Ondansetron for nausea and vomiting associated with moderately emetogenic cancer chemotherapy.
This multicenter, randomized, double-blind study compared the efficacy and tolerability of ondansetron 8 mg twice daily for 3 days with placebo in preventing nausea and vomiting in 81 patients receiving cyclophosphamide-doxorubicin-based chemotherapy. The first dose of study drug was administered 30 minutes before the initiation of chemotherapy. Patients received a rescue antiemetic if the investigator deemed it necessary or if the patient experienced more than two emetic episodes during the 3-day study. Sixty-one percent of patients treated with ondansetron compared with 6% of patients receiving placebo (P < 0.001) had no emetic episodes during the 3-day study. Among patients with at least one emetic episode, the mean time to emesis was 24 hours 18 minutes in the ondansetron group compared with 8 hours 1 minute in the placebo group (P < 0.001). In the intent-to-treat analysis, 78% of patients in the ondansetron group and 29% of patients in the placebo group completed the study with no need for rescue therapy. Clinical laboratory and adverse-event profiles were similar between groups. The most common adverse event was headache, occurring in 23% of ondansetron patients and 24% of placebo patients. This study is the first double-blind, placebo-controlled trial to demonstrate that ondansetron 8 mg twice daily is effective in the prevention of nausea and vomiting associated with cyclophosphamide-doxorubicin-based chemotherapy. The twice-daily regimen may encourage patient compliance and may be more cost-effective than regimens that need to be given three times daily.
DiBenedetto
J
J
Oncology/Hematology Associates, Providence, Rhode Island, USA.
Cubeddu
L X
LX
Ryan
T
T
Kish
J A
JA
Sciortino
D
D
Beall
C
C
Eisenberg
P D
PD
Henderson
C
C
Griffin
D
D
Wentz
A
A
D000903:Antibiotics, Antineoplastic / Q000009:adverse effects; D000932:Antiemetics / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018906:Antineoplastic Agents, Alkylating / Q000009:adverse effects; D003520:Cyclophosphamide / Q000009:adverse effects; D004311:Double-Blind Method; D004317:Doxorubicin / Q000009:adverse effects; D005260:Female; D006801:Humans; D008297:Male; D009325:Nausea / Q000139:chemically induced / Q000517:prevention & control*; D017294:Ondansetron / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D014839:Vomiting / Q000139:chemically induced / Q000517:prevention & control*
D000903:Antibiotics, Antineoplastic; D000932:Antiemetics; D018906:Antineoplastic Agents, Alkylating; D017294:Ondansetron; D004317:Doxorubicin; D003520:Cyclophosphamide