Diego Cortinovis1, Rita Chiari2, Annamaria Catino3, Francesco Grossi4, Filippo DE Marinis5, Francesca Sperandi6, Francovito Piantedosi7, Milena Vitali8, Hector J Soto Parra9, Maria Rita Migliorino10, Carlo Tondini11, Davide Tassinari12, Antonio Frassoldati13, Francesco Verderame14, Antonio Pazzola15, Francesco Cognetti16, Gennaro Palmiotti17, Paolo Marchetti18, Armando Santoro19, Diana Giannarelli16, Francesca Colonese20, Angelo Delmonte21. 1. Medical Oncology/Lung Unit, San Gerardo Hospital, Monza, Italy d.cortinovis@asst-monza.it. 2. Medical Oncology, Santa Maria della Misericordia Hospital, Perugia, Italy. 3. National Cancer Research Centre, Giovanni Paolo II Institute, Bari, Italy. 4. Lung Cancer Unit, San Martino Hospital, Genoa, Italy. 5. European Institute of Oncology, Milan, Italy. 6. Sant'Orsola Malpighi Hospital, Bologna, Italy. 7. Colli - Monaldi Hospital, Naples, Italy. 8. Foundation IRCCS, National Tumor Institute, Milan, Italy. 9. Vittorio Emanuele Hospital, Catania, Italy. 10. San Camillo - Forlanini Hospital, Rome, Italy. 11. Papa Giovanni XXIII Hospital, Bergamo, Italy. 12. Romagna University Hospital, Rimini, Italy. 13. Ferrara University Hospital, Ferrara, Italy. 14. Villa Sofia-Cervello Hospital, Palermo, Italy. 15. Sassari Hospital, Sassari, Italy. 16. Regina Elena National Tumor Institute, Rome, Italy. 17. Venere Hospital, Bari, Italy. 18. Sant'Andrea Hospital, Rome, Italy. 19. Humanitas Cancer Center Milan, Rozzano, Italy. 20. Medical Oncology/Lung Unit, San Gerardo Hospital, Monza, Italy. 21. Romagna Scientific Institute for the Treatment of Tumors, Meldola, Italy.
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. Copyright
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. Copyright
Authors: Sarah B Goldberg; Kurt A Schalper; Scott N Gettinger; Amit Mahajan; Roy S Herbst; Anne C Chiang; Rogerio Lilenbaum; Frederick H Wilson; Sacit Bulent Omay; James B Yu; Lucia Jilaveanu; Thuy Tran; Kira Pavlik; Elin Rowen; Heather Gerrish; Annette Komlo; Richa Gupta; Hailey Wyatt; Matthew Ribeiro; Yuval Kluger; Geyu Zhou; Wei Wei; Veronica L Chiang; Harriet M Kluger Journal: Lancet Oncol Date: 2020-04-03 Impact factor: 41.316