PMID- 31585984
OWN - NLM
STAT- MEDLINE
DCOM- 20201208
LR  - 20240327
IS  - 1549-490X (Electronic)
IS  - 1083-7159 (Print)
IS  - 1083-7159 (Linking)
VI  - 25
IP  - 1
DP  - 2020 Jan
TI  - Axicabtagene Ciloleucel, an Anti-CD19 Chimeric Antigen Receptor T-Cell Therapy 
      for Relapsed or Refractory Large B-Cell Lymphoma: Practical Implications for the 
      Community Oncologist.
PG  - e138-e146
LID - 10.1634/theoncologist.2019-0395 [doi]
AB  - Axicabtagene ciloleucel is the first U.S. Food and Drug Administration-approved 
      autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy for the 
      treatment of patients with relapsed or refractory large B-cell lymphoma after >/=2 
      prior systemic therapies. Although axicabtagene ciloleucel is administered only 
      at authorized treatment centers, community oncologists play a critical role in 
      the CAR T-cell treatment journey, recognizing potentially eligible patients for 
      referral and then, after treatment, closely collaborating with treatment centers 
      to monitor and manage patients long term. ZUMA-1, the pivotal, multicenter, phase 
      I/II study of 108 patients treated with axicabtagene ciloleucel, resulted in an 
      objective response rate of 83%, including 58% complete responses. With a 
      27.1-month median follow-up, 39% of patients had ongoing responses. CAR T-cell 
      therapy is associated with the potentially life-threatening adverse events (AEs) 
      of cytokine release syndrome and neurologic events, which generally occur early 
      after treatment. In ZUMA-1, cytokine release syndrome and neurologic events were 
      generally reversible and grade >/=3 cytokine release syndrome and neurologic events 
      occurred in 11% and 32% of patients, respectively. Frequent prolonged AEs 
      included hypogammaglobulinemia, B-cell aplasia, and cytopenias requiring 
      supportive care until recovery of hematopoietic function. Rate of 
      treatment-related mortality was low, at <2%. With appropriate management of 
      common AEs, axicabtagene ciloleucel offers the potential for long-term durable 
      responses in patients who otherwise lack curative treatment options. IMPLICATIONS 
      FOR PRACTICE: Community oncologists should be familiar with key aspects of 
      chimeric antigen receptor (CAR) T-cell indications and eligibility to help 
      recognize and refer potential patients for this paradigm-changing treatment 
      option at the appropriate time during the disease course. To ensure optimal 
      long-term outcomes for patients who have been treated with CAR T-cell therapy, 
      oncologists must also be familiar with common prolonged AEs and their monitoring 
      and management.
CI  - (c) AlphaMed Press 2019.
FAU - Jacobson, Caron A
AU  - Jacobson CA
AD  - Dana-Farber Cancer Institute, Boston, Massachusetts, USA.
FAU - Farooq, Umar
AU  - Farooq U
AD  - University of Iowa, Iowa City, Iowa, USA.
FAU - Ghobadi, Armin
AU  - Ghobadi A
AD  - Washington University School of Medicine and Siteman Cancer Center, St. Louis, 
      Missouri, USA.
LA  - eng
GR  - P30 CA086862/CA/NCI NIH HHS/United States
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20191004
PL  - England
TA  - Oncologist
JT  - The oncologist
JID - 9607837
RN  - 0 (Antigens, CD19)
RN  - 0 (Biological Products)
RN  - 0 (Receptors, Antigen, T-Cell)
RN  - 0 (Receptors, Chimeric Antigen)
RN  - U2I8T43Y7R (axicabtagene ciloleucel)
SB  - IM
MH  - Antigens, CD19/physiology/*therapeutic use
MH  - Biological Products
MH  - Humans
MH  - Immunotherapy, Adoptive
MH  - Lymphoma, Large B-Cell, Diffuse/*drug therapy/mortality/pathology
MH  - Receptors, Antigen, T-Cell/*immunology
MH  - Receptors, Chimeric Antigen/*immunology
MH  - Survival Analysis
PMC - PMC6964143
OTO - NOTNLM
OT  - Diffuse large B-cell lymphoma
OT  - High-grade B-cell lymphoma
OT  - Immunotherapy
OT  - Primary mediastinal B-cell lymphoma
OT  - Transformed follicular lymphoma
COIS- Disclosures of potential conflicts of interest may be found at the end of this 
      article.
EDAT- 2019/10/06 06:00
MHDA- 2020/12/15 06:00
PMCR- 2020/01/01
CRDT- 2019/10/06 06:00
PHST- 2019/05/22 00:00 [received]
PHST- 2019/07/18 00:00 [accepted]
PHST- 2019/10/06 06:00 [pubmed]
PHST- 2020/12/15 06:00 [medline]
PHST- 2019/10/06 06:00 [entrez]
PHST- 2020/01/01 00:00 [pmc-release]
AID - theoncologist.2019-0395 [pii]
AID - ONCO13091 [pii]
AID - 10.1634/theoncologist.2019-0395 [doi]
PST - ppublish
SO  - Oncologist. 2020 Jan;25(1):e138-e146. doi: 10.1634/theoncologist.2019-0395. Epub 
      2019 Oct 4.