Comparison of ondansentron (GR 38032F) versus ondansentron plus alprazolam as antiemetic prophylaxis during cisplatin-containing chemotherapy.

Author(s): Tsavaris N, Charalambidis G, Pagou M, Karabelis A, Mylonakis N, Bacoyiannis C, Kosmidis P

Affiliation(s): Second Department of Medical Oncology, Metaxa Cancer Hospital, Piraeus, Greece.

Publication date & source: 1994-12, Am J Clin Oncol., 17(6):516-21.

Publication type: Clinical Trial; Randomized Controlled Trial

The purpose of our study was to evaluate the effectiveness of alprazolam (APZ) as an adjuvant drug to ondansentron against cisplatin-induced emesis. All patients received CDDP 100 mg/m2, and had previously received chemotherapy. We established two groups of patients randomly: Group A patients received 5-HT3 alone, and Group B received 5-HT3 and APZ. The drugs were administered as follows: 5-HT3 was given at a dose of 1 ampule 8 mg in 100 ml N/S in 10 minutes i.v. infusion before the infusion of CDDP. We continued with 1 tablet 8 mg in the afternoon and 1 before sleeping the first day; for the next two days, patients received 3 tablets 8 mg/day. APZ was given in tablets of 0.25 mg 60 minutes before CDDP infusion and then with the second and third dose of 5-HT3. We did not find significant differences in clinical parameters and factors, especially anxiety, that influenced vomiting between the examined groups. The mean number of vomiting episodes without gastric content (4.76 episodes) and the mean duration of nausea (195 minutes), were greater in Group A than in Group B (1.39 episodes, p < .0001; 91 minutes, p < .049). Differences also were found in the mean number of vomiting episodes with gastric content between the examined groups (A: 1.97; B: 1.09; p < .135). The intense of nausea and vomiting according to WHO classification was greater in Group A (grade 0, p < .004; grade 2, p < .020) than in Group B. Patients of Group B had fewer problems with appetite (p < .027), and more intense sedative effect (grade 0 [p < .001], 1 [0.027], 2 [0.022]) than patients of Group A. In conclusion APZ improved the antiemetic efficacy of ondansentron in cisplatin-induced emesis.