Abidi, M.H., Tageja, N., Ayash, L., Abrams, J., Ratanatharathorn, V., Al-Kadhimi, Z., … Uberti, J. (2011). Aprepitant for prevention of nausea and vomiting secondary to high-dose cyclophosphamide administered to patients undergoing autologous peripheral blood stem cells mobilization: A phase II trial. Supportive Care in Cancer, 20, 2363–2369.

To investigate the efficacy and safety of aprepitant as a three-day antiemetic regimen for patients receiving single-dose cyclophosphamide 4 g/m² for peripheral blood stem cell mobilization

Baseline nausea and vomiting was recorded pretreatment, then patients received granisetron, dexamethasone, and 125 mg oral aprepitant followed by cyclophosphamide on day 1. Patients received 80 mg oral aprepitant on days 2 and 3. No rescue medication use was allowed. Nausea, vomiting, and use of antiemetics were monitored daily for 5 days, then 7 and 30 days after initiation of chemotherapy. Toxicity was monitored using the National Cancer Institute's (NCI's) Common Toxicity Criteria (CTC), version 3.0.

• The study reported on 35 patients.
• Median age was 48 years with a range of 23–64 years.
• The sample was 57% male and 43% female.
• Patients had been diagnosed with multiple myeloma (n = 19), non-Hodgkin lymphoma (n = 11), Hodgkin disease (n = 4), and acute promyelocytic leukemia (n = 1).
• The sample included 30 Caucasians, 4 African Americans, and 1 other. 
• All patients had Southwest Oncology Group (SWOG) performance statuses of 2 or lower, history of fewer than five alcohol drinks per day for the last year, and no use of chronic systemic steroids or antiemetics.

This was a single site study conducted in Detroit, MI. The setting type was not specified.

• Patients were undergoing the active treatment phase of care.
• The study has clinical applicability for peripheral blood stem cell mobilization.

This was a phase 2, clinical trial.

• Nausea was recorded using a visual analog scale with 5-25 mm = mild nausea and more than 25 mm = severe nausea.
• Each emesis episode was defined as expulsion of stomach contents through the mouth separated by at least one minute.
• A retching episode was defined as an unproductive attempt to vomit stomach contents separated by at least one minute.
• NCI CTC v. 3 was used to record adverse events.

• Just over half of patients (57%, n = 20) reported no acute vomiting (0–24 hours postchemotherapy) and no acute use of rescue medication; 63% (n = 22) patients experienced no delayed vomiting (25–120 hours postchemotherapy); and 43% (n = 15) patients reported no more than mild nausea during the first five days. 
• No grade 3 or higher toxicities were found to be related to aprepitant. Common adverse events (less than grade 3) were nausea, vomiting, fatigue, diarrhea, febrile neutropenia, headache, and hiccups. No patient discontinued aprepitant due to adverse events; no treatment-related mortality was reported.

Aprepitant provides protection of acute and delayed vomiting following cyclophosphamide administration during stem cell mobilization. Aprepitant does not adequately control nausea following cyclophosphamide administration during stem cell mobilization.

• The sample size was small with fewer than 100 patients.
• No control group was included. 
• No pharmacokinetic assessment of the medication was included. 
• The authors did not specify who evaluated toxicities or how monitoring was done.

Patients receiving cyclophosphamide for stem cell mobilization can experience nausea and vomiting requiring interventions.  The addition of aprepitant to an antiemetic regimen of 5-HT₃ antagonist plus dexamethasone improved control of acute and delayed vomiting following cyclophosphamide administration during stem cell mobilization. Aprepitant was associated with few toxicities.