Italian cohort of the nivolumab EAP in squamous NSCLC: Efficacy and safety in patients with CNS metastases: Anticancer Research

D. Cortinovis, R. Chiari, A. Catino, F. Grossi, F.D.E. Marinis, F. Sperandi, F. Piantedosi, M. Vitali, H.J. Soto Parra, M.R. Migliorino, C. Tondini, D. Tassinari, A. Frassoldati, F. Verderame, A. Pazzola, F. Cognetti, G. Palmiotti, P. Marchetti, A. Santoro, D. GiannarelliF. Colonese, A. 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. © 2019 International Institute of Anticancer Research. All rights reserved.
Original languageEnglish
Pages (from-to)4265-4271
Number of pages7
JournalAnticancer Res.
Issue number8
Publication statusPublished - 2019


  • Brain metastases
  • Immunotherapy
  • PD1 inhibitor
  • Real-world evidence
  • aminotransferase
  • amylase
  • nivolumab
  • triacylglycerol lipase
  • adult
  • aged
  • aminotransferase blood level
  • amylase blood level
  • anemia
  • anorexia
  • Article
  • asthenia
  • cancer chemotherapy
  • cancer patient
  • cancer survival
  • central nervous system metastasis
  • clinical article
  • clinical effectiveness
  • cohort analysis
  • diarrhea
  • fatigue
  • female
  • fever
  • gastrointestinal pain
  • human
  • Italy
  • loss of appetite
  • male
  • non small cell lung cancer
  • overall survival
  • patient safety
  • pneumonia
  • priority journal
  • progression free survival
  • rash
  • side effect
  • treatment response
  • triacylglycerol lipase blood level
  • blood brain barrier
  • brain tumor
  • cancer staging
  • central nervous system tumor
  • clinical trial
  • drug effect
  • middle aged
  • pathology
  • secondary
  • Adult
  • Aged
  • Blood-Brain Barrier
  • Brain Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Central Nervous System Neoplasms
  • Cohort Studies
  • Female
  • Humans
  • Male
  • Middle Aged
  • Neoplasm Staging
  • Nivolumab


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