Objective To compare the effect and safety of 5-HT3 and tropisetron combined with neurokinin-1 antagonist aprepitant or not for the prevention of highly and moderately emetogenic multiple-day chemotherapy-induced nausea and vomiting (CINV).
Methods There were 53 patients received 5-HT3 and tropisetron combined with aprepitant (aprepitant group) and 49 patients received 5-HT3 and tropisetron (standard group). The primary end-points of the study were the CR in the overall phase (OP)(0-120h) between aprepitant group and standard group. The first time of vomiting between two groups was compared by Kaplan-Meier curves. The impact of CINV on the quality of life was assessed by the Functional Living Index-Emesis (FLIE). Aprepitant-related side-effect was also recorded.
Results (1) The primary end-points CR during overall phase were 83.0% vs. 53.1% between the aprepitant group and standard group (P < 0.05). The secondary end-points CR during acute phase and delay phase were 94.3% vs. 75.5%, 84.9% vs. 49.0% between two groups respectively (P < 0.05). (2) It was observed longer time to first emesis in the aprepitant group than standard group from Kaplan-Meier curves. The score≥108 which meant no effect on quality of life assessed by FLIE were 48.0% and 20.8% between two groups (P < 0.05). (3) The main aprepitant-related side-effects were upper abdominal pain and constipation.
Conclusion It should been recommended that 5-HT3 and tropisetron combined neurokinin-1 antagonist aprepitant for the prevention of highly and moderately emetogenic multiple-day chemotherapy-induced nausea and vomiting have better effect and safety than only 5-HT3 and tropisetron.
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