Roila, F., Ruggeri, B., Ballatori, E., Fatigoni, S., Caserta, C., Licitra, L., . . . Italian Group for Antiemetic Research. (2015). Aprepitant versus metoclopramide, both combined with dexamethasone, for the prevention of cisplatin-induced delayed emesis: A randomized, double-blind study. Annals of Oncology, 26, 1248–1253.

The purpose of the study was to compare the combination of aprepitant and decadron versus metoclopramide and decadron for delayed emesis in patients receiving the same combination of aprepiant, palonosetron, and dexamethasone for the prophylaxis of cisplatin-induced acute emesis.

All patients received on day 1 a combination of 0.25 mg of palonosetron administered IV 30 minutes before the beginning of chemotherapy followed by 12 mg of decadron. Aprepitant was orally administered one hour before chemotherapy. Patients were randomized to receive delayed antiemetics with decadron 8 mg once daily day 2 to 4 plus aprepitant 80 mg daily on day 2 and 3, or decadron 8 mg twice daily on days 2 to 4 plus metoclopramide 20 mg four times a day on days 2 to 4. Patients recorded a diary card days 1 to 6 with reports of nausea, vomiting, adverse events and any rescue treatments using FLIE, and nausea intensity on a visual analog scale.

• N: 284   
• AGE: Adult (categorized as less than 50, 50 to 64, and 65 and up.
• MALES: MTC + Dex arm 71.5%, APR + Dex 71.4%  
• FEMALES: MTC + Dex 28.5%, Apr + Dex 28.6%
• CURRENT TREATMENT: Chemotherapy
• OTHER KEY SAMPLE CHARACTERISTICS: Chemotherapy naïve cancer patients scheduled to receive cisplatin containing chemotherapy at doses 50 mg/m² or above

• SITE: Multi-site   
• SETTING TYPE: Not specified    
• LOCATION: Italy

PHASE OF CARE: Active anti-tumor treatment

Multicenter, double-blind, parallel, randomized 1:1 study aimed to evaluate the efficacy of aprepitant versus metoclopramide

Fisher’s exact test was used to compare the two groups with respect to the endpoints expressed by a binary variable, as well as to evaluate the differential safety. FLIE was used for patient diary and symptom reporting, as well as a visual analog scale for nausea.

During days 2 to 5, complete response was similar in both antiemetic prophylaxes (82.5% with M + D, and 80.3% with A + D).

The effectiveness and safety of the two combinations in the treatment of cisplatin induced CINV in the delayed phase are similar. However, they have very different cost profiles. These are important considerations for treatment-related decisions.

• Self reported lack of power
• May not detect small differences

Both aprepitant + decadron and metoclopramide + decadron are effective for delayed emesis for patients receiving cisplatin. Because of the substantial cost difference, consideration should be given to metoclopramide + decadron for delayed nausea.