중등도 구토유발성 약물요법제로 인한 오심 및 구토의 예방에 있어서 정맥주사용 Granisetron과 정맥주사용 Ondansetron 및 경구용 유지요법의 제 3상 비교임상시험

Abstract

Nausea and vomiting are common and the most distressing side effects of cancer chemotherapy. As these symtoms can cause emotional instability and malnutrion from poor oral intake, which further lead to decrease the effect of chemotherapy, it is important to prevent emesis adequately and effectively. Ondansetron is a selective 5-HT, receptor antagonist and is reported to be effective in preventing cisplatin-induced emesis, Granisetron is a potent and the most selective 5-HT, receptor antagonist currently available. We conducted a prospective, randomized, open, single center, parallel group study to compare the antiemetic effect and safety of granisetron versus ondansetron in patients receiving moderately emetogenic chemotherapy. Form December l994 to May 1995, 65 consecutive patients who planned to receive moderately emetogenic chemotherapy(80 to 100 mg/§³ of cisplatin or 40 mg/§³of doxorubicin) were enrolled in this study. Granisetron was administered intravenously prior to chemotherapy at a dose of 3mg, and up to two doses of granisetron could be administered as rescue therapy within the first 24 hour period. Ondansetron 8 mg was given intravenously prior to chemotherapy followed by 2 more doses at 8 and 16 hours after chemotherapy. Finally, we evaluated 63 patients(32 receiving granisetron and 31 receiving ondansetron). In the first 24 hours after chemotherapy, complete and major response were achieved in 78.1 % of patients receiving granisetron and 74.2 % of patients receiving ondansetron(P=0.7163). There were also no differences in the control of delayed nausea and vomiting between two groups(56.3% vs 45.2%, P=0.3826). There were no differences in percentages of patients who received rescue therapy across the treatment groups: 3I.5% for granisetron vs. 45.2% for ondansetron during the study(P=0.3803). During the first 24 hours following chemotherapy, there were no differences in time to first episodes of nausea(granisetron 14 hours 20 minutes vs ondansetron 13 hours) and vomiting(granisetron 20 hours vs ondansetron 19 hours 20 minutes) between two groups. There were no significant adverse effects or toxicities with these antiemetics. We concluded that single dose granisetron was as effective in prophylaxis of emesis induced by moderatly emetogenic chemotherapy as triple doses of ondansetron and oral maintainence combination. For the non-responders to granisetron, combination of granisetron with other antiemetics of different action mechanism or maintainence granisetron trials are warranted.