P1.04-51 Treatment with Immune Checkpoint Inhibitors for Advanced NSCLC in Elderly and Frail Patients. A Real-Life Experience

Abstract

Immune checkpoint inhibitors (ICIs) has changed the standard treatment in advanced stage non-small cell lung cancer (NSCLC). However, patients above 75 years and patients in performance status (PS) 2 are underrepresented in randomized clinical trials. Hence, the efficacy and safety of treatment in these large subgroups of patients remains unclear. We report a real-life study of such patients treated with immunotherapy in a second-line setting. Data from consecutive patients with advanced NSCLC who had 2nd line treatment with ICIs at the University Hospitals in Copenhagen during November 2015 to March 2019 were obtained from medical records. Treatment efficacy and safety was evaluated, and treatment related adverse events (AEs) were registered. A total of 224 NSCLC patients were treated with either nivolumab or pembrolizumab: The median follow up time of was 12.3 months. The median progression free survival (PFS) was 4.9 months, and median overall survival (OS) was 12.9 months CI [9.7-14.6]. The median age was 67.7 years, while 45 patients (20%) were 75 years or older. There were no significant difference when comparing patients ≥75 years vs. <75 years with respect to PFS (5.3 vs. 4.9 months, p = 0.81) nor in OS (14.2 vs. 12.8 months, p = 0.93). PFS and OS were correlated with PS: The PFS was 7.7, 4.7 and 2.0 months (p = 0.0003) in PS 0, PS 1 and PS 2, respectively. OS was 20.9, 12.0 and 3.0 months (p >0.0001) in PS0, PS1 and PS 2, respectively. AEs were reported in 183 patients (82%), among whom 44 patients (20%) experienced grade 3-5. There were no difference in AEs in younger patients compared to older ≥75 years (p = 0.18). The incidence of grade 3-5 AEs was significantly higher among patients in PS 2 (35%) compared to PS 0-1 (17%), (p <0.001). NSCLC patients ≥75 years had efficacy and safety profiles in second-line ICIs comparable to those of younger patients. However, treatment with ICIs in patients with PS 2 was associated with a significant lower PFS and OS. The high risk of seriously AEs in patients with PS 2 is of concern and warrants further investigation.