title: APF530 (granisetron injection extended-release) in a three-drug regimen for delayed CINV in highly emetogenic chemotherapy.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  APF530 versus the standard three-drug regimen provided superior control of delayed-phase CINV following HEC. ClinicalTrials.gov : NCT02106494.
authors.affiliation: Compass Oncology, US Oncology Research, Tualatin, OR, USA.
authors.forename: Ian D
authors.initials: ID
authors.lastname: Schnadig
authors.affiliation: The Oncology Institute of Hope & Innovation, Whittier, CA, USA.
authors.forename: Richy
authors.initials: R
authors.lastname: Agajanian
authors.affiliation: Cancer Center of Kansas, Wichita, KS, USA.
authors.forename: Christopher
authors.initials: C
authors.lastname: Dakhil
authors.affiliation: Gabrail Cancer Center, Canton, OH, USA.
authors.forename: Nashat Y
authors.initials: NY
authors.lastname: Gabrail
authors.affiliation: South Carolina Oncology Associates, Columbia, SC, USA.
authors.forename: Robert E
authors.initials: RE
authors.lastname: Smith
authors.affiliation: Tulsa Cancer Institute, Tulsa, OK, USA.
authors.forename: Charles
authors.initials: C
authors.lastname: Taylor
authors.affiliation: Cancer Care Centers of South Texas, San Antonio, TX, USA.
authors.forename: Sharon T
authors.initials: ST
authors.lastname: Wilks
authors.affiliation: The West Clinic, Memphis, TN, USA.
authors.forename: Lee S
authors.initials: LS
authors.lastname: Schwartzberg
authors.affiliation: TFS, Princeton, NJ, USA.
authors.forename: William
authors.initials: W
authors.lastname: Cooper
authors.affiliation: EMB Statistical Solutions, LLC, Overland Park, KS, USA.
authors.forename: Michael C
authors.initials: MC
authors.lastname: Mosier
authors.affiliation: Heron Therapeutics, Inc., San Diego, CA, USA (at time of study).
authors.forename: J Yvette
authors.initials: JY
authors.lastname: Payne
authors.affiliation: Drug Safety Navigator, LLC, Durham, NC, USA.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Klepper
authors.affiliation: North Shore Hematology Oncology, East Setauket, NY, USA.
authors.forename: Jeffrey L
authors.initials: JL
authors.lastname: Vacirca
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000932:Antiemetics / Q000008:administration & dosage*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects*; D003692:Delayed-Action Preparations / Q000008:administration & dosage; D003907:Dexamethasone / Q000008:administration & dosage / Q000009:adverse effects; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D017829:Granisetron / Q000008:administration & dosage*; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D009025:Morpholines / Q000008:administration & dosage; D009325:Nausea / Q000139:chemically induced / Q000517:prevention & control*; D017294:Ondansetron / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome; D014839:Vomiting / Q000139:chemically induced / Q000517:prevention & control*; D055815:Young Adult
chemical_list: D000932:Antiemetics; D003692:Delayed-Action Preparations; D003907:Dexamethasone; D017829:Granisetron; D009025:Morpholines; D017294:Ondansetron; C579707:fosaprepitant
keywords: chemotherapy-induced nausea and vomiting (CINV); extended-release granisetron; highly emetogenic chemotherapy (HEC)