Abstract

"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."

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