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

Harry Raftopoulos; Ralph Boccia; William Cooper; Erin O'Boyle; Richard J Gralla

doi:10.2217/fon.15.185

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.

Authors

Harry Raftopoulos^{1

2}, Ralph Boccia³, William Cooper⁴, Erin O'Boyle⁵, Richard J Gralla⁶

Affiliations

¹ Merck & Co, RY34-B2114, Mailstop B270, 126 East Lincoln Avenue Rahway, NJ 07065, USA.
² At the time of writing this article: Hofstra North Shore-LIJ School of Medicine, 450 Lakeville Road, Lake Success, NY 11042, USA.
³ Center for Cancer & Blood Disorders, 6410 Rockledge Drive #660, Bethesda, MD 20819, USA.
⁴ TFS International, 70 Church Street, Flemington, NJ 08822, USA.
⁵ FibroGen, Inc., 409 Illinois Street, San Francisco, CA 94158, USA.
⁶ Albert Einstein College of Medicine, Jacobi Medical Center, 1400 Pelham Parkway South, Bronx, NY 10461, USA.

PMID: 26289588
DOI: 10.2217/fon.15.185

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