@article{c112de0a87d14a349130f9c4df7ccda9,
title = "Italian Cohort of the Nivolumab EAP in Squamous NSCLC: Efficacy and Safety in Patients With CNS Metastases",
abstract = "BACKGROUND/AIM: Brain metastases are an additional challenge in patients with non-small-cell lung cancer (NSCLC) because most chemotherapy agents cannot cross the blood-brain barrier. Nivolumab has demonstrated efficacy in patients with advanced squamous NSCLC, but because patients with central nervous system (CNS) metastases are typically excluded from registration trials, 'field-practice' data are needed. PATIENTS AND METHODS: Patients in the Italian cohort of the Expanded Access Program (EAP) who had CNS metastases at baseline were analyzed. RESULTS: Thirty-seven patients with CNS metastases received a median of six doses of nivolumab. Three patients (8%) had grade 3-4 adverse events and one patient discontinued due to an adverse event. The objective response rate was 19%. Median overall survival was 5.8 (95% confidence interval=1.9-9.8) months and median progression-free survival was 4.9 (95% confidence interval=2.7-7.1) months. CONCLUSION: The safety and efficacy of nivolumab in patients with CNS metastases appear to be similar to those seen in the overall EAP cohort in Italy.",
keywords = "Adult, Aged, Blood-Brain Barrier/drug effects, Brain Neoplasms/drug therapy/pathology/secondary, Carcinoma, Non-Small-Cell Lung/drug therapy/epidemiology/pathology, Central Nervous System Neoplasms/drug therapy/pathology/secondary, Cohort Studies, Female, Humans, Italy/epidemiology, Male, Middle Aged, Neoplasm Staging, Nivolumab/administration & dosage, Brain metastases, PD1 inhibitor, immunotherapy, real-world evidence",
author = "D. Cortinovis and R. Chiari and A. Catino and F. Grossi and {DE Marinis}, F. and F. Sperandi and F. Piantedosi and M. Vitali and Parra, {H. J. S.} and Migliorino, {M. R.} and C. Tondini and D. Tassinari and A. Frassoldati and F. Verderame and A. Pazzola and F. Cognetti and G. Palmiotti and P. Marchetti and A. Santoro and D. Giannarelli and F. Colonese and A. Delmonte",
note = "LR: 20190807; CI: Copyright(c) 2019; JID: 8102988; 31YO63LBSN (Nivolumab); OTO: NOTNLM; 2019/05/28 00:00 [received]; 2019/06/20 00:00 [revised]; 2019/06/21 00:00 [accepted]; 2019/08/02 06:00 [entrez]; 2019/08/02 06:00 [pubmed]; 2019/08/08 06:00 [medline]; ppublish M1 - Journal Article",
year = "2019",
language = "Italian",
volume = "39",
pages = "4265--4271",
journal = "Anticancer Research",
issn = "0250-7005",
publisher = "International Institute of Anticancer Research",
number = "8",
}