Background Immune checkpoint inhibitors (ICI) have advanced the therapeutic landscape of advanced cancers. However, older adults, who constitute a growing proportion of cancer patients, have been underrepresented in clinical trials that led to ICI approvals. This exclusion created a knowledge gap regarding the safety and efficacy of ICI in older adults, leading to reluctance among clinicians to prescribe these therapies. In this study, we aim to investigate the safety profile of ICI in older adults with various types of cancer.
Methods We conducted a retrospective analysis of electronic health records from TriNetX Research Network (TriNetX LLC., Cambridge, Massachusetts, USA) to identify patients aged 75 years and older with a diagnosis of lung, renal cell carcinoma (RCC), bladder, or melanoma, who received ICI treatment. These included Anti-PD-1 (Cemiplimab, Nivolumab, or Pembrolizumab), Anti-PDL-1 (Atezolizumab, Avelumab, or Durvalumab) or anti-PD-1 and CTLA-4 (Nivolumab+Ipilimumab) combination. We recorded immune related adverse events (irAE) during the first year following ICI treatment, as irAE are rare after this period. The International Classification of Disease 10 Clinical Modification (ICD-10-CM) codes R21 and L80 were used to identify skin toxicities; while E03.2, E03.8, E03.9, and E05 were used to identify thyroid dysfunction; K52.3, K52.8, and K52.9 were used to identify colitis; J70.2, J70.3, J70.4, J70.8, J84.11, and J84.9 were used to identify pneumonitis; K71, K75.4, and K75.9 were used to identify hepatitis. Patients with reported irAE before ICI were excluded.
Results A total of 19177 patients were included in the analysis with lung cancer (n=10237) being the most common diagnosis, followed by melanoma (n=6745), RCC (n=2801), and bladder cancer (n=2685). A total of 4934 irAE were recorded in all ICI arms, with thyroid dysfunction (n=2012) being the most common, followed by skin toxicities (n=1577) as seen (table 1).
Conclusions Our study demonstrates that elderly patients with cancer who receive ICI treatment are not at increased risk of irAE compared to younger patients. These findings suggest that age alone should not preclude older adults from receiving ICI therapy, and that these treatments can be safely and effectively used in older adults.
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