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 Giannarelli; Francesca Colonese; Angelo Delmonte

doi:10.21873/anticanres.13590

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 journal › Article › peer-review

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 language	English
Pages (from-to)	4265-4271
Number of pages	7
Journal	Anticancer Research
Volume	39
Issue number	8
DOIs	https://doi.org/10.21873/anticanres.13590
Publication status	Published - Aug 2019

Keywords

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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10.21873/anticanres.13590

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Cortinovis, D., Chiari, R., Catino, A., Grossi, F., DE Marinis, F., Sperandi, F., Piantedosi, F., Vitali, M., Parra, H. J. S., Migliorino, M. R., Tondini, C., Tassinari, D., Frassoldati, A., Verderame, F., Pazzola, A., Cognetti, F., Palmiotti, G., Marchetti, P., Santoro, A., ... Delmonte, A. (2019). Italian Cohort of the Nivolumab EAP in Squamous NSCLC: Efficacy and Safety in Patients With CNS Metastases. Anticancer Research, 39(8), 4265-4271. https://doi.org/10.21873/anticanres.13590

Cortinovis, D, Chiari, R, Catino, A , Grossi, F , DE Marinis, F, Sperandi, F, Piantedosi, F, Vitali, M, Parra, HJS, 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

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

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.",

keywords = "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",

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

year = "2019",

month = aug,

doi = "10.21873/anticanres.13590",

language = "English",

volume = "39",

pages = "4265--4271",

journal = "Anticancer Research",

issn = "0250-7005",

publisher = "International Institute of Anticancer Research",

number = "8",

}

TY - JOUR

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 - DE Marinis, Filippo

AU - Sperandi, Francesca

AU - Piantedosi, Francovito

AU - Vitali, Milena

AU - Parra, Hector J Soto

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 - 2019/8

Y1 - 2019/8

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.

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.

KW - Adult

KW - Aged

KW - Blood-Brain Barrier/drug effects

KW - Brain Neoplasms/drug therapy

KW - Carcinoma, Non-Small-Cell Lung/drug therapy

KW - Central Nervous System Neoplasms/drug therapy

KW - Cohort Studies

KW - Female

KW - Humans

KW - Italy/epidemiology

KW - Male

KW - Middle Aged

KW - Neoplasm Staging

KW - Nivolumab/administration & dosage

U2 - 10.21873/anticanres.13590

DO - 10.21873/anticanres.13590

M3 - Article

C2 - 31366516

SN - 0250-7005

VL - 39

SP - 4265

EP - 4271

JO - Anticancer Research

JF - Anticancer Research

IS - 8

ER -

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

Abstract

Keywords

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