Outcomes of patients with non-small cell lung cancer and poor performance status treated with immune checkpoint inhibitors in the real-world setting

Background Immune-checkpoint inhibitors (ICIs) are standard treatments for metastatic non-small cell lung cancer (NSCLC). Patients with poor performance status (PS) are underrepresented in clinical trials. We evaluate the efficacy and safety of ICIs in a real-world setting. Methods We conducted a multi-institutional retrospective study to assess clinical outcomes of NSCLC treated with ICIs. We categorized pts within two groups (PS 0–1 vs 2) and assessed clinical outcomes and safety. Results Two hundred and sixty nine patients were included, 44 patients (16.4%) had baseline PS 2 and 223 patients (82.9%) PS 0–1. The overall response rate (ORR) was 30.4%, median PFS was 7.26 months (95% CI 5.1–9.4), and median OS was 15.18 months (95% CI 9.5–20.9). Patients with a PS 2 were most likely to received ICIs in the second or later line (84.1% vs 64.6%; p = 0.01), had baseline steroids (21.4% vs 8.2%; p 0.010), lower response rate (16.7% vs 34.5%; p 0.02) and clinical benefit (35.7% vs 71%; p 0.000) compared to PS 0–1 pts. Moreover, PS ≥ 2 patients had shorter PFS, median 2.2 months (95% CI 1.3–3.1) compared to 9.9 months (95% CI 6.7–13.1] and shorter OS, 3.3 months (95% CI 2.6–4.2) versus 24.1 months (95% CI 16.1–32.1), respectively. PS was significantly associated with PFS and OS in multivariate analysis. As it was expected, immunotherapy was well tolerated with a safety profile comparable to the previous published data. Conclusion Based on these retrospective results, patients with poor baseline performance status seem to have poor clinical outcomes with ICIs in the real-world setting.