A One-Bag Rapid Desensitization Protocol for Paclitaxel Hypersensitivity: A Noninferior Alternative to a Multi-Bag Rapid Desensitization Protocol

Jae Ha Lee, Mira Moon, Young Chan Kim, Soo Jie Chung, Jihyun Oh, Dong Yoon Kang, Suh Young Lee, Kyung Hun Lee, James Yun, Hye Ryun Kang

Research output: Contribution to journalArticle

Abstract

Background: Desensitization is used to safely continue treatment with a culprit drug in patients with drug hypersensitivity. Currently, a multi-bag protocol is widely used for rapid desensitization, but performing the desensitization procedure is labor intensive as pharmacists and nurses need to prepare and administer diluted solutions. However, it has not been investigated whether dilution is essential for successful desensitization. Objective: To investigate the efficacy and safety of a nondilution, 1-bag protocol in comparison with a conventional multi-bag protocol for desensitization of patients with paclitaxel hypersensitivity. Methods: Patients who underwent paclitaxel desensitization between 2011 and 2018 were analyzed in this retrospective cohort study. The completion rate, time to completion, and occurrence and severity of breakthrough reaction (BTR) between a 1-bag protocol and a multi-bag protocol were compared. Results: A total of 211 desensitization procedures were performed, of which 207 procedures (98.1%) were completed successfully. The administration time was significantly shorter in the 1-bag protocol group compared with the conventional multi-bag protocol group (266.0 ± 149.3 minutes vs 484.2 ± 178.6 minutes, P < .05) without differences in the completion rate (97.6% vs 98.9%, P = .645), the incidence of BTR (16.1% vs 27.6%, P = .778), and the proportion of severe BTR (2.6% vs 5.7%, P = .134). Conclusions: A nondilution, 1-bag protocol is noninferior to a multi-bag rapid desensitization protocol and can be a safe and effective option for paclitaxel desensitization.

Original languageEnglish
Pages (from-to)696-703
Number of pages8
JournalJournal of Allergy and Clinical Immunology: In Practice
Volume8
Issue number2
DOIs
StatePublished - Feb 2020

Fingerprint

Paclitaxel
Hypersensitivity
Drug Hypersensitivity
Pharmacists
Cohort Studies
Retrospective Studies
Nurses
Safety
Incidence
Pharmaceutical Preparations
Therapeutics

Keywords

  • Antineoplastic agents
  • Desensitization
  • Drug hypersensitivity
  • Immunologic
  • Paclitaxel

Cite this

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title = "A One-Bag Rapid Desensitization Protocol for Paclitaxel Hypersensitivity: A Noninferior Alternative to a Multi-Bag Rapid Desensitization Protocol",
abstract = "Background: Desensitization is used to safely continue treatment with a culprit drug in patients with drug hypersensitivity. Currently, a multi-bag protocol is widely used for rapid desensitization, but performing the desensitization procedure is labor intensive as pharmacists and nurses need to prepare and administer diluted solutions. However, it has not been investigated whether dilution is essential for successful desensitization. Objective: To investigate the efficacy and safety of a nondilution, 1-bag protocol in comparison with a conventional multi-bag protocol for desensitization of patients with paclitaxel hypersensitivity. Methods: Patients who underwent paclitaxel desensitization between 2011 and 2018 were analyzed in this retrospective cohort study. The completion rate, time to completion, and occurrence and severity of breakthrough reaction (BTR) between a 1-bag protocol and a multi-bag protocol were compared. Results: A total of 211 desensitization procedures were performed, of which 207 procedures (98.1{\%}) were completed successfully. The administration time was significantly shorter in the 1-bag protocol group compared with the conventional multi-bag protocol group (266.0 ± 149.3 minutes vs 484.2 ± 178.6 minutes, P < .05) without differences in the completion rate (97.6{\%} vs 98.9{\%}, P = .645), the incidence of BTR (16.1{\%} vs 27.6{\%}, P = .778), and the proportion of severe BTR (2.6{\%} vs 5.7{\%}, P = .134). Conclusions: A nondilution, 1-bag protocol is noninferior to a multi-bag rapid desensitization protocol and can be a safe and effective option for paclitaxel desensitization.",
keywords = "Antineoplastic agents, Desensitization, Drug hypersensitivity, Immunologic, Paclitaxel",
author = "Lee, {Jae Ha} and Mira Moon and Kim, {Young Chan} and Chung, {Soo Jie} and Jihyun Oh and Kang, {Dong Yoon} and Lee, {Suh Young} and Lee, {Kyung Hun} and James Yun and Kang, {Hye Ryun}",
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A One-Bag Rapid Desensitization Protocol for Paclitaxel Hypersensitivity : A Noninferior Alternative to a Multi-Bag Rapid Desensitization Protocol. / Lee, Jae Ha; Moon, Mira; Kim, Young Chan; Chung, Soo Jie; Oh, Jihyun; Kang, Dong Yoon; Lee, Suh Young; Lee, Kyung Hun; Yun, James; Kang, Hye Ryun.

