Abstract
This randomized, double-blind, parallel-group, multicenter study compared the antiemetic effectiveness, safety, and tolerability of two different intravenous (i.v.) doses of dolasetron mesylate (0.6 and 1.8 mg/kg) in cancer patients receiving their first course of high-dose cisplatin- containing chemotherapy (≤75 mg/m 2). Efficacy was assessed by recording the timing, number, and severity of emetic episodes in the 24 h following high- dose cisplatin. Safety was evaluated by monitoring adverse events, vital signs, clinical laboratory parameters, and electrocardiograms. Of the 62 patients enrolled in the study, 29 received 0.6 mg/kg of dolasetron mesylate and 33 received 1.8 mg/kg. Patients who received dolasetron mesylate 1.8 mg/kg consistently experienced a greater degree of antiemetic control than those who received 0.6 mg/kg. Complete responses were achieved by 55% of patients who received 1.8 mg/kg compared with 31% for the 0.6-mg/kg group. The 1.8-mg/kg group achieved a significantly (p = 0.039) higher complete/major response rate than the 0.6-mg/kg group (77% vs 55%, respectively) and a significantly (p = 0.004) longer time to the first emetic episode (>24 h vs 13.5 h, respectively). More than 80% of patients were either satisfied or very satisfied with dolasetron treatment. The most common adverse events were mild to moderate in intensity, consistent with other studies, and included headache (24.1% of patients) and diarrhea (4.8%). These results demonstrated that a single 1.8-mg/kg i.v. dose of dolasetron mesylate provided effective antiemetic activity in a majority of patients given high- dose cisplatin for the first time and should be evaluated further in clinical trials.
Original language | English (US) |
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Pages (from-to) | 619-623 |
Number of pages | 5 |
Journal | American Journal of Clinical Oncology: Cancer Clinical Trials |
Volume | 19 |
Issue number | 6 |
DOIs | |
State | Published - Nov 26 1996 |
Externally published | Yes |
Keywords
- 5- HT
- Antiemetic
- Chemotherapy-induced emesis
- Cisplatin
- Clinical trial
- Dolasetron
- Emesis
- Nausea
- antagonist
ASJC Scopus subject areas
- Oncology
- Cancer Research