Abstract
Background: Immune-related adverse events (irAEs) have been associated with improved efficacy in advanced non-small cell lung cancer (NSCLC) patients receiving anti-PD-(L)1 blockade agents, while the concurrent use of corticosteroids seems to worsen it. We evaluated outcomes in advanced NSCLC patients treated with anti-PD-(L)1 blockade agents in relation to the presence of irAEs and the reasons for using corticosteroids: whether for palliative cancer-related reasons or for the management of irAEs.Methods: Clinical outcomes in advanced NSCLC patients treated with anti-PD-(L)1 blockade agents were calculated with regard to the presence of irAEs and the use of corticosteroids. A landmark analysis was performed to avoid immortal time bias due to the time-dependent nature of irAEs.Results: Out of a total of 267 patients, the 56.9% of patients who experienced irAEs had significantly improved outcomes. In the landmark analysis, median progression-free survival (PFS) was 12.4 months for patients with irAEs vs. 4.1 months for patients without irAEs (p < 0.001), while median overall survival (OS) was 28.2 vs. 12.5 months, respectively (p < 0.001). Likewise, objective response and disease control rates were significantly higher in patients experiencing irAEs: 48.6 vs. 22.8% and 77.1 vs. 39.6% (p < 0.001), respectively. Median OS was significantly shorter for patients receiving ≥10 mg of prednisone equivalent daily for cancer-related symptoms than for the rest of patients (<10 mg prednisone equivalent daily or for management of irAEs): 6 vs. 15.9 months (p < 0.001).Conclusions: IrAEs were associated with improved efficacy in advanced NSCLC patients when a landmark analysis was applied. Patients receiving corticosteroids had significantly poorer outcomes when they were used for cancer-related symptoms.
Highlights
Immunotherapy has become established as a new standardof-care for multiple solid malignancies, including non-small cell lung cancer (NSCLC)
Examples of these agents are nivolumab and pembrolizumab, monoclonal antibodies against the programmed cell death-1 receptor (PD-1) and atezolizumab, durvalumab, and avelumab, against its ligand PD-L1
Most of these agents have been approved in different settings for the treatment of patients with NSCLC [3,4,5,6,7,8], which has led the scientific community to advance by exploring combinations of anti-PD-(L)1 blockade agents with chemotherapy and/or other immune-checkpoint blockade to achieve better results [9,10,11]
Summary
Immunotherapy has become established as a new standardof-care for multiple solid malignancies, including non-small cell lung cancer (NSCLC). Immunecheckpoint blockade agents targeting the inhibitory pathways of the immune cascade have resulted in an increase in the response against tumor cells [1, 2] Examples of these agents are nivolumab and pembrolizumab, monoclonal antibodies against the programmed cell death-1 receptor (PD-1) and atezolizumab, durvalumab, and avelumab, against its ligand PD-L1. Most of these agents have been approved in different settings for the treatment of patients with NSCLC [3,4,5,6,7,8], which has led the scientific community to advance by exploring combinations of anti-PD-(L) blockade agents with chemotherapy and/or other immune-checkpoint blockade to achieve better results [9,10,11]. We evaluated outcomes in advanced NSCLC patients treated with anti-PD-(L) blockade agents in relation to the presence of irAEs and the reasons for using corticosteroids: whether for palliative cancer-related reasons or for the management of irAEs
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