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

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.