Stiff, P.J., Fox-Geiman, M.P., Kiley, K., Rychlik, K., Parthasarathy, M., Fletcher-Gonzalez, D., … Rodriguez, T.E. (2013). Prevention of nausea and vomiting associated with stem cell transplant: results of a prospective, randomized trial of aprepitant used with highly emetogenic preparative regimens. Biology of Blood and Marrow Transplantation, 19(1), 49-55.e1.doi: 10.1016/j.bbmt.2012.07.019
To evaluate the safety and efficacy of oral aprepitant in combination with ondansetron and dexamethasone in the prevention of acute and delayed nausea and vomiting compared to ondansetron and dexamethasone alone in patients receiving highly emetogenic preparative regimens before autologous or allogeneic stem cell transplant (SCT).
Patients were stratified by gender and randomized to one of two treatments. The aprepitant group received 125 mg oral aprepitant on day one then 80 mg daily during the preparative regimen + 3 days, 7.5 mg dexamethasone IV, and 8 mg ondansetron by mouth every eight hours daily during preparative regimen + 1 day. The placebo group received an oral placebo daily during the preparative regimen + 3 days, 10 mg IV dexamethasone, and 8 mg oral ondansetron every eight hours daily during the preparative regimen +1 day. Lorazepam was used for breakthrough nausea or vomiting. Prochlorperazine was allowed only for repeated episodes of vomiting (defined as more than four episodes in any 12-hour period). The primary objective was complete response (CR) rate, defined as no emesis with no or mild nausea.
The study was conducted at Loyola University Medical Center Cardinal Bernardin Cancer Center in Maywood, IL.
All patients were in active antitumor treatment.
This study was a single center, comparative (placebo controlled), randomized, double-blind, phase III trial.
Patients rated the number of emetic episodes and nausea severity on a 100-mm visual analog scale (VAS).
Aprepitant in combination with dexamethasone and ondansetron significantly decreased emesis and significant nausea, without an increase in regimen-related toxicities. The regimen did not affect short-term survival and had no significant impact on the use of as-needed antiemetics or overall nausea scores. It did not negatively affect patient outcomes.
Five myeloablative high-dose cyclophosphamide preparative regimens were used. Only two regimens included total body irradiation (TBI), which is thought to cause more nausea.
Similar to standard-dose chemotherapy regimens, aprepitant demonstrated a much higher impact on emesis than it did on nausea. Aprepitant in combination with dexamethasone and ondansetron significantly decreased emesis and significant nausea, without increasing toxicities or affecting short-term survival; the regimen had no significant impact on the use of as-needed antiemetics or overall nausea scores. Findings suggest that aprepitant assisted in control of nausea as well as emesis.