Double-blind, randomized comparison of the antiemetic efficacy of intravenous dolasetron mesylate and intravenous ondansetron in the prevention of acute cisplatin-induced emesis in patients with cancer. Dolasetron Comparative Chemotherapy-induced Emesis Prevention Group.

Hesketh, Paul J.; Navari, Rudolph M.; Grote, Thomas; Gralla, Richard J.; Hainsworth, John D.; Kris, Mark G.; Anthony, Lowell; Khojasteh, Ali; Tapazoglou, Efstathios; Benedict, Claude R.; Hahne, William F.

doi:10.1200/jco.1996.14.8.2242

Cited by 139 publications

(83 citation statements)

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“…Of interest, the duration of action of granisetron has been shown to be at least 24 hours, considerably longer than that predicted by its halflife [45], and is a possible consequence of its noncompetitive antagonism of the 5-HT 3 receptor [46]. However, while such pharmacologic differences may be expected to translate into clinical relevance, the full significance of these variations remains thus far equivocal [1,47]. Nevertheless, Schnell 192 these differences may differentiate individuals' responses to their given antiemetic therapies, impacting on acute control of nausea and vomiting and the overall success of treatment.…”

Section: A Comparable Pharmacologic Profile?mentioning

confidence: 99%

“…5-HT 3 -receptor antagonists have become the agents of choice in preventing acute CINV following both moderately and highly emetogenic chemotherapy [11,51]. Complete response and total control rates seen with specific drugs range from 60%-80% for moderately emetogenic chemotherapy [4,[52][53][54], 40%-60% for cisplatin-containing therapy [4,33,55,56], and 25%-60% for high-dose cisplatin regimens [33,35,47,57,58].…”

Section: Optimizing Efficacymentioning

confidence: 99%

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Chemotherapy-Induced Nausea and Vomiting: The Importance of Acute Antiemetic Control

Schnell¹

2003

The Oncologist

186

167

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Nausea and vomiting are two of the most feared side effects of cancer chemotherapy and radiotherapy. Chemotherapy-induced nausea and vomiting can be broadly categorized as acute (occurring within 24 hours of therapy), delayed (persisting for 6-7 days after therapy), or anticipatory (occurring prior to chemotherapy administration). Breakthrough and refractory nausea and vomiting describe the symptoms of uncontrolled emesis. Evidence suggests that good control of nausea and vomiting during the acute period correlates with the control of delayed emesis. Conversely, protection failure during the first 24 hours has a high predictive value for delayed emesis in the same cycle.The 5-HT 3 -receptor antagonists, regarded as the 'gold standard' in antiemetic therapy, are the first-line treatment for moderately and highly emetogenic chemotherapy and radiotherapy regimens in adults and children. Evidence suggests that the 5-HT 3 -receptor antagonists administered in combination with corticosteroids afford the best protection from symptoms of acute emesis and, by extrapolation, the most effective prevention of delayed emesis.Antiemetic therapeutic guidelines stress that the goal of therapy is to prevent cytostatic-induced nausea and vomiting. Therefore, the prophylactic use of the most effective antiemetic regimen-taking into consideration the emetogenicity of the chemotherapy and individual patient characteristics-must be adhered to in order to prevent acute, delayed, and anticipatory nausea and vomiting.

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Section: A Comparable Pharmacologic Profile?mentioning

confidence: 99%

Section: Optimizing Efficacymentioning

confidence: 99%

Chemotherapy-Induced Nausea and Vomiting: The Importance of Acute Antiemetic Control

Schnell¹

2003

The Oncologist

186

167

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“…In a randomized double-blind comparison in patients with cancer, Hesketh et al (1996) assess the efficacy of antiemetic agents in preventing cisplatin-induced nausea and vomiting. The trial was performed to show noninferiority of dolasetron mesylate at doses of 1.8 mg/kg (E 1 ) and 2.4 mg/kg (E 2 ), respectively, over the standard ondansetron (C) at its approved dose of 32 mg.…”

Section: Examplementioning

confidence: 99%

“…Clinical trials to show therapeutic equivalence of two treatments are well established since more than a decade (Hesketh et al 1996;Diehm, Trampisch, Lange & Schmidt 1996;Tebbe et al 1998;Chouela et al 1999;Dammann et al 2000). Here in most cases, a new therapy (e.g.…”

Section: Introductionmentioning

confidence: 99%

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Testing noninferiority in three‐armed clinical trials based on likelihood ratio statistics

et al. 2007

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Clinical noninferiority trials with three (or more) groups recently have received much attention, e.g. due to the fact that regulatory agencies often require that a placebo group has to be evaluated in addition to a new experimental drug and an active control. We discuss the likelihood ratio tests for binary endpoints and various noninferiority hypotheses. We find that, depending on the particular hypothesis, either the LR test reduces asymptotically to the intersection union test, or to a test which follows asymptotically a mixture of generalized χ 2 -distributions. The performance of this asymptotic is investigated and an exact modification is given. It is shown that this test considerably outperforms multiple testing methods with respect to power, such as the Bonferroni adjustment. The methods are illustrated with a cancer study where antiemetic agents were compared. Finally, we discuss the extension of the results to other settings, such as normal endpoints.

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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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Double-blind, randomized comparison of the antiemetic efficacy of intravenous dolasetron mesylate and intravenous ondansetron in the prevention of acute cisplatin-induced emesis in patients with cancer. Dolasetron Comparative Chemotherapy-induced Emesis Prevention Group.

Abstract: A single IV dose of dolasetron mesylate (1.8 or 2.4 mg/kg) has comparable safety and efficacy to a single 32-mg IV dose of ondansetron in patients receiving cisplatin chemotherapy.

Cited by 139 publications

References 22 publications

Chemotherapy-Induced Nausea and Vomiting: The Importance of Acute Antiemetic Control

Chemotherapy-Induced Nausea and Vomiting: The Importance of Acute Antiemetic Control

Testing noninferiority in three‐armed clinical trials based on likelihood ratio statistics

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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