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 60 mg/m of
cisplatin as the first-line treatment were randomly assigned to receive AGD (oral
aprepitant 125 mg on day 1 and 80 mg on days 2-3; intravenous
granisetron 3 mg on day 1; intravenous
dexamethasone 6.6 mg on day 1 and oral
dexamethasone 4 mg on days 2-3) or PD (intravenous
palonosetron 0.75 mg on day 1; intravenous
dexamethasone 13.2 mg on day 1 and oral
dexamethasone 8 mg on days 2-3). The primary endpoint was a complete response during the overall study period (0-120 h 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.