Antiemetic efficacy of two different single intravenous doses of dolasetron in patients receiving high-dose cisplatin-containing chemotherapy

Allen Yeilding, Luigi Bertoli, Peter Eisenberg, Patricia Plezia, Manuel R. Modiano, David S. Alberts, Ali Khojasteh, Michael B. Cramer, William F. Hahne

Research output: Contribution to journalArticlepeer-review

17 Scopus citations

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 languageEnglish (US)
Pages (from-to)619-623
Number of pages5
JournalAmerican Journal of Clinical Oncology: Cancer Clinical Trials
Volume19
Issue number6
DOIs
StatePublished - Nov 26 1996
Externally publishedYes

Keywords

  • 5- HT
  • Antiemetic
  • Chemotherapy-induced emesis
  • Cisplatin
  • Clinical trial
  • Dolasetron
  • Emesis
  • Nausea
  • antagonist

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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