1. Evaluation of the efficacy and safety of nivolumab in the second- or later-line treatment of patients with locally advanced/metastatic non-small cell lung cancer in Türkiye: a retrospective multicenter non-interventional registry study.
- Author
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Karadurmus N, Kaplan MA, Sendur MAN, Urun Y, Demirci U, Karaca SB, Goktas Aydin S, Aykan MB, Bilici A, Sezer A, Yilmaz U, Abali H, Yumuk PF, Degirmencioglu S, Demirkazik A, Paydas S, Mirili C, Turna H, Kargi A, Ozdogan M, Guven DC, Ozguroglu M, and Kilickap S
- Subjects
- Humans, Male, Female, Retrospective Studies, Middle Aged, Aged, Registries, Turkey epidemiology, Adult, Aged, 80 and over, Treatment Outcome, Antineoplastic Agents, Immunological adverse effects, Antineoplastic Agents, Immunological therapeutic use, Neoplasm Metastasis, Carcinoma, Non-Small-Cell Lung drug therapy, Carcinoma, Non-Small-Cell Lung pathology, Carcinoma, Non-Small-Cell Lung mortality, Nivolumab adverse effects, Nivolumab therapeutic use, Nivolumab administration & dosage, Lung Neoplasms drug therapy, Lung Neoplasms pathology, Lung Neoplasms mortality
- Abstract
Objective: To evaluate the efficacy and safety of nivolumab in the second-line (2L) or later-line (LL) treatment of patients with locally advanced/metastatic non-small cell lung cancer (NSCLC) in real-life setting in Türkiye., Methods: This study was designed as a national, multi-center, retrospective study. The study population was evaluated in two groups for the line of nivolumab therapy: those receiving nivolumab in the 2L (Group 2L) and third-line (3L) or LL (Group 3L/LL). Efficacy was evaluated based on one-year overall survival (OS) and progression-free survival (PFS). Safety was evaluated based on treatment-related adverse events (AEs) and nivolumab discontinuation rate., Results: Of 244 patients, 52.9% were in Group 2L and 47.1% were in Group 3L/LL. Demographic and clinical characteristics did not differ between the groups. In Group 2L and Group 3L/LL, one-year OS and PFS rates were 60.8% and 61.4% ( p = 0.592) and 31.2% and 21.3% ( p = 0.078), respectively. The objective response rate (ORR) was 34.7% in Group 2L and 27.3% in Group 3L/LL ( p = 0.262). The percentage of patients reporting at least one AE in Groups 2L and 3L/LL was 34.9% and 43.5%, respectively ( p = 0.169). Fatigue was the most common (16.4%) treatment-related AE in each group. The groups were comparable regarding the AE frequency. Nivolumab was discontinued in 61 patients in Group 2L and 53 patients in Group 3L/LL, with the most common reason being disease progression (57.4% and 66.0%, respectively)., Conclusion: Nivolumab is safe and effective in the 2L or 3L/LL treatment of locally advanced/metastatic NSCLC and associated with acceptable AEs in real-life setting.
- Published
- 2024
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