Randomized, double blind, dose‐response trial across four oral doses of dolasetron for the prevention of acute emesis after moderately emetogenic chemotherapy

Rubenstein, Edward; Gralla, Richard J.; Hainsworth, John D.; Hesketh, Paul J.; Grote, Thomas; Modiano, Manuel; Khojasteh, Ali; Kalman, Leonard; Benedict, Claude R.; Hahne, William F.

doi:10.1002/(sici)1097-0142(19970315)79:6<1216::aid-cncr22>3.3.co;2-f

Cited by 8 publications

(7 citation statements)

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“…In contrast, oral dolasetron is approved in the U.S. for use with moderately emetogenic chemotherapy at a dose of 100 mg administered within 1 hour before chemotherapy [63]. However, a dose-related response for oral dolasetron has been shown to occur at doses between 25 and 200 mg [64,65]. Indeed, a significant linear dose-response relationship was observed in 399 cancer patients receiving moderately emetogenic chemotherapy over the entire dolasetron dose range of 25-200 mg (p < 0.001), with complete response rates of 60.5% and 76.3% achieved with the 100 mg and 200 mg doses, respectively [64].…”

Section: Optimizing Efficacymentioning

confidence: 86%

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

Schnell¹

2003

The Oncologist

187

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: Optimizing Efficacymentioning

confidence: 86%

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

Schnell¹

2003

The Oncologist

187

167

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“…These transient changes occurred at 1 to 2 hours post-therapy and appeared related to plasma concentrations of the major metabolite of dolasetron. A similar study of oral dolasetron (n = 319) repeated these results in patients who received doxorubicin (≥40 mg/m 2 alone or 25-75 mg/m 2 with cyclophosphamide) or cyclophosphamide (500 to 1,200 mg/m 2 ) as the primary chemotherapeutic agent [35]. The changes resolved within 24 hours and were not considered clinically relevant.…”

Section: Noncomparative Studiesmentioning

confidence: 88%

“…It is difficult to compare results of this study with those of other studies because of multiple chemotherapy agents and the high dose of granisetron employed. Cardiac effects following dolasetron therapy were observed in two clinical studies that specifically excluded patients with preexisting cardiomyopathy, CHF, complete bundle branch block, ≥1º heart block, or arrhythmias requiring medication [7,35]. Both studies evaluated escalating doses (25, 50, 100, or 200 mg) of oral dolasetron.…”

Section: Noncomparative Studiesmentioning

confidence: 99%

The Cardiotoxic Potential of the 5-HT3 Receptor Antagonist Antiemetics: Is There Cause for Concern?

Keefe

2002

The Oncologist

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Purpose. To review and evaluate the potential cardiac effects of 5-HT 3 antiemetic treatment in patients who may be predisposed to cardiac complications resulting from malignancy, cytotoxic oncologic regimens, or preexisting comorbid conditions. Design. A literature review was conducted on the negative cardiovascular effects of chemotherapeutic agents, and, more specifically, on the cardiac interactions of the 5-HT 3 receptor antagonists commonly used to treat chemotherapy-induced nausea and vomiting.Results. Clinical studies in healthy subjects have reported electrocardiograph changes following administration of 5-HT 3 receptor antagonists. However, there are limited data on the use of 5-HT 3 antiemetics when administered with cardiotoxic chemotherapy. Nonetheless, the development of significant electrocardiograph changes with some agents may indicate a potential for significant cardiac effects in patients, particularly those who may be predisposed to cardiac complication.Conclusions. As the predicted human life span increases, clinicians will be treating a larger, older oncology population. Because two of the most common major comorbidities are cardiovascular related, we need to be acutely aware of the toxic effects of chemotherapy, as well as the possible cardiac interaction of supportive agents, specifically the 5-HT 3 antiemetics. Until more data are made available, the best antiemetic option for patients receiving emetogenic and cardiotoxic chemotherapy may be the agent with the fewest apparent cardiac effects.

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“…These responses were validated using frequency and severity of nausea, emesis, and retching as self-recorded in a daily diary according to standard, previously reported methods. 12 Results of symptoms and QOL are reported based on the daily telephone follow-up.…”

Section: Methodsmentioning

confidence: 99%

Measuring chemotherapy‐induced nausea and emesis

Martin

Rubenstein

Elting

et al. 2003

Cancer

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Randomized, double blind, dose‐response trial across four oral doses of dolasetron for the prevention of acute emesis after moderately emetogenic chemotherapy

Cited by 8 publications

References 1 publication

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

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

The Cardiotoxic Potential of the 5-HT3 Receptor Antagonist Antiemetics: Is There Cause for Concern?

Measuring chemotherapy‐induced nausea and emesis

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