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Aprepitant as an add-on therapy in children receiving highly emetogenic chemotherapy: a randomized, double-blind,
Sameer Bakhshi1, Atul Batra2, Bivas Biswas2
1Department of Medical Oncology, Dr. B.R.A. Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi, 110029, India. sambakh@hotmail.com.
Insights
Aprepitant significantly reduced chemotherapy-induced vomiting (CIV) in children when added to standard antiemetics. This study demonstrates aprepitant
Area of Science:
- Pediatric Oncology
- Clinical Pharmacology
- Gastroenterology
Background:
- Aprepitant, a neurokinin-1 receptor antagonist, is recommended for adults to prevent chemotherapy-induced vomiting (CIV).
- Limited data exist for pediatric use, leading to current non-recommendation for children under 12.
- Pediatric Oncology Group of Ontario guidelines do not recommend aprepitant for CIV prevention in young children.
Purpose of the Study:
- To evaluate the efficacy of aprepitant as an add-on therapy for preventing chemotherapy-induced vomiting in children.
- To assess the safety and effectiveness of aprepitant in pediatric patients undergoing highly emetogenic chemotherapy.
Main Methods:
- A randomized, double-blind, placebo-controlled trial in chemotherapy-naïve children aged 5-18 years.
- Patients received ondansetron and dexamethasone, with one group receiving aprepitant and the other placebo.
- The primary outcome was the incidence of acute moderate to severe vomiting within 24 hours post-chemotherapy.
Main Results:
- Aprepitant significantly reduced acute moderate to severe vomiting from 72% in the placebo group to 38% (p=0.001).
- Complete response rates (no vomiting or retching) were significantly higher in the aprepitant group (48% vs. 12%, p<0.001).
- No major adverse effects were reported by patients or guardians.
Conclusions:
- Aprepitant, as an add-on therapy, significantly decreases chemotherapy-induced vomiting in the acute phase for children.
- The study supports the use of aprepitant in combination with ondansetron and dexamethasone for pediatric patients receiving highly emetogenic chemotherapy.
- Results indicate aprepitant is a safe and effective option for managing CIV in pediatric oncology settings.
Background:
Aprepitant, a neurokinin-1 receptor antagonist, in combination with 5 HT-3 antagonist and dexamethasone is recommended in adults receiving moderately and highly emetogenic chemotherapy to reduce chemotherapy-induced vomiting (CIV). Data for use of aprepitant in children is limited and hence aprepitant is not recommended by Pediatric Oncology Group of Ontario guidelines for prevention of CIV in children <12 years.
Methods:
A randomized, double-blind, placebo-controlled trial was conducted at a single center in chemotherapy naïve children (5-18 years) receiving highly emetogenic chemotherapy. All patients received intravenous ondansetron (0.15 mg/kg) and dexamethasone (0.15 mg/kg) prior to chemotherapy followed by oral ondansetron and dexamethasone. Patients randomly assigned to aprepitant arm received oral aprepitant (15-40 kg = days 1-3, 80 mg; 41-65 kg = day 1, 125 mg and days 2-3, 80 mg) 1 h before chemotherapy. Control group received placebo as add-on therapy. Primary outcome measure was the incidence of acute moderate to severe vomiting, which was defined as more than two vomiting episodes within 24 h after the administration of the first chemotherapy dose until 24 h after the last chemotherapy dose in the block. Complete response (CR) was defined as absence of vomiting and retching during the specified phase.
Results:
Of the 96 randomized patients, three were excluded from analysis; 93 patients were analyzed (50 in aprepitant arm and 43 in placebo arm). Acute moderate and severe vomiting was reported in 72 % patients receiving placebo and 38 % patients receiving aprepitant (p = 0.001). Complete response rates during acute phase were significantly higher in aprepitant arm (48 vs. 12 %, p < 0.001). No major adverse effects were reported by patients/guardians.
Conclusions:
This double-blind, randomized, placebo-controlled trial shows that aprepitant significantly decreases the incidence of CIV during acute phase when used as an add-on drug with ondansetron and dexamethasone in children receiving highly emetogenic chemotherapy.
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