Observational studyThe oncologist2026
Incidence of and risk factors for immune checkpoint inhibitor-related pneumonitis in thoracic malignancies: a prospective multicenter study.
Observational study in The oncologist, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundImmune checkpoint inhibitors (ICIs) have fundamentally changed cancer treatment, but ICI-related pneumonitis (ICI-P) remains a major clinical concern. Although numerous studies have reported its incidence and risk factors, the retrospective nature of these studies makes accurate assessment difficult in a real-world clinical setting. PATIENTS AND
methodsThis prospective multicenter observational study enrolled patients with advanced or recurrent thoracic malignancies treated with nivolumab, pembrolizumab, or atezolizumab. Thoracic high-resolution computed tomography (HRCT) examinations were performed at the start of ICI therapy and at the onset of ICI-P. The primary endpoint was ICI-P incidence. The secondary endpoints included evaluation of risk factors, with a focus on the lung lesions present at ICI initiation. Fine-Gray analyses with 3 models were used to identify risk factors.
resultsAmong 614 eligible patients, 78 (12.7%) developed ICI-P. During a median observation period of 14.4 months, 29 patients developed grade ≥3 pneumonitis and 7 patients died owing to ICI-P. In the multivariable Fine-Gray analyses, independent risk factors for ICI-P included heavy smoking history (>50 pack-years; subdistribution hazard ratio [SHR], 1.90; 95% confidence interval [CI], 1.17-3.10), baseline interstitial lung abnormalities (ILAs; SHR, 3.42; 95% CI, 2.05-5.71), use of PD-1 inhibitors (SHR, 2.15; 95% CI, 1.28-3.63), and immunochemotherapy (SHR, 2.16; 95% CI, 1.17-3.98).
conclusionIn this prospective real-world cohort, the incidence of ICI-P was relatively high, and ILAs detected by HRCT, heavy smoking history, and treatment with a PD-1 inhibitor alone or in combination with cytotoxic chemotherapy were identified as independent risk factors.
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