Jae-Ha Lee1, Mira Moon1, Young-Chan Kim2, Soo Jie Chung2, Jihyun Oh2, Dong-Yoon Kang1, Suh-Young Lee3, Kyung-Hun Lee4, James Yun5, Hye-Ryun Kang6. 1. Seoul National University Hospital Regional Pharmacovigilance Center, Seoul, Korea. 2. Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea. 3. Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea; Institute of Allergy and Clinical Immunology, Seoul National University Medical Research Center, Seoul National University College of Medicine, Seoul, Korea. 4. Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea; Cancer Research Institute, Seoul National University Hospital, Seoul, Korea. 5. Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia; Division of Medicine, Nepean Hospital, Sydney, NSW, Australia. 6. Seoul National University Hospital Regional Pharmacovigilance Center, Seoul, Korea; Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea; Institute of Allergy and Clinical Immunology, Seoul National University Medical Research Center, Seoul National University College of Medicine, Seoul, Korea. Electronic address: helenmed@snu.ac.kr.
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.
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 paclitaxelhypersensitivity. 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.
Authors: Hyun Hwa Kim; Jeongmin Seo; Yoon Hae Ahn; Hyunjee Kim; Jeong-Eun Yoon; Jang Ho Suh; Dong Yoon Kang; Suh Young Lee; Hye-Ryun Kang Journal: Front Allergy Date: 2022-02-11