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Research ArticleClinical Studies

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 and ANGELO DELMONTE
Anticancer Research August 2019, 39 (8) 4265-4271; DOI: https://doi.org/10.21873/anticanres.13590
DIEGO CORTINOVIS
1Medical Oncology/Lung Unit, San Gerardo Hospital, Monza, Italy
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  • For correspondence: d.cortinovis@asst-monza.it
RITA CHIARI
2Medical Oncology, Santa Maria della Misericordia Hospital, Perugia, Italy
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ANNAMARIA CATINO
3National Cancer Research Centre, Giovanni Paolo II Institute, Bari, Italy
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FRANCESCO GROSSI
4Lung Cancer Unit, San Martino Hospital, Genoa, Italy
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FILIPPO DE MARINIS
5European Institute of Oncology, Milan, Italy
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FRANCESCA SPERANDI
6Sant'Orsola Malpighi Hospital, Bologna, Italy
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FRANCOVITO PIANTEDOSI
7Colli – Monaldi Hospital, Naples, Italy
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MILENA VITALI
8Foundation IRCCS, National Tumor Institute, Milan, Italy
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HECTOR J. SOTO PARRA
9Vittorio Emanuele Hospital, Catania, Italy
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MARIA RITA MIGLIORINO
10San Camillo – Forlanini Hospital, Rome, Italy
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CARLO TONDINI
11Papa Giovanni XXIII Hospital, Bergamo, Italy
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DAVIDE TASSINARI
12Romagna University Hospital, Rimini, Italy
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ANTONIO FRASSOLDATI
13Ferrara University Hospital, Ferrara, Italy
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FRANCESCO VERDERAME
14Villa Sofia-Cervello Hospital, Palermo, Italy
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ANTONIO PAZZOLA
15Sassari Hospital, Sassari, Italy
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FRANCESCO COGNETTI
16Regina Elena National Tumor Institute, Rome, Italy
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GENNARO PALMIOTTI
17Venere Hospital, Bari, Italy
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PAOLO MARCHETTI
18Sant'Andrea Hospital, Rome, Italy
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ARMANDO SANTORO
19Humanitas Cancer Center Milan, Rozzano, Italy
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DIANA GIANNARELLI
16Regina Elena National Tumor Institute, Rome, Italy
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FRANCESCA COLONESE
1Medical Oncology/Lung Unit, San Gerardo Hospital, Monza, Italy
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ANGELO DELMONTE
20Romagna Scientific Institute for the Treatment of Tumors, Meldola, Italy
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  • Errata - February 01, 2020

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.

  • Brain metastases
  • immunotherapy
  • PD1 inhibitor
  • real-world evidence

Footnotes

  • Authors' Contributions

    All Authors contributed to the drafting of and making the decision to submit the article for publication. All remaining Authors have no relationships to disclose.

  • Conflicts of Interest

    LC received fees for speakers' bureau participation from AstraZeneca, Bristol-Myers Squibb, and Novartis. DG received fees for speakers' bureau participation from Boehringer Ingelheim and Lilly, and travel, accommodation, and expenses from Bristol-Myers Squibb. AA received honoraria from Boehringer Ingelheim, Bristol-Myers Squibb, and Lilly, and served in a consulting/advisory role for Boehringer Ingelheim, Bristol-Myers Squibb, GlaxoSmithKline, Lilly, and MSD Oncology. DC received honoraria from Roche, MSD, Boehringer Ingrlheim and served in a consulting/advisory for MSD, BMS, Boehirnger Ingelheim, AZ. FG received honoraria from Bristol-Myers Squibb, MSD, AstraZeneca, Roche and served in a consulting/advisory role for Boehringer Ingelheim, Bristol-Myers Squibb, MSD, Roche, Pierre Fabre, Astra Zeneca. MRM received Honoraria /advisory role from Boehringer Ingelheim, Bristol-Myers Squibb, AstraZeneca, Pfizer.

  • Funding

    Bristol-Myers Squibb, Inc.

