Slow-release granisetron (APF530) versus palonosetron for chemotherapy-induced nausea/vomiting: analysis by American Society of Clinical Oncology emetogenicity criteria

Future Oncol. 2015 Sep;11(18):2541-51. doi: 10.2217/fon.15.185. Epub 2015 Aug 20.

Abstract

Background: APF530 is a novel sustained-release formulation of granisetron. In a Phase III trial, APF530 500 mg was noninferior to palonosetron 0.25 mg in preventing acute chemotherapy-induced nausea and vomiting (CINV) after moderately (MEC) or highly emetogenic chemotherapy (HEC) and delayed CINV after MEC, but not superior in preventing delayed CINV after HEC. Emetogenicity was classified by Hesketh criteria; this reanalysis uses newer American Society of Clinical Oncology criteria.

Methods: Complete responses (no emesis or rescue medication) after cycle one were reanalyzed after reclassification of MEC and HEC by American Society of Clinical Oncology criteria.

Results: APF530 maintained noninferiority to palonosetron.

Conclusion: Single-dose APF530 is a promising alternative to palonosetron for preventing acute and delayed CINV after MEC or HEC. The Clinicaltrials.gov identifier for this study is NCT00343460.

Keywords: APF530; cancer; chemotherapy-induced nausea and vomiting; extended-release; granisetron; subcutaneous.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Antiemetics / administration & dosage
  • Antiemetics / adverse effects
  • Antineoplastic Agents / adverse effects*
  • Antineoplastic Agents / therapeutic use
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use
  • Delayed-Action Preparations*
  • Female
  • Granisetron / administration & dosage*
  • Granisetron / adverse effects
  • Humans
  • Isoquinolines / administration & dosage*
  • Isoquinolines / adverse effects
  • Male
  • Middle Aged
  • Nausea / drug therapy*
  • Nausea / etiology*
  • Neoplasms / complications
  • Neoplasms / drug therapy
  • Palonosetron
  • Quinuclidines / administration & dosage*
  • Quinuclidines / adverse effects
  • Serotonin Antagonists / administration & dosage
  • Serotonin Antagonists / adverse effects
  • Treatment Outcome
  • Vomiting / drug therapy*
  • Vomiting / etiology*

Substances

  • Antiemetics
  • Antineoplastic Agents
  • Delayed-Action Preparations
  • Isoquinolines
  • Quinuclidines
  • Serotonin Antagonists
  • Palonosetron
  • Granisetron

Associated data

  • ClinicalTrials.gov/NCT00343460