Slow-release granisetron (APF530) versus palonosetron for chemotherapy-induced nausea/vomiting: analysis by American Society of Clinical Oncology emetogenicity criteria. (September 2015)

• Record Type: Journal Article
• Authors: Raftopoulos, Harry; Boccia, Ralph; Cooper, William; O'Boyle, Erin; Gralla, Richard J
• Is Part Of: Future oncology. Volume 11:Number 18(2015)
• Page Start: 2541
• Page End: 2551
• Publication Date: 2015-09
• Subjects: APF530 -- cancer -- chemotherapy-induced nausea and vomiting -- extended-release -- granisetron -- subcutaneous; Oncology -- Periodicals; 616.99405
• DOI: 10.2217/fon.15.185
• Languages: English
• ISSNs: 1479-6694

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. TheClinicaltrials.gov identifier for this study is NCT00343460.