Of 640 patients treated with single-agent ICI, 90 (14%) had been administered corticosteroids at a 10 mg prednisone-equivalent daily dose or higher, and 107 had received corticosteroids at any dose at the time they started PD-1/PD-L1 blockade.1 A third (33%) of the patients had been prescribed steroids for dyspnea, approximately a fifth (21%) for fatigue, and 19% for brain metastases.1

In multivariate analysis for all patients from both centers, adjusting for smoking history, performance status, and brain metastasis, baseline corticosteroids remained statistically significantly associated with decreased PFS (hazard ratio [HR] 11.3; P = .03) and OS (HR 1.7; P < .001).

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Only patients who had taken single-agent PD-1/PD-L1-targeting ICI were included in the analyses. The study did not assess the effect of steroid therapy for patients receiving both immunotherapy and chemotherapy.1

Three patients from each cancer center experienced partial responses (PRs) to ICI despite also being prescribed baseline corticosteroids, the authors noted.1

“These patients received 10 mg to 20 mg of corticosteroids for palliative indications, such as fatigue, respiratory symptoms, and pain,” they reported.1 “There were no evident differences in the clinical features of patients who experienced responses; all responders had an Eastern Cooperative Oncology Group performance status of 1. Four of the 6 patients had continued response to therapy for more than 15 months, although the responses of 2 patients were more limited, including 1 patient whose response lasted only 2.4 months and was followed by rapid clinical deterioration and death as a result of progressive disease.”

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Non-small cell lung cancers (NSCLC) were long thought to be nonimmunogenic — but the discovery that they are in fact subject to tumor antigen immune surveillance and attack by a patient’s immune system once tumors are denied use of PD-1/PD-L1 immune checkpoint manipulation or other immune-evasion mechanisms — opened the door to the current era of immune-checkpoint blockade immunotherapies.3,4

Up to 14% of patients with NSCLC also have an autoimmune disease, but these patients (and patients on corticosteroid therapy for other reasons) were typically excluded from ICI clinical cancer trials, precisely because corticosteroids can be immunosuppressive.2,5,6 Indeed, corticosteroid therapy is a common tool in the management of immune-related adverse events (irAEs) among patients on ICI.

Since patients on corticosteroid therapy have been excluded from clinical trials of ICI agents, only “real-world” clinical data could address the effect of baseline steroids on patient outcomes, the authors noted.1