Effectiveness and Safety of Immunotherapy in Advanced NSCLC with Pericardial Effusions: A Global Retrospective Multicenter Study

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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Journal
The Oncologist
Published
2026-07-25
DOI
https://doi.org/10.1093/oncolo/oyag277
Primary Topic
Cancer Immunotherapy and Biomarkers
Type
article
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article

Effectiveness and Safety of Immunotherapy in Advanced NSCLC with Pericardial Effusions: A Global Retrospective Multicenter Study

Elias Bou Farhat, Federica Pecci, Edoardo Garbo, Eddy Saad et al.
The Oncologist
Cancer Immunotherapy and Biomarkers
article

Effectiveness and Safety of Immunotherapy in Advanced NSCLC with Pericardial Effusions: A Global Retrospective Multicenter Study

Elias Bou Farhat, Federica Pecci, Edoardo Garbo, Eddy Saad, Walid Macaron, Shirly Grynberg, Biagio Ricciuti, Javier Baena-, James Korolewicz, Igor Stukalin, Vishal Navani, MT Li, Mercedes Herrera, Jennifer M. Kwan, Arjun Mittra, Karl Semaan, Frank Aboubakar Nana, Malak Hoballah, Amin H. Nassar, Simone Foderaro, Salim S. Hayek, Tomas G. Neilan, Abdul Rafeh Naqash, Francesco Paoloni, Chul Kim, Edward El-Am, Omar Chehab, Marc Eid, Smith Cd, Gao Y, Ronnie Shapira, Sagal Pannu, Pasi Janne, Aakash Desai, Nicholas Jones, Alexi Vasbinder, Dory Freeman, Joao A C Lima, Sarah Abou Alaiwi, Paul Sackstein, Toni K Choueiri, Eleonora Gariazzo, Talal El Zarif, Narjust Florez, Valentina Santo, Ryan A Denu, Daniel Meyers, Alessio Cortellini, Kaushal Parikh, Noha Abdel-wahab, David J Pinato, Mihaela Aldea
article en

Abstract

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.

The Oncologist
Marche Polytechnic University (IT), Università degli Studi del Piemonte Orientale “Amedeo Avogadro” (IT), Brigham and Women's Hospital (US), Cliniques Universitaires Saint-Luc (BE), Cleveland Clinic (US), The University of Texas MD Anderson Cancer Center (US), Johns Hopkins University (US), Università Campus Bio-Medico (IT), University of Calgary (CA), Georgetown University (US), Sheba Medical Center (IL), Cleveland Foundation (US), Johns Hopkins Medicine (US), Hammersmith Hospital (GB), Abu Dhabi Department of Education and Knowledge (AE), MedStar Georgetown University Hospital (US), University of Alabama at Birmingham (US), Yale University (US), Research Institute Hospital 12 de Octubre (ES), Massachusetts General Hospital (US), Victorian Comprehensive Cancer Centre (AU), Michigan Medicine (US), Dana-Farber Cancer Institute (US), Assiut University Hospitals (EG), Mayo Clinic in Arizona (US), Oklahoma State University Oklahoma City (US), Campus Bio Medico University Hospital (IT), The Ohio State University (US)
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Openalex Percentile: Top 11%
Cancer Immunotherapy and Biomarkers
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