Roila, F., Ruggeri, B., Ballatori, E., Del Favero, A., & Tonato, M. (2014). Aprepitant versus dexamethasone for preventing chemotherapy-induced delayed emesis in patients with breast cancer: A randomized double-blind study. Journal of Clinical Oncology, 32, 101–106.

To determine if dexamethasone is superior to aprepitant in the prevention of delayed emesis in patients with breast cancer receiving chemotherapy that includes anthracyclines and cyclophosphamide

Patients were randomized using computer generated numbers, and blinding was performed by a special company. On day 1, 30 minutes prior to chemotherapy, all patients received palonosetron at 0.25 mg IV in a 30-second bolus and dexamethasone at 8 mg IV diluted in 100 ml of saline IV over 15 minutes. Aprepitant at 125 mg was administered orally one hour prior to chemotherapy. On days 2 and 3, patients randomly received either dexamethasone at 4 mg twice daily or aprepitant at 80 mg daily. Patients receiving aprepitant took a placebo in the evenings, and all pills were placed in identical capsules. On days 1–5, patients could receive either prochlorperazine at 10 mg via a suppository or metoclopramide at 10 mg intramuscularly as rescue medication. Adherence to medications on days 2 and 3 was checked by counting the remaining pills. Data were collected on days 1–6 after chemotherapy.

• N = 551  
• MEAN AGE = 53 years (median = 50 years)
• MALES: < 1%, FEMALES: > 99%
• KEY DISEASE CHARACTERISTICS: Breast cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Chemotherapy-naïve patients with breast cancer receiving anthracyclines plus cyclophosphamide

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

• PHASE OF CARE: Active antitumor treatment

Randomized, double-blinded, parallel study

• Daily diary to record the number of vomiting episodes, adverse events, rescue medications, and the presence, intensity, and duration of nausea
• Functional Living Index–Emesis (FLIE)
• Visual Analog Scale (VAS) for nausea

There was no significant difference in complete responses between the two groups in the acute (p = 0.39) or delayed phases (p = 1). There were no statistically significant differences in total control (p = 0.27), vomiting (p = 0.39), nausea (p = 0.24), significant nausea (p = 0.10), number of emetic episodes (p = 0.07), maximum severity of nausea (p = 0.26), or duration of nausea (p = 0.13) between the two groups in the delayed phase. Patients receiving dexamethasone experienced more insomnia (p = 0.02) and heartburn (p = 0.03) than those in the aprepitant group. More patients in the aprepitant group reported sedation and anorexia, but these results were not statistically significant.

In patients with breast cancer receiving chemotherapy containing anthracyclines and cyclophosphamide, dexamethasone and aprepitant have similar efficacy for the management of delayed chemotherpy-induced nausea and vomiting (CINV) when the optimal prophylactic treatment for acute CINV is administered. Patients who receive dexamethasone may experience a slight increase in adverse events compared to those taking aprepitant.

Nurses can help patients consider the differences in efficacy, safety, and cost of dexamethasone versus aprepitant when selecting an appropriate pharmacologic intervention for delayed CINV. In addition, nurses can help ensure that patients receive the optimal prophylactic treatment recommended for CINV with chemotherapy regimes that contain anthracyclines and cyclophosphamides.