Kim, H.J., Shin, S.W., Song, E.K., Lee, N.R., Kim, J.S., Ahn, J.S., . . . Kang, J.H. (2015). Ramosetron versus ondansetron in combination with aprepitant and dexamethasone for the prevention of highly emetogenic chemotherapy-induced nausea and vomiting: A multicenter, randomized phase III trial, KCSG PC10-21. Oncologist, 20, 1440–1447.
To compare the efficacy and safety of the combination of ramosetron, aprepitant, and dexamethasone (RAD) with the efficacy and safety of the combination of ondansetron, aprepitant, and dexamethasone (OAD) in treating highly emetogenic chemotherapy (HEC)-induced nausea and vomiting
Patients were assigned to either the RAD or OAD groups (1:1 ratio) according to a stratified block randomization table. Aprepitant (125 mg one hour prior to chemotherapy on day 1 and 80 mg on days 2–3) and dexamethasone (12 mg 30 minutes prior to chemotherapy on day 1 and 8 mg on days 2–4) were administered orally. Ramosetron (0.3 mg on day 1) and ondansetron (16 mg on day 1) were administered IV to the RAD group and OAD group, respectively, 30 minutes before chemotherapy. Rescue antiemetics were used per the attending physician’s discretion. Patients were then asked to keep a record of vomiting or retching episodes in a diary and Rhodes Index of Nausea and Vomiting scores for five days.
Complete response (CR) rates for the acute, delayed, and overall phases were similar for both the ramosetron- and ondansetron-based regimens. No differences existed between groups in the use of rescue medication.
RAD was noninferior to OAD in the prevention of HEC-induced nausea and vomiting irrespective of patient age, type of cancer, or chemotherapeutic regimen. RAD demonstrated efficacy in the acute, delayed, and overall phases. RAD was more effective than OAD in men.
RAD can be considered a standard regimen for HEC-induced nausea and vomiting. The adverse event rate is similar to ondansetron.