Does a single dose of palonosetron have any role in preventing acute chemotherapy-induced nausea and vomiting in pediatric osteosarcoma patients without dexamethasone? A randomized clinical trial

Adv Clin Exp Med. 2022 Mar;31(3):223-230. doi: 10.17219/acem/142332.

Abstract

Background: Chemotherapy-induced nausea and vomiting (CINV) is a troublesome side-effect of chemotherapy in pediatric patients undergoing osteosarcoma treatment. In this context, the role of 5-hydroxytryptamine-3 (5-HT3) receptor antagonists needs to be explored.

Objectives: To evaluate the superiority of single-dose palonosetron over granisetron in pediatric patients undergoing highly emetogenic chemotherapy (HEC) for osteosarcoma.

Material and methods: In this double-blind, randomized study, pediatric patients were assessed in terms of acute nausea and vomiting following HEC for osteosarcoma. These children were assigned to group 1 (palonosetron) and group 2 (granisetron) without any other antiemetic prophylaxis. The primary outcome variable was the children's segment with a complete response (CR) during the acute phase of the 1st on-study chemotherapy cycle. The risk factors associated with the emesis were analyzed. The patients were followed up for the first 24 h after chemotherapy.

Results: A total number of 200 children were evaluated in terms of the response, and other factors that might alter the response were assessed in the 2 groups. These 200 children underwent 604 blocks of chemotherapy. Complete responses were documented in 83% and 72% of children receiving palonosetron and granisetron, respectively, during the acute phase. Only dexamethasone, used as a rescue medication, was found to be a significant risk factor that predisposed to the response (p < 0.05).

Conclusions: Single-dose palonosetron is an effective alternative to granisetron for preventing CINV in children receiving HEC for osteosarcoma.

Keywords: 5-HT3 receptor antagonists; chemotherapy; emesis; granisetron; palonosetron.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Antineoplastic Agents* / adverse effects
  • Antineoplastic Agents* / therapeutic use
  • Child
  • Dexamethasone / therapeutic use
  • Humans
  • Isoquinolines / therapeutic use
  • Nausea / chemically induced
  • Nausea / drug therapy
  • Nausea / prevention & control
  • Osteosarcoma* / chemically induced
  • Osteosarcoma* / drug therapy
  • Palonosetron / therapeutic use
  • Quinuclidines / therapeutic use
  • Vomiting / chemically induced
  • Vomiting / drug therapy
  • Vomiting / prevention & control

Substances

  • Antineoplastic Agents
  • Isoquinolines
  • Quinuclidines
  • Palonosetron
  • Dexamethasone