Abstract
PURPOSE: To compare the antiemetic combination of palonosetron, dexamethasone, and aprepitant (PDA) with antiemetic combination of ondansetron and dexamethasone (OD) in head and neck cancer patients receiving docetaxel, carboplatin, and 5-FU based chemotherapy. METHODS: Sixty previously untreated patients were randomly divided into two groups of thirty patients each. The PDA group received a combination of palonosetron 0.25 mg intravenously (IV), dexamethasone 12 mg IV, and capsule aprepitant per oral. OD group received ondansetron 16 mg IV, and dexamethasone 12 mg IV for emesis control. The primary objective was to compare the efficacy of two antiemetic schedules for preventing acute and delayed CINV (chemotherapy-induced nausea and vomiting). The primary efficacy end point was complete response (CR). RESULTS: All the patients tolerated both schedules well. The antiemetic response for acute emesis (first 24 hours) in PDA versus OD group was: CR was 86.7 versus 60%. For delayed emesis (from day 2-5) in PDA versus OD group CR was 83.3 versus 53.3%. The intensity of acute nausea (first 24 hours) in PDA versus OD group was: no nausea-70 versus 46.6%. The intensity of delayed nausea (from day 2-5) in PDA versus OD was: no nausea-76.6 versus 43.3%. The CR to both acute and delayed emesis (no vomiting from day 1-5) in PDA versus OD group was 83.3 versus 53.3% (p < 0.05, significant). The CR to nausea (no nausea from day 1-5) in PDA versus OD group was 70 versus 43.3% (p < 0.05, significant). CONCLUSION: Although both the schedules were tolerated well, the PDA schedule (palonosetron, aprepitant, and dexamethasone) was significantly better than the OD schedule (ondansetron and dexamethasone) in controlling cancer CINV in the acute as well as delayed phases.