Dose-ranging evaluation of the serotonin antagonist dolasetron mesylate in patients receiving high-dose cisplatin Journal Article

Authors: Kris, M. G.; Grunberg, S. M.; Gralla, R. J.; Baltzer, L.; Zaretsky, S. A.; Lifsey, D.; Tyson, L. B.; Schmidt, L.; Hahne, W. F.
Article Title: Dose-ranging evaluation of the serotonin antagonist dolasetron mesylate in patients receiving high-dose cisplatin
Abstract: Purpose: This dose-ranging trial of intravenous dolasetron mesylate (MDL73, 147EF) was performed to determine its adverse and antiemetic effects in patients receiving cisplatin at doses ≥ 100 mg/m2. Patients and Methods: Eighty-nine patients treated with initial cisplatin received a single intravenous dose of dolasetron mesylate administered over 20 minutes beginning 30 minutes before chemotherapy. The following four dose levels were studied: 1.8, 2.4, 3.0, and 5.0 mg/kg. Emesis and adverse effects were measured for 24 hours after cisplatin. Results: All adverse effects were mild and transient including loose stools, headache, serum AST/ALT elevations, and asymptomatic prolongation of ECG intervals. Among the dose levels, no-emesis rates from 24% to 52% were observed, and the percentage of patients having zero, one, or two emetic episodes ranged from 48% to 82%. Complete control of vomiting increased as the dose was escalated to 2.4 mg/kg, but did not improve further with higher doses. Conclusion: Dolasetron mesylate can be administered safely at doses up to 5.0 mg/kg, with comparable complete protection rates and increased adverse effects at doses greater than 2.4 mg/kg. Antiemetic activity was seen after cisplatin. Trials comparing single infusions of dolasetron mesylate and ondansetron are under way.
Keywords: adult; cancer chemotherapy; aged; major clinical study; clinical trial; cisplatin; dose response; vomiting; ondansetron; intravenous drug administration; dolasetron mesilate; antiemetic activity; human; male; female; priority journal; article
Journal Title: Journal of Clinical Oncology
Volume: 12
Issue: 5
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology  
Date Published: 1994-05-01
Start Page: 1045
End Page: 1049
Language: English
DOI: 10.1200/jco.1994.12.5.1045
PROVIDER: scopus
PUBMED: 8164028
Notes: Article -- Source: Scopus
Altmetric Score
MSK Authors
  1. Mark Kris
    612 Kris
  2. Leslie Tyson
    55 Tyson