TY - JOUR
T1 - Use of nivolumab in elderly patients with advanced squamous non–small-cell lung cancer
T2 - results from the Italian cohort of an expanded access programme
AU - Grossi, Francesco
AU - Crinò, Lucio
AU - Logroscino, Antonio
AU - Canova, Stefania
AU - Delmonte, Angelo
AU - Melotti, Barbara
AU - Proto, Claudia
AU - Gelibter, Alain
AU - Cappuzzo, Federico
AU - Turci, Daniele
AU - Gamucci, Teresa
AU - Antonelli, Paola
AU - Marchetti, Paolo
AU - Santoro, Armando
AU - Giusti, Sabrina
AU - Di Costanzo, Francesco
AU - Giustini, Lucio
AU - Del Conte, Alessandro
AU - Livi, Lorenzo
AU - Giannarelli, Diana
AU - de Marinis, Filippo
PY - 2018/9/1
Y1 - 2018/9/1
N2 - 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.
AB - 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.
KW - Aged
KW - Immunotherapy
KW - Italy
KW - Non–small-cell lung cancer
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UR - http://www.scopus.com/inward/citedby.url?scp=85049735176&partnerID=8YFLogxK
U2 - 10.1016/j.ejca.2018.05.015
DO - 10.1016/j.ejca.2018.05.015
M3 - Article
AN - SCOPUS:85049735176
VL - 100
SP - 126
EP - 134
JO - European Journal of Cancer
JF - European Journal of Cancer
SN - 0959-8049
ER -