Retrospective evaluation of the "neutrophil-lymphocyte ratio" (NLR) in patients affected by locally advanced unresectable stage III NSCLC treated with Durvalumab within the Italian expanded access program (EAP): results of the neutrality trial

Background: Very little is known regarding the clinical value of inflammatory blood markers, such as NLR, Systemic Immune Inflammation (SII), derived NLR (dNLR) and Lung Immune Prognostic Index (LIPI) in stage III NSCLC patients treated as per PACIFIC regimen. Methods: Neutrality trial (ESR-19-20410) is a retrospective multicentric study aimed at assessing the clinical impact of these blood inflammatory indexes on the clinical outcomes of such population. Unresectable stage III NSCLC patients were enrolled in two cohorts: the Durvalumab one, encompassing 94 patients treated within the Italian EAP, and the historical one, including 96 patients treated with radio-chemotherapy alone. Blood count tests were recorded at established time points from start of treatment. Results: In the Durvalumab cohort, baseline NLR ≥5 significantly correlated with PFS (HR 1.93, 95% CI 1.12-3.30, p < 0.017; median 38.2 vs 21.4 months for NLR<5 and ≥5, p 0.015). The dNLR at baseline was also significantly correlated with PFS, with an HR of 2.14 (95% CI 1.14-4.02, p = 0.018; median 35.6 vs 18.7 months for dNLR<3 vs ≥3, p = 0.016). The median PFS of the good prognostic LIPI index group was significantly better than the intermediate group (p-value < 0.004), and the poor group (p-value < 0.039). In the historical cohort, SII correlated significantly with PFS when considered as a continuous variable (HR for each increment by 1: 1.02, 95% CI 1.01-1.03; p 0.007). Conclusion: Neutrality trial confirmed the potential prognostic role of blood inflammatory indexes in patients with unresectable stage III NSCLC treated as per PACIFIC regimen.