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.

• N = 338   
• AGE = 197 were older than 65 years 
• MALES: 79.2% (RAD), 58.1% (OAD); FEMALES: 20.8% (RAD), 41.9% (OAD) 
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Patients with a pathologically confirmed malignant disease who were scheduled to receive HEC on their first day of treatment. Most patients had lung cancer.
• OTHER KEY SAMPLE CHARACTERISTICS: Mostly patients with lung cancer, chemotherapy naïve patients, patients on cisplatin-containing regimens, and patients who were on a single-day regimen

• SITE: Multi-site   
• SETTING TYPE: Multiple settings    
• LOCATION: Seventeen institutions of the Korean Cancer Study Group

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Elder care 

• Prospective, single-blind, randomized

• Rhodes Index of Nausea and Vomiting-Form 2
• Common Toxicity Criteria for Adverse Events (CTCAE)
• Chi-square test
• Fisher exact test
• Wilcoxon rank-sum test
• Visual analog scale (VAS)
• Generalized estimating equations (GEE)

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.

• Risk of bias (no blinding)
• Risk of bias (sample characteristics)
• Patients with various diseases and chemotherapeutic regimens

RAD can be considered a standard regimen for HEC-induced nausea and vomiting. The adverse event rate is similar to ondansetron.