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Intravenous Fosaprepitant Versus Oral Aprepitant for Children Receiving Highly Emetogenic Chemotherapy: An
Azgar Abdul Rasheed1, Shuvadeep Ganguly2, Manraj Singh Sra3
1Department of Medical Oncology, KIMS Cancer Centre, Trivandrum, India.
Insights
Fosaprepitant did not prove non-inferior to aprepitant for preventing vomiting in children receiving highly emetogenic chemotherapy. Both antiemetic regimens showed similar safety profiles and side effects in pediatric patients.
Area of Science:
- Oncology
- Pharmacology
- Pediatrics
Background:
- Fosaprepitant is a prodrug of aprepitant, a neurokinin-1 receptor antagonist.
- Aprepitant is effective in preventing chemotherapy-induced nausea and vomiting (CINV) in adults.
- Previous studies established non-inferiority of fosaprepitant to aprepitant in adult cancer patients receiving highly emetogenic chemotherapy (HEC).
Purpose of the Study:
- To evaluate the non-inferiority of intravenous fosaprepitant compared to oral aprepitant in pediatric patients receiving HEC.
- To assess the efficacy and safety of fosaprepitant versus aprepitant in controlling chemotherapy-induced nausea and vomiting in children.
Main Methods:
- An open-label, randomized, non-inferiority trial involving children aged 5-18 years receiving their first HEC cycle.
- Patients were randomized to receive either intravenous fosaprepitant or oral aprepitant, along with ondansetron and dexamethasone.
- The primary endpoint was the complete response rate of vomiting in the acute phase, with a non-inferiority margin of 15%.
Main Results:
- Non-inferiority was not established as the lower bound of the confidence interval for the complete response rate in the acute phase exceeded the -15% margin (-6.1%; 90% CI: -15.7% to +3.6%).
- Complete response rates in the delayed and overall phases also did not demonstrate non-inferiority.
- Vomiting grade, nausea incidence/severity, and adverse events were comparable between the fosaprepitant and aprepitant groups.
Conclusions:
- Fosaprepitant did not meet the non-inferiority criteria compared to aprepitant in pediatric patients undergoing HEC.
- The study suggests that current dosing or administration of fosaprepitant may not be equivalent to aprepitant in this population.
- Further research may be needed to optimize fosaprepitant regimens for pediatric CINV management.
Background:
Fosaprepitant is non-inferior to aprepitant in adults receiving highly emetogenic chemotherapy (HEC). We evaluated whether fosaprepitant is non-inferior to aprepitant in children receiving HEC.
Methods:
In this open-label, non-inferiority trial, children aged 5-18 years, receiving their first cycle of HEC, were randomized 1:1 to the fosaprepitant or aprepitant group. The fosaprepitant group received a single intravenous dose of 4 mg/kg (max 150 mg). The aprepitant group received oral aprepitant capsules (weight 15 to <30 kg: 80 mg Days 1-3; weight ≥30 kg, or age ≥12 years: 125 mg Day 1, 80 mg Days 2 and 3). Both groups received ondansetron and dexamethasone. The primary outcome was the complete response (CR) rate of vomiting during the acute phase (AP) with a non-inferiority margin of 15%. Secondary outcomes included CR rates in the delayed (DP) and overall phases (OP), grade of vomiting, incidence and severity of nausea, and adverse effects.
Results:
A total of 279 children were included in the modified intention-to-treat analysis (fosaprepitant group: 140; aprepitant group: 139). In AP, the difference of CR rate between fosaprepitant [76 (54.3%)] and aprepitant groups [84 (60.4%)] was -6.1% [90% CI: -15.7% to +3.6%], with the lower limit exceeding -15%, failing to establish non-inferiority. The CR rate with fosaprepitant versus aprepitant was 62.1% (n = 87) versus 65.5% (n = 91) in DP (difference: -3.4%; 90% CI: -12.7% to 6.1%) and 42.9% (n = 60) versus 49.6% (n = 69) in the OP (difference: -6.7%; 90% CI: -16.5% to 3.1%). Grade of vomiting, incidence and severity of nausea, and adverse effects were similar between the two groups.
Conclusions:
Non-inferiority of fosaprepitant compared to aprepitant was not demonstrated in children undergoing their first cycle of HEC.
Trial Registration:
Clinical Trials Registry, India (CTRI/2019/05/019082).
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