The efficacy of premedication with 10 mg versus 20 mg of intravenous dexamethasone for prevention of paclitaxel hypersensitivity reaction in low-risk gynecologic cancer patients: a non-inferiority, randomized controlled mono-institutional trial
Abstract Background Dexamethasone has been used extensively to prevent hypersensitivity reactions to paclitaxel. However, the optimal dose of dexamethasone is controversial, varying between 20 mg and 10 mg. We conducted this randomized controlled trial to illustrate that these 2 dosages of dexametha...
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2025-08-01
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| Online Access: | https://doi.org/10.1186/s12885-025-14769-7 |
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| author | Nutthakarn Sa-ngiamphorn Prapaporn Suprasert Chaiyut Charoentum |
| author_facet | Nutthakarn Sa-ngiamphorn Prapaporn Suprasert Chaiyut Charoentum |
| author_sort | Nutthakarn Sa-ngiamphorn |
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| description | Abstract Background Dexamethasone has been used extensively to prevent hypersensitivity reactions to paclitaxel. However, the optimal dose of dexamethasone is controversial, varying between 20 mg and 10 mg. We conducted this randomized controlled trial to illustrate that these 2 dosages of dexamethasone are non-inferior to the prevention of paclitaxel HSRs. Methods Gynecologic cancer patients who naively receive paclitaxel and carboplatin were invited to participate in this study. All participants received the same premedication with intravenous dexamethasone 20 mg, oral lorazepam 0.5 mg, and intravenous chlorpheniramine 10 mg at the first cycle. If they did not develop hypersensitivity reactions, they were randomized to receive either intravenous 20 mg or 10 mg dexamethasone with the same other premedication. The attending nurse recorded the patient’s symptoms regarding hypersensitivity reactions. The main outcome was hypersensitivity reaction events in each arm, with a non-inferiority margin of 0.11. Results A total of 122 patients were included and randomly assigned to receive dexamethasone 10 mg (n = 61) or dexamethasone 20 mg (n = 61). The overall incidence of hypersensitivity reactions in patients who received dexamethasone 10 mg and dexamethasone 20 mg was 9.8% and 13.1%, respectively, the risk difference between dexamethasone 10 mg and dexamethasone 20 mg not exceeding the non-inferiority margin of 0.11 (Risk Difference = -0.03, 95% confidence interval = -0.15 to 0.08). Conclusion Dexamethasone 10 mg was non-inferior to dexamethasone 20 mg in terms of prevention of paclitaxel hypersensitivity reactions. |
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| institution | Kabale University |
| issn | 1471-2407 |
| language | English |
| publishDate | 2025-08-01 |
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| series | BMC Cancer |
| spelling | doaj-art-92a191799c9d47d7a4705fe7a6f8f1282025-08-20T03:46:54ZengBMCBMC Cancer1471-24072025-08-012511910.1186/s12885-025-14769-7The efficacy of premedication with 10 mg versus 20 mg of intravenous dexamethasone for prevention of paclitaxel hypersensitivity reaction in low-risk gynecologic cancer patients: a non-inferiority, randomized controlled mono-institutional trialNutthakarn Sa-ngiamphorn0Prapaporn Suprasert1Chaiyut Charoentum2Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Faculty of Medicine, Chiang Mai UniversityDivision of Gynecologic Oncology, Department of Obstetrics and Gynecology, Faculty of Medicine, Chiang Mai UniversityDivision of Medical Oncology, Department of Medicine, Faculty of Medicine, Chiang Mai UniversityAbstract Background Dexamethasone has been used extensively to prevent hypersensitivity reactions to paclitaxel. However, the optimal dose of dexamethasone is controversial, varying between 20 mg and 10 mg. We conducted this randomized controlled trial to illustrate that these 2 dosages of dexamethasone are non-inferior to the prevention of paclitaxel HSRs. Methods Gynecologic cancer patients who naively receive paclitaxel and carboplatin were invited to participate in this study. All participants received the same premedication with intravenous dexamethasone 20 mg, oral lorazepam 0.5 mg, and intravenous chlorpheniramine 10 mg at the first cycle. If they did not develop hypersensitivity reactions, they were randomized to receive either intravenous 20 mg or 10 mg dexamethasone with the same other premedication. The attending nurse recorded the patient’s symptoms regarding hypersensitivity reactions. The main outcome was hypersensitivity reaction events in each arm, with a non-inferiority margin of 0.11. Results A total of 122 patients were included and randomly assigned to receive dexamethasone 10 mg (n = 61) or dexamethasone 20 mg (n = 61). The overall incidence of hypersensitivity reactions in patients who received dexamethasone 10 mg and dexamethasone 20 mg was 9.8% and 13.1%, respectively, the risk difference between dexamethasone 10 mg and dexamethasone 20 mg not exceeding the non-inferiority margin of 0.11 (Risk Difference = -0.03, 95% confidence interval = -0.15 to 0.08). Conclusion Dexamethasone 10 mg was non-inferior to dexamethasone 20 mg in terms of prevention of paclitaxel hypersensitivity reactions.https://doi.org/10.1186/s12885-025-14769-7DexamethasonePremedicationPaclitaxelHypersensitivity |
| spellingShingle | Nutthakarn Sa-ngiamphorn Prapaporn Suprasert Chaiyut Charoentum The efficacy of premedication with 10 mg versus 20 mg of intravenous dexamethasone for prevention of paclitaxel hypersensitivity reaction in low-risk gynecologic cancer patients: a non-inferiority, randomized controlled mono-institutional trial BMC Cancer Dexamethasone Premedication Paclitaxel Hypersensitivity |
| title | The efficacy of premedication with 10 mg versus 20 mg of intravenous dexamethasone for prevention of paclitaxel hypersensitivity reaction in low-risk gynecologic cancer patients: a non-inferiority, randomized controlled mono-institutional trial |
| title_full | The efficacy of premedication with 10 mg versus 20 mg of intravenous dexamethasone for prevention of paclitaxel hypersensitivity reaction in low-risk gynecologic cancer patients: a non-inferiority, randomized controlled mono-institutional trial |
| title_fullStr | The efficacy of premedication with 10 mg versus 20 mg of intravenous dexamethasone for prevention of paclitaxel hypersensitivity reaction in low-risk gynecologic cancer patients: a non-inferiority, randomized controlled mono-institutional trial |
| title_full_unstemmed | The efficacy of premedication with 10 mg versus 20 mg of intravenous dexamethasone for prevention of paclitaxel hypersensitivity reaction in low-risk gynecologic cancer patients: a non-inferiority, randomized controlled mono-institutional trial |
| title_short | The efficacy of premedication with 10 mg versus 20 mg of intravenous dexamethasone for prevention of paclitaxel hypersensitivity reaction in low-risk gynecologic cancer patients: a non-inferiority, randomized controlled mono-institutional trial |
| title_sort | efficacy of premedication with 10 mg versus 20 mg of intravenous dexamethasone for prevention of paclitaxel hypersensitivity reaction in low risk gynecologic cancer patients a non inferiority randomized controlled mono institutional trial |
| topic | Dexamethasone Premedication Paclitaxel Hypersensitivity |
| url | https://doi.org/10.1186/s12885-025-14769-7 |
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