A randomized, double-blind comparison of single-dose and divided multiple-dose dolasetron for cisplatin-induced emesis

Harman, G. S.; Omura, George; Ryan, Kevin; Hainsworth, John D.; Cramer, Michael B.; Hahne, William F.

doi:10.1007/s002800050490

Cited by 37 publications

(19 citation statements)

References 10 publications

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“…As in previous dolasetron studies [14,15,23,30,31] and other 5-HT 3 antagonists trials [32,33], tiredness and headache were the most commonly reported adverse events. As in previous studies with 5-HT 3 receptor antagonists [3,13,15,22,23,31,32,34], we also noted asymptomatic changes in ECG intervals.…”

Section: Discussionmentioning

confidence: 79%

“…In addition, preliminary data in adults suggest that a single intravenous dose of dolasetron is more effective than multiple smaller doses [14]. Meanwhile, these studies have demonstrated that the safety profile of dolasetron is comparable to other selective 5-HT 3 antagonists such as ondansetron, granisetron, and tropisetron [7,23].…”

Section: Discussionmentioning

confidence: 97%

“…In adults, terminal disposition half-life (t 1/2 ) is approximately 7.5 hr with an apparent clearance of 9.3 to 9.5 ml/min/kg (Hoechst Marion Roussel Canada Research). Dolasetron has been shown to be effective and well tolerated in randomized, double-blind trials in adult patients undergoing high-dose cisplatin chemotherapy [13][14][15]. However, conclusions drawn from clinical studies in adults cannot necessarily be extrapolated to children [16,17].…”

Section: Introductionmentioning

confidence: 99%

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Open-label comparison of the antiemetic efficacy of single intravenous doses of dolasetron mesylate in pediatric cancer patients receiving moderately to highly emetogenic chemotherapy

Coppes

Lau

Ingram

et al. 1999

Med. Pediatr. Oncol.

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Background Nausea and vomiting are among the most unpleasant adverse side effects of cancer therapy. Procedure An open‐label dose‐escalation study was conducted to assess the appropriate intravenous dose of dolasetron for pediatric patients undergoing chemotherapy. Patients received dolasetron in single intravenous doses of 0.6 (n = 10), 1.2 (n = 12), 1.8 (n = 12), or 2.4 (n = 12) mg/kg 30 min before receiving emetogenic chemotherapy. Pharmacokinetic parameters were evaluated at each dose level and efficacy was evaluated over the first 24 hr following the administration of dolasetron. Results A complete response was achieved in 10% of patients given 0.6 mg/kg, 25% of patients given 1.2 mg/kg, 67% of patients given 1.8 mg/kg, and 33% of patients given 2.4 mg/kg. Peak plasma concentrations (Cmax) were observed between 0.33 and 0.75 hr following dolasetron infusion. Cmax and area under plasma concentration‐time (AUC) increased with larger doses of dolasetron, while terminal disposition half‐life (t1/2) and apparent clearance (Clapp) were not significantly changed with respect to dose. For 1.8‐mg/kg dolasetron, the t1/2 was 4.98 hr and the maximum plasma concentration (tmax) 0.47 hr. Adverse events were mild to moderate. No serious events occurred. Conclusions. This study suggests that a single intravenous dose of 1.8 mg/kg is the optimum single intravenous dose for controlling chemotherapy‐induced emesis in pediatric patients. Med. Pediatr. Oncol. 33:99–105, 1999. © 1999 Wiley‐Liss, Inc.

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Section: Discussionmentioning

confidence: 79%

Section: Discussionmentioning

confidence: 97%

Section: Introductionmentioning

confidence: 99%

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Open-label comparison of the antiemetic efficacy of single intravenous doses of dolasetron mesylate in pediatric cancer patients receiving moderately to highly emetogenic chemotherapy

Coppes

Lau

Ingram

et al. 1999

Med. Pediatr. Oncol.

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“…The majority of adverse events were mild to moderate in intensity. Headache, which is associated with the use of 5-HT3 receptor antagonists in cancer chemotherapy [2,4,5,8,[11][12][13][14]16], was seen in 1/37 (2.7%) patients treated with dolasetron in this study. Vital signs were not consistently altered by study medication.…”

Section: Discussionmentioning

confidence: 94%

“…Because emesis associated with therapeutic irradiation is not as severe or as likely as with chemotherapy, we tested lower doses of dolasetron than the maximally effective dose used to prevent chemotherapy-induced emesis. Preliminary dosing studies suggested that efficacy in preventing emesis related to highly emetogenic chemotherapy begins at 0.6 mg/kg dolasetron and reaches a plateau at the 1.8-mg/kg dose [2,4,8]. The objectives of this trial were to determine whether a single i.v.…”

