Francesco Grossi1, Lucio Crinò2, Antonio Logroscino3, Stefania Canova4, Angelo Delmonte5, Barbara Melotti6, Claudia Proto7, Alain Gelibter8, Federico Cappuzzo9, Daniele Turci10, Teresa Gamucci11, Paola Antonelli12, Paolo Marchetti13, Armando Santoro14, Sabrina Giusti15, Francesco Di Costanzo16, Lucio Giustini17, Alessandro Del Conte18, Lorenzo Livi19, Diana Giannarelli20, Filippo de Marinis21. 1. Ospedale Policlinico San Martino, Genova, Italy. Electronic address: francesco.grossi@hsanmartino.it. 2. Istituto Scientifico Romagnolo per Lo Studio e La Cura Dei Tumori (IRST), Meldola, Italy. 3. Clinical Cancer Center IRCCS Istituto Tumori "Giovanni Paolo II" Bari, Italy. 4. Department of Oncology, ASST Monza, Presidio San Gerardo, Monza, Italy. 5. Istituto Scientifico Romagnolo per Lo Studio e La Cura Dei Tumori (IRST), IRCCS, Meldola, Italy. 6. Sant'Orsola - Malpighi University Hospital, Bologna, Italy. 7. Istituto Nazionale Tumori, Milan, Italy. 8. Università Degli Studi di ROMA "La Sapienza", Rome, Italy. 9. AUSL Romagna, Ospedale Santa Maria Delle Croci, Ravenna, Italy. 10. AUSL Della Romagna Presidi Ospedalieri di Ravenna, Faenza, Italy. 11. ASL Frosinone - Presidio Ospedaliero SS Trinità, Sora, Italy. 12. ASST Valle Olona, Presidio Ospedaliero di Busto Arsizio, Busto Arsizio, Italy. 13. Azienda Ospedaliera Sant'Andrea, Rome, Italy. 14. Humanitas Cancer Center, Rozzano, Milan, Italy. 15. Azienda USL Toscana Sudest, Arezzo, Italy. 16. AOU Careggi SC Medical Oncology, Florence, Italy. 17. ASUR Marche, Area Vasta 4 Fermo, Italy. 18. AO Santa Maria Degli Angeli, Pordenone, Italy. 19. AOU Careggi SODC Radioterapia, Firenze, Italy. 20. Istituto Nazionale Tumori Regina Elena, Rome, Italy. 21. European Institute of Oncology, Milan, Italy.
Abstract
AIM: This analysis evaluated the efficacy and safety of nivolumab, an immune checkpoint inhibitor, in elderly patients with stage IIIB or IV squamous non-small-cell lung cancer (NSCLC) enrolled in the expanded access programme (EAP) in Italy. METHODS: Nivolumab was available on physician request. Safety data included adverse events (AEs). Efficacy data included investigator-assessed tumour response, progression date and survival information. Results were analysed for patients aged <65, 65-<75 and ≥75 years and for the overall population. RESULTS: A total of 371 patients with squamous NSCLC were enrolled at 96 centres between April 2015 and September 2015; 34% (n = 126), 47% (n = 175) and 19% (n = 70) were aged <65, 65-<75 and ≥75 years, respectively. Efficacy was similar among patients aged <65, 65-<75 and ≥75 years and the overall population (objective response rates: 18%, 18%, 19% and 18%, respectively; disease control rates: 49%, 47%, 43% and 47%, respectively). Median overall survival was reduced in patients aged ≥75 years (5.8 months) versus patients aged <65; years (8.6 months), patients aged 65-<75 years (8.0 months) and the overall population (7.9 months). The incidence of grade 3-4 treatment-related AEs was low in patients aged 65, 65-<75 and ≥75 years and the overall population (3%, 9%, 3%, 6%, respectively). Discontinuation rates due to treatment-related AEs were low irrespective of age (4-5%). CONCLUSIONS: These EAP results suggest that elderly patients with advanced squamous NSCLC benefit from nivolumab, with tolerability similar to that in the overall population.
AIM: This analysis evaluated the efficacy and safety of nivolumab, an immune checkpoint inhibitor, in elderly patients with stage IIIB or IV squamous non-small-cell lung cancer (NSCLC) enrolled in the expanded access programme (EAP) in Italy. METHODS:Nivolumab was available on physician request. Safety data included adverse events (AEs). Efficacy data included investigator-assessed tumour response, progression date and survival information. Results were analysed for patients aged <65, 65-<75 and ≥75 years and for the overall population. RESULTS: A total of 371 patients with squamous NSCLC were enrolled at 96 centres between April 2015 and September 2015; 34% (n = 126), 47% (n = 175) and 19% (n = 70) were aged <65, 65-<75 and ≥75 years, respectively. Efficacy was similar among patients aged <65, 65-<75 and ≥75 years and the overall population (objective response rates: 18%, 18%, 19% and 18%, respectively; disease control rates: 49%, 47%, 43% and 47%, respectively). Median overall survival was reduced in patients aged ≥75 years (5.8 months) versus patients aged <65; years (8.6 months), patients aged 65-<75 years (8.0 months) and the overall population (7.9 months). The incidence of grade 3-4 treatment-related AEs was low in patients aged 65, 65-<75 and ≥75 years and the overall population (3%, 9%, 3%, 6%, respectively). Discontinuation rates due to treatment-related AEs were low irrespective of age (4-5%). CONCLUSIONS: These EAP results suggest that elderly patients with advanced squamous NSCLC benefit from nivolumab, with tolerability similar to that in the overall population.
Authors: Roberto Ferrara; Diego Signorelli; Claudia Proto; Arsela Prelaj; Marina Chiara Garassino; Giuseppe Lo Russo Journal: Transl Lung Cancer Res Date: 2021-06