Francesco Grossi1, Carlo Genova2, Lucio Crinò3, Angelo Delmonte3, Daniele Turci4, Diego Signorelli5, Antonio Passaro6, Hector Soto Parra7, Annamaria Catino8, Lorenza Landi9, Francesco Gelsomino10, Marcello Tiseo11, Gianfranco Puppo12, Fausto Roila13, Serena Ricciardi14, Giuseppe Tonini15, Francesco Cognetti16, Luca Toschi17, Davide Tassinari18, Alessandro Scoppola19, Diana Giannarelli20, Enrico Cortesi21. 1. Medical Oncology Unit, Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico, Milano, Italy. Electronic address: Francesco.Grossi@policlinico.mi.it. 2. Lung Cancer Unit, IRCCS Ospedale Policlinico San Martino, Genova, Italy. 3. Department of Medical Oncology, Istituto Scientifico Romagnolo per Lo Studio e La Cura Dei Tumori (IRST) IRCCS, Meldola, Italy. 4. Medical Oncology Unit, Ospedale "S. Maria Delle Croci", Ravenna, Italy. 5. Medical Oncology Department, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milano, Italy. 6. Division of Thoracic Oncology, IEO, European Institute of Oncology IRCCS, Milano, Italy. 7. Department of Oncology, Azienda Ospedaliero-Universitaria (AOU) Policlinico Vittorio Emanuele, Catania, Italy. 8. Medical Oncology Unit - Patologia Toracica, IRCCS Istituto Tumori Giovanni Paolo II -Bari, Italy. 9. Oncology-Hematology Department, AUSL Della Romagna, Ravenna, Italy. 10. Oncology Unit, AOU Policlinico Sant'Orsola-Malpighi, Bologna, Italy. 11. Department of Medicine and Surgery, Università Degli Studi di Parma e Oncologia Medica, Azienda Ospedaliero-Universitaria di Parma, Italy. 12. Pulmonology Unit, Ospedale di Macerata, Italy. 13. Medical Oncology Unit, Ospedale S. Maria Della Misericordia, Perugia, Italy. 14. Pulmonary Oncology Unit, Azienda Ospedaliera San Camillo-Forlanini, Roma, Italy. 15. Oncology Department, Università Campus Bio-Medico, Roma, Italy. 16. Medical Oncology Unit, Università La Sapienza, Istituto Nazionale Tumori Regina Elena, Roma, Italy. 17. Department of Oncology-Hematology, IRCCS Istituto Clinico Humanitas, Rozzano, Italy. 18. Oncology Unit, AUSL Della Romagna, Rimini, Italy. 19. Medical Oncology Department, Istituto Dermopatico Dell'Immacolata, Roma, Italy. 20. BIostatistics, Istituto Nazionale Tumori Regina Elena, Roma, Italy. 21. Oncology Unit, Policlinico Umberto I, Roma, Italy.
Abstract
BACKGROUND: Nivolumab was the first immune checkpoint inhibitor approved for previously treated advanced non-small cell lung cancer (NSCLC). Before its introduction in the market, nivolumab was made available to NSCLC patients through an expanded access program (EAP). Here we present the Italian cohort of patients with non-squamous NSCLC enrolled in a worldwide nivolumab EAP, with subgroup analyses involving elderly patients, patients with central nervous system (CNS) metastases and patients receiving nivolumab beyond progression. METHODS: Pretreated patients with advanced non-squamous NSCLC received nivolumab at 3 mg/kg every 2 weeks up to 24 months. Efficacy data (investigator-assessed tumour response, progression date and survival) and safety data were collected. FINDINGS: 1588 patients were treated across 153 Italian centres. Overall response rate and disease control rate were 18% and 44%, respectively; median overall survival (OS) was 11.3 months (95% CI: 10.2-12.4). Elderly patients (≥70 n = 522; ≥75 n = 232) achieved outcomes similar to the global study population; patients with CNS metastases (n = 409) had an OS of 8.6 months (95% CI: 6.4-10.8), and a 1-year OS rate of 43%. Nivolumab was administered beyond progression to 276 patients (26%), 57 of whom achieved subsequent disease control; the median OS of patients receiving nivolumab beyond progression was 16.2 months (95% CI: 14.0-18.4), while 1-year OS rate was 62%. INTERPRETATION: To date, this is the largest clinical experience with nivolumab in a real-world setting. Our data support its use in clinical practice for pretreated non-squamous NSCLC, including patients with older age or CNS metastases.
BACKGROUND:Nivolumab was the first immune checkpoint inhibitor approved for previously treated advanced non-small cell lung cancer (NSCLC). Before its introduction in the market, nivolumab was made available to NSCLCpatients through an expanded access program (EAP). Here we present the Italian cohort of patients with non-squamous NSCLC enrolled in a worldwide nivolumab EAP, with subgroup analyses involving elderly patients, patients with central nervous system (CNS) metastases and patients receiving nivolumab beyond progression. METHODS: Pretreated patients with advanced non-squamous NSCLC received nivolumab at 3 mg/kg every 2 weeks up to 24 months. Efficacy data (investigator-assessed tumour response, progression date and survival) and safety data were collected. FINDINGS: 1588 patients were treated across 153 Italian centres. Overall response rate and disease control rate were 18% and 44%, respectively; median overall survival (OS) was 11.3 months (95% CI: 10.2-12.4). Elderly patients (≥70 n = 522; ≥75 n = 232) achieved outcomes similar to the global study population; patients with CNS metastases (n = 409) had an OS of 8.6 months (95% CI: 6.4-10.8), and a 1-year OS rate of 43%. Nivolumab was administered beyond progression to 276 patients (26%), 57 of whom achieved subsequent disease control; the median OS of patients receiving nivolumab beyond progression was 16.2 months (95% CI: 14.0-18.4), while 1-year OS rate was 62%. INTERPRETATION: To date, this is the largest clinical experience with nivolumab in a real-world setting. Our data support its use in clinical practice for pretreated non-squamous NSCLC, including patients with older age or CNS metastases.
Authors: Christine M Cramer-van der Welle; Marjon V Verschueren; Merel Tonn; Bas J M Peters; Franz M N H Schramel; Olaf H Klungel; Harry J M Groen; Ewoudt M W van de Garde Journal: Sci Rep Date: 2021-03-18 Impact factor: 4.379