Abstract
18558 Background: Adition of D to the standard antiemetic treatment for CINV prevention is frequent, despite the lack of benefit evidence in controlled clinical trials. In this study we compare the impact of O treatment with or without D on daily life, in patients (pts) under treatment with high or moderately emetogenic C. Methods: Longitudinal, randomized and prospective study. All pts who received anticancer treatment with high or moderately emetogenic C were included, and randomly assigned to group A (O 8 mg iv and D 8 mg iv) or group B (O 8 mg iv). Evaluable pts did not have to receive any medication which could modify the antiemetic effect of treatment within the 24 hours following the administration of CH and had to be able to answer an autoadministered questionnaire. After 24 hours, the Functional Living Index- Emesis (FLIE), a daily life index which consists of 18 questions divided into two domains: nausea and vomiting, had to be completed. Data were analyzed by independent mean sample t-test, and ANOVA One-Way, with a 0.05 significance level. Results: Between December/04 and November/05 233 patients (age average: 59.24; range 21–87) were randomly assigned to antiemetic treatment with (n = 125) or without D (n = 108). Both groups were well balanced as regards the type of chemotherapy, sex and age, and all patients were evaluable. No significant effects were observed between both groups when the global data were analyzed. However, when the sample was stratified by type of chemotherapy, a significantly lower impairment (55.1 vs 51.3; p < .05) was detected in the nausea domain in those patients who received moderately emetogenic chemotherapy. Conclusion: In our sample of patients we observed benefits in the impact on daily life, by the addition of D to the O as preventive treatment of CINV, in those patients that received moderately emetogenic chemotherapy. No significant financial relationships to disclose.
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