  • Nivolumab Expanded Access Program in Squamous NSCLC: Investigators in Italy

    Mario Airoldi, Città della Salute e della Scienza di Torino, Torino; Oscar Alabiso, Azienda Ospedaliero Universitaria Maggiore della Carità di Novara, Novara; Giuseppe Altavilla, Policlinico di Messina, Messina; Paola Antonelli, Ospedale di Busto Arsizio, Busto Arsizio; Antonio Ardizzoia, Ospedale Alessandro Manzoni, Lecco; Andrea Ardizzoni, Policlinico Sant'Orsola-Malpighi, Bologna; Salvatore Artale, Azienda Ospedaliero Sant'Antonio Abate di Gallarate, Gallarate; Fabrizio Artioli, Ospedale di Carpi, Carpi; Editta Baldini, Azienda USL 2 Lucca, Lucca; Carmelo Bengala, Ospedale di Grosseto, Grosseto; Antonio Bernardo, Fondazione Maugeri, Pavia; Alessandro Bertolini, Azienda Ospedaliera Valtellina e Valchiavenna, Sondrio; Paolo Bidoli, Ospedale San Gerardo, Monza; Sergio Bracarda, Azienda USL 8, Arezzo; Alba Brandes, Ospedale di Bellaria, Bologna; Emilio Bria, Università degli Studi di Verona, Verona; Luana Calabrò, Policlinico Le Scotte, Siena; Giacomo Cartenì, Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli, Napoli; Fausto Barbieri, Azienda Ospedaliero Universitaria di Modena, Modena; Federico Cappuzzo, Presidio Ospedaliero di Livorno, Livorno; Luigi Cavanna, Ospedale Guglielmo da Saliceto, Piacenza; Antonio Chella, Azienda Ospedaliero Universitaria Pisana, Pisa; Fortunato Ciardiello, Seconda Università degli Studi di Napoli, Napoli; Saverio Cinieri, Presidio Ospedaliero Antonio Perrino, Brindisi; Libero Ciuffreda, Città della Salute e della Scienza di Torino, Torino; Mario Alberto Clerico, Ospedale degli Infermi, Biella; Francesco Cognetti, Istituto Nazionale Tumori Regina Elena, Roma; Pier Franco Conte, Istituto Oncologico Veneto, Padova; Enrico Cortesi, Policlinico Umberto I, Roma; Lucio Crinò, Azienda Ospedaliero Perugia, Perugia; Domenico Cristiano Corsi, Ospedale Fatebenefratelli San Giovanni Calibita, Roma; Andrea De Censi, Ospedali Galliera, Genova; Filippo De Marinis, Istituto Europeo di Oncologia, Milano; Elvira De Marino, Ospedale Sant'Andrea, Vercelli; Sabino De Placido, Azienda Ospedaliero Universitaria Federico II, Napoli; Alessandro Del Conte, Azienda Ospedaliero Santa Maria degli Angeli, Pordenone; Angelo Delmonte; Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola; Francesco Di Costanzo, Azienda Ospedaliero Universitaria Careggi, Firenze; Angelo Di Leo, AUSL4 - Nuovo Ospedale di Prato - Santo Stefano, Prato; Marco Di Lieto, Azienda USL 3 di Pistoia, Pistoia; Liberato Di Lullo, Presidio Ospedaliero F. Veneziale, Isernia; Daniele Fagnani, Azienda Socio-Sanitaria Territoriale di Vimercate, Vimercate; Alfredo Falcone, Azienda Ospedaliero Universitaria Pisana Spedali Riuniti di Santa Chiara, Pisa; Gabriella Farina, Ospedale Fatebenefratelli, Milano; Gianpiero Fasola, Azienda Ospedaliero Universitaria Santa Maria della Misericordia, Udine; Francesco Ferraù, Ospedale San Vincenzo, Taormina; Luisa Fioretto, Ospedale Santa Maria Annunziata, Bagno a Ripoli; Paolo Foa, Azienda Ospedaliero San Paolo, Milano; Guido Francini, Policlinico Le Scotte, Siena; Antonio Frassoldati, Arcispedale Santa Anna, Ferrara; Domenico Galetta, Istituto Tumori Giovanni Paolo II, Bari; Marco Galliano, Ospedale Acqui Terme, Aqui Terme; Teresa Gamucci, Presidio Ospedaliero SS