A Clinical Trail of Polonosetron Plus Dexamethasone in Preventing Cisplatin-Based Chemotherapy Induced Nausea and Vomiting

Objective: To observe and assess the efficacy and safety of palonosetron plus dexamethasone in preventing cisplatin-based chemotherapy induced nausea and vomiting. Methods: This study was performed as a randomized,clinical control trial. Seventy-two patients administered highly emetogenic cisplatin-based (≥50 mg/m2) chemotherapy were included in the clinical trail. Patients were received a single dose of palonosetron 0.25 mg i.v. bolus (treatment group, n = 35), and tropisetron 2 mg i.v. drop (control group, n = 37). Dexamethasone (16 mg, 8 mg and 8 mg) was administered on day 1, 2 and 3 before chemotherapy in patients of the two groups. The complete remission rate (CRR) of vomiting and percentage of no vomiting attack were observed during the acute phase (0-24 h post chemotherapy), delayed phase (24-120 h post chemotherapy) and both phases (0-120 h post chemotherapy) in patents of groups. Patients were administered methoxychlorproeainamide for rescue therapy if needed. Results: There was no significant difference in CRR during acute phase and delayed phase between treatment group and control group (P 0.05). The CRR of both phase (0-120 h post chemotherapy)was significantly higher in treatment group than that of control group(P 0.05).There was no significant difference in percentage of no vomiting attack during acute phase (P 0.05), but there was a significant difference during delayed phase and both phases (P 0.05) between treatment group and control group. The adverse reaction were mild and generelly well tolerated included headache, constipation, dizzy and abdominal discomfort in patients of two groups. Conclusion: The therapy of palonosetron plus dexamethasone is effective and safe for preventing both acute and delayed nausea and vomiting in patients with highly emetogenic chemotherapy, which is superior to tropisetron in preventing chemotherapy-induced delayed nausea and vomiting.