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


CONCLUSIONS
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.
Merck & Co, RY34-B2114, Mailstop B270, 126 East Lincoln Avenue Rahway, NJ 07065, USA.|At the time of writing this article: Hofstra North Shore-LIJ School of Medicine, 450 Lakeville Road, Lake Success, NY 11042, USA.
Harry
H
Raftopoulos
Center for Cancer & Blood Disorders, 6410 Rockledge Drive #660, Bethesda, MD 20819, USA.
Ralph
R
Boccia
TFS International, 70 Church Street, Flemington, NJ 08822, USA.
William
W
Cooper
FibroGen, Inc., 409 Illinois Street, San Francisco, CA 94158, USA.
Erin
E
O'Boyle
Albert Einstein College of Medicine, Jacobi Medical Center, 1400 Pelham Parkway South, Bronx, NY 10461, USA.
Richard J
RJ
Gralla
D000328:Adult; D000368:Aged; D000932:Antiemetics / Q000008:administration & dosage / Q000009:adverse effects; D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use; D003692:Delayed-Action Preparations; D005260:Female; D017829:Granisetron / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007546:Isoquinolines / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000188:drug therapy* / Q000209:etiology*; D009369:Neoplasms / Q000150:complications / Q000188:drug therapy; D000077924:Palonosetron; D011812:Quinuclidines / Q000008:administration & dosage* / Q000009:adverse effects; D012702:Serotonin Antagonists / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome; D014839:Vomiting / Q000188:drug therapy* / Q000209:etiology*
D000932:Antiemetics; D000970:Antineoplastic Agents; D003692:Delayed-Action Preparations; D017829:Granisetron; D007546:Isoquinolines; D000077924:Palonosetron; D011812:Quinuclidines; D012702:Serotonin Antagonists
APF530; cancer; chemotherapy-induced nausea and vomiting; extended-release; granisetron; subcutaneous