Efficacy and safety of oral granisetron versus i.v. granisetron in patients undergoing peripheral blood progenitor cell and bone marrow transplantation.
This randomized, controlled, double-blind pilot study assessed the efficacy and safety of oral versus i.v. granisetron, both in combination with non-5-HT3 antiemetics, in preventing emesis caused by high-dose chemotherapy. Fifty-one patients who underwent peripheral blood progenitor cell transplantation (PBPCT) or bone marrow transplantation (BMT) were evaluated. Efficacy was assessed by the number of emetic episodes during the worst 24 h period. A complete response (CR) was defined as no vomiting, partial response (PR) as less than three emetic episodes and failure as three or more emetic episodes. Patients who received oral granisetron experienced significantly (p<0.0008) fewer emetic episodes than those who received i.v. granisetron; however, the number of emetic episodes over the worst 24 h was similar between the oral and i.v. granisetron groups (13 and 15, respectively), as were the overall response rates (CR+PR, 54.5 and 41.4%, respectively). Both dosage forms were well tolerated. Based on these findings, further comparative studies of oral granisetron are warranted in patients undergoing PBPCT or BMT.
Abang
A M
AM
University of Oklahoma Health Sciences Center, College of Pharmacy, Oklahoma City 73190, USA. AAbang@obius.jnj.com
Takemoto
M H
MH
Pham
T
T
Mandanas
R A
RA
Roy
V
V
Selby
G B
GB
Carter
T H
TH
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000932:Antiemetics / Q000008:administration & dosage*; D016026:Bone Marrow Transplantation; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D017829:Granisetron / Q000008:administration & dosage*; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D012702:Serotonin Antagonists / Q000008:administration & dosage*; D033581:Stem Cell Transplantation; D014839:Vomiting / Q000517:prevention & control*
D000932:Antiemetics; D017829:Granisetron; D012702:Serotonin Antagonists