Palonosetron compared with ondansetron in pediatric cancer patients: multicycle analysis of a randomized Phase III study

Future Oncol. 2017 Aug;13(19):1685-1698. doi: 10.2217/fon-2017-0189. Epub 2017 Jun 1.

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

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Antiemetics / administration & dosage
  • Antiemetics / adverse effects
  • Antiemetics / therapeutic use*
  • Antineoplastic Agents / adverse effects*
  • Antineoplastic Agents / therapeutic use
  • Child
  • Child, Preschool
  • Humans
  • Infant
  • Infant, Newborn
  • Isoquinolines / administration & dosage
  • Isoquinolines / adverse effects
  • Isoquinolines / therapeutic use*
  • Nausea / drug therapy*
  • Nausea / etiology*
  • Neoplasms / complications*
  • Neoplasms / drug therapy
  • Ondansetron / administration & dosage
  • Ondansetron / adverse effects
  • Ondansetron / therapeutic use*
  • Palonosetron
  • Quinuclidines / administration & dosage
  • Quinuclidines / adverse effects
  • Quinuclidines / therapeutic use*
  • Treatment Outcome
  • Vomiting / drug therapy*
  • Vomiting / etiology*

Substances

  • Antiemetics
  • Antineoplastic Agents
  • Isoquinolines
  • Quinuclidines
  • Ondansetron
  • Palonosetron