Jang, G., Song, H.H., Park, K.U., Kim, H.S., Choi, D.R., Kwon, J.H., . . . Zang, D.Y. (2013). A phase II study to evaluate the efficacy of ramosetron, aprepitant, and dexamethasone in preventing cisplatin-induced nausea and vomiting in chemotherapy-naive cancer patients. Cancer Research and Treatment, 45(3), 172–177. 

To evaluate the efficacy of ramosetron, aprepitant, and dexamethasone in preventing chemotherapy-induced nausea and vomiting (CINV) in patients receiving cisplatin-based chemotherapy

On day 1, all patients received intravenous 0.6 mg ramosetron and oral 12 mg dexamethasone 30 minutes before chemotherapy, and they received 125 mg aprepitant orally one hour before chemotherapy. On days 2 and 3, patients received 80 mg aprepitant and 8 mg dexamethasone orally in the morning. On day 4, patients only received 8 mg dexamethasone. Patients could take rescue antiemetic medications at any time for vomiting or severe nausea. Antiemetic rescue medications were determined by treating physicians.

• N = 39  
• MEDIAN AGE = 59 years (range = 43–74 years)
• MALES: 75.6%, FEMALES: 24.4%
• KEY DISEASE CHARACTERISTICS: Multiple types of cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Both adjuvant and palliative chemotherapy (primarily palliative)

• SITE: Multi-site    
• SETTING TYPE: Outpatient    
• LOCATION: Korea

• PHASE OF CARE: Multiple phases of care
• APPLICATIONS: Palliative care 

Prospective, open-label study

• Complete response (no vomiting and no rescue medications divided into acute phase [0–24 hours], delayed phase [24–120 hours], and overall phase)
• Absolute complete response (no vomiting, no rescue medications, and no nausea) 
• Multinational Association of Supportive Care in Cancer Visual Analog Scale (MASCC VAS)
• Common Toxicity Criteria for Adverse Events (CTCAE) clinical and laboratory adverse events

Complete response (CR) was achieved by 94.9% of patients in the acute phase, 92.3% in the delayed phase, and 92.3% in the overall phase. Absolute CR was achieved by 74.4% in the acute phase, 51.3% in the delayed phase, and 46.2% in the overall phase. The median nausea score during the acute phase was 0 (interquartile range [IQR] 0–1), 0 in the delayed phase (IQR 0–4), and 2 during the overall phase (IQR 0–4). On the VAS, mild nausea was observed in 10% of patients in the acute phase and 13% of patients in the delayed phase. Moderate to severe nausea was observed in 15% of patients in the acute phase and 36% of patients in the delayed phase.

The combination of ramosetron, aprepitant, and dexamethasone is an effective CINV regimen. The overwhelming majority of patients in this study achieved a complete response and experienced no nausea or vomiting in both the acute and delayed phase after chemotherapy.

• Small sample (< 100)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)

Ramosetron, aprepitant, and dexamethasone is an effective regimen to prevent CINV in patients receiving cisplatin-based therapy. Almost all of the patients were able to achieve a complete response in both the acute and delayed phase after administration of chemotherapy. In this study, the majority of patients were receiving palliative care, therefore this combination of drugs should be considered for palliative care patients.