Granisetron plus alprazolam versus granisetron alone in the control of emesis in patients with operable breast cancer receiving anthracycline containing chemotherapy: A phase III trial

Abstract

8081 Background: Even with optimal antiemetic treatment, about only 20% of patients are completely free from nausea and vomiting (NV). Benzodiazepines have been previously shown to be useful in the prophylaxis of NV. Alprazolam, a newer benzodiazepine, has antidepressant effect and may be useful in NV control. Methods: Nineteen operable breast cancer patients were included in this randomized prospective crossover open label trial. All of them received 4–6 cycles of single day anthracycline containing chemotherapy. Patients received either granisetron (G) alone 3 mg intravenously 15 minute before chemotherapy and then 2×1 mg per os for 5 days, or in combination with alprazolam (A) 0.5 mg per os starting a night and 15 minutes before chemotherapy and continued 2×0.5 mg per os for 5 days. Group A patients received G+A first and then crossed over G alone after the 2nd or 3rd cycle. Group B patients received the reverse order. Eithy four cycles were evaluated. Results: In Group A, Complete Remission (CR) plus Major Response (MR) rate was higher significantly (93.9%) with G+A than G alone (83.3%) (p=.0001) in the first 24 hour period. In Group B, CR plus MR ratio in G+A cycles (100%) was significantly higher than (85.7%) in G alone cycles (p=0.035) in 24 hour period and in 25–129 hour period (92% v.s. 90.5%, p=0.022). When the data were analyzed independently, CR plus MR ratio was signficantly better in G+A cycles (97%) than in G alone (79%) in 24 hour period (p=0.044). Conclusions: Alprazolam increases the efficacy of granisetron in patients with breast cancer who received anthracycline containing regimen. No significant financial relationships to disclose.