Real-World Data on Immune-Checkpoint Inhibitors in Elderly Patients with Advanced Non-Small Cell Lung Cancer: A...

Background/Objectives: Non-small cell lung cancer (NSCLC) accounts for approximately 85% of lung cancer cases, with an increasing incidence in patients over 65 years. Although immune-checkpoint inhibitors (ICIs) have transformed the treatment landscape, elderly patients remain underrepresented in pivotal clinical trials, highlighting the need for real-world evidence on their efficacy and tolerability in this population. Methods: We conducted a multicenter, retrospective study of advanced NSCLC patients treated with ICI alone or in combination with chemotherapy between April 2017 and December 2023. Patients were categorized into three age groups: ≤65 (younger group, YG), 66-79 (older group, OG), and ≥80 years (advanced older group, AOG). Efficacy and safety outcomes were compared across groups. Results: Among 452 patients, 221 (48.9%) were in the OG and 36 (8%) in the AOG. Median progression-free survival (PFS) was similar across groups: 8.3 months (YG), 8.4 months (OG; p = 0.872 vs. YG), and 10.5 months (AOG; p = 0.628 vs. YG). Median overall survival (OS) showed a non-significant trend favoring younger patients: 15.1 months (YG), 10.3 months (OG; p = 0.076 vs. YG), and 12.5 months (AOG; p = 0.070 vs. YG). Grade ≥ 3 immune-related adverse events (irAEs) occurred in 9.7% (YG), 5.9% (OG), and 8.3% (AOG). In patients ≥ 66 years, irAEs were associated with longer PFS (18.1 vs. 6 months; p < 0.001). Conclusions: ICIs demonstrated comparable PFS and OS across age groups, including patients aged ≥ 80 years. Chronological age did not increase irAE incidence. The development of irAEs may serve as a favorable prognostic factor in elderly patients.