Prophylactic Antiemetic Regimen Effective in Pediatric Hematologic Malignancies
A combination of prophylaxis plus fosaprepitant may be superior to ondansetron for use in the pediatric population.
Fosaprepitant as antiemetic prophylaxis during treatment with moderately and highly emetogenic chemotherapy appears to be safe, efficacious, and feasible in pediatric patients with hematologic malignancies who are younger than 12 years, according to results from a retrospective study. Researchers from Germany reported at the 2017 American Society of Hematology Annual Meeting (ASH 2017) that a combination prophylaxis with fosaprepitant may be superior to ondansetron, with fewer pediatric patients experiencing vomiting.
The researchers found that a combination prophylaxis with fosaprepitant resulted in an 11-fold lower rate of vomiting events in chemotherapy-induced nausea and vomiting (CINV) in the acute phase and a 4-fold lower rate in delayed CINV.
Antiemetic prophylaxis with a combination of ondansetron, corticosteroids, and aprepitant were previously shown to produce favorable results in adults compared with ondansetron and corticosteroids alone. However, there has been little investigation in pediatric populations. Semjon Willier, MD, who is with Dr von Hauner Children's Hospital at Ludwig-Maximilians-University, Munich, Germany, and colleagues conducted a retrospective single-center analysis with 79 pediatric patients. The children ranged in age from 8 months to 18 years (median, 8 years) and they all received either fosaprepitant (3.5 to 4 mg/kg [maximum 150 mg])/ondansetron combination prophylaxis or ondansetron only.
Intravenous ondansetron was started at least 30 minutes prior to start of chemotherapy and administered throughout the chemotherapy cycle. Single-dose administration fosaprepitant was started at least 1 hour before the first application of chemotherapy as an intravenous infusion over 30 minutes.
The groups were analyzed for occurrence and frequency of vomiting. They were also evaluated for an additional need for dimenhydrinate medication and drug-related clinical (exanthema, sweating, fever, loss of appetite, diarrhea, constipation) and laboratory (increases in ALT, AST, bilirubin, creatinine, urea; decreases in calcium, potassium, sodium) side effects.
The researchers found 33.3% of patients experienced vomiting and the total number of vomiting events (n=44) was significantly higher (P =.02449 and P <.0001) in the control group compared with the fosaprepitant group (n=4 events) in acute-phase CINV. The findings were similar for delayed CINV. The number of patients experiencing vomiting was 69.2% in the control group compared to 22.5% for the fosaprepitant group. There was also a significantly higher number of vomiting events (131 events in the control group compared to 33 events in the fosaprepitant group).
The number of patients needing additional medication with dimenhydrinate, and more importantly, the total number of administered dimenhydrinate doses were significantly higher in the control group (69.2% vs 47.5% in the fosaprepitant group). No significant differences in clinical side effects were reported. In addition, there were no significant changes in laboratory parameters between the 2 study groups. The authors state that larger, randomized, prospective trials with pediatric patients are warranted to further validate these findings.
Willier S, Cabanillas Stanchi KM, von Have M, et al. Safety and efficacy of single-dose intravenous fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting in pediatric patients with hematooncological malignancies after moderate and high emetogenic chemotherapy. Poster presentation at: 2017 American Society of Hematology Annual Meeting; December 9-12, 2017; Atlanta, GA. Abstract 3220.