Italian Cohort of the Nivolumab EAP in Squamous NSCLC: Efficacy and Safety in Patients With CNS Metastases

• Published in: Anticancer research 2019-08, Vol.39 (8), p.4265-4271
• Main Authors: Cortinovis, Diego, Chiari, Rita, Catino, Annamaria, Grossi, Francesco, DE Marinis, Filippo, Sperandi, Francesca, Piantedosi, Francovito, Vitali, Milena, Parra, Hector J Soto, Migliorino, Maria Rita, Tondini, Carlo, Tassinari, Davide, Frassoldati, Antonio, Verderame, Francesco, Pazzola, Antonio, Cognetti, Francesco, Palmiotti, Gennaro, Marchetti, Paolo, Santoro, Armando, Giannarelli, Diana, Colonese, Francesca, Delmonte, Angelo
• Format: Article
• Language: English
• Subjects: Adult; Aged; Blood-Brain Barrier - drug effects; Brain; Brain cancer; Brain Neoplasms - drug therapy; Brain Neoplasms - pathology; Brain Neoplasms - secondary; Carcinoma, Non-Small-Cell Lung - drug therapy; Carcinoma, Non-Small-Cell Lung - epidemiology; Carcinoma, Non-Small-Cell Lung - pathology; Central nervous system; Central Nervous System Neoplasms - drug therapy; Central Nervous System Neoplasms - pathology; Central Nervous System Neoplasms - secondary; Chemotherapy; Clinical trials; Cohort Studies; Confidence intervals; Effectiveness; Female; Humans; Immunotherapy; Italy - epidemiology; Lung cancer; Male; Metastases; Metastasis; Middle Aged; Monoclonal antibodies; Neoplasm Staging; Nivolumab - administration & dosage; Non-small cell lung carcinoma; Safety; Survival; Targeted cancer therapy
• ISSN: 0250-7005; 1791-7530
• DOI: 10.21873/anticanres.13590

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 in the Italian cohort of the Expanded Access Program (EAP) who had CNS metastases at baseline were analyzed. 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. 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.