[Translated article] Real-world evidence of immune-related adverse events as predictive factor of response in non-small cell lung cancer

OBJECTIVE: The aim of the study was to assess whether immune-related adverse events (irAE) act as predictive biomarkers of response to immune checkpoint inhibitors in non-small-cell lung cancer in real-life practice. METHODS: Retrospective observational study in a third-level hospital. INCLUSION CRITERIA: adult patients with locally advanced or metastatic non-small-cell lung cancer treated with nivolumab, pembrolizumab or atezolizumab following platinum. PRIMARY ENDPOINT: association between ≥2 irAE and progression free survival (PFS) and overall survival (OS). Secondary endpoints: PFS, OS, overall response rate defined as the percentage of patients who achieve partial response or complete response, disease control rate and adverse events graded according to the Common Terminology Criteria for Adverse Events v5. Statistical analysis was performed using SPSS v23. RESULTS: Fifty-seven patients treated with nivolumab (n = 25) pembrolizumab (n = 11) or atezolizumab (n = 21) were included. Median age was 62 (31-83) years and 81% had stage IV. Median PFS was 7.8 months (95% CI: 4.3-11.3) and OS was 13.4 months (95% CI: 5.8-20.9). Overall response rate and disease control rate were 28.1% and 59.6% respectively. irAEs occurred in 44% of patients, most frequently arthralgia, myalgia, and transaminase elevation. Grade 3 irAEs included: 3 cases of colitis, 2 pneumonitis, 1 hepatitis, 1 cutaneous toxicity, and 1 adrenal insufficiency. Survival was significantly longer in patients with ≥2 irAEs compared to those with <2: OS 28.4 vs 11.9 months (p = 0.025) and PFS 24.5 vs 5.2 months (p = 0.013). CONCLUSIONS: Patients experiencing 2 or more irAEs showed significantly improved survival, supporting the role of irAEs as potential biomarkers of response to immunotherapy in non-small-cell lung cancer.