@article{a26c3c71a867496c8f5b74d4b4d95afa,
title = "Italian cohort of the nivolumab EAP in squamous NSCLC: Efficacy and safety in patients with CNS metastases: Anticancer Research",
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, {\textquoteleft}field-practice{\textquoteright} 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. {\textcopyright} 2019 International Institute of Anticancer Research. All rights reserved.",
keywords = "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",
author = "D. Cortinovis and R. Chiari and A. Catino and F. Grossi and F.D.E. Marinis and F. Sperandi and F. Piantedosi and M. Vitali and {Soto Parra}, H.J. and M.R. Migliorino and C. Tondini and D. Tassinari and A. Frassoldati and F. Verderame and A. Pazzola and F. Cognetti and G. Palmiotti and P. Marchetti and A. Santoro and D. Giannarelli and F. Colonese and A. Delmonte",
note = "Export Date: 26 February 2020 CODEN: ANTRD Correspondence Address: Cortinovis, D.; SC Oncologia Medica/SS Lung Unit, ASST Ospedale San Gerardo, Via Pergolesi 33, Italy; email: d.cortinovis@asst-monza.it Chemicals/CAS: aminotransferase, 9031-66-7; amylase, 9000-90-2, 9000-92-4, 9001-19-8; nivolumab, 946414-94-4; triacylglycerol lipase, 9001-62-1; Nivolumab Funding details: Bristol-Myers Squibb, BMS Funding text 1: The Authors thank the patients and their families who made this EAP possible, as well as the clinical study teams who were involved in this program. Professional medical writing and editorial assistance was provided by William Watkins of StemScientific, funded by Bristol-Myers Squibb. Editorial assistance was provided by Luca Giacomelli, Ph.D., Laura Brogelli, and Aashni Shah (Polistudium srl.), supported by internal funds. 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year = "2019",
doi = "10.21873/anticanres.13590",
language = "English",
volume = "39",
pages = "4265--4271",
journal = "Anticancer Res.",
issn = "0250-7005",
publisher = "International Institute of Anticancer Research",
number = "8",
}