Aprepitant, granisetron, and dexamethasone versus palonosetron and dexamethasone for prophylaxis of cisplatin-induced nausea and vomiting in patients with upper gastrointestinal cancer: a randomized crossover phase II trial (KDOG 1002).

We conducted a randomized trial to compare the safety and effectiveness of aprepitant, granisetron, and dexamethasone (AGD) with those of palonosetron and dexamethasone (PD) in patients who received highly emetogenic chemotherapy (HEC). Patients with esophageal or gastric cancer who were scheduled to receive HEC including at least 60mg/m(2) of cisplatin as the first-line treatment were randomly assigned to receive AGD (oral aprepitant 125mg on day 1 and 80mg on days 2-3; intravenous granisetron 3mg on day 1; intravenous dexamethasone 6.6mg on day 1 and oral dexamethasone 4mg on days 2-3) or PD (intravenous palonosetron 0.75mg on day 1; intravenous dexamethasone 13.2mg on day 1 and oral dexamethasone 8mg on days 2-3). The primary endpoint was a complete response during the overall study period (0-120h after the start of chemotherapy) in the first cycle. Eighty-five patients were enrolled, and 84 were eligible. The complete response rate did not differ between the treatment groups, but the proportion of patients with no vomiting was significantly higher in the AGD group than in the PD group (81.4 vs. 58.5%; P=0.031). The results of a quality-of-life survey indicated that the proportion of patients with no or minimal impact on daily life in the vomiting domain was significantly higher in the AGD group (79.1 vs. 53.7%; P=0.020). The primary endpoint of complete response was not achieved, but AGD seems to be more effective than PD for the prevention of HEC-induced vomiting.