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Late Immune-Related Adverse Events After At Least Two Years of Immune Checkpoint Inhibitor Therapy: Incidence and
Omar Elghawy1, Adam Barsouk1, Jonathan H Sussman1
1Division of Hematology and Oncology, Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.
Background:
Limited data are available on late immune-related adverse events (IRAEs) in patients with metastatic NSCLC receiving immunotherapy (ICI) beyond 2 years.
Methods:
A single-institution retrospective analysis including patients who received longer than 2 years of ICI therapy for metastatic NSCLC between 2012 and 2023 was performed. Late IRAEs were defined as those occurring longer than 2 years after initiation of ICI therapy. The association of late IRAE with OS and PFS was assessed using an extended Cox regression with late IRAE modeled as a time-varying covariate.
Results:
In a cohort of 76 patients who received longer than 2 years of ICI, the median duration of treatment was 41.9 months, and 44 out of 76 (58%) experienced an early IRAE before 2 years. After 2 years on ICI, 38 out of 76 (50%) of patients experienced a late IRAE, many of whom (39%) had no previous early IRAE. Higher rates of late IRAEs were seen in females (p = 0.032), White patients (p = 0.041), and patients with previous grade 2 or higher IRAE (p = 0.020). Late IRAE occurrence was not associated with median progression-free survival or median overall survival.
Conclusions:
In patients receiving extended-duration ICI beyond 2 years, late IRAEs were common and often occurred in patients without previous history of IRAE. These findings support consideration of ICI discontinuation at 2 years.
Insights
Late immune-related adverse events (IRAEs) are common in metastatic non-small cell lung cancer (NSCLC) patients receiving over two years of immunotherapy (ICI). These events often occur without prior IRAEs, suggesting a potential benefit from discontinuing ICI at two years.
Area of Science:
- Oncology
- Immunotherapy
- Clinical Research
Background:
- Limited data exist on late immune-related adverse events (IRAEs) in metastatic non-small cell lung cancer (NSCLC) patients undergoing prolonged immunotherapy (ICI) treatment.
- Understanding these late-onset IRAEs is crucial for optimizing long-term cancer care.
Purpose of the Study:
- To investigate the incidence and characteristics of late IRAEs in patients with metastatic NSCLC receiving ICI for over two years.
- To assess the association between late IRAEs and patient outcomes, including overall survival (OS) and progression-free survival (PFS).
Main Methods:
- Retrospective analysis of 76 metastatic NSCLC patients treated with ICI for over two years (2012-2023).
- Late IRAEs defined as events occurring >2 years after ICI initiation.
- Extended Cox regression used to model the association of late IRAEs with OS and PFS.
Main Results:
- 50% of patients experienced late IRAEs after two years of ICI, with 39% having no prior IRAE history.
- Higher rates of late IRAEs were observed in females and White patients.
- Late IRAE occurrence was not significantly associated with improved OS or PFS.
Conclusions:
- Late IRAEs are frequent in patients receiving extended immunotherapy beyond two years for metastatic NSCLC.
- A significant proportion of late IRAEs occur in patients without a history of early IRAEs.
- These findings suggest that discontinuing ICI therapy at the two-year mark may warrant consideration.
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