A phase 2 pharmacokinetic and pharmacodynamic dose-finding study of oral NEPA for chemotherapy-induced nausea and vomiting in pediatric patients with cancer.
Priya Patel, Oleg Arakaev, Mikhail Melnikov et al.
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In 30 seconds
This phase 2 randomized controlled trial assessed the pharmacokinetics, pharmacodynamics, efficacy, and safety of oral netupitant combined with oral palonosetron (NEPA) in pediatric patients (< 18 years) undergoing chemotherapy. Among 65 evaluable patients, complete response rates were 85.3% in the acute phase for the lower netupitant dose group, indicating NEPA's effectiveness in preventing chemotherapy-induced nausea and vomiting.
Key findings
- Complete response rates were 85.3%, 70.6%, and 70.6% for the lower netupitant dose in acute, delayed, and overall phases, respectively.
- For the higher netupitant dose, complete response rates were 87.1%, 71.0%, and 67.7% in the same phases.
- A trend toward increased complete response was observed with higher netupitant exposure in the delayed phase.
Why it matters
Chemotherapy-induced nausea and vomiting significantly impacts pediatric patients' quality of life. Effective antiemetic regimens are crucial for improving treatment adherence and overall outcomes in this vulnerable population.