A multicenter,double-blind,randomized control clinical trail of palonosetron hydrochloride injection to prevent chemotherapy-induced nausea and vomitting

OBJECTIVE: To observe and assess the efficacy and safety of palonosetron hydrochloride injection made in China for preventing chemotherapy-induced nausea and vomitting in accordance with documents of SFDA. METHODS: This study was performed as a multicenter, randomized, double-blind control clinical trial. The patients were randomized to receive a single dose of palonosetron 0.25 mg (treatment group), or granisetron 3 mg(control group), each administered 30 min before initiation of severely emetogenic chemotherapy. To observe the acute emetic episodes,delay emetic episodes, and nausea, and administer rescue medication (granisetron and dexamethasone) if the patient needed. RESULTS: Two hundred and twenty-three patients form six centers were randomized to the clinical trail, and 111 pts receiving palonosetron, 123 pts receiving granisetron. The proportion of patients with no emetic episodes during the 24 h after chemotherapy administration (acute period) in treatment group and control group weren't different(85.59% vs. 78.57%,P=0.142 0),but the proportion of patients with no emetic episodes during delay (24h-7 days post-chemotherapy) and overall (0-7 days) periods were higher in the treatment group than those of in the control group(63.96% vs. 50.00%,P=0.028 2; 62.16% vs. 46.43%,P=0.014 0). Palonosetron was superior to granisetron in control of nausea(P=0.019 8). The number of emetic episodes in the treatment group wasn't so many as that of the control group(average:1.76±4.27 times/case vs. 3.08±6.20 times/case,P=0.028 9). The time to emetic episodes in the treatment group was longer than in the control group (P=0.037 7). The time to rescue medication, the proportion of patients with rescue medication, the times of rescue medication and the degree of KPS score declining weren't significant deviation. 8.11% and 8.04% of patients in the treatment group and control group appeared lightly constipation, abdominal siatention and headache(P=1.000 0);but more patients demanded temperantia for anxiety and agrypnia in the control group(0.90% vs. 10.71%,P=0.002 6). CONCLUSION: Palonosetron hydrochloride injection is superior to granisetron for preventing chemotherapy-induced vomitting and nauesa, and it is safer than granisetron.