Key result
Pre-existing pericardial effusion is not linked to increased irAE risk during ICI therapy for NSCLC.
Why the study?
Data are limited on immune checkpoint inhibitor use in patients with non-small cell lung cancer and known pericardial effusions.
Does pre-existing pericardial effusion increase immune-related adverse events or worsen survival in patients with advanced NSCLC receiving immune checkpoint inhibitors?
Cohort (n=1,248)
Yes
Does pre-existing pericardial effusion increase immune-related adverse events or worsen survival in patients with advanced NSCLC receiving immune checkpoint inhibitors?
Absolute Event Rate: 42% vs 38%
Pre-existing pericardial effusions do not preclude the use of immune checkpoint inhibitors in advanced NSCLC, as they do not increase the risk of immune-related adverse events or worsen survival.
May support ICI continuation despite pre-existing pericardial effusions in advanced NSCLC; leaves open prospective confirmation.
Background There is limited data on immune checkpoint inhibitor (ICI) use in patients with non-small cell lung cancer (NSCLC) and known pericardial effusions. Methods This international multi-center observational retrospective study included patients with advanced NSCLC with or without pericardial effusions receiving ICIs. Immune-related adverse events (irAEs) were graded per CTCAE v5.0. Overall survival (OS) and progression-free survival (PFS) were estimated by the Kaplan-Meier method. Cox proportional hazards multivariable models assessed the association between survival outcomes and clinicopathologic variables, and an inverse probability of treatment weighting (IPTW) model compared outcomes between the two groups. Results A total of 1,248 patients with advanced NSCLC treated with ICIs across 13 institutions were included. Of these, 85 patients (6.8%) had pre-existing pericardial effusions. Compared to controls, patients with pericardial effusions were younger (median age 63 vs. 67 years, p=0.007), diagnosed more frequently with PD-L1 positive tumors (96% vs. 76%, p<0.001), and had a higher median number of baseline metastatic sites (3 vs. 1, p<0.001). IrAEs were similar between both groups (42% vs. 38%), and no cardiac irAEs occurred in patients with pericardial effusions. PFS (median 5.6 vs. 4.6 months, p=0.3) and OS (median 10.2 vs. 14.7 months, p=0.50) were not statistically different between patients with pericardial effusions and the controls, respectively. In both multivariable and IPTW models, pericardial effusions were not associated with PFS or OS. Conclusions Among patients with NSCLC and pre-existing pericardial effusions, ICIs demonstrate meaningful clinical benefit similar to those without effusions, with no new cardiac or severe toxicities.
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Zarif et al. (2026) conducted a cohort in Advanced non-small cell lung cancer (NSCLC) (n=1,248). Pre-existing pericardial effusions vs. No pericardial effusion was evaluated on Safety of ICI therapy, defined by the number of immune-related adverse events (irAEs) of any grade. In patients with advanced NSCLC receiving immune checkpoint inhibitors, pre-existing pericardial effusions were not associated with an increased risk of immune-related adverse events (42% vs 38%) compared to those without effusions.
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