PMID- 31791821
OWN - NLM
STAT- MEDLINE
DCOM- 20210624
LR  - 20210624
IS  - 1879-4076 (Electronic)
IS  - 1879-4068 (Linking)
VI  - 11
IP  - 5
DP  - 2020 Jun
TI  - Real life safety and effectiveness of nivolumab in older patients with non-small 
      cell lung cancer: Results from the Belgian compassionate use program.
PG  - 796-801
LID - S1879-4068(19)30188-2 [pii]
LID - 10.1016/j.jgo.2019.09.011 [doi]
AB  - OBJECTIVES: To compare real life effectiveness and safety of nivolumab in 
      patients with non-small cell lung cancer (NSCLC), according to age and Eastern 
      Cooperative Group performance status (ECOG-PS). METHODS: We performed a 
      retrospective analysis of patients treated with nivolumab for NSCLC within a 
      Belgian compassionate use program from July 2015 until December 2016. Safety and 
      effectiveness were compared between patients aged >/=70 years and < 70 years and 
      between ECOG-PS 0/1 and >/= 2. RESULTS: A total of 324 patients with NSCLC were 
      included. There was no significant difference between older (>/=70) and younger 
      (<70 years) patients with regards to progression free survival (PFS) (4 months 
      (95%CI 2.6;4.8) versus 3.7 months (95%CI 1;7), p = 0.483) and overall survival 
      (OS) (9.3 months (95% CI 5.5;13.1 months) versus 8.4 months (95%CI 6.3; 10.5), 
      p = 0,638). Patients with an ECOG-PS >/=2 had a significant lower median PFS and OS 
      compared to patients with an ECOG-PS 0-1 (2.2 (95%CI 1.4; 2.9) versus 5.6 months 
      (95%CI 4.1; 7.1), p = 0.001 and 3.4 (95%CI 2.3; 4.5) versus 11.1 months (95%CI 
      8.9; 13.2), p < 0.001 respectively). No significant difference in all grades or 
      grade 3/4 adverse events (AEs) were observed between the different age groups 
      (p = 0.526 and p = 0.603 respectively). Patients with an ECOG-PS 0/1 had 
      significantly more all grades AEs (p = 0.009) but no difference in grade 3/4 AEs 
      was observed (p = 0.406) compared to ECOG-PS >/=2. CONCLUSION: This real life 
      retrospective study confirms that safety and effectiveness of nivolumab is 
      similar between different age groups, but that effectiveness is driven by 
      performance status.
CI  - Copyright (c) 2019 Elsevier Inc. All rights reserved.
FAU - Joris, Sofie
AU  - Joris S
AD  - Department of Medical Oncology, Oncologisch Centrum, UZ Brussel, Vrije 
      Universiteit Brussel, Brussel, Belgium.
FAU - Pieters, Thierry
AU  - Pieters T
AD  - Cliniques Universitaires Saint-Luc UCL, Brussel, Belgium.
FAU - Sibille, Anne
AU  - Sibille A
AD  - Department of pulmonology, CHU de Liege, ULiege, Liege, Belgium.
FAU - Bustin, Frederique
AU  - Bustin F
AD  - Department of pulmonology, CHR de La Citadelle, Liege, Belgium.
FAU - Jacqmin, Laurence
AU  - Jacqmin L
AD  - Department of pulmonology, Clinique Saint-Luc Bouge, Namur, Belgium.
FAU - Kalantari, Hassan Rezaei
AU  - Kalantari HR
AD  - Department of pulmonology, CHR Verviers, Verviers, Belgium.
FAU - Surmont, Veerle
AU  - Surmont V
AD  - Department of pulmonology, UZ Gent, Gent, Belgium.
FAU - Goeminne, Jean-Charles
AU  - Goeminne JC
AD  - Department of medical oncology, CHU-UCL-Namur Site Sainte Elisabeth, Namur, 
      Belgium.
FAU - Clinckart, Frederic
AU  - Clinckart F
AD  - Department of pulmonology, Hopital de Jolimont, Jolimont, Belgium.
FAU - Pat, Karin
AU  - Pat K
AD  - Department of pulmonology, Jessa Ziekenhuis, Hasselt, Belgium.
FAU - Demey, Wim
AU  - Demey W
AD  - Department of medical oncology, AZ Klina, Brasschaat, Belgium.
FAU - Deschepper, Koen
AU  - Deschepper K
AD  - Department of pulmonology, AZ Nikolaas, Sint Niklaas, Belgium.
FAU - Lambrechts, Marc
AU  - Lambrechts M
AD  - Department of pulmonology, AZ Sint Maarten, Mechelen, Belgium.
FAU - Holbrechts, Stephane
AU  - Holbrechts S
AD  - Department of medical oncology, CHU Ambroise Pare, Mons, Belgium.
FAU - Schallier, Denis
AU  - Schallier D
AD  - Department of Medical Oncology, Oncologisch Centrum, UZ Brussel, Vrije 
      Universiteit Brussel, Brussel, Belgium.
FAU - Decoster, Lore
AU  - Decoster L
AD  - Department of Medical Oncology, Oncologisch Centrum, UZ Brussel, Vrije 
      Universiteit Brussel, Brussel, Belgium. Electronic address: 
      lore.decoster@uzbrussel.be.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20191130
PL  - Netherlands
TA  - J Geriatr Oncol
JT  - Journal of geriatric oncology
JID - 101534770
RN  - 0 (Antineoplastic Agents, Immunological)
RN  - 31YO63LBSN (Nivolumab)
SB  - IM
MH  - Age Factors
MH  - Aged
MH  - Antineoplastic Agents, Immunological/administration & dosage/adverse effects
MH  - Belgium
MH  - *Carcinoma, Non-Small-Cell Lung/drug therapy
MH  - Compassionate Use Trials
MH  - Humans
MH  - *Lung Neoplasms/drug therapy
MH  - *Nivolumab/administration & dosage/adverse effects
MH  - Retrospective Studies
OTO - NOTNLM
OT  - Nivolumab
OT  - Non-small cell lung cancer
OT  - Older
OT  - Performance status
COIS- Declaration of Competing Interest This research was funded by a grant from 
      Bristol Meyers Squibb, Belgium. Lore Decoster received research grant from BMS, 
      Bhoeringer Ingelheim; Travel grants from BMS, Roche en MSD; Advisory boards from 
      MSD, Roche, Astra Zeneca. Thierry Pieters received speaker's fees from BMS during 
      the study period.
EDAT- 2019/12/04 06:00
MHDA- 2021/06/25 06:00
CRDT- 2019/12/04 06:00
PHST- 2019/05/02 00:00 [received]
PHST- 2019/08/01 00:00 [revised]
PHST- 2019/09/30 00:00 [accepted]
PHST- 2019/12/04 06:00 [pubmed]
PHST- 2021/06/25 06:00 [medline]
PHST- 2019/12/04 06:00 [entrez]
AID - S1879-4068(19)30188-2 [pii]
AID - 10.1016/j.jgo.2019.09.011 [doi]
PST - ppublish
SO  - J Geriatr Oncol. 2020 Jun;11(5):796-801. doi: 10.1016/j.jgo.2019.09.011. Epub 
      2019 Nov 30.