PMID- 32698673
OWN - NLM
STAT- MEDLINE
DCOM- 20210419
LR  - 20211204
IS  - 1542-6270 (Electronic)
IS  - 1060-0280 (Linking)
VI  - 55
IP  - 3
DP  - 2021 Mar
TI  - Axicabtagene Ciloleucel: Clinical Data for the Use of CAR T-cell Therapy in 
      Relapsed and Refractory Large B-cell Lymphoma.
PG  - 390-405
LID - 10.1177/1060028020944233 [doi]
AB  - OBJECTIVE: To evaluate the literature for axicabtagene ciloleucel (axi-cel), a 
      first-in-class chimeric antigen receptor (CAR) T-cell therapy, in the treatment 
      of relapsed/refractory (r/r) large B-cell lymphoma (LBCL). DATA SOURCES: We 
      conducted a PubMed (inception to June 22, 2020) and ClinicalTrials.gov search 
      using the following terms: CD19, chimeric antigen receptor, and lymphoma. STUDY 
      SELECTION AND DATA EXTRACTION: All retrospective and prospective studies 
      evaluating the use of axi-cel in LBCL were reviewed. DATA SYNTHESIS: In the 
      pivotal ZUMA-1 trial, axi-cel exhibited unprecedented overall and complete 
      response rates of 83% and 58%, respectively. With a median follow-up of 27.1 
      months, 39% of patients had ongoing responses. Furthermore, postmarketing 
      retrospective analyses found similar response rates in a more clinically diverse 
      LBCL patient population. Novel CAR T-cell therapy elicits unique and potentially 
      life-threatening toxicities that include cytokine release syndrome (CRS) and 
      immune effector cell-associated neurotoxicity syndrome (ICANS). Studies reported 
      grade >/=3 CRS in 7% to 14% of patients and grade >/=3 ICANS in 31% to 55% of 
      patients. RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE: Axi-cel was the first 
      US Food and Drug Administration-approved genetically engineered autologous CAR 
      T-cell agent in r/r LBCL, representing an important milestone and paradigm shift 
      in cancer treatment. Adoptive T-cell immunotherapy is a breakthrough treatment 
      modality requiring careful patient selection, multidisciplinary collaboration, 
      comprehensive patient counseling, and expert training to ensure optimal 
      treatment. CONCLUSIONS: The initial and ongoing results with axi-cel are 
      encouraging, but long-term safety and efficacy data are lacking. Additional 
      studies are required to identify axi-cel's ideal place in LBCL therapy.
FAU - Halford, Zachery
AU  - Halford Z
AUID- ORCID: 0000-0002-7032-0398
AD  - Union University College of Pharmacy, Jackson, TN, USA.
FAU - Anderson, Mary Kate
AU  - Anderson MK
AD  - Union University College of Pharmacy, Jackson, TN, USA.
FAU - Bennett, Lunawati L
AU  - Bennett LL
AD  - Union University College of Pharmacy, Jackson, TN, USA.
LA  - eng
PT  - Journal Article
DEP - 20200722
PL  - United States
TA  - Ann Pharmacother
JT  - The Annals of pharmacotherapy
JID - 9203131
RN  - 0 (Antigens, CD19)
RN  - 0 (Biological Products)
RN  - 0 (Receptors, Chimeric Antigen)
RN  - U2I8T43Y7R (axicabtagene ciloleucel)
SB  - IM
MH  - Antigens, CD19/pharmacology/*therapeutic use
MH  - Biological Products
MH  - Humans
MH  - Immunotherapy, Adoptive/*methods
MH  - Lymphoma, Large B-Cell, Diffuse/*drug therapy/pathology
MH  - Prospective Studies
MH  - Receptors, Chimeric Antigen/*metabolism
MH  - Recurrence
MH  - Retrospective Studies
OTO - NOTNLM
OT  - CAR T-cell
OT  - NHL
OT  - axicabtagene ciloleucel
OT  - chimeric antigen receptor
OT  - cytokine release syndrome
OT  - immunotherapy
OT  - large B-cell lymphoma
EDAT- 2020/07/24 06:00
MHDA- 2021/04/20 06:00
CRDT- 2020/07/24 06:00
PHST- 2020/07/24 06:00 [pubmed]
PHST- 2021/04/20 06:00 [medline]
PHST- 2020/07/24 06:00 [entrez]
AID - 10.1177/1060028020944233 [doi]
PST - ppublish
SO  - Ann Pharmacother. 2021 Mar;55(3):390-405. doi: 10.1177/1060028020944233. Epub 
      2020 Jul 22.