Meattini, I., Francolini, G., Scotti, V., Cardillo, C.D.L., Cappelli, S., Meacci, F., . . . Mangoni, M. (2015). Aprepitant as prophylaxis of chemotherapy-induced nausea and vomiting in anthracyclines and cyclophosphamide-based regimen for adjuvant breast cancer. Medical Oncology, 32, 1–5. 

To appraise the effectiveness and safety of a three-drug antiemetic prophylaxis treatment in patients with breast cancer receiving a regimen of ​5-fluorouracil, epirubicin, and cyclophosphamide

All patients received the same antiemetic prophylaxis regimen consisting of aprepitant (oral 125 mg on day 1 and oral 80 mg on days 2 and 3), palonosetron (0.25 mg IV on day 1), and dexamethasone (12 mg IV on day 1). The acute phase was defined as the first 24 hours after chemotherapy, and the delayed phase was defined as days 2–5 following chemotherapy. Complete response (CR) was defined as no vomiting or rescue treatment, and complete protection was defined as no vomiting, no rescue treatment, and no significant nausea. Total control was defined as no vomiting, no rescue treatment, and no nausea. Data were collected for five days following the administration of chemotherapy.

• N = 92  
• MEDIAN AGE = 55 years (range = 37–72 years)
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Breast cancer

• SITE: Single site    
• SETTING TYPE: Outpatient    
• LOCATION: University of Florence, Largo

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

Cross-sectional, descriptive, single-arm design (design was not specifically mentioned in the article)

• Presence of nausea and vomiting
• Intensity of nausea
• Use of antiemetic drugs
• Additional symptoms

Only cycle 1 data were used in this study. In the acute phase, 89.1% of patients achieved CR, and 81.5% achieved CR in the delayed phase. Complete protection was achieved in 67.4% of patients in the acute phase and 62.0% of patients in the delayed phase. Total control was achieved in 52.2% of patients in the acute phase and 48.9% of patients in the delayed phase.

Prophylaxis consisting of aprepitant, palonosetron, and dexamethasone was safe, effective, and highly recommended in patients receiving anthracycline-based regimens (although it is not classified as a highly emetogenic chemotherapy by all international guidelines). Additional controlled trials are strongly needed to better define the optimal approach in emesis prophylaxis.

• Small sample (< 100)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Measurement/methods not well described

The majority of patients in this study experienced CR in the acute and delayed phases after chemotherapy administration. Triple-drug therapy was an appropriate intervention for chemotherapy-induced nausea and vomiting prophylaxis in patients with breast cancer receiving anthracycline and cyclophosphamide treatment.