Use of nivolumab in elderly patients with advanced squamous non–small-cell lung cancer: results from the Italian cohort of an expanded access programme. (September 2018)

• Record Type: Journal Article
• Authors: Grossi, Francesco; Crinò, Lucio; Logroscino, Antonio; Canova, Stefania; Delmonte, Angelo; Melotti, Barbara; Proto, Claudia; Gelibter, Alain; Cappuzzo, Federico; Turci, Daniele; Gamucci, Teresa; Antonelli, Paola; Marchetti, Paolo; Santoro, Armando; Giusti, Sabrina; Di Costanzo, Francesco; Giustini, Lucio; Del Conte, Alessandro; Livi, Lorenzo; Giannarelli, Diana; de Marinis, Filippo
• Is Part Of: European journal of cancer. Volume 100(2018)
• Page Start: 126
• Page End: 134
• Publication Date: 2018-09
• Subjects: Aged -- Immunotherapy -- Italy -- Non–small-cell lung cancer; Cancer -- Periodicals; Neoplasms -- Periodicals; Cancer -- Périodiques; Cancer; Tumors; Electronic journals; Periodicals; Electronic journals; 616.994
• DOI: 10.1016/j.ejca.2018.05.015
• Languages: English
• ISSNs: 0959-8049

Abstract

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. Highlights: Elderly patients with squamous non–small-cell lung cancer in an Italian expanded access programme benefited from nivolumab. Objective response rates were similar (18–19%) for ages <65, 65–<75 and ≥75 years and all ages. Median overall survival was reduced for ages ≥75 years (5.8 months) versus all ages (8.0 months). Safety and tolerability with nivolumab were similar irrespective of age.