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

Diego Cortinovis, Rita Chiari, Annamaria Catino, Francesco Grossi, Filippo DE Marinis, Francesca Sperandi, Francovito Piantedosi, Milena Vitali, Hector J Soto Parra, Maria Rita Migliorino, Carlo Tondini, Davide Tassinari, Antonio Frassoldati, Francesco Verderame, Antonio Pazzola, Francesco Cognetti, Gennaro Palmiotti, Paolo Marchetti, Armando Santoro, Diana GiannarelliFrancesca Colonese, Angelo Delmonte

Research output: Contribution to journalArticlepeer-review


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.

Original languageEnglish
Pages (from-to)4265-4271
Number of pages7
JournalAnticancer Research
Issue number8
Publication statusPublished - Aug 2019


  • Adult
  • Aged
  • Blood-Brain Barrier/drug effects
  • Brain Neoplasms/drug therapy
  • Carcinoma, Non-Small-Cell Lung/drug therapy
  • Central Nervous System Neoplasms/drug therapy
  • Cohort Studies
  • Female
  • Humans
  • Italy/epidemiology
  • Male
  • Middle Aged
  • Neoplasm Staging
  • Nivolumab/administration & dosage


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