The Anti-Emetic Efficiacy of Intravenous Dolasetron Mesilate plus Dexamethasone versus Intravenous Dolasetron Mesilate Alone in Patients Receiving Fractionated Chemotherapy

Abstract

Purpose: Fractionated cisplatin-containing regimens are routinely used for chemotherapy of certain types of cancer. Dolasetron has been shown to be effective in preventing acute emesis related to cisplatin chemotherapy over 24 h; its effectiveness has not been evaluated in fractionated cisplatin-containing chemotherapy. This trial assesses the efficacy of dolasetron alone or dolasetron plus dexamethasone in preventing nausea and vomiting related to fractionated cisplatin chemotherapy. Patients and Methods: 96 hospitalized cancer patients were randomized to receive 100 mg i. v. dolasetron or 100 mg i. v. dolasetron + 20 mg dexamethasone before chemotherapy primarily with cisplatin (15–50 mg/m² ) infused over ≤ 4 h for at least 2 but not more than 5 consecutive days. Dolasetron was administered to all patients 30 min before chemotherapy. Dexamethasone or placebo was administered in double-blind fashion 5 min before chemotherapy. Efficacy was measured at hour 24 of each study day using complete response (no vomiting and no rescue medication) and maximum nausea severity, self-assessed by patients using a 100-mm visual analogue scale. Results: Overall complete response rates were significantly higher in the dolasetron plus dexamethasone group compared with the dolasetron-only group (p < 0.003, Fisher’s exact test). Complete response rates on study days 1 and 2 were also significantly higher with dolasetron plus dexamethasone than with dolasetron alone (day 1: 98 vs. 70%, p = 0.0290; day 2: 89 vs. 62%, p = 0.0286 by Fisher’s exact test). Test results were not significant on days 3–5 due to the small number of patients (day 3: n = 37, day 4: n = 32; day 5: n = 24). Treatment and location of the primary tumor exerted the only statistically significant effects on complete response (treatment: p = 0.006; location of primary tumor: p = 0.021 by log linear analysis of contingency tables). Both treatments were administered safely. Conclusion: As seen with other 5-HT₃ receptor antagonist antiemetics, the addition of dexamethasone to dolasetron significantly increases effectiveness in preventing nausea and vomiting related to fractionated cisplatin chemotherapy. Both dolasetron and dolasetron plus dexamethasone were well tolerated.