.6%) obtained a stable disease. Median overall survival was 8.71 months; normal LDH was significantly associated with better prognosis (14.45 vs 6.08 months; P = 0.016). Fifty-five pts have died; 48 of them because of progressive disease and the others for comorbidities. In our series treatment was well tolerated: only 5 pts had severe (G3-4) toxicity and no treatment-related death was reported. Adverse events were managed with corticosteroids and no pt needed additional immunosuppressive agents. Conclusions: anti-PD1 antibodies seem equally effective and well tolerated even in late elderly advanced melanoma pts, whose access to treatment should not be restricted solely because of advanced age.
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