Anti-PD1 antibodies effective and well tolerated in older patients with advanced melanoma
January 16, 2020
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.
Source:
Laura Ridolfi, Francesco De Rosa, Elisabetta Petracci, Enrica Teresa Tanda, Elena Marra, Jacopo Pigozzo, Riccardo Marconcini, Michele Guida, Gian Carlo Antonini Cappellini, Giulia Gallizzi, Marcella Occelli, Laura Pala, Elisabetta Gambale, Melissa Bersanelli, Giovanna Galdo, Alessio Cortellini, Francesca Morgese, Federica Zoratto, Luigia Stefania Stucci, Sabino Strippoli, Massimo Guidoboni, Anti-PD1 antibodies in patients aged ≥ 75 years with metastatic melanoma: A retrospective multicentre study, Journal of Geriatric Oncology, 2020, ISSN 1879-4068,
https://doi.org/10.1016/j.jgo.2019.12.012.