Abstract
BackgroundNivolumab, an anti-programmed death 1 (PD-1) monoclonal antibody, has shown survival benefit in clinical trials of various malignant tumors. Nivolumab-induced pneumonitis is major immune-related adverse event (irAE) that is occasionally serious and life-threatening. The aim of this study was to examine the association between pre-existing interstitial lung disease (ILD) on chest computed tomography (CT) and nivolumab-induced pneumonitis among different types of solid tumors.MethodsWe retrospectively collected the clinical data of 311 patients who were diagnosed with non-small cell lung cancer (NSCLC), head and neck cancer (HNC), or gastric cancer (GC), and treated with nivolumab monotherapy. Patients who underwent chest CT immediately before starting nivolumab without previous thoracic radiotherapy or other immune checkpoint inhibitors were eligible. We collected baseline patient characteristics and assessed pre-existing ILD on baseline chest CT.ResultsFinally, 188 patients were included in the analysis: 96 patients with NSCLC, 43 patients with HNC, and 49 patients with GC. NSCLC patients had a significantly higher rate of pre-existing ILD compared with HNC/GC patients (P = 0.047). Nivolumab-induced pneumonitis occurred in 11.7% (22 of 188), including 14.6% (14 of 96) of NSCLC, and 8.7% (8 of 92) of HNC/GC. Univariate and multivariate logistic regression analyses revealed that pre-existing ILD (odds ratio, 5.92; 95% confidence interval (CI), 2.07–18.54, P = 0.0008) and male sex (odds ratio, 5.58; 95% CI, 1.01–104.40, P = 0.049) significantly increased the risk of nivolumab-induced pneumonitis.ConclusionOur results indicated that pre-existing ILD and male sex are risk factors for nivolumab-induced pneumonitis in solid tumors.
Highlights
Nivolumab, an anti-programmed death 1 (PD-1) monoclonal antibody, has shown survival benefit in clinical trials of various malignant tumors
We recently reported that pre-existing interstitial lung diseases (ILD) is a risk factor for anti-PD-1-induced pneumonitis in patients with nonsmall-cell lung cancer (NSCLC); it is not clear if this tendency applies to other types of tumors [7]
There was no significant difference in the univariate analysis, the NSCLC group tended to have a higher incidence of pneumonitis (14.6%) compared with the head and neck cancer (HNC)/gastric cancer (GC) group (8.7%), which was related to the high trend of complicating preexisting ILD in the NSCLC group (P = 0.047)
Summary
An anti-programmed death 1 (PD-1) monoclonal antibody, has shown survival benefit in clinical trials of various malignant tumors. In the previous phase III clinical trials of nivolumab, the incidence of nivolumab-induced pneumonitis was reported as 3.5–5% in NSCLC, 2.1% in squamous cell HNC, and < 1% in GC, and it appears to vary among the different cancer types [2,3,4,5]. We speculated that these tumorspecific bias in the incidence of pneumonitis may be related to pre-existing ILD, regardless of the tumor type. Patients complicated with ILD are routinely excluded from clinical trials, these questions need to be resolved by real-world data
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