APF530 (Granisetron Injection Extended-Release) in a Three-Drug Regimen for Delayed CINV in Highly Emetogenic Chemotherapy | Zendy

Ian D. Schnadig | Zendy; Richy Agajanian | Zendy; Christopher Dakhil | Zendy; Nashat Gabrail | Zendy; Robert E. Smith | Zendy; Charles Taylor | Zendy; Sharon Wilks | Zendy; Lee S. Schwartzberg | Zendy; William Cooper | Zendy; Michael Mosier | Zendy; JoAnne Payne | Zendy; Michael J. Klepper | Zendy; Jeffrey Vacirca | Zendy

Open Access

APF530 (Granisetron Injection Extended-Release) in a Three-Drug Regimen for Delayed CINV in Highly Emetogenic Chemotherapy

Author(s) -

Ian D. Schnadig,

Richy Agajanian,

Christopher Dakhil,

Nashat Gabrail,

Robert E. Smith,

Charles Taylor,

Sharon Wilks,

Lee S. Schwartzberg,

William Cooper,

Michael Mosier,

JoAnne Payne,

Michael J. Klepper,

Jeffrey Vacirca

Publication year - 2016

Publication title -

future oncology

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 0.857

H-Index - 72

eISSN - 1744-8301

pISSN - 1479-6694

DOI - 10.2217/fon-2016-0070

Subject(s) - ondansetron , medicine , granisetron , chemotherapy induced nausea and vomiting , regimen , anesthesia , dexamethasone , chemotherapy , nausea , vomiting , adverse effect , antiemetic

Aim: APF530, extended-release granisetron, provides sustained release for ≥5 days for acute- and delayed-phase chemotherapy-induced nausea and vomiting (CINV). We compared efficacy and safety of APF530 versus ondansetron for delayed CINV after highly emetogenic chemotherapy (HEC), following a guideline-recommended three-drug regimen. Methods: HEC patients received APF530 500 mg subcutaneously or ondansetron 0.15 mg/kg intravenously, with dexamethasone and fosaprepitant. Primary end point was delayed-phase complete response (no emesis or rescue medication). Results: A higher percentage of APF530 versus ondansetron patients had delayed-phase complete response (p = 0.014). APF530 was generally well tolerated; treatment-emergent adverse event incidence was similar across arms, mostly mild-to-moderate injection-site reactions. Conclusion: APF530 versus the standard three-drug regimen provided superior control of delayed-phase CINV following HEC. ClinicalTrials.gov : NCT02106494.

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