Real-World Treatments and Clinical Outcomes in Advanced NSCLC without Actionable Mutations after Introduction of Immunotherapy in Japan

Simple Summary The aim of this study was to evaluate treatment patterns and real-world clinical outcomes since immunotherapy was introduced in Japan as the initial (first-line) therapy for treating patients with lung cancer, the leading cause of cancer-related deaths in Japan. For 1182 patients with advanced non-small-cell lung cancer, the survival rate at two years after starting first-line therapy was 40% with platinum doublet chemotherapy, 58% with immunotherapy, and 31% with nonplatinum regimens. The results of this large study enabled us to describe the characteristics of a real-world patient population, together with the treatment patterns for advanced non-small-cell lung cancer and clinical outcomes from real-world settings, where most patients receive treatment. Most first-line therapies were administered in accordance with contemporaneous national treatment guidelines, and the study findings indicate improvement in real-world clinical outcomes for patients with advanced non-small-cell lung cancer since the introduction of first-line immunotherapy. The aims of this study were to describe systemic treatment patterns and clinical outcomes for unresectable advanced/metastatic non-small-cell lung cancer (NSCLC) by first-line regimen type in real-world clinical settings in Japan after the introduction of first-line immune checkpoint inhibitor (ICI) monotherapy in 2017. Using retrospective chart review at 23 study sites, we identified patients >= 20 years old initiating first-line systemic therapy from 1 July 2017 to 20 December 2018, for unresectable stage IIIB/C or IV NSCLC; the data cutoff was 30 September 2019. Eligible patients had recorded programmed death-ligand 1 (PD-L1) tumor proportion score (TPS) and no known actionable EGFR/ALK/ROS1/BRAF genomic alteration. Kaplan-Meier method was used to determine time-to-event endpoints. Of 1208 patients, 647 patients (54%) received platinum doublet, 463 (38%) received ICI monotherapy, and 98 (8%) received nonplatinum cytotoxic regimen as first-line therapy. PD-L1 TPS was >= 50%, 1-49% and <1% for 44%, 30%, and 25% of patients, respectively. Most patients with PD-L1 TPS >= 50% received ICI monotherapy (453/529; 86%). Excluding 26 patients with ECOG performance status of 3-4 from outcome analyses, the median patient follow-up was 11.3 months. With first-line platinum doublet, ICI monotherapy, and nonplatinum cytotoxic regimens, median overall survival (OS) was 16.3 months (95% CI, 14.0-20.1 months), not reached, and 14.4 months (95% CI, 10.3-21.2 months), respectively; 24-month OS was 40%, 58%, and 31%, respectively. Differences in OS relative to historical cohort data reported in Japan are consistent with improvement over time in real-world clinical outcomes for advanced NSCLC.