Abstract

8557 Background: 5-HT3 antagonists are one of the mainstays of antiemetic treatment and they can be used either intravenously or orally. Nevertheless sometimes neither intravenous (IV) nor oral administration is possible, such as in patients unable to admit oral intake managed in an outpatient setting. Our objective was to assess if pharmacokinetics of subcutaneous (SC) granisetron were comparable to IV delivery, using Area Under the Curve between 0 and 12 hours (AUC 0–12 h) as our main endpoint. Methods: Patients receiving platinum-based chemotherapy were randomized to receive granisetron 3 mg by either SC or IV administration during the first cycle and by the other route during the second one. Blood samples were drawn at 15, 30, 45, 60, 90 minutes and 2, 3, 4, 6, 8 and 12 hours after granisetron. Drug levels were determined by HPLC with fluorescence detection after liquid-liquid extraction of the samples, with a quantitation limit of 1 ng/ml. Clinical assessment of emesis in both cycles was performed. Results were analyzed using Student’s t-test and Wilcoxon test for paired samples. Assuming a 20% difference in AUC 0–12 h between both routes, 25 patients were required to obtain statistical significance (α=0.05, β=0.10). The protocol was approved by the Ethics Committee and all patients signed informed consent. Results: From May to November 2005, 30 patients were included and 25 of them were evaluable. SC granisetron resulted in a 27% increase in AUC 0–12 h (95% CI: 7–74) and higher levels at 12 hours (see table). Cmax was higher and was reached faster by IV route. Emetic symptoms were equivalent with both alternatives. Conclusion: SC administration of granisetron achieves higher AUC 0–12 h than IV administration, resulting in increased exposition to the drug. This is the first study that shows that SC granisetron is a valid alternative to IV or oral use. This new route of administration might be specially relevant for outpatient management of emesis in cancer patients. [Table: see text] No significant financial relationships to disclose.

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