Comparison of oral versus intravenous ramosetron in prevention of acute cisplatin-induced emesis: a randomized controlled trial.
OBJECTIVE
To compare the antiemetic efficacy of a single oral versus intravenous (i.v.) ramosetron, a new class of selective 5-HT3 receptor antagonists, in gynecologic cancer patients receiving high-dose cisplatin.


METHODS
Between February 2003 and July 2003, 109 patients with gynecologic cancer scheduled to receive single agent cisplatin chemotherapy at a dose of 75 mg/m2 were randomized to receive either 0.2 mg oral (51 cases) or 0.3 mg i.v. (58 cases) ramosetron 1 h and 30 min respectively before chemotherapy. Patients were evaluated for 24 h after chemotherapy. The number of nausea and vomiting including adverse events were recorded every 6 h.


RESULTS
51 and 58 patients received oral and i.v. ramosetron respectively. Both groups were similar regarding age, performance status, body mass index and diagnosis of gynecologic cancer. 95 per cent of cases were cervical cancer. Antiemetic effect was significantly higher in the oral group when compared with the i.v. group during the first 6 hours and during the period of 18 to 24 hours after administration of cisplatin chemotherapy. Overall in 24 h, patients receiving oral ramosetron experienced no emesis slightly higher than that of the i.v. group (55% and 36% respectively, p = 0.05). Adverse events were mild and transient and were not significantly different in both groups, except tiredness which was more frequent in the i.v. group.


CONCLUSIONS
Oral ramosetron at a dosage of 0.2 mg is as effective as 0.3 mg of intravenous ramosetron in prevention of acute emesis in patients receiving 75 mg/m2 of cisplatin chemotherapy.
Tantipalakorn
Charuwan
C
Department of Obstetrics & Gynecology, Faculty of Medicine, Chiang Mai University, 50200 Thailand.
Srisomboon
Jatupol
J
Thienthong
Hunsa
H
Pantusart
Aree
A
Suprasert
Prapaporn
P
Saereesongkhun
Chanram
C
Eamtang
Saisunee
S
Sutthichat
Amphika
A
Pautad
Nuthaya
N
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000932:Antiemetics / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use; D001562:Benzimidazoles / Q000008:administration & dosage*; D017024:Chemotherapy, Adjuvant / Q000009:adverse effects; D016009:Chi-Square Distribution; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D005833:Genital Neoplasms, Female / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D006801:Humans; D007275:Injections, Intravenous; D008875:Middle Aged; D017060:Patient Satisfaction; D011336:Probability; D012307:Risk Factors; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014839:Vomiting / Q000139:chemically induced* / Q000188:drug therapy*
D000932:Antiemetics; D001562:Benzimidazoles; C071315:ramosetron; D002945:Cisplatin