| OBJECTIVE:To evaluate the efficacy and safety of the first and second generation 5-HT3 receptor antagonists(5-HT3RA)in combination with dexamethasone(DXM)for prevention of chemotherapy-induced nausea and vomiting(CINV)by high emetic chemotherapy for multiple-day.METHODS:Patients who received two consecutive identical courses(containing highly emetogenic drugs and lasting?3 days)were randomly assigned to group AB with palonosetron 0.25 mg on day 1 and day 3 additional day 5,DXM 10 mg on day 1 and 5 mg per day on day 2 through day 5 or to group BA with tropisetron 5 mg on day 1 through 3 addtional day 4 and day 5 or ondansetron 8mg on day 1 through 5,DXM usage was the same as before with the initial course and crossover to the opposite treatment with the second course.The primary objectives were complete response(CR)and complete control(CC).Secondary end points were emetic episodes(acute and delayed),therapy-related adverse effects(AEs),rescue antiemetic medication and risk factors associated with CINV.RESULTS:A total of 106 patients were included and 105 of whom could be evaluated for efficacy and safety.1.The incidence of daily diet reduction and nausea in palonosetron group(group A)was lower than that in the first generation of 5-HT3RA group(group B).The incidence of diet reduction on day 4 and day 5 were significant difference(respectively 27.8%vs.46.2%and 21.1%vs.37.3%,all P<0.05).The incidence of nausea through day 4 to day 7 were significant difference(respectively 48.9%,46.7%,31.1%and 22.2%vs.67.7%,65.6%,51.6%and 45.2%,all P<0.05).Except for day 1,the incidence of vomiting in group A was lower than that in group B.The incidence of vomiting in group day 4 was 12.2%vs.25.8%,with significant difference(P=0.019).2.The incidence of nausea in group A was lower than that in group B at acute phase,delayed phase and the whole course(11.1%,63.3%and 64.4%vs.14.0%,74.2%and 74.2%,respectively),but there were no significant defference between two group(all P>0.05).The incidence of vomiting in group A was lower than that in group B(22.2%and 23.3%vs.37.3%and 37.7%)in the delayed period and the whole course,and the difference was statistically significant(P<0.05).The incidence of vomiting in acute phase was similar between the two groups(4.4%vs.3.2%)with no significant difference(P>0.05).In the delayed phase and the whole course,the incidence of vomiting in group A was lower than that in group B(22.2%and 23.3%vs.37.3%and 37.7%)with significant difference(P<0.05).3.The duration of nausea in Palonosetron group was less than that in the first generation 5-HT3RA group(31.2%vs.15.6%)and the difference was statistically significant(P<0.05).4.The CR rates in acute phase were 94.4%and 94.6%(P>0.05),in delayed phase were 70.0%and 55.9%(P<0.05),and in whole phase were 68.9%and 55.9%(P>0.05).In acute phase,the CC rates were 67.8%and 55.9%(P>0.05),in delayed phase,53.3%and 36.6%(P=0.023),and in whole phase,52.2%and 36.6%(P=0.033),respectively.5.The rates of rescue antiemetic medication in group A and B were 18.8%and 19.4%,with no significant difference(P>0.05).6.There was no significant difference in the incidence of AEs(abdominal pain,headache,constipation,fatigue,etc.)between the two groups(P>0.05).7.The incidence of vomiting was significantly higher in women,patients younger than 55 years old and patients with previous history of chemotherapy vomiting than in men,patients older than 55 years old and patients without previous history of chemotherapy vomiting(all P<0.05).Conclusion:1.The complete response and complete control rate of the second generation of 5-HT3RA(Palonosetron)for acute nausea and vomiting caused by multi-day high emetic chemotherapy were similar to those of the first generation of 5-HT3RA,but the complete response rate and complete control rate for delayed nausea and vomiting are better than those of the first generation of 5-HT3RA,and the safety is good.2.Women,age<55 years old and past CINV history were risk factors for chemotherapy-related vomiting. |
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