Randomized, controlled trial of dexamethasone versus dexamethasone plus hydrocortisone as prophylaxis for hypersensitivity reactions due to paclitaxel treatment for gynecologic cancer
© 2017 by IGCS and ESGO. Objective: The aim of this studywas to assess intravenous hydrocortisone (HCT) added to standard dexamethasone (DXM) prophylaxis for paclitaxel-associated hypersensitivity reactions (HSRs). Methods: Paclitaxel naives scheduled for 6 cycles of paclitaxel (plus platinum) were...
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th-cmuir.6653943832-577822018-09-05T03:49:44Z Randomized, controlled trial of dexamethasone versus dexamethasone plus hydrocortisone as prophylaxis for hypersensitivity reactions due to paclitaxel treatment for gynecologic cancer Dhammapoj Jeerakornpassawat Prapaporn Suprasert Medicine © 2017 by IGCS and ESGO. Objective: The aim of this studywas to assess intravenous hydrocortisone (HCT) added to standard dexamethasone (DXM) prophylaxis for paclitaxel-associated hypersensitivity reactions (HSRs). Methods: Paclitaxel naives scheduled for 6 cycles of paclitaxel (plus platinum) were randomized to DXM alone (20 mg intravenously [IV]) versus DXM plus HCT (100 mg IV) as premedication including chlorpheniramine (10 mg IV), diphenhydramine (25 mg orally), and ranitidine (50 mg IV) 30 minutes before infusion. Clinic nurses observed for HSRs. Groups were well balanced for cancer type, stage, drug allergy, chemotherapy naivete, mean age, body mass index, and paclitaxel dose. Results: The 44 DXM controls underwent 213 cycles and the 42 investigational DXM plus HCT group 192 per protocol cycles. Hypersensitivity reactions were observed among 9 (4.2%) DXM only cycles compared with 1 (0.5%) among DXM plus HCT cycles (P = 0.022). Hypersensitivity reactions occurred in 8 (18%) DXM only patients and in 1 (2.4%) among those correctly receivingDXM plus HCT (P = 0.030). All HSRs occurred in cycles 1 to 3, within 10 to 40 minutes after infusion initiation, and peaked in cycle 2 (5/39) for DXM recipients and in cycle 3 (1/30) for DXM plus HCT. Hypersensitivity reaction severity was grade 1 in 3DXMonly recipients and grade 2 in 6DXMand 1DXMplusHCT.Asole grade 3 HSR was in an intention-to-treat DXM-HCT patient, who erroneously received no HCT. Hypersensitivity reaction symptomswere facial flushing (8 episodes), dyspnea (7), palmar rash (1), and transient hypotension (1). Paclitaxel infusionwas suspended for treatment ofHSRs; in all cases, symptoms mitigated and infusion successfully restarted for the remaining dose. Conclusions: Adding HCT to routine DXM prophylaxis significantly decreased paclitaxel HSR frequency. 2018-09-05T03:49:44Z 2018-09-05T03:49:44Z 2017-01-01 Journal 15251438 1048891X 2-s2.0-85041656883 10.1097/IGC.0000000000001069 https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85041656883&origin=inward http://cmuir.cmu.ac.th/jspui/handle/6653943832/57782 |
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Medicine Dhammapoj Jeerakornpassawat Prapaporn Suprasert Randomized, controlled trial of dexamethasone versus dexamethasone plus hydrocortisone as prophylaxis for hypersensitivity reactions due to paclitaxel treatment for gynecologic cancer |
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© 2017 by IGCS and ESGO. Objective: The aim of this studywas to assess intravenous hydrocortisone (HCT) added to standard dexamethasone (DXM) prophylaxis for paclitaxel-associated hypersensitivity reactions (HSRs). Methods: Paclitaxel naives scheduled for 6 cycles of paclitaxel (plus platinum) were randomized to DXM alone (20 mg intravenously [IV]) versus DXM plus HCT (100 mg IV) as premedication including chlorpheniramine (10 mg IV), diphenhydramine (25 mg orally), and ranitidine (50 mg IV) 30 minutes before infusion. Clinic nurses observed for HSRs. Groups were well balanced for cancer type, stage, drug allergy, chemotherapy naivete, mean age, body mass index, and paclitaxel dose. Results: The 44 DXM controls underwent 213 cycles and the 42 investigational DXM plus HCT group 192 per protocol cycles. Hypersensitivity reactions were observed among 9 (4.2%) DXM only cycles compared with 1 (0.5%) among DXM plus HCT cycles (P = 0.022). Hypersensitivity reactions occurred in 8 (18%) DXM only patients and in 1 (2.4%) among those correctly receivingDXM plus HCT (P = 0.030). All HSRs occurred in cycles 1 to 3, within 10 to 40 minutes after infusion initiation, and peaked in cycle 2 (5/39) for DXM recipients and in cycle 3 (1/30) for DXM plus HCT. Hypersensitivity reaction severity was grade 1 in 3DXMonly recipients and grade 2 in 6DXMand 1DXMplusHCT.Asole grade 3 HSR was in an intention-to-treat DXM-HCT patient, who erroneously received no HCT. Hypersensitivity reaction symptomswere facial flushing (8 episodes), dyspnea (7), palmar rash (1), and transient hypotension (1). Paclitaxel infusionwas suspended for treatment ofHSRs; in all cases, symptoms mitigated and infusion successfully restarted for the remaining dose. Conclusions: Adding HCT to routine DXM prophylaxis significantly decreased paclitaxel HSR frequency. |
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Journal |
author |
Dhammapoj Jeerakornpassawat Prapaporn Suprasert |
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Dhammapoj Jeerakornpassawat Prapaporn Suprasert |
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Dhammapoj Jeerakornpassawat |
title |
Randomized, controlled trial of dexamethasone versus dexamethasone plus hydrocortisone as prophylaxis for hypersensitivity reactions due to paclitaxel treatment for gynecologic cancer |
title_short |
Randomized, controlled trial of dexamethasone versus dexamethasone plus hydrocortisone as prophylaxis for hypersensitivity reactions due to paclitaxel treatment for gynecologic cancer |
title_full |
Randomized, controlled trial of dexamethasone versus dexamethasone plus hydrocortisone as prophylaxis for hypersensitivity reactions due to paclitaxel treatment for gynecologic cancer |
title_fullStr |
Randomized, controlled trial of dexamethasone versus dexamethasone plus hydrocortisone as prophylaxis for hypersensitivity reactions due to paclitaxel treatment for gynecologic cancer |
title_full_unstemmed |
Randomized, controlled trial of dexamethasone versus dexamethasone plus hydrocortisone as prophylaxis for hypersensitivity reactions due to paclitaxel treatment for gynecologic cancer |
title_sort |
randomized, controlled trial of dexamethasone versus dexamethasone plus hydrocortisone as prophylaxis for hypersensitivity reactions due to paclitaxel treatment for gynecologic cancer |
publishDate |
2018 |
url |
https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85041656883&origin=inward http://cmuir.cmu.ac.th/jspui/handle/6653943832/57782 |
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