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

F. Grossi, L. Crino, A. Logroscino, S. Canova, A. Delmonte, B. Melotti, C. Proto, A. Gelibter, F. Cappuzzo, D. Turci, T. Gamucci, P. Antonelli, P. Marchetti, A. Santoro, S. Giusti, F. Di Costanzo, L. Giustini, A. Del Conte, L. Livi, D. GiannarelliF. de Marinis

Research output: Contribution to journalArticle

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 /=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 /=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 /=75 years, respectively. Efficacy was similar among patients aged /=75 years, respectively. Efficacy was similar among patients aged /=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 /=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 /=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 /=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.
Original languageEnglish
Pages (from-to)126-134
Number of pages9
JournalEuropean Journal of Cancer
Volume100
DOIs
Publication statusPublished - Sep 1 2018

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Non-Small Cell Lung Carcinoma
Population
Survival
nivolumab
Safety
Italy
Research Personnel
Physicians

Keywords

  • Aged
  • Immunotherapy
  • Italy
  • Non-small-cell lung cancer

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Use of nivolumab in elderly patients with advanced squamous non-small-cell lung cancer: results from the Italian cohort of an expanded access programme. / Grossi, F.; Crino, L.; Logroscino, A.; Canova, S.; Delmonte, A.; Melotti, B.; Proto, C.; Gelibter, A.; Cappuzzo, F.; Turci, D.; Gamucci, T.; Antonelli, P.; Marchetti, P.; Santoro, A.; Giusti, S.; Costanzo, F. Di; Giustini, L.; Conte, A. Del; Livi, L.; Giannarelli, D.; Marinis, F. de.

In: European Journal of Cancer, Vol. 100, 01.09.2018, p. 126-134.

Research output: Contribution to journalArticle

Grossi, F, Crino, L, Logroscino, A, Canova, S, Delmonte, A, Melotti, B, Proto, C, Gelibter, A, Cappuzzo, F, Turci, D, Gamucci, T, Antonelli, P, Marchetti, P, Santoro, A, Giusti, S, Costanzo, FD, Giustini, L, Conte, AD, Livi, L, Giannarelli, D & Marinis, FD 2018, 'Use of nivolumab in elderly patients with advanced squamous non-small-cell lung cancer: results from the Italian cohort of an expanded access programme', European Journal of Cancer, vol. 100, pp. 126-134. https://doi.org/10.1016/j.ejca.2018.05.015
Grossi, F. ; Crino, L. ; Logroscino, A. ; Canova, S. ; Delmonte, A. ; Melotti, B. ; Proto, C. ; Gelibter, A. ; Cappuzzo, F. ; Turci, D. ; Gamucci, T. ; Antonelli, P. ; Marchetti, P. ; Santoro, A. ; Giusti, S. ; Costanzo, F. Di ; Giustini, L. ; Conte, A. Del ; Livi, L. ; Giannarelli, D. ; Marinis, F. de. / Use of nivolumab in elderly patients with advanced squamous non-small-cell lung cancer: results from the Italian cohort of an expanded access programme. In: European Journal of Cancer. 2018 ; Vol. 100. pp. 126-134.
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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 /=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 /=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 /=75 years, respectively. Efficacy was similar among patients aged /=75 years, respectively. Efficacy was similar among patients aged /=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 /=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 /=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 /=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.",
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T1 - Use of nivolumab in elderly patients with advanced squamous non-small-cell lung cancer: results from the Italian cohort of an expanded access programme

AU - Grossi, F.

AU - Crino, L.

AU - Logroscino, A.

AU - Canova, S.

AU - Delmonte, A.

AU - Melotti, B.

AU - Proto, C.

AU - Gelibter, A.

AU - Cappuzzo, F.

AU - Turci, D.

AU - Gamucci, T.

AU - Antonelli, P.

AU - Marchetti, P.

AU - Santoro, A.

AU - Giusti, S.

AU - Costanzo, F. Di

AU - Giustini, L.

AU - Conte, A. Del

AU - Livi, L.

AU - Giannarelli, D.

AU - Marinis, F. de

N1 - LR: 20180725; CI: Copyright (c) 2018; JID: 9005373; OTO: NOTNLM; 2018/02/11 00:00 [received]; 2018/05/06 00:00 [revised]; 2018/05/21 00:00 [accepted]; 2018/07/18 06:00 [pubmed]; 2018/07/18 06:00 [medline]; 2018/07/18 06:00 [entrez]; ppublish

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 /=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 /=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 /=75 years, respectively. Efficacy was similar among patients aged /=75 years, respectively. Efficacy was similar among patients aged /=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 /=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 /=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 /=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 /=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 /=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 /=75 years, respectively. Efficacy was similar among patients aged /=75 years, respectively. Efficacy was similar among patients aged /=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 /=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 /=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 /=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

U2 - 10.1016/j.ejca.2018.05.015

DO - 10.1016/j.ejca.2018.05.015

M3 - Article

VL - 100

SP - 126

EP - 134

JO - European Journal of Cancer

JF - European Journal of Cancer

SN - 0959-8049

ER -