A multicenter, double-blind, randomized control clinical trail of palonosetron hydrochloride capsules for prevention of chemotherapy-induced nausea and vomiting

LUO Linhua; GUAN Xiaoxiang; QIN Shukui; CHEN Yingxia; SHI Jianhua; CHENG Ying; ZHENG Rongsh-eng; YAO Yang; HAN Baohui; YU Shiying

Abstract：Objective To observe and evaluate the efficacy and safety of palonosetron hydrochloride capsules made in China for prevention of chemotherapy?induced nausea and vomiting. Methods This study was performed as a multicenter, randomized, double?blind control clinical trial. The patients were randomized to administer palonosetron hydrochloride capsule( 0?5mg) and a simu?lator of granisetron dispersible tablet(experimental group), or a granisetron dispersible tablet(1mg) and a simulator of palonosetron ( control group) , each administered 1 hour before initiation of moderate emetogenic chemotherapy. After 12h for chemotherapy, experi?mental group were administered a simulator of granisetron dispersible tablet and control group were administered a granisetron dispers?ible tablet ( 1mg) . The acute emetic episodes, delayed emetic episodes, nausea, physical status and VAS scores was recorded, admin?ister rescue medication ( granisetron combined with dexamethasone) was taken if patients needed. Results A total of 240 patients from seven clinical research centers in China were randomized to the clinical trial with 122 patients in experimental group and 118 patients in control group. The proportion of patients with emetic episodes overall periods ( 0?7days) was lower in experimental group than in control group (21?31% vs.33?33%, P=0?0422). The proportion of patients with no emetic episodes during the 24h after chemotherapy ad?ministration ( acute period ) between experimental group and control group was no significant difference through full analysis set (86?89% vs.85?47%, P=0?8338), and the proportion of patients with no emetic episodes during delay (24h?7days post?chemothera?py) between experimental group and control group was significant difference through per?protocol set analysis( 74?38% vs. 61?54%, P=0?0490). The average vomiting times of experimental group and control group were 0?15±0?52 and 0?31±0?68 respectively in sec?ond day of chemotherapy(P=0?0090). There were no significant difference for rates of grade 0 nausea and PS scores between two groups in 1?5 days of chemotherapy( P>0?05) , except to VAS scores in 2?4 days of chemotherapy( P<0?05) . The adverse reactions of experimental group and control group included constipation( 2 cases) , total bilirubin( 2 cases) and constipation( 4 cases) , drug derma?titis(1 case),respectively. The adverse reaction rates between two groups were 3?28% and 4?24% respectively(P>0?05). Conclusion <br> Palonosetron hydrochloride capsule is similar to granisetron for preventing chemotherapy?induced acute nausea and vomiting, and su?perior to granisetron for delayed nausea and vomiting. Palonosetron hydrochloride capsule is safe and convenient administration.