Abstract
Objectives: Programmed death-1(PD-1)/programmed death ligand-1 (PD-L1) antibodies have clinical benefits for cancer patients facing immune-related adverse events (irAEs). However, the effect of steroid use on the prognosis of patients with non-small cell lung cancer (NSCLC) receiving PD-1 blockade remains unclear. Methods: NSCLC patients with complete response (CR)/partial response (PR) or stable disease (SD)/not evaluable (NE) status plus progression-free survival (PFS) of 180 days after PD-1 blockade from December 2015 to December 2018 were retrospectively registered in our study and were divided into two groups: those with and without systemic steroid use for irAEs. Results: In total, 126 patients who had benefitted from PD-1 blockade were enrolled in our study; among them, 44 received systemic steroids for irAEs, and 82 had no adverse events or, if they did, did not receive systemic steroids. Among the 44 patients requiring steroids, interstitial lung disease (ILD), adrenal insufficiency, diarrhea, and liver dysfunction were observed in 19, 9, 4, and 4 patients, respectively. More side effects were observed in the group treated by steroids. The median PFS and overall survival (OS) in patients with and without systemic steroid use were 11.7 and 16.0 months (p < 0.037) and 35.0 and 41.0 months (p < 0.28), respectively. In univariate and multivariate analyses of survival, systemic steroid treatment for irAEs was significantly associated with PFS. The occurrence of ILD, adrenal insufficiency, and fever was significant in patients who used systemic steroids for irAEs. Conclusions: Patients administered systemic steroids for irAEs due to PD-1 blockade treatment exhibited shorter PFS than those who were not. Systemic steroids might affect survival after PD-1 blockade even for patients who once acquired its clinical benefit.
Highlights
Immune checkpoint inhibitors (ICIs), such as programmed death-1(PD-1)/programmed death ligand-1 (PD-L1) antibodies, have been recognized as standard care for patients with advanced non-small cell carcinoma (NSCLC)
Our present study emphasized the clinical differences between patients with and without systemic steroid use for immunerelated adverse events (irAEs) who gained clinical benefit from ICI treatment
We found that systemic steroid use for irAEs affected the prognosis of patients who benefitted from treatment with progressive disease (PD)-1 blockade
Summary
Immune checkpoint inhibitors (ICIs), such as programmed death-1(PD-1)/programmed death ligand-1 (PD-L1) antibodies, have been recognized as standard care for patients with advanced non-small cell carcinoma (NSCLC). Immunerelated adverse events (irAEs) frequently occur in patients who exhibit a therapeutic response to ICI treatment [5]. Steroids and immunosuppressive agents have been identified as the most important countermeasures for treating irAEs. In particular, careful attention to the management of irAEs should be indispensable in patients with lung cancer, melanoma, and renal cancer during combined treatment with ICIs, such as PD-1 blockade and cytotoxic. It has been shown that glucocorticoid exposure decreases the transcription of pro-inflammatory cytokine genes, such as tumor necrosis factor-α, interleukin (IL)-1β, and IL-6, in human mononuclear cells [9]. The appropriate dosage of steroids for irAE management remain unclear
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