TY - JOUR
T1 - Dose-ranging evaluation of the serotonin antagonist dolasetron mesylate in patients receiving high-dose cisplatin
AU - Kris, Mark G.
AU - Grunberg, Steven M.
AU - Gralla, Richard J.
AU - Baltzer, Lorraine
AU - Zaretsky, Susan A.
AU - Lifsey, Deborah
AU - Tyson, Leslie B.
AU - Schmidt, Lisa
AU - Hahne, William F.
PY - 1994/5
Y1 - 1994/5
N2 - 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.
AB - 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.
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U2 - 10.1200/JCO.1994.12.5.1045
DO - 10.1200/JCO.1994.12.5.1045
M3 - Article
C2 - 8164028
AN - SCOPUS:0028354474
SN - 0732-183X
VL - 12
SP - 1045
EP - 1049
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 5
ER -