In: Journal of Allergy and Clinical Immunology: In Practice, Vol. 8, No. 2, 02.2020, p. 696-703.

Research output: Contribution to journalArticle

TY - JOUR

T1 - A One-Bag Rapid Desensitization Protocol for Paclitaxel Hypersensitivity

T2 - A Noninferior Alternative to a Multi-Bag Rapid Desensitization Protocol

AU - Lee, Jae Ha

AU - Moon, Mira

AU - Kim, Young Chan

AU - Chung, Soo Jie

AU - Oh, Jihyun

AU - Kang, Dong Yoon

AU - Lee, Suh Young

AU - Lee, Kyung Hun

AU - Yun, James

AU - Kang, Hye Ryun

PY - 2020/2

Y1 - 2020/2

N2 - Background: Desensitization is used to safely continue treatment with a culprit drug in patients with drug hypersensitivity. Currently, a multi-bag protocol is widely used for rapid desensitization, but performing the desensitization procedure is labor intensive as pharmacists and nurses need to prepare and administer diluted solutions. However, it has not been investigated whether dilution is essential for successful desensitization. Objective: To investigate the efficacy and safety of a nondilution, 1-bag protocol in comparison with a conventional multi-bag protocol for desensitization of patients with paclitaxel hypersensitivity. Methods: Patients who underwent paclitaxel desensitization between 2011 and 2018 were analyzed in this retrospective cohort study. The completion rate, time to completion, and occurrence and severity of breakthrough reaction (BTR) between a 1-bag protocol and a multi-bag protocol were compared. Results: A total of 211 desensitization procedures were performed, of which 207 procedures (98.1%) were completed successfully. The administration time was significantly shorter in the 1-bag protocol group compared with the conventional multi-bag protocol group (266.0 ± 149.3 minutes vs 484.2 ± 178.6 minutes, P < .05) without differences in the completion rate (97.6% vs 98.9%, P = .645), the incidence of BTR (16.1% vs 27.6%, P = .778), and the proportion of severe BTR (2.6% vs 5.7%, P = .134). Conclusions: A nondilution, 1-bag protocol is noninferior to a multi-bag rapid desensitization protocol and can be a safe and effective option for paclitaxel desensitization.

AB - Background: Desensitization is used to safely continue treatment with a culprit drug in patients with drug hypersensitivity. Currently, a multi-bag protocol is widely used for rapid desensitization, but performing the desensitization procedure is labor intensive as pharmacists and nurses need to prepare and administer diluted solutions. However, it has not been investigated whether dilution is essential for successful desensitization. Objective: To investigate the efficacy and safety of a nondilution, 1-bag protocol in comparison with a conventional multi-bag protocol for desensitization of patients with paclitaxel hypersensitivity. Methods: Patients who underwent paclitaxel desensitization between 2011 and 2018 were analyzed in this retrospective cohort study. The completion rate, time to completion, and occurrence and severity of breakthrough reaction (BTR) between a 1-bag protocol and a multi-bag protocol were compared. Results: A total of 211 desensitization procedures were performed, of which 207 procedures (98.1%) were completed successfully. The administration time was significantly shorter in the 1-bag protocol group compared with the conventional multi-bag protocol group (266.0 ± 149.3 minutes vs 484.2 ± 178.6 minutes, P < .05) without differences in the completion rate (97.6% vs 98.9%, P = .645), the incidence of BTR (16.1% vs 27.6%, P = .778), and the proportion of severe BTR (2.6% vs 5.7%, P = .134). Conclusions: A nondilution, 1-bag protocol is noninferior to a multi-bag rapid desensitization protocol and can be a safe and effective option for paclitaxel desensitization.

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KW - Desensitization

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KW - Immunologic

KW - Paclitaxel

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