Gore, L., Chawla, S., Petrilli, A., Hemenway, M., Schissel, D., Chua, V., … Adolescent Aprepitant in Cancer Study Group. (2009). Aprepitant in adolescent patients for prevention of chemotherapy-induced nausea and vomiting: A randomized, double-blind, placebo-controlled study of efficacy and tolerability. Pediatric Blood and Cancer, 52, 242–247.
To evaluate the tolerability, efficacy, and pharmacokinetics of aprepitant with a 5-HT3 receptor antagonist and corticosteroid in adolescents with cancer
Patients were randomized to receive either a regimen of aprepitant plus dexamethasone and ondansetron or the control arm of ondansetron and dexamethasone. On the day of chemotherapy, aprepitant or placebo was administered 1 hour before and dexamethasone and ondansetron were given 30 minutes before chemotherapy. Rescue medication was permitted. Patient follow-up was done between days 6 and 8 and between days 19 and 29. Patients recorded episodes of vomiting in diaries for five days following chemotherapy. For the experimental arm, aprepitant was given at 125 mg day 1, 80 mg days 2 and 3, 4 mg day 4; 8 mg dexamethasone day 1, 4 mg days 2 and 3; and ondansetron at 0.15 mg/kg, three times per day on days 1 and 2. In the control arm, patients received 16 mg dexamethasone on day 1, 8 mg on days 2–4, and ondansetron at 0.15 mg/kg, three times per day on days 1 and 2.
The study was conducted at a single outpatient setting at Children’s Hospital, University of Colorado.
The patients were pediatric, in active treatment.
This was a randomized, double-blind, parallel group study.
More patients in the aprepitant group achieved CR for CINV control in the acute and delayed phases, as well as in the overall study period. The addition of aprepitant to the antiemetic regimen appeared to be well tolerated in adolescents, with an overall adverse event profile similar to that seen in adults.
Findings suggest that aprepitant in addition to standard antiemetic treatment is tolerable and may be helpful in patients between the ages of 11 and 19. Further study of the efficacy of antiemetic regimens in the pediatric and adolescent populations is warranted.