Nivolumab treatment of NSCLC patients in clinical practice in Greater Poland: Long term survival analysis.
Authors: Bryl Maciej , Golda-Gocka Iwona , Stencel Katarzyna Magdalena , Piwkowski Cezary , Kasprzyk Mariusz 
Published: June 2023

e21178

Background: Immunotherapy has changes the landscape of advanced NSCLC therapy. Clinical trilas showed promising results but real world evidences are the definitive confirmation. This study evaluates distant outcomes and toxicity of treatment with nivolumab in patients with NSCLC in daily clinical practice. Methods: Study included 84 pts. with adv. NSCLC, receiving nivolumab (NIVO) in the early access programme (EAP) at the Greater Poland Centre of Pulmonology and Thoracic Surgery in Poznań in 2016-19: 57 men and 27 women; aged between 26 and 88 years (mean 63); majority with ECOG PS 1; 40 pts. with squamous and 44 with non-squamous NSCLC; 86.9% stage IV. Responses were assessed according to RECIST 1.1 criteria and toxicity according CTCAE v.4. OS and PFS were analyzed in relation to selected demographic and clinical parameters. Type of response as well as incidence, nature, time of occurrence and severity of adverse events (AEs) were assessed. Neutrophil-lymphocyte ratio (NLR) in relation to OS, PFS and immunotherapy-related AEs were also analyzed. Results: Partial remission (PR)/disease stabilization (SD) or disease progression (PD) were observed in 61% and in 39% of patients, respectively. The best responses were obtained in patients > 70 years, with stage IIIB, receiving nivolumab in 1st-line treatment. The 1, 2, 3, 4, 5 and 6-year OS rates were 42,9%, 23,8%, 20,2%, 17,86%, 11,9% and 10,7% respectively. After 4, 5 and 6 years 5,95%, 5,95% and 4,76% patients remains on treatment respectively. The median OS was 9.6 months. The 1, 2 and 3-year PFS rates were 19%, 15.5%, and 11.9%, respectively. The median PFS was 4,7 months. Age, sex, stage, and treatment line appeared to be factors significantly affecting OS and PFS. The objective response rate (ORR) and disease control rate (DCR) also correlated with OS and PFS. Treatment-related AEs occurred in 66,7% of patients, primarily grade 1-2; 44% of AEs occurred in the first 3 months of treatment. Discontinuation rate due to AEs was 20.2%, and treatment-related toxic effects caused fatalities in 11,9% of patients. The AEs risk was higher in patients receiving NIVO in ≥4 treatment line. High baseline NLR was associated with shorter OS and PFS. There was also a correlation between baseline and final NLR values, occurrence of grade 1-2 AEs, and grade 3-5 AEs. Conclusions: Majority of patients with advanced NSCLC treated with NIVO achieved PR or SD. The long-term outcomes are satisfactory with 3-year OS rate > 20% and 3-year PFS rate of 1.9%. Female sex, age > 60 years, lower stage, treatment with NIVO in 1-line and PR/SD achieving were predictors of improved long-term outcomes. NIVO has acceptable toxicity profile, mostly with mild-to-moderate AEs and low discontinuation rate. Most AEs occur in the first 3 months of therapy, mainly in patients treated in later lines. NLR could be potential predictor of both response and toxicity; however, studies with larger cohorts are necessary.