Laura Ridolfi1, Francesco De Rosa1, Elisabetta Petracci2, Enrica Teresa Tanda3, Elena Marra4, Jacopo Pigozzo5, Riccardo Marconcini6, Michele Guida7, Gian Carlo Antonini Cappellini8, Giulia Gallizzi9, Marcella Occelli10, Laura Pala11, Elisabetta Gambale12, Melissa Bersanelli13, Giovanna Galdo14, Alessio Cortellini15, Francesca Morgese16, Federica Zoratto17, Luigia Stefania Stucci18, Sabino Strippoli19, Massimo Guidoboni1. 1. Immunotherapy, Cell Therapy and Biobank, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy. 2. Unit of Biostatistics and Clinical Trials, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy. Electronic address: elisabetta.petracci@irst.emr.it. 3. Department of Medical Oncology, San Martino Polyclinic, Genoa, Italy. 4. Department of Medical Sciences, Dermatology Clinic, University of Turin, Turin, Italy. 5. Melanoma and Esophageal Oncology Unit, Veneto Institute of Oncology (IOV) IRCCS, Padua, Italy. 6. Medical Oncology Department, S. Chiara Hospital, University of Pisa, Pisa, Italy. 7. Medical Oncology Department, National Cancer Research Centre "Giovanni Paolo II", Bari, Italy. 8. Medical Oncology Unit, Istituto Dermopatico dell'Immacolata (IDI) IRCCS, Rome, Italy. 9. S.C. Oncology, SS. Antonio e Biagio General Hospital, Alessandria, Italy. 10. Medical Oncology Unit, S. Croce & Carle Teaching Hospital, Cuneo, Italy. 11. Division of Medical Oncology for Melanoma and Sarcoma, European Institute of Oncology (IEO), Milan, Italy. 12. Medical Oncology and Immunotherapy, Center for Immuno-Oncology, University Hospital of Siena and University of Siena, Siena, Italy. 13. Medical Oncology Unit, University Hospital of Parma and Department of Medicine and Surgery, University of Parma, Parma, Italy. 14. Unit of Medical Oncology, Department of Onco-Hematology, IRCCS-CROB Referral Cancer Center of Basilicata, Rionero in Vulture, Italy. 15. Department of Biotechnological and Applied Clinical Sciences, S. Salvatore Hospital, University of L'Aquila, L'Aquila, Italy. 16. Oncology Clinic, Università Politecnica delle Marche, Ancona, Italy. 17. Depatment of Oncology, Frosinone Hospital, Frosinone, Italy. 18. U.O. Medical Oncology, Oncology Clinic, University of Bari, Bari, Italy. 19. Medical Oncology Unit, Barletta Hospital, Barletta, Italy.
Abstract
BACKGROUND: Advanced age is associated with comorbidities and immune system impairment, which may influence the efficacy and tolerability of immune checkpoint inhibitors. There is evidence that anti-PD1 antibodies in advanced melanoma are equally effective in patients >65 years. However, data on patients >75 years are lacking as co-morbidities and logistics often exclude them from clinical trials. METHODS: We retrospectively reviewed the clinical records of older patients with advanced melanoma undergoing any-line treatment with an anti-PD1 (nivolumab/pembrolizumab) to investigate its clinical effectiveness and toxicity in a real-life setting. Clinical response was assessed using RECIST criteria and toxicity was evaluated according to CTCAE 4.0. Progression-free survival (PFS) and overall survival (OS) were estimated with the Kaplan-Meier method and the Cox model was used to assess potential prognostic factors. RESULTS: 174 patients were considered; 59.2% males, median age 79 years (range 75-93). The majority had a performance status of 0 and normal lactate dehydrogenase (LDH) levels (55.2% and 52.4%, respectively). 69.1% had multiple co-morbidities. 56.9% received nivolumab. 36.7% of cases showed an objective response and the disease control rate was 56.3%. Median OS was 17.2 months [95% CI: 8.87-not reached] and a better prognosis was observed for patients with normal LDH (p < .001) and lower performance status (p < .001). Treatment was well tolerated, only 11 patients experiencing severe (grade 3/4) toxicity. There were no treatment-related deaths. Adverse events were managed with corticosteroids and additional immunosuppressive agents were unnecessary. CONCLUSIONS: Anti-PD1 antibodies appear effective and well tolerated in older patients with advanced melanoma.
BACKGROUND: Advanced age is associated with comorbidities and immune system impairment, which may influence the efficacy and tolerability of immune checkpoint inhibitors. There is evidence that anti-PD1 antibodies in advanced melanoma are equally effective in patients >65 years. However, data on patients >75 years are lacking as co-morbidities and logistics often exclude them from clinical trials. METHODS: We retrospectively reviewed the clinical records of older patients with advanced melanoma undergoing any-line treatment with an anti-PD1 (nivolumab/pembrolizumab) to investigate its clinical effectiveness and toxicity in a real-life setting. Clinical response was assessed using RECIST criteria and toxicity was evaluated according to CTCAE 4.0. Progression-free survival (PFS) and overall survival (OS) were estimated with the Kaplan-Meier method and the Cox model was used to assess potential prognostic factors. RESULTS: 174 patients were considered; 59.2% males, median age 79 years (range 75-93). The majority had a performance status of 0 and normal lactate dehydrogenase (LDH) levels (55.2% and 52.4%, respectively). 69.1% had multiple co-morbidities. 56.9% received nivolumab. 36.7% of cases showed an objective response and the disease control rate was 56.3%. Median OS was 17.2 months [95% CI: 8.87-not reached] and a better prognosis was observed for patients with normal LDH (p < .001) and lower performance status (p < .001). Treatment was well tolerated, only 11 patients experiencing severe (grade 3/4) toxicity. There were no treatment-related deaths. Adverse events were managed with corticosteroids and additional immunosuppressive agents were unnecessary. CONCLUSIONS: Anti-PD1 antibodies appear effective and well tolerated in older patients with advanced melanoma.