Section: Introductionmentioning

confidence: 99%

A double-blind, placebo-controlled trial of i.v. dolasetron mesilate in the prevention of radiotherapy-induced nausea and vomiting in cancer patients

Bey

Wilkinson

Resbeut

et al. 1996

Support Care Cancer

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The aim of this work was to measure the safety and efficacy of single i.v. doses of dolasetron mesilate for the control of emesis caused by single high-dose (at least 6 Gy) radiotherapy to the upper abdomen. The double-blind, placebo-controlled, multicenter study stratified patients on the basis of being naive or nonnaive to radiotherapy. Patients with or without a history of previous chemotherapy were enrolled. Patients were randomized to receive placebo or 0.3, 0.6, or 1.2 mg/kg dolasetron mesilate 30 min before radiotherapy, then monitored for 24 h. Antiemetic efficacy was assessed from the time to the first emetic episode or rescue, from whether there was a complete response (0 emetic episodes /no rescue medication) or a complete-plus-major response (0-2 emetic episodes/no rescue medication), from the severity of nausea (rated by patients and the investigator), and from the investigator's assessment of efficacy. Fifty patients completed the study (owing to changing medical practice, enrollment objectives were not met; consequently, no significant linear dose trend was expected). Pooled dolasetron was superior to the placebo in its effect on the time to first emesis or rescue in radiotherapy-nonnaive patients (P = 0.015). Dolasetron was statistically superior to the placebo in the overall population on the basis of a complete plus major response: 54%, 100%, 93%, and 83% for the placebo and 0.3-, 0.6-, and 1.2-mg/kg doses respectively (P = 0.002). The low response in the highest dose group may be due to an imbalance in the number of chemotherapy-nonnaive patients in that group. Dolasetron was superior to the placebo on the basis of nausea assessed by the investigator (P = 0.024) and administration of rescue medication (P = 0.006). Complete response at the 0.3-mg/ kg dose was superior to results with the placebo (P = 0.050). Treatment-related adverse events were rare, mild to moderate in intensity, and evenly distributed across the four groups. Overall, dolasetron mesilate was effective and well-tolerated in the control of single, high-dose radiotherapy-induced emesis.

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Open‐label comparison of the antiemetic efficacy of single intravenous doses of dolasetron mesylate in pediatric cancer patients receiving moderately to highly emetogenic chemotherapy

Coppes¹,

Lau²,

Ingram³

et al. 1999

Med. Pediatr. Oncol.

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Background. Nausea and vomiting are among the most unpleasant adverse side effects of cancer therapy.Procedure. An open-label dose-escalation study was conducted to assess the appropriate intravenous dose of dolasetron for pediatric patients undergoing chemotherapy. Patients received dolasetron in single intravenous doses of 0.6 (n = 10), 1.2 (n = 12), 1.8 (n = 12), or 2.4 (n = 12) mg/kg 30 min before receiving emetogenic chemotherapy. Pharmacokinetic parameters were evaluated at each dose level and efficacy was evaluated over the first 24 hr following the administration of dolasetron. Results. A complete response was achieved in 10% of patients given 0.6 mg/ kg, 25% of patients given 1.2 mg/kg, 67% of patients given 1.8 mg/kg, and 33% of patients given 2.4 mg/kg. Peak plasma concentrations (C max ) were observed between 0.33 and 0.75 hr following dolasetron infusion. C max and area under plasma concentration-time (AUC) increased with larger doses of dolasetron, while terminal disposition half-life (t 1/2 ) and apparent clearance (Cl app ) were not significantly changed with respect to dose. For 1.8-mg/kg dolasetron, the t 1/2 was 4.98 hr and the maximum plasma concentration (t max ) 0.47 hr. Adverse events were mild to moderate. No serious events occurred. Conclusions. This study suggests that a single intravenous dose of 1.8 mg/ kg is the optimum single intravenous dose for controlling chemotherapy-induced emesis in pediatric patients. Med. Pediatr. Oncol. 33:99-105, 1999.

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A randomized, double-blind comparison of single-dose and divided multiple-dose dolasetron for cisplatin-induced emesis

Cited by 37 publications

References 10 publications

Open-label comparison of the antiemetic efficacy of single intravenous doses of dolasetron mesylate in pediatric cancer patients receiving moderately to highly emetogenic chemotherapy

Open-label comparison of the antiemetic efficacy of single intravenous doses of dolasetron mesylate in pediatric cancer patients receiving moderately to highly emetogenic chemotherapy

A double-blind, placebo-controlled trial of i.v. dolasetron mesilate in the prevention of radiotherapy-induced nausea and vomiting in cancer patients

Open‐label comparison of the antiemetic efficacy of single intravenous doses of dolasetron mesylate in pediatric cancer patients receiving moderately to highly emetogenic chemotherapy

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