| Objective:In order to assess the safety and antiemetic efficacy of multiple-day dosing of palonosetron plus dexamethasone,We conducted this study that compared palonosetron to tropisetron combined with dexamethasone in malignant patients receiving multiple-day cisplatin-based chemotherapy.Methods:Patients receiving two consecutive identical courses of a 3-day cisplatin-based chemotherapy were randomly assigned to group AB and group BA.Palonosetron was administered on day 1 and 3,combined with dexametha-sone every day during the entire period of chemotherapy for the initial course of group AB.And tropisetron plus dexamethasone was administered daily for group BA during the entire period of chemotherapy.Patients were crossover to the opposite treatment with the second course.Results:In all,40 patients were screened for the study and 39 were evaluable.18 patients were randomly assigned to group AB and 21 to group BA.During the delayed phase(d4-7),nausea and vomiting were absent in 56.4%of patients of the palonosetron group and 30.8%of the control group(P=0.022).During the overall period of observation(d1-7),the number was 56.4%and 28.2%,P=0.012.There were 56.4%and 69.2%of patients free from nausea or vomiting during the overall period of observation(d1-7)of the palonosetron group,significantly higher than the control group(P=0.039,P=0.012,respective-ly).During the acute phase(dl-3),the absent of nausea and vomiting was numerically superior with palonosetron(64.1%and 46.2%),but there was no statistical difference between the groups,P=0.111.There was no statistical difference of toxicity with palonosetron compared with tropisetron,P>0.05.Conclusion:There was a significant improvement in totally control of delayed CINV with multiple-day dosing of palonosetron plus dexamethasone for patients receiving multiple-day cisplatin-based chemotherapy,and it was safe and well tolerated. |
PDF Full Text Request