Jordan, K., Jahn, F., Jahn, P., Behlendorf, T., Stein, A., Ruessel, J., … Schmoll, H. J. (2011). The NK-1 receptor-antagonist aprepitant in high-dose chemotherapy (high-dose melphalan and high-dose T-ICE: Paclitaxel, ifosfamide, carboplatin, etoposide): Efficacy and safety of a triple antiemetic combination. Bone Marrow Transplantation, 46(6), 784–789.

To assess the role of an neurokinin 1 (NK1) antagonist in antimetic protection in combination with granisetron and dexamethasone in patients receiving high-dose chemotherapy (HDC)

• Patient undergoing multiple days of HDC received granisetron, dexamethasone, and aprepitant during chemotherapy and two days after the completion of chemotherapy.
• Patients were receiving two HDC regimens for at least two days.
  • Melphalan, 70 mg – 100 mg/m², days 1-4, followed by peripheral blood stem cell translant (PBSCT)
  • Paclitaxel, carboplatin, etoposide, and ifosfamide

• This study consisted of 64 patients.
• Patient mean age was 42.3 with a range of 21–67. The percentage of patients younger than age 35 was 18%.
• The study consisted of 52 male patients (81.2%) and 12 female patients (18.8%).
• Patients had been diagnosed with multiple myeloma (MM) (32.8%), thymic cancinoma (6.3%), testicular cancer (35.9%), sarcoma (23.4%), and unknown primary (1.6%).
• Additionally, 9.4% of patients had received previous gastrointestinal (GI) surgery, 7.8% had a history of alcohol abuse, 7.8% had a history of loss of appetite, 6.3% had preexisting nausea, 1.6% had preexisting dizziness, and 14.1% had anxiety.

This study was conducted at a single site at a university hospital in Halle, Germany.

• All patients were in active treatment.
• The study has clinical application for elderly care.

This was a nonrandomized, single-center, observational trial.

• Complete response (CR) was defined as no vomiting and no use of rescue medications in the overall phase (days 1 until 5 days postchemotherapy).
• Nausea and vomiting were recorded daily on a special documentary chart.  All adverse events were recorded to evaluate the tolerability and were graded according to the common terminology criteria.
• All other drugs administered to the patient during the study were recorded.

• For the overall evaluation phase, the primary endpoint of CR was achieved with 40 (63%) patients.
• For the acute phase (during days of HDC), CR was achieved in 53 patients (83%).
• For the delayed phase (days 1 through 5 after the end of HDC) CR was seen in 45 patients (70%).
• Acute nausea was observed in 13 patients (20%), delayed nausea in 24 patients (24%), and overall nausea in 30 patients (47%).
• At the day of retransfusion of stem cells (second day of delayed phase in all HDC groups), the CR rate was 84% and the rate of nausea was 19%.
• The authors concluded that randomized studies may be necessary to add aprepitant to guidelines.

The study demonstrated a good toxicity profile with the addition of aprepitant to the standard antiemetic regimen, with improvement in the prevention of chemotherapy-induced nausea and vomiting (CINV) during multiday, high-dose regimens.

• The study had a small sample with fewer than 100 patients.
• Tools or scales used to measure nausea were not reported.
• A description of how vomiting and nausea were recorded on the special documentation form was not included.
• The authors did not describe how the nurses were trained to use the form and whether it was only recorded by registered nurses.
• Methodological limitations exist with comparing the results with those only from the current literature.

• The addition of aprepitant to standard antiemetic regimens during multiday HDC administration provides additional protection for both acute and delayed CINV.
• The possible reaction between aprepitant and Ifosfamide was within the reported range of induced encephalopathy (26%, range = 10%–30%).