Comparison of an extended-release formulation of granisetron (APF530) versus
palonosetron for the prevention of chemotherapy-induced nausea and vomiting
associated with moderately or highly emetogenic chemotherapy: results of a
prospective, randomized, double-blind, noninferiority phase 3 trial.
Author(s): Raftopoulos H(1), Cooper W, O'Boyle E, Gabrail N, Boccia R, Gralla RJ.
Affiliation(s): Author information:
(1)Hofstra North Shore-LIJ School of Medicine, 450 Lakeville Road, Lake Success,
NY, 11042, USA, hraftopo@nshs.edu.
Publication date & source: 2015, Support Care Cancer. , 23(3):723-32
PURPOSE: Subcutaneous APF530 provides controlled sustained release of granisetron
to prevent acute (0-24 h) and delayed (24-120 h) chemotherapy-induced nausea and
vomiting (CINV). This randomized, double-blind phase 3 trial compared APF530 and
palonosetron in preventing acute and delayed CINV after moderately (MEC) or
highly emetogenic chemotherapy (HEC).
METHODS: Patients receiving single-day MEC or HEC received single-dose APF530 250
or 500 mg subcutaneously (SC) (granisetron 5 or 10 mg) or intravenous
palonosetron 0.25 mg. Primary objectives were to establish APF530 noninferiority
to palonosetron for preventing acute CINV following MEC or HEC and delayed CINV
following MEC and to determine APF530 superiority to palonosetron for preventing
delayed CINV following HEC. The primary efficacy end point was complete response
(CR [using CI difference for APF530-palonosetron]). A lower confidence bound
greater than -15 % indicated noninferiority.
RESULTS: In the modified intent-to-treat population (MEC = 634; HEC = 707), both
APF530 doses were noninferior to palonosetron in preventing acute CINV after MEC
(CRs 74.8 % [-9.8, 9.3] and 76.9 % [-7.5, 11.4], respectively, vs. 75.0 %
palonosetron) and after HEC (CRs 77.7 % [-11.5, 5.5] and 81.3 % [-7.7, 8.7],
respectively, vs. 80.7 % palonosetron). APF530 500 mg was noninferior to
palonosetron in preventing delayed CINV after MEC (CR 58.5 % [-9.5, 12.1] vs.
57.2 % palonosetron) but not superior in preventing delayed CINV after HEC.
Adverse events were generally mild and unrelated to treatment, the most common
(excluding injection-site reactions) being constipation.
CONCLUSIONS: A single subcutaneous APF530 injection offers a convenient
alternative to palonosetron for preventing acute and delayed CINV after MEC or
HEC.
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