PMID- 38396377
OWN - NLM
STAT- MEDLINE
DCOM- 20240226
LR  - 20240227
IS  - 2045-7634 (Electronic)
IS  - 2045-7634 (Linking)
VI  - 13
IP  - 3
DP  - 2024 Feb
TI  - Guidelines for outpatient administration of naxitamab: Experience from Atrium 
      Health Levine Children's Hospital.
PG  - e7045
LID - 10.1002/cam4.7045 [doi]
LID - e7045
AB  - AIM: In this publication, we will share our experience of AE management, provide 
      guidance for appropriate staffing, and the discuss the importance of patient 
      education when treating patients with R/R HR neuroblastoma using naxitamab. 
      BACKGROUND: Approved treatments for patients with refractory and/or relapsed 
      (R/R) high-risk (HR) neuroblastoma are limited, and there is a high unmet need 
      for new treatment combinations. Naxitamab is a disialoganglioside 2 (GD2)-binding 
      antibody that was approved by the United States Food and Drug Administration in 
      2020 for use in combination with granulocyte-macrophage colony-stimulating factor 
      for the treatment of patients with R/R HR neuroblastoma in the bone and/or bone 
      marrow and who have demonstrated a partial response, minor response, or stable 
      disease with prior therapy. METHODS: The pediatric oncology team at Atrium Health 
      Levine Children's Hospital has successfully treated several patients with 
      naxitamab both alone and in combination with chemotherapy, with no patients 
      requiring unplanned overnight hospitalization and few severe adverse events 
      (AEs). To accomplish this, the team at Levine Children's Hospital established 
      standard operating procedures for naxitamab, a therapy defined as high acuity due 
      to the potential for acute AEs with rapid onset and that benefits from continuous 
      monitoring by a nursing team and a dedicated provider. CONCLUSIONS: This will 
      provide a practical guide for institutions offering naxitamab to their patients, 
      and ensure successful administration of this high acuity treatment in the 
      outpatient setting.
CI  - (c) 2024 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.
FAU - Trovillion, Erin Murphy
AU  - Trovillion EM
AUID- ORCID: 0000-0002-1762-0324
AD  - Atrium Health Levine Children's Hospital, Charlotte, North Carolina, USA.
FAU - Michael, Meghan
AU  - Michael M
AD  - Atrium Health Levine Children's Hospital, Charlotte, North Carolina, USA.
FAU - Jordan, Cathryn C
AU  - Jordan CC
AD  - Atrium Health Levine Children's Hospital, Charlotte, North Carolina, USA.
FAU - Brown, Lauren
AU  - Brown L
AD  - Atrium Health Levine Children's Hospital, Charlotte, North Carolina, USA.
FAU - Phillips, Katlin
AU  - Phillips K
AD  - Atrium Health Levine Children's Hospital, Charlotte, North Carolina, USA.
FAU - Oesterheld, Javier
AU  - Oesterheld J
AD  - Atrium Health Levine Children's Hospital, Charlotte, North Carolina, USA.
FAU - Saulnier-Sholler, Giselle
AU  - Saulnier-Sholler G
AUID- ORCID: 0000-0002-5599-4757
AD  - Atrium Health Levine Children's Hospital, Charlotte, North Carolina, USA.
LA  - eng
PT  - Journal Article
PL  - United States
TA  - Cancer Med
JT  - Cancer medicine
JID - 101595310
RN  - 0 (naxitamab-gqgk)
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Glycolipids)
RN  - 0 (Antibodies, Monoclonal, Humanized)
SB  - IM
MH  - Child
MH  - Humans
MH  - *Antibodies, Monoclonal
MH  - Outpatients
MH  - *Neuroblastoma/drug therapy
MH  - Hospitals
MH  - *Glycolipids
MH  - *Antibodies, Monoclonal, Humanized
PMC - PMC10891358
OTO - NOTNLM
OT  - immunotherapy
OT  - naxitamab
OT  - neuroblastoma
COIS- Erin Trovillion has served on an advisory board for Y-mAbs Therapeutics, Inc. 
      Meghan Michael has no disclosures. Cathryn Jordan has no disclosures. Lauren 
      Brown has no disclosures. Katlin Phillips has no disclosures. Javier Oesterheld 
      has served on an advisory board for Y-mAbs Therapeutics, Inc., and Servier 
      Pharmaceuticals. Giselle Saulnier-Sholler has served as a speaker for Y-mAbs 
      Therapeutics, Inc.
EDAT- 2024/02/24 11:44
MHDA- 2024/02/26 06:45
PMCR- 2024/02/23
CRDT- 2024/02/24 00:52
PHST- 2024/01/02 00:00 [revised]
PHST- 2023/08/25 00:00 [received]
PHST- 2024/02/13 00:00 [accepted]
PHST- 2024/02/26 06:45 [medline]
PHST- 2024/02/24 11:44 [pubmed]
PHST- 2024/02/24 00:52 [entrez]
PHST- 2024/02/23 00:00 [pmc-release]
AID - CAM47045 [pii]
AID - 10.1002/cam4.7045 [doi]
PST - ppublish
SO  - Cancer Med. 2024 Feb;13(3):e7045. doi: 10.1002/cam4.7045.