Trinità, Sora; Marina Garassino, Istituto Nazionale Tumori, Milano; Luca Gianni, Ospedale San Raffaele, Milano; Carmelo Giannitto, Ospedale Gravina e Santo Pietro, Caltagirone; Lucio Giustini, Ospedale di Fermo, Fermo; Cesare Gridelli, Azienda Ospedaliero San Giuseppe Moscati, Avellino; Francesco Grossi, Azienda Ospedaliero Universitaria San Martino – Istituto Nazionale per la Ricerca sul Cancro, Genova; Alfonso Illiano, Azienda Ospedaliero dei Colli, Napoli; Lorenzo Livi, Azienda Ospedaliero Universitaria Careggi, Firenze; Paolo Marchetti, Ospedale Sant'Andrea, Roma; Maria Rita Migliorino, San Camillo Forlanini, Roma; Enrico Mini, Azienda Ospedaliero Universitaria Careggi, Firenze; Vincenzo Montesarchio, Azienda Ospedaliero dei Colli, Napoli; Alessandro Morabito, Istituto Pascale, Napoli; Alessandro Mozzicafreddo, Ospedale Umberto Parini, Aosta; Donato Natale, Ospedale Santo Spirito, Pescara; Gianmauro Numico, Azienda Ospidaliera Nazionale SS Antonio e Biagio e Cesare Arrigo, Alessandria; Gennaro Palmiotti, Ospedale di Venere, Bari; Lorenzo Pavesi, Fondazione Maugeri, Pavia; Antonio Pazzola, Ospedale Civile SS Annunziata, Sassari; Paolo Pedrazzoli, Policlinico San Matteo, Pavia; Francovito Piantedosi, Azienda Ospedaliero dei Colli, Napoli; Graziella Pinotti, Ospedale di Circolo e Fondazione Macchi, Varese; Carmine Pinto, Arcispedale Santa Maria Nuova di Reggio Emilia, Reggio Emilia; Fausto Roila, Azienda Ospedaliero Santa Maria, Terni; Enzo Maria Ruggeri, Ospedale Belcolle, Viterbo; Antonio Santo, Gruppo Interdisciplinare Veronese Oncologia Polmonare – Azienda Ospedaliero Universitaria Integrata di Verona, Verona; Armando Santoro, Istituto Clinico Humanitas, Milano; Maria Giuseppina Sarobba, ASL3 Nuoro San Francesco, Nuoro; Alessandro Scoppola, Istituto Dermopatico dell'Immacolata, Roma; Salvatore Siena, Niguarda cancer Center Ospedale Niguarda ca' Granda, Milano; Rosa Rita Silva, Azienda Sanitaria Unica Regionale Marche, Fabriano; Hector Soto Parra, Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele, Catania; Giammarco Surico, Ospedale Vito Fazzi, Lecce; Pierosandro Tagliaferri, Policlinico Mater Domini Germaneto, Catanzaro; Davide Tassinari, Ospedale Rimini, Rimini; Natale Tedde, Presidio Ospedale di Olbia, Olbia; Marcello Tiseo, Azienda Ospedaliero Universitaria di Parma, Parma; Carlo Tondini, Ospedale Papa Giovanni XXIII, Bergamo; Giuseppe Tonini, Campus Biomedico, Roma; Marco Tucci, Policlinico di Bari, Bari; Daniele Turci, Ospedale S. Maria delle Croci, Ravenna; Francesco Verderame, Azienda Ospedaliera “Villa Sofia – Cervello,” Palermo;; Guido Vietti Ramus, Ospedale San Giovanni Bosco, Torino.

  • Received May 28, 2019.
  • Revision received June 20, 2019.
  • Accepted June 21, 2019.
  • Copyright© 2019, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved
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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
Anticancer Research Aug 2019, 39 (8) 4265-4271; DOI: 10.21873/anticanres.13590

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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
Anticancer Research Aug 2019, 39 (8) 4265-4271; DOI: 10.21873/anticanres.13590
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Keywords

  • brain metastases
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