PT - JOURNAL ARTICLE AU - DIEGO CORTINOVIS AU - RITA CHIARI AU - ANNAMARIA CATINO AU - FRANCESCO GROSSI AU - FILIPPO DE MARINIS AU - FRANCESCA SPERANDI AU - FRANCOVITO PIANTEDOSI AU - MILENA VITALI AU - HECTOR J. SOTO PARRA AU - MARIA RITA MIGLIORINO AU - CARLO TONDINI AU - DAVIDE TASSINARI AU - ANTONIO FRASSOLDATI AU - FRANCESCO VERDERAME AU - ANTONIO PAZZOLA AU - FRANCESCO COGNETTI AU - GENNARO PALMIOTTI AU - PAOLO MARCHETTI AU - ARMANDO SANTORO AU - DIANA GIANNARELLI AU - FRANCESCA COLONESE AU - ANGELO DELMONTE TI - Italian Cohort of the Nivolumab EAP in Squamous NSCLC: Efficacy and Safety in Patients With CNS Metastases AID - 10.21873/anticanres.13590 DP - 2019 Aug 01 TA - Anticancer Research PG - 4265--4271 VI - 39 IP - 8 4099 - http://ar.iiarjournals.org/content/39/8/4265.short 4100 - http://ar.iiarjournals.org/content/39/8/4265.full SO - Anticancer Res2019 Aug 01; 39 AB - 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.