Impact of performance status on survival outcomes and health care utilization in patients with advanced non–small cell lung cancer treated with immune checkpoint inhibitors.
Authors: Meyers Daniel E. , Pasternak Meghann , Dolter Samantha , Grosjean Heidi A.I. , Lim Chloe , Stukalin Igor , Navani Vishal , Heng Daniel Yick Chin , Cheung Winson Y. , Morris Don G. , Pabani Aliyah 
Published: June 2022

9053 Background: Immune checkpoint inhibitors (ICIs) have revolutionized the treatment paradigm of non-small cell lung cancer (NSCLC). Despite the high prevalence of patients with poor Eastern Cooperative Oncology Group (ECOG) performance status (PS ≥2) in real-world practice, landmark studies have typically excluded this patient group from enrolment. The primary objective of this study was to evaluate the impact of ECOG PS on clinical outcomes and health care utilization in a large cohort of NSCLC patients treated with ICI in real-world practice. Methods: Using the Alberta Immunotherapy Database, we identified consecutive patients who received at least one dose of Pembrolizumab or Nivolumab for the treatment of advanced NSCLC between 1/1/2010 and 12/30/2019. The data cut-off date was 10/1/2020. Baseline clinical, pathological, and laboratory-based data were collected retrospectively. The primary outcome was median overall survival (mOS), as stratified by ECOG PS. The secondary outcomes were median time-to-treatment failure (mTTF) and metrics of health care utilization, including emergency department (ED) visits, hospitalizations, and death in hospital. Kaplan-Meier survival curves were used to determine survival outcomes, and compared with the log-rank test. The association between ECOG PS and healthcare utilization were represented with risk ratios and evaluated using chi-square tests. Results: A total of 790 patients were included. Median follow-up time was 20.6 months. 29.2% (n = 231) had PS ≥2 at the time of ICI initiation. As compared with the favorable PS group (PS < 2), patients with PS ≥2 had significantly lower mOS - 3.3 months (95% CI 2.5-4.0) versus 13.4 months (95% CI 11.7-16.0) (HR, 3.0; 95% CI 2.5-3.6, p < 0.0001), and mTTF – 1.4 months (95% CI 0.9-1.8) versus 4.9 months (95% CI 4.4-5.6) (HR, 2.2; 95% CI 1.9-2.6, p < 0.0001). 3- and 12-month survival rates were also significantly lower in the PS ≥2 group as compared with the PS < 2 group (52.8% versus 86.4% and 13.4% versus 41.0%, p < 0.0001 for both comparisons). Patients with PS ≥2 were also significantly more likely to present to the ED (RR 1.6; 95% CI, 1.3-2.0, p < 0.001) and be admitted to hospital (RR 2.3; 95% CI 1.7-3.0, p < 0.0001) within the first month after treatment initiation. These patients were also significantly more likely to die in hospital during their first admission (RR 2.7; 95% CI 1.8-4.1, p < 0.0001), as well as at any point during treatment (RR 2.2; 95% CI 1.60-3.0, p < 0.0001). Conclusions: NSCLC patients with poor ECOG PS at the time of ICI initiation had significantly worse survival outcomes and were significantly more likely to utilize health care services than those with favorable ECOG PS. The large proportion of patients with poor ECOG PS further justifies the urgent need for randomized trials evaluating the efficacy of ICI in this high-risk population.