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

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

Research output: Contribution to journal › Article › peer-review

12 Scopus citations

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.

Original language	English (US)
Pages (from-to)	2541-2551
Number of pages	11
Journal	Future Oncology
Volume	11
Issue number	18
DOIs	https://doi.org/10.2217/fon.15.185
State	Published - Sep 1 2015
Externally published	Yes

Keywords

APF530
cancer
chemotherapy-induced nausea and vomiting
extended-release
granisetron
subcutaneous

ASJC Scopus subject areas

Oncology
Cancer Research

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.2217/fon.15.185

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

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",

author = "Harry Raftopoulos and Ralph Boccia and William Cooper and Erin O'Boyle and Gralla, {Richard J.}",

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year = "2015",

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doi = "10.2217/fon.15.185",

language = "English (US)",

volume = "11",

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T1 - Slow-release granisetron (APF530) versus palonosetron for chemotherapy-induced nausea/vomiting

T2 - Analysis by American Society of Clinical Oncology emetogenicity criteria

AU - Raftopoulos, Harry

AU - Boccia, Ralph

AU - Cooper, William

AU - O'Boyle, Erin

AU - Gralla, Richard J.

PY - 2015/9/1

Y1 - 2015/9/1

N2 - 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.

AB - 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.

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KW - chemotherapy-induced nausea and vomiting

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KW - granisetron

KW - subcutaneous

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

Abstract

Keywords

ASJC Scopus subject areas

UN SDGs

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