Format

Send to

Choose Destination
Future Oncol. 2016 Jun;12(12):1469-81. doi: 10.2217/fon-2016-0070. Epub 2016 Mar 21.

APF530 (granisetron injection extended-release) in a three-drug regimen for delayed CINV in highly emetogenic chemotherapy.

Author information

1
Compass Oncology, US Oncology Research, Tualatin, OR, USA.
2
The Oncology Institute of Hope & Innovation, Whittier, CA, USA.
3
Cancer Center of Kansas, Wichita, KS, USA.
4
Gabrail Cancer Center, Canton, OH, USA.
5
South Carolina Oncology Associates, Columbia, SC, USA.
6
Tulsa Cancer Institute, Tulsa, OK, USA.
7
Cancer Care Centers of South Texas, San Antonio, TX, USA.
8
The West Clinic, Memphis, TN, USA.
9
TFS, Princeton, NJ, USA.
10
EMB Statistical Solutions, LLC, Overland Park, KS, USA.
11
Heron Therapeutics, Inc., San Diego, CA, USA (at time of study).
12
Drug Safety Navigator, LLC, Durham, NC, USA.
13
North Shore Hematology Oncology, East Setauket, NY, USA.

Abstract

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.

KEYWORDS:

chemotherapy-induced nausea and vomiting (CINV); extended-release granisetron; highly emetogenic chemotherapy (HEC)

PMID:
26997579
DOI:
10.2217/fon-2016-0070
[Indexed for MEDLINE]
Free full text

Supplemental Content

Full text links

Icon for Atypon
Loading ...
Support Center