The addition of aprepitant to palonosetron and dexamethasone showed efficacy at reducing chemotherapy-induced nausea and vomiting in a clinical trial of female patients with gastrointestinal cancer. The trial results were recently published in JAMA Network Open.
This multicenter phase 3 clinical trial (ClinicalTrials.gov: NCT03674294) based in China included female patients who were 50 years of age or younger, with little to no history of alcohol use. Enrolled patients were receiving either fluorouracil, leucovorin, and irinotecan (FOLFIRI) or fluorouracil, leucovorin, and oxaliplatin (FOLFOX) for gastrointestinal cancer. All patients were given palonosetron and dexamethasone, and they were randomized to receive either aprepitant on days 1 through 3 or a placebo.
The rate of complete response (CR), or the proportion of patients without emesis or rescue medication, was the primary endpoint. For primary endpoint analysis this was based on the overall phase of 0 to 120 hours, while secondary endpoints involved CR rates during acute (0 to 24 hours) and delayed (24 to 120 hours) phases, in addition to other analyses.
Efficacy analysis included 123 patients receiving aprepitant and 120 receiving the placebo. The CR rates for the overall phase were 87.0% for the aprepitant group and 66.7% in the placebo group (P <.001). Significantly higher CR rates with aprepitant were also seen in both acute and delayed phases. In the acute phase the CR rate with aprepitant was 92.7%, compared with 75.8% for the placebo group (P <.001). In the delayed phase the rate was 88.6% with aprepitant, compared with 70.0% with the placebo (P <.001).
From a safety population of 125 patients receiving aprepitant and 118 receiving the placebo, the incidence of 1 or more adverse events was similar across treatment groups (P =.79). None of the reported grade 3 or 4 adverse events were deemed related to aprepitant treatment.
“This study demonstrates increased antiemetic efficacy of the combination of aprepitant with
palonosetron and dexamethasone during FOLFOX or FOLFIRI chemotherapy,” the study investigators concluded in their report.
Wang DS, Hu MT, Wang ZQ, et al. Effect of aprepitant for the prevention of chemotherapy-induced nausea and vomiting in women: a randomized clinical trial. JAMA Netw Open. 2021;4(4):e215250. doi:10.1001/jamanetworkopen.2021.5250