Immune checkpoint inhibitors (ICIs) have advanced the treatment of patients with non–small-cell lung cancer (NSCLC). However, pivotal clinical trials have excluded patients with poor Eastern Cooperative Oncology Group (ECOG) performance status (PS ≥2) despite their prevalence in the real-world setting.1 The main objective of this study was to evaluate the impact of ECOG PS on clinical outcomes and healthcare utilization in a large cohort of patients with NSCLC treated with ICIs in a real-world setting.
The study used the Alberta Immunotherapy Database to identify patients with advanced NSCLC who received ≥1 doses of pembrolizumab or nivolumab between January 1, 2010, and December 30, 2019. The data cutoff was October 1, 2020. In addition, baseline clinical, pathologic, and laboratory-based data were collected retrospectively.
The primary outcome of the study was median overall survival stratified by ECOG PS, and the secondary outcomes were median time-to-treatment failure (mTTF) and healthcare utilization measures, including emergency department visits, hospitalizations, and death in hospital. Kaplan-Meier survival curves were used to assess survival outcomes and compared with the log-rank test. In addition, the association between ECOG PS and healthcare utilization was represented with risk ratios and evaluated using chi-square tests.
The study included 790 patients with a median follow-up time of 20.6 months. Of these patients, 29.2% (n = 231) had PS ≥2 at the time of ICI initiation. Patients with PS ≥2 had significantly lower median overall survival (3.3 months; 95% confidence interval [CI], 2.5-4.0) than those with favorable PS (PS <2) (13.4 months; 95% CI, 11.7-16.0) (hazard ratio [HR], 3.0; 95% CI, 2.5-3.6; P <.0001), and lower mTTF of 1.4 months (95% CI, 0.9-1.8) compared with 4.9 months (95% CI, 4.4-5.6) (HR, 2.2; 95% CI, 1.9-2.6; P <.0001). In addition, the 3- and 12-month survival rates were also significantly lower in the PS ≥2 group than in the PS <2 group (52.8% vs 86.4% and 13.4% vs 41.0%; P <.0001 for both comparisons).
In addition, patients with PS ≥2 were significantly more likely to utilize the emergency department (relative risk [RR], 1.6; 95% CI, 1.3-2.0; P <.001) and be admitted to the hospital (RR, 2.3; 95% CI, 1.7-3.0; P <.0001) within the first month after treatment initiation. These patients were also significantly more likely to die in the hospital during their first admission (RR, 2.7; 95% CI, 1.8-4.1; P <.0001) and at any point during treatment (RR, 2.2; 95% CI, 1.6-3.0; P <.0001).
The researchers concluded that patients with NSCLC in the real-world setting who have poor ECOG PS at the time of ICI initiation had significantly worse survival outcomes and were significantly more likely to utilize healthcare services than those with favorable ECOG PS. These findings highlight the need for randomized trials to evaluate the efficacy of ICI in this high-risk population.
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