Aprepitant in adolescent patients for prevention of chemotherapy-induced nausea and vomiting: A randomized, double-blind, placebo-controlled study of efficacy and tolerability
| Autor: | Lia, Gore, Sant, Chawla, Antonio, Petrilli, Molly, Hemenway, Debra, Schissel, Vickey, Chua, Alexandra D, Carides, Arlene, Taylor, Suzanne, Devandry, Jack, Valentine, Judith K, Evans, Bettina, Oxenius, Joanna L, Weinstein |
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| Rok vydání: | 2009 |
| Předmět: |
Neutropenia
Adolescent Drug-Related Side Effects and Adverse Reactions Metabolic Clearance Rate Vomiting medicine.drug_class Nausea Morpholines Cmax Antineoplastic Agents Dexamethasone Placebos Ondansetron Young Adult Double-Blind Method Humans Medicine Antiemetic Child Aprepitant business.industry Hematology Treatment Outcome Oncology Tolerability Area Under Curve Anesthesia Pediatrics Perinatology and Child Health NK1 receptor antagonist medicine.symptom business medicine.drug Chemotherapy-induced nausea and vomiting |
| Zdroj: | Pediatric Blood & Cancer. 52:242-247 |
| ISSN: | 1545-5017 1545-5009 |
| DOI: | 10.1002/pbc.21811 |
| Popis: | Background The neurokinin-1 receptor antagonist aprepitant, plus a 5HT3 antagonist and corticosteroid is well-tolerated and effective in preventing chemotherapy-induced nausea and vomiting in adults but has not been formally assessed in adolescents. Procedure Patients age 11–19 years old receiving emetogenic chemotherapy were randomized 2:1 to aprepitant triple therapy (aprepitant [A] 125 mg p.o., dexamethasone [D] 8 mg p.o., and ondansetron [O] 0.15 mg/kg i.v. t.i.d. day 1; A 80 mg, D 4 mg, and O 0.15 mg/kg t.i.d. day 2; A 80 mg and D 4 mg day 3; and D 4 mg day 4) or a control regimen (D 16 mg and O 0.15 mg/kg t.i.d. day 1; D 8 mg and O 0.15 mg/kg t.i.d. day 2; and D 8 mg days 3 and 4). The primary endpoint was the difference in drug-related adverse events during and for 14 days following treatment. Efficacy and aprepitant pharmacokinetics were assessed. Results Baseline characteristics were similar between aprepitant (N = 28) and control (N = 18) groups. Febrile neutropenia was more frequent in the aprepitant group (25% vs. 11.1%). Complete response (CR) rates were 35.7% for aprepitant triple therapy versus 5.6% for the control group. Mean plasma aprepitant AUC0–24 hr and Cmax on day 1 and mean trough concentrations on days 2 and 3 were consistently lower compared to historical data obtained from healthy adults; however, the differences were not clinically significant. Conclusion Aprepitant triple therapy was generally well tolerated; CR were greater with aprepitant, although not statistically significant. Pharmacokinetics suggest that the adult dosing regimen is appropriate for adolescents. Pediatr Blood Cancer 2009;52:242–247. © 2008 Wiley-Liss, Inc. |
| Databáze: | OpenAIRE |
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