Guidelines for outpatient administration of naxitamab: Experience from Atrium Health Levine Children's Hospital.

immunotherapy naxitamab neuroblastoma

Journal

Cancer medicine
ISSN: 2045-7634
Titre abrégé: Cancer Med
Pays: United States
ID NLM: 101595310

Informations de publication

Date de publication:
Feb 2024
Historique:
revised: 02 01 2024
received: 25 08 2023
accepted: 13 02 2024
medline: 24 2 2024
pubmed: 24 2 2024
entrez: 24 2 2024
Statut: ppublish

Résumé

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. 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. 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. 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.

Sections du résumé

AIM OBJECTIVE
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 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 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 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.

Identifiants

pubmed: 38396377
doi: 10.1002/cam4.7045
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

e7045

Informations de copyright

© 2024 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.

Références

Whittle SB, Smith V, Doherty E, Zhao S, McCarty S, Zage PE. Overview and recent advances in the treatment of neuroblastoma. Expert Rev Anticanc Ther. 2017;17:369-386. doi:10.1080/14737140.2017.1285230
Key statistics about neuroblastoma. American Cancer Society. 2021 https://www.cancer.org/cancer/neuroblastoma/about/key-statistics.html
Pinto N, Naranjo A, Hibbitts E, et al. Predictors of differential response to induction therapy in high-risk neuroblastoma: a report from the Children's oncology group (COG). Eur J Cancer. 2019;112:66-79. doi:10.1016/j.ejca.2019.02.003
van Golen CM, Schwab TS, Kim B, et al. Insulin-like growth factor-I receptor expression regulates neuroblastoma metastasis to bone. Cancer Res. 2006;66:6570-6578. doi:10.1158/0008-5472.CAN-05-1448
Ara T, DeClerck YA. Mechanisms of invasion and metastasis in human neuroblastoma. Cancer Metastasis Rev. 2006;25:645-657. doi:10.1007/s10555-006-9028-9
Uemura S, Ishida T, Thwin KKM, et al. Dynamics of minimal residual disease in neuroblastoma patients. Front Oncol. 2019;9:455. doi:10.3389/fonc.2019.00455
Mora J, Chan GC, Morgenstern DA, et al. Outpatient administration of naxitamab in combination with granulocyte-macrophage colony-stimulating factor in patients with refractory and/or relapsed high-risk neuroblastoma: management of adverse events. Cancer Rep (Hoboken). 2023;6:e1627. doi:10.1002/cnr2.1627
Nysom K, Morad AG, Rafael MS, et al. Pain mitigation and management strategies for anti-GD2 infusions: an expert consensus. Pediatr Blood Cancer. 2023;70:e30217. doi:10.1002/pbc.30217
Cabral J, Fernandez EI, Toy B, Secola R. Multidisciplinary clinical care in the management of patients receiving anti-GD2 immunotherapy for high-risk neuroblastoma. Paediatr Drugs. 2023;25:13-25. doi:10.1007/s40272-022-00544-9
Cohen M, Allessi K, Kirwan B, Heinz N. Home in time for supper: humanized anti-GD2 antibody in the outpatient setting (abstract 404). https://www.anrmeeting.org/dl/ANR2018/ANR_Abstract_Book_5-3-18.pdf
Danyelza® (naxitamab-gqgk). Prescribing Information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761171lbl.pdf
Castañeda A, Gorostegui M, Miralles SL, et al. How we approach the treatment of patients with high-risk neuroblastoma with naxitamab: experience from the hospital Sant Joan de Déu in Barcelona, Spain. ESMO Open. 2022;7:100462. doi:10.1016/j.esmoop.2022
Starcke K, Mayr J, von Georgi R. Emotion modulation through music after sadness induction-the iso principle in a controlled experimental study. Int J Environ Res Public Health. 2021;18:12486. doi:10.3390/ijerph182312486

Auteurs

Erin Murphy Trovillion (EM)

Atrium Health Levine Children's Hospital, Charlotte, North Carolina, USA.

Meghan Michael (M)

Atrium Health Levine Children's Hospital, Charlotte, North Carolina, USA.

Cathryn C Jordan (CC)

Atrium Health Levine Children's Hospital, Charlotte, North Carolina, USA.

Lauren Brown (L)

Atrium Health Levine Children's Hospital, Charlotte, North Carolina, USA.

Katlin Phillips (K)

Atrium Health Levine Children's Hospital, Charlotte, North Carolina, USA.

Javier Oesterheld (J)

Atrium Health Levine Children's Hospital, Charlotte, North Carolina, USA.

Giselle Saulnier-Sholler (G)

Atrium Health Levine Children's Hospital, Charlotte, North Carolina, USA.

Classifications MeSH