PMID- 32798213
OWN - NLM
STAT- MEDLINE
DCOM- 20210728
LR  - 20210728
IS  - 1879-4076 (Electronic)
IS  - 1879-4068 (Linking)
VI  - 12
IP  - 2
DP  - 2021 Mar
TI  - Real-world adverse events associated with CAR T-cell therapy among adults 
      age >/= 65 years.
PG  - 239-242
LID - S1879-4068(20)30145-4 [pii]
LID - 10.1016/j.jgo.2020.07.006 [doi]
AB  - INTRODUCTION: Chimeric antigen receptor (CAR) T-cell therapy has emerged as a 
      promising treatment for relapsed or refractory large B-cell lymphoma (LBCL) with 
      the Food and Drug Administration (FDA) approvals of axicabtagene ciloleucel 
      (axi-cel) and tisagenlecleucel (tis-cel). Although the incidence of LBCL is 
      highest among patients age >/= 65, clinical trials supporting approval of these 2 
      products primarily enrolled younger patients. Safety data for axi-cel and tis-cel 
      in older patients is limited. METHODS: In this analysis, we queried the FDA 
      Adverse Events Reporting System (FAERS) database for cases associated with 
      axi-cel or tis-cel from the FDA approval dates for the LBCL indication for each 
      product through December 31, 2019, and compared adverse events (AEs) reported for 
      cases involving patients aged <65 and >/= 65. RESULTS: A total of 804 cases were 
      retrieved, with 333 (41%) involving patients age >/= 65. Cytokine release syndrome 
      (CRS) was the most common AE reported in both age groups. Cases involving older 
      patients had a significantly higher proportion of neurological AEs, including CAR 
      T-cell-related encephalopathy syndrome (8% vs. 4%, p = 0.03). Some individual 
      clinical features of CRS were significantly more common among younger age group 
      cases, including pyrexia (33% vs. 23%, p < 0.01), tachycardia (10% vs. 5%, 
      p < 0.01), and thrombocytopenia (4% vs. 2%, p = 0.03). DISCUSSION: In this 
      age-based analysis of FAERS reports for patients treated with axi-cel or tis-cel, 
      we identified differences in patterns of AEs experienced. This large-scale 
      post-marketing study complements clinical trial safety data and may help inform 
      clinicians' decision making when treating adult patients with CAR-T cell therapy.
CI  - Copyright (c) 2020 Elsevier Inc. All rights reserved.
FAU - Zettler, Marjorie E
AU  - Zettler ME
AD  - Cardinal Health Specialty Solutions, Cardinal Health, Dublin, OH, United States 
      of America.
FAU - Feinberg, Bruce A
AU  - Feinberg BA
AD  - Cardinal Health Specialty Solutions, Cardinal Health, Dublin, OH, United States 
      of America.
FAU - Phillips, Eli G Jr
AU  - Phillips EG Jr
AD  - Cardinal Health Specialty Solutions, Cardinal Health, Dublin, OH, United States 
      of America.
FAU - Klink, Andrew J
AU  - Klink AJ
AD  - Cardinal Health Specialty Solutions, Cardinal Health, Dublin, OH, United States 
      of America.
FAU - Mehta, Sonam
AU  - Mehta S
AD  - Cardinal Health Specialty Solutions, Cardinal Health, Dublin, OH, United States 
      of America.
FAU - Gajra, Ajeet
AU  - Gajra A
AD  - Cardinal Health Specialty Solutions, Cardinal Health, Dublin, OH, United States 
      of America. Electronic address: ajeet.gajra@cardinalhealth.com.
LA  - eng
PT  - Journal Article
DEP - 20200811
PL  - Netherlands
TA  - J Geriatr Oncol
JT  - Journal of geriatric oncology
JID - 101534770
SB  - IM
MH  - Aged
MH  - Humans
MH  - Immunotherapy, Adoptive
MH  - *Lymphoma, Large B-Cell, Diffuse
MH  - *Thrombocytopenia
COIS- Declaration of Competing Interest All authors report employment with Cardinal 
      Health; AG reports employment with ICON Clinical Research.
EDAT- 2020/08/17 06:00
MHDA- 2021/07/29 06:00
CRDT- 2020/08/17 06:00
PHST- 2020/03/25 00:00 [received]
PHST- 2020/05/22 00:00 [revised]
PHST- 2020/07/06 00:00 [accepted]
PHST- 2020/08/17 06:00 [pubmed]
PHST- 2021/07/29 06:00 [medline]
PHST- 2020/08/17 06:00 [entrez]
AID - S1879-4068(20)30145-4 [pii]
AID - 10.1016/j.jgo.2020.07.006 [doi]
PST - ppublish
SO  - J Geriatr Oncol. 2021 Mar;12(2):239-242. doi: 10.1016/j.jgo.2020.07.006. Epub 
      2020 Aug 11.