A Prospective Comparison of the Ondansetron Plus Aprepitant, Versus Ondansetron for the Prevention of Chemotherapy Induced Nausea and Vomiting

OBJECTIVE The objective of study is to compare Ondansetron plus Aprepitant versus Ondansetron-s safety for the prevention of chemotherapy induced nausea and vomiting in patients receiving Cisplatin and 5-Fluorouracil as their treatment for managing cervix cancer and head and neck cancer. METHODS The study was conducted in a Radiotherapy Department of tertiary care teaching hospital. Patients with cervix cancer and head and neck cancer who were scheduled to receive treatment with cisplatin and 5-fluorouracil were randomized to receive 1 of 2 treatment regimens, the standard therapy group received intravenous ondansetron 8 mg and intravenous dexamethasone 4 mg on Days 1-3. The aprepitant group received oral aprepitant 125 mg, intravenous ondansetron 8 mg, and oral dexamethasone 4 mg on Day 1, oral aprepitant 80 mg and oral dexamethasone 8 mg once daily on Days 2-3. RESULTS Of the 86 patients screened 82 were randomized. Twenty-seven (75 %) of 36 patients achieved a CR in the acute phase (days 1 through 5) on the aprepitant cycle, and fourteen (32.5 %) of 43patients had a CR on the placebo cycle. In the delayed phase (days 6 through 8), 23 (64 %) of the patients on the aprepitant cycle had a CR, and 21 (48.8 %) of the patients on the placebo cycle achieved CR. The overall number of patients with CR for days 1through 8 was 19 (52.7 %) on the aprepitant cycle compared with 12 (27.9 %) on the placebo cycle. CONCLUSION There was a significant improvement in complete response rate with aprepitant combined with a 5HT3-RA and dexamethasone as on par with 5HT3-RA and dexamethasone alone.