The real-world experience with nivolumab in previously treated patients with advanced non small cell lung cancer (NSCLC): A Galician Lung Cancer Group clinical practice

• Published in: Journal of clinical oncology Vol. 35; no. 15_suppl; p. e20564
• Main Authors: Areses, MC, Campelo, Rosario Garcia, García González, Jorge, Afonso, Francisco Javier, Lazaro, Martin Emilio, Campos, Begoña, Azpitarte, Cristina, Amenedo, Margarita, Santomé, Lucía, Ron, David Arias, Alonso-Jaudenes, Guillermo, Baron, Francisco, Vilchez, Rocio, Casal, Joaquin, Fernandez, Natalia, Carou, Iria, Mosquera, Joaquin, Anido, Urbano, Garcia Mata, Jesus, Firvida, Jose-luis
• Format: Journal Article
• Language: English
• Published: 20.05.2017
• ISSN: 0732-183X; 1527-7755
• DOI: 10.1200/JCO.2017.35.15_suppl.e20564

Abstract only e20564 Background: Nivolumab, was the first checkpoint inhibitor to show a survival benefit in previously treated patients with advanced NSCLC in two randomized trials (CheckMate 017 and 057). Experience in routine clinical practice may differ from that seen in a controlled clinical trial. This is an observational study that represents the real-world experience. Methods: Elegibility criteria included, histologically confirmed NSCLC stage IIIB vs IV, evaluable disease and at least one prior therapy. Patients received nivolumab 3 mg/kg IV (60 min) every 2 weeks until progressive disease or unacceptable toxicity. The aim of the study was to report the efficacy and safety profile of Nivolumab in pretreated patients with advanced NSCLC of our everyday clinical practice. The exploratory assessments include response rate (RR), progression-free survival (PFS), overall survival (OS) and treatment related adverse events (AEs). Results: From August 2015 to January 2017, with a median follow time of 18 months, 188 patients were enrolled from 9 different centers. Patients demographics were: median age 62 years, 44 female and 144 male; 17 never smoker and 171 former or current smoker; 105 adenocarcinoma, 7 large-cell carcinoma, 66 squamous, 3 adenosquamous and 7 NSCLC; 61 stage IIIB and 129 stage IV; 42 with central nervous system metastasis; and 70 received 2 or more prior therapy lines. Among 156 patients evaluated, 1,3% had CR, 28,2% PR, 29,7% SD and 40,8% PD. At the time of database lock, the median of PFS was 2.9 IC 95% (2,3-3.4) and OS was 12,8 IC 95% (9,2-16,4). The evaluation of PFS and OS by baseline characteristics doesn´t revealed statistical significance. Grade 1-2 treatment related adverse events (AEs) occurred in 58% of the patients: asthenia (22%), rash (14%), diarrhea (8%), anorexia (7%), endocrine (6%) and neumonitis (1,5%). Grade 3-4 AEs occurred in 5 patients; (3) diarrhea and (2) neumonitis and there were 3 treatment-related deaths. Conclusions: This study represents the real-word experience with nivolumab and the results are consistent with those previously reported in the CheckMate 017 and 057 trials.