Efficacy of nivolumab in patients treated by corticosteroid due to immune-related adverse events.

Abstract

163 Background: Nivolumab is a standard treatment for metastatic or refractory non-small cell lung cancer (NSCLC). Because immune-related adverse events (irAEs) are common and can be severe, a number of these patients require systemic corticosteroids. irAEs are reportedly associated with improved survival in melanoma patients treated with nivolumab. To date, little information is available regarding the effect of corticosteroid on the efficacy of nivolumab in terms of progression-free survival (PFS) and overall survival (OS). Methods: We reviewed consecutive patients who received nivolumab for metastatic or refractory NSCLC between December 2015 and August 2017. Nivolumab was administered at the standard dose of 3 mg/kg every two weeks. We recorded the patient demographics, efficacy and safety of nivolumab, previous and subsequent treatments, information about irAEs, corticosteroid usage, and survival. PFS and OS were calculated from the start of nivolumab treatment. A Cox proportional hazards regression model was applied using variables with the potential to influence the PFS: sex, age, performance status (PS), smoking history, driver gene alterations, histology, line of nivolumab treatment, and irAEs. Results: A total of 184 patients received nivolumab. Among them, 117 (64%) were male, the median age was 64 years (range, 34-83 years), 23 (13%) had a PS of 2 or more, 125 (68%) were ex-smokers, 37 (20%) had squamous NSCLC, and 37 (20%) had some kind of driver gene alteration, mainly EGFR mutation. Fifty patients (27%) experienced some grade of irAEs, and 37 (20%) patients required corticosteroid treatment. A multivariate analysis identified the occurrence of irAEs (hazard ratio [HR], 0.55; 95% confidence interval [CI] 0.33-0.91) and smoking (HR, 0.60;95% CI, 0.36-0.99) as independent predictors of a favorable PFS. There were no apparent differences in the proportions of patients who survived with or without the use of corticosteroid for irAEs: 73% vs. 71% at 6 months and 46% vs. 45% at 18 months. Conclusions: The occurrence of irAEs was positively associated with the PFS, and corticosteroid treatment did not have an adverse effect on OS in patients with NSCLC who were treated with nivolumab.