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 D.E. 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 journalArticle

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.

Original languageEnglish
Pages (from-to)4265-4271
Number of pages7
JournalAnticancer Research
Volume39
Issue number8
DOIs
Publication statusPublished - Jan 1 2019

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Patient Safety
Non-Small Cell Lung Carcinoma
Central Nervous System
Neoplasm Metastasis
Confidence Intervals
nivolumab
Italy
Disease-Free Survival
Safety
Drug Therapy
Survival
Brain

Keywords

  • Brain metastases
  • Immunotherapy
  • PD1 inhibitor
  • Real-world evidence

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Italian cohort of the nivolumab EAP in squamous NSCLC : Efficacy and safety in patients with CNS metastases. / Cortinovis, Diego; Chiari, Rita; Catino, Annamaria; Grossi, Francesco; Marinis, Filippo D.E.; Sperandi, Francesca; Piantedosi, Francovito; Vitali, Milena; Soto Parra, Hector J.; 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.

In: Anticancer Research, Vol. 39, No. 8, 01.01.2019, p. 4265-4271.

Research output: Contribution to journalArticle

Cortinovis, D, Chiari, R, Catino, A, Grossi, F, Marinis, FDE, Sperandi, F, Piantedosi, F, Vitali, M, Soto Parra, HJ, Migliorino, MR, Tondini, C, Tassinari, D, Frassoldati, A, Verderame, F, Pazzola, A, Cognetti, F, Palmiotti, G, Marchetti, P, Santoro, A, Giannarelli, D, Colonese, F & Delmonte, A 2019, 'Italian cohort of the nivolumab EAP in squamous NSCLC: Efficacy and safety in patients with CNS metastases', Anticancer Research, vol. 39, no. 8, pp. 4265-4271. https://doi.org/10.21873/anticanres.13590
Cortinovis, Diego ; Chiari, Rita ; Catino, Annamaria ; Grossi, Francesco ; Marinis, Filippo D.E. ; Sperandi, Francesca ; Piantedosi, Francovito ; Vitali, Milena ; Soto Parra, Hector J. ; 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. / Italian cohort of the nivolumab EAP in squamous NSCLC : Efficacy and safety in patients with CNS metastases. In: Anticancer Research. 2019 ; Vol. 39, No. 8. pp. 4265-4271.
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T1 - Italian cohort of the nivolumab EAP in squamous NSCLC

T2 - Efficacy and safety in patients with CNS metastases

AU - Cortinovis, Diego

AU - Chiari, Rita

AU - Catino, Annamaria

AU - Grossi, Francesco

AU - Marinis, Filippo D.E.

AU - Sperandi, Francesca

AU - Piantedosi, Francovito

AU - Vitali, Milena

AU - Soto Parra, Hector J.

AU - Migliorino, Maria Rita

AU - Tondini, Carlo

AU - Tassinari, Davide

AU - Frassoldati, Antonio

AU - Verderame, Francesco

AU - Pazzola, Antonio

AU - Cognetti, Francesco

AU - Palmiotti, Gennaro

AU - Marchetti, Paolo

AU - Santoro, Armando

AU - Giannarelli, Diana

AU - Colonese, Francesca

AU - Delmonte, Angelo

PY - 2019/1/1

Y1 - 2019/1/1

N2 - 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.

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