Phase II Trial of Ramosetron Plus Dexamethasone in the Prevention of Cisplatin-Induced Nausea and Vomiting

Objective: To evaluate the clinical efficacy of ramosetron hydrochloride in the combination with dexametha-sone for the prevention of nausea and vomiting induced by cisplatin. Material and Method: Thirty in-patients with malignant tumor being treated with cisplatin at a dose of 70 mg/ m2 or more for a total of 94 cycles were scheduled to receive ramosetron 0.3 mg IV given 30 minutes before chemotherapy and dexamthasone 20 mg IV on day 1 for the prevention of acute emesis and continued with ramosetron tablet 0.1 mg one tablet orally one hour before chemotherapy or in the morning in case of no chemotherapy scheduled and dexamethasone capsule 5 mg 2 capsules twice daily on day 2 to day 5 for the prevention of delayed emesis. The evaluation period started concomitantly with the start of chemotherapy (hour 0) and continued until 24 hours after completion of chemotherapy. The antiemetic efficacy of ramosetron plus dexamethasone was analyzed according to the occurrence of nausea and vomiting within 24 hours of treatment cycle. The study emphasized both on acute and delayed emesis control. Assessment: The degree of severity of nausea was determined according to the following criteria: 0: None: nausea does not occur, 1: Mild: slight nausea but no disruption to daily acitivites, 2: Moderate: nausea and some disruption to daily activities, 3: Severe: extreme nausea and severe disruption to daily activities. The control of vomiting episodes was determined according to the frequency of vomiting (including retching) as the following criteria: Complete: 0 emesis episode, Major: 1-2 emesis episodes, Minor: 3-5 emesis episodes