PMID- 30014881
OWN - NLM
STAT- MEDLINE
DCOM- 20190401
LR  - 20190401
IS  - 1879-0852 (Electronic)
IS  - 0959-8049 (Linking)
VI  - 100
DP  - 2018 Sep
TI  - Use of nivolumab in elderly patients with advanced squamous non-small-cell lung 
      cancer: results from the Italian cohort of an expanded access programme.
PG  - 126-134
LID - S0959-8049(18)30873-6 [pii]
LID - 10.1016/j.ejca.2018.05.015 [doi]
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.
CI  - Copyright (c) 2018 Elsevier Ltd. All rights reserved.
FAU - Grossi, Francesco
AU  - Grossi F
AD  - Ospedale Policlinico San Martino, Genova, Italy. Electronic address: 
      francesco.grossi@hsanmartino.it.
FAU - Crino, Lucio
AU  - Crino L
AD  - Istituto Scientifico Romagnolo per Lo Studio e La Cura Dei Tumori (IRST), 
      Meldola, Italy.
FAU - Logroscino, Antonio
AU  - Logroscino A
AD  - Clinical Cancer Center IRCCS Istituto Tumori "Giovanni Paolo II" Bari, Italy.
FAU - Canova, Stefania
AU  - Canova S
AD  - Department of Oncology, ASST Monza, Presidio San Gerardo, Monza, Italy.
FAU - Delmonte, Angelo
AU  - Delmonte A
AD  - Istituto Scientifico Romagnolo per Lo Studio e La Cura Dei Tumori (IRST), IRCCS, 
      Meldola, Italy.
FAU - Melotti, Barbara
AU  - Melotti B
AD  - Sant'Orsola - Malpighi University Hospital, Bologna, Italy.
FAU - Proto, Claudia
AU  - Proto C
AD  - Istituto Nazionale Tumori, Milan, Italy.
FAU - Gelibter, Alain
AU  - Gelibter A
AD  - Universita Degli Studi di ROMA "La Sapienza", Rome, Italy.
FAU - Cappuzzo, Federico
AU  - Cappuzzo F
AD  - AUSL Romagna, Ospedale Santa Maria Delle Croci, Ravenna, Italy.
FAU - Turci, Daniele
AU  - Turci D
AD  - AUSL Della Romagna Presidi Ospedalieri di Ravenna, Faenza, Italy.
FAU - Gamucci, Teresa
AU  - Gamucci T
AD  - ASL Frosinone - Presidio Ospedaliero SS Trinita, Sora, Italy.
FAU - Antonelli, Paola
AU  - Antonelli P
AD  - ASST Valle Olona, Presidio Ospedaliero di Busto Arsizio, Busto Arsizio, Italy.
FAU - Marchetti, Paolo
AU  - Marchetti P
AD  - Azienda Ospedaliera Sant'Andrea, Rome, Italy.
FAU - Santoro, Armando
AU  - Santoro A
AD  - Humanitas Cancer Center, Rozzano, Milan, Italy.
FAU - Giusti, Sabrina
AU  - Giusti S
AD  - Azienda USL Toscana Sudest, Arezzo, Italy.
FAU - Di Costanzo, Francesco
AU  - Di Costanzo F
AD  - AOU Careggi SC Medical Oncology, Florence, Italy.
FAU - Giustini, Lucio
AU  - Giustini L
AD  - ASUR Marche, Area Vasta 4 Fermo, Italy.
FAU - Del Conte, Alessandro
AU  - Del Conte A
AD  - AO Santa Maria Degli Angeli, Pordenone, Italy.
FAU - Livi, Lorenzo
AU  - Livi L
AD  - AOU Careggi SODC Radioterapia, Firenze, Italy.
FAU - Giannarelli, Diana
AU  - Giannarelli D
AD  - Istituto Nazionale Tumori Regina Elena, Rome, Italy.
FAU - de Marinis, Filippo
AU  - de Marinis F
AD  - European Institute of Oncology, Milan, Italy.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20180713
PL  - England
TA  - Eur J Cancer
JT  - European journal of cancer (Oxford, England : 1990)
JID - 9005373
RN  - 0 (Antineoplastic Agents, Immunological)
RN  - 31YO63LBSN (Nivolumab)
SB  - IM
MH  - Adult
MH  - Age Factors
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Agents, Immunological/adverse effects/*therapeutic use
MH  - Carcinoma, Non-Small-Cell Lung/*drug therapy/mortality/pathology
MH  - Compassionate Use Trials
MH  - Female
MH  - Humans
MH  - Italy
MH  - Lung Neoplasms/*drug therapy/mortality/pathology
MH  - Male
MH  - Middle Aged
MH  - Nivolumab/adverse effects/*therapeutic use
MH  - Time Factors
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Aged
OT  - Immunotherapy
OT  - Italy
OT  - Non-small-cell lung cancer
EDAT- 2018/07/18 06:00
MHDA- 2019/04/02 06:00
CRDT- 2018/07/18 06:00
PHST- 2018/02/11 00:00 [received]
PHST- 2018/05/06 00:00 [revised]
PHST- 2018/05/21 00:00 [accepted]
PHST- 2018/07/18 06:00 [pubmed]
PHST- 2019/04/02 06:00 [medline]
PHST- 2018/07/18 06:00 [entrez]
AID - S0959-8049(18)30873-6 [pii]
AID - 10.1016/j.ejca.2018.05.015 [doi]
PST - ppublish
SO  - Eur J Cancer. 2018 Sep;100:126-134. doi: 10.1016/j.ejca.2018.05.015. Epub 2018 
      Jul 13.