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Single-dose fosaprepitant in combination with the standard antiemetic regimen of granisetron and dexamethasone appears to be safe and effective as an antiemetic prophylaxis in pediatric patients receiving moderately or highly emetogenic chemotherapy, according to data presented at the 2017 American Society of Hematology Annual Meeting (ASH 2017).
Researchers reported that the efficacy of a triple-prophylaxis with the NK1R-antagonist fosaprepitant in combination with the 5-HT3R-antagonist granisetron and the corticosteroid dexamethasone was significantly superior compared with a prophylaxis regimen with granisetron plus dexamethasone alone.
Michaela Döring, Dr Med, who is with the University Children’s Hospital in Tuebingen, Germany, and colleagues conducted a comparative analysis to assess the efficacy and safety of a combination of intravenous fosaprepitant, granisetron, and dexamethasone compared with a standard prophylaxis regimen of granisetron and dexamethasone alone in 86 pediatric patients. In this retrospective single-center chart analysis, all the patients (median age 7 years [2 to 7 years]) received either antiemetic prophylaxis regimen via intravenous infusion (less than 30 minutes) of fosaprepitant (maximum 150 mg) and/or granisetron (maximum 3 mg) and dexamethasone (maximum 4 mg).
The two regimens were compared based on vomiting frequency, percentages of patients experiencing vomiting, and additional therapeutic medication with dimenhydrinate in the acute chemotherapy-induced nausea and vomiting (CINV; less than 24 hours) phase and the delayed CINV phase (24 to 100 hours). The researchers also assessed drug-related clinical side effects (exanthema, sweating, and gastrointestinal symptoms) and laboratory side effects (changes in liver and kidney parameters, electrolytes).
The study showed that both prophylaxis regimens were similarly safe. In addition, there were no differences with respect to clinical or laboratory drug-related adverse events (AEs). No patients had to discontinue the antiemetic medications. The percentages of patients experiencing vomiting was significantly lower in the fosaprepitant group, both in the acute CINV phase (P <.01) and in the delayed CINV phase (P <.001) compared with the granisetron and dexamethasone combination alone. Significantly fewer vomiting events occurred in the fosaprepitant group in the acute CINV phase (P <.001) and the delayed CINV phase (P <.001). The researchers also found that a significantly lower percentage of patients required additional medication with dimenhydrinate (P <.001).
In previous studies, fosaprepitant has demonstrated favorable results in adult patients receiving moderately and highly emetogenic chemotherapy when used in a combination prophylaxis with granisetron. This is the first study to look at this triple combination in a pediatric population.
Döring M, Cabanillas Stanchi KM, Queudeville M, et al. Antiemetic prophylaxis with granisetron and fosaprepitant during moderate and high emetogenic chemotherapy in pediatric patients. Poster presentation at: 2017 American Society of Hematology Annual Meeting; December 9-12, 2017; Atlanta, GA. Abstract 3228.