Abstract
Aim:
To investigate across multiple cycles the efficacy and safety of palonosetron in the prevention of chemotherapy-induced nausea and vomiting in pediatric cancer patients receiving highly or moderately emetogenic chemotherapy (HEC/MEC).
Patients & methods:
Patients were randomly assigned to 10, 20 μg/kg palonosetron or 3 × 150 μg/kg ondansetron for up to four cycles of HEC/MEC.
Results:
In all on-study chemotherapy cycles, complete response rates were higher in patients in the 20 μg/kg palonosetron group than the ondansetron group. Treatment-emergent adverse events were comparable between the palonosetron 20 μg/kg and ondansetron groups.
Conclusion:
Over four cycles of HEC/MEC, 20 μg/kg palonosetron was an efficacious and safe treatment for the prevention of chemotherapy-induced nausea and vomiting in pediatric cancer patients.
Keywords:
antiemetic; chemotherapy; palonosetron; pediatric cancer.
Publication types
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Clinical Trial, Phase III
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Multicenter Study
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Randomized Controlled Trial
MeSH terms
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Adolescent
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Antiemetics / administration & dosage
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Antiemetics / adverse effects
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Antiemetics / therapeutic use*
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Antineoplastic Agents / adverse effects*
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Antineoplastic Agents / therapeutic use
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Child
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Child, Preschool
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Humans
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Infant
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Infant, Newborn
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Isoquinolines / administration & dosage
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Isoquinolines / adverse effects
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Isoquinolines / therapeutic use*
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Nausea / drug therapy*
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Nausea / etiology*
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Neoplasms / complications*
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Neoplasms / drug therapy
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Ondansetron / administration & dosage
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Ondansetron / adverse effects
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Ondansetron / therapeutic use*
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Palonosetron
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Quinuclidines / administration & dosage
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Quinuclidines / adverse effects
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Quinuclidines / therapeutic use*
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Treatment Outcome
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Vomiting / drug therapy*
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Vomiting / etiology*
Substances
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Antiemetics
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Antineoplastic Agents
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Isoquinolines
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Quinuclidines
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Ondansetron
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Palonosetron