Intravenous fosaprepitant for the prevention of chemotherapy-induced vomiting in children: A double-blind, placebo-controlled, phase III randomized trial
| Autor: | Prasanth Ganesan, Trivadi S. Ganesan, Swaminathan Rajaraman, Tenali Gnana Sagar, Venkatraman Radhakrishnan, Archit Joshi, Jaikumar Ramamoorthy, Manikandan Dhanushkodi |
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| Rok vydání: | 2018 |
| Předmět: |
Male
Vomiting Nausea Morpholines Placebo Fosaprepitant law.invention Ondansetron 03 medical and health sciences 0302 clinical medicine Double-Blind Method Randomized controlled trial law Neoplasms Antineoplastic Combined Chemotherapy Protocols medicine Humans Retching Child business.industry Infant Hematology Prognosis Pediatric cancer Oncology Case-Control Studies Child Preschool 030220 oncology & carcinogenesis Anesthesia Pediatrics Perinatology and Child Health Antiemetics Administration Intravenous Female medicine.symptom business Follow-Up Studies 030215 immunology medicine.drug |
| Zdroj: | Pediatric Blood & Cancer. 66:e27551 |
| ISSN: | 1545-5009 |
| DOI: | 10.1002/pbc.27551 |
| Popis: | BACKGROUND Fosaprepitant is a neurokinin-1 receptor antagonist, approved for the prevention of chemotherapy-induced nausea and vomiting. The data on the use of fosaprepitant in children are limited and therefore we conducted a phase III randomized controlled trial. PROCEDURE Children aged 1-12 years scheduled to receive moderately or highly emetogenic chemotherapy were randomly assigned to arm-A (fosaprepitant) or arm-B (placebo). Children recruited to arm-A received intravenous ondansetron plus dexamethasone followed by fosaprepitant infusion. Children recruited to arm-B received the same drugs as those given to children in arm-A, except that fosaprepitant was substituted with a placebo. Ondansetron and dexamethasone were continued for 48 hours after completion of chemotherapy. The primary end point of the study was to determine the proportion of patients who achieved a complete response (CR), defined as no vomiting, no retching, and no use of rescue medication, during the 24-120 hours (delayed phase) after administration of the last dose of chemotherapy. Secondary end points were the proportion of patients who achieved a CR during the acute phase (0-24 hours) and overall after administration of the last dose of chemotherapy. RESULTS One-hundred-sixty-three patients were analyzed (81 in the fosaprepitant arm and 82 in the placebo arm). CR rates were significantly higher in the fosaprepitant arm compared to those in the placebo arm during the acute phase (86% vs 60%, P |
| Databáze: | OpenAIRE |
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