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 > or = 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.
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 > or = 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.
Authors: Matthew D Hellmann; Isrid Sturm; Zuzana Jirakova Trnkova; John Lettieri; Konstanze Diefenbach; Naiyer A Rizvi; Scott N Gettinger Journal: Clin Lung Cancer Date: 2015-04-20 Impact factor: 4.785
Authors: B Chevallier; P Cappelaere; T Splinter; M Fabbro; J L Wendling; L Cals; G Catimel; M Giovannini; D Khayat; P Bastit; N Claverie Journal: Support Care Cancer Date: 1997-01 Impact factor: 3.603
Authors: P J Hesketh; D R Gandara; A M Hesketh; A Facada; E A Perez; L M Webber; L A Martin; M B Cramer; W F Hahne Journal: Support Care Cancer Date: 1996-03 Impact factor: 3.603
Authors: Mitesh J Borad; Arundhati D Soman; Martin Benjamin; Daniel Casa; Waibhav D Tembe; Barbara F Piper; Ramesh Ramanathan; Raoul Tibes; Gayle Jameson; Karen Ansaldo; Daniel D Von Hoff Journal: Invest New Drugs Date: 2012-12-16 Impact factor: 3.850