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Real-World Utilization and Safety of Daratumumab IV Rapid Infusions Administered in a Community Setting: A Retrospective Observational Study

BACKGROUND: Some institutions have implemented a daratumumab intravenous rapid-infusion protocol in which patients with multiple myeloma (MM) receive their third and subsequent infusions within ~ 90 min instead of ≥ 3 h. OBJECTIVE: This study sought to understand the utilization, effectiveness, and...

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Autores principales: Gordan, Lucio, Chang, Melody, Lafeuille, Marie-Hélène, Romdhani, Hela, Paramasivam, Fuad, Maiese, Eric M., McKay, Caroline
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8128966/
https://www.ncbi.nlm.nih.gov/pubmed/33565004
http://dx.doi.org/10.1007/s40801-020-00226-3
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author Gordan, Lucio
Chang, Melody
Lafeuille, Marie-Hélène
Romdhani, Hela
Paramasivam, Fuad
Maiese, Eric M.
McKay, Caroline
author_facet Gordan, Lucio
Chang, Melody
Lafeuille, Marie-Hélène
Romdhani, Hela
Paramasivam, Fuad
Maiese, Eric M.
McKay, Caroline
author_sort Gordan, Lucio
collection PubMed
description BACKGROUND: Some institutions have implemented a daratumumab intravenous rapid-infusion protocol in which patients with multiple myeloma (MM) receive their third and subsequent infusions within ~ 90 min instead of ≥ 3 h. OBJECTIVE: This study sought to understand the utilization, effectiveness, and infusion reactions (IRs) observed in patients with MM who received daratumumab rapid infusions. METHODS: Electronic medical records from Florida Cancer Specialists & Research Institute were used. Adult patients with MM who received one or more rapid daratumumab infusion (full dose in ≤ 110 min) at their third or later infusion of the first daratumumab-containing regimen (index date: 16 November 2015 to 15 March 2019) were included. IRs included events that (1) occurred ≤ 24 h post-daratumumab infusion or (2) were stated as an IR in the patient charts. Non-IR adverse events (AEs) were events attributed to daratumumab in patient charts that did not meet the IR definition. RESULTS: In total, 147 patients received one or more rapid infusion in their first daratumumab-containing regimen. Median time from initial MM diagnosis to index date was 2.5 years. Non-IR AEs occurred in 10.2% of patients during treatment, and 36.7% experienced one or more IR after receiving a daratumumab infusion. No IRs occurred after a rapid infusion. The overall response rate was 91.1% (after rapid infusions only: 71.3%). CONCLUSIONS: This study provides real-world evidence on the practice patterns of daratumumab rapid infusions in a large community-based oncology clinic system. These results suggest that treatment regimens including daratumumab rapid infusions at the third infusion or later were well-tolerated, and their effectiveness was comparable to that observed in clinical trials. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40801-020-00226-3.
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spelling pubmed-81289662021-05-27 Real-World Utilization and Safety of Daratumumab IV Rapid Infusions Administered in a Community Setting: A Retrospective Observational Study Gordan, Lucio Chang, Melody Lafeuille, Marie-Hélène Romdhani, Hela Paramasivam, Fuad Maiese, Eric M. McKay, Caroline Drugs Real World Outcomes Original Research Article BACKGROUND: Some institutions have implemented a daratumumab intravenous rapid-infusion protocol in which patients with multiple myeloma (MM) receive their third and subsequent infusions within ~ 90 min instead of ≥ 3 h. OBJECTIVE: This study sought to understand the utilization, effectiveness, and infusion reactions (IRs) observed in patients with MM who received daratumumab rapid infusions. METHODS: Electronic medical records from Florida Cancer Specialists & Research Institute were used. Adult patients with MM who received one or more rapid daratumumab infusion (full dose in ≤ 110 min) at their third or later infusion of the first daratumumab-containing regimen (index date: 16 November 2015 to 15 March 2019) were included. IRs included events that (1) occurred ≤ 24 h post-daratumumab infusion or (2) were stated as an IR in the patient charts. Non-IR adverse events (AEs) were events attributed to daratumumab in patient charts that did not meet the IR definition. RESULTS: In total, 147 patients received one or more rapid infusion in their first daratumumab-containing regimen. Median time from initial MM diagnosis to index date was 2.5 years. Non-IR AEs occurred in 10.2% of patients during treatment, and 36.7% experienced one or more IR after receiving a daratumumab infusion. No IRs occurred after a rapid infusion. The overall response rate was 91.1% (after rapid infusions only: 71.3%). CONCLUSIONS: This study provides real-world evidence on the practice patterns of daratumumab rapid infusions in a large community-based oncology clinic system. These results suggest that treatment regimens including daratumumab rapid infusions at the third infusion or later were well-tolerated, and their effectiveness was comparable to that observed in clinical trials. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40801-020-00226-3. Springer International Publishing 2021-02-09 /pmc/articles/PMC8128966/ /pubmed/33565004 http://dx.doi.org/10.1007/s40801-020-00226-3 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by-nc/4.0/Open AccessThis article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Original Research Article
Gordan, Lucio
Chang, Melody
Lafeuille, Marie-Hélène
Romdhani, Hela
Paramasivam, Fuad
Maiese, Eric M.
McKay, Caroline
Real-World Utilization and Safety of Daratumumab IV Rapid Infusions Administered in a Community Setting: A Retrospective Observational Study
title Real-World Utilization and Safety of Daratumumab IV Rapid Infusions Administered in a Community Setting: A Retrospective Observational Study
title_full Real-World Utilization and Safety of Daratumumab IV Rapid Infusions Administered in a Community Setting: A Retrospective Observational Study
title_fullStr Real-World Utilization and Safety of Daratumumab IV Rapid Infusions Administered in a Community Setting: A Retrospective Observational Study
title_full_unstemmed Real-World Utilization and Safety of Daratumumab IV Rapid Infusions Administered in a Community Setting: A Retrospective Observational Study
title_short Real-World Utilization and Safety of Daratumumab IV Rapid Infusions Administered in a Community Setting: A Retrospective Observational Study
title_sort real-world utilization and safety of daratumumab iv rapid infusions administered in a community setting: a retrospective observational study
topic Original Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8128966/
https://www.ncbi.nlm.nih.gov/pubmed/33565004
http://dx.doi.org/10.1007/s40801-020-00226-3
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