A multicentre, double-blind study comparing placebo, ondansetron and ondansetron plus dexamethasone for the control of cisplatin-induced delayed emesis

Olver, Ian; Paska, W.; Depierre, A; Seitz, Jean François; Goedhals, L.; McQuade, B.; McRae, J. R.; Wilkinson, James

doi:10.1093/oxfordjournals.annonc.a010798

Cited by 68 publications

(40 citation statements)

References 17 publications

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“…However, due to cost considerations, many of these agents are often used at lower than optimal doses. In the U.S., the approved dose of intravenous ondansetron is 32 mg; however, ondansetron is frequently given at doses as low as 8 mg when administered as part of a combination treatment approach for moderately or highly emetogenic chemotherapy [59][60][61][62]. The impact of such a practice on symptom control may jeopardize effective patient management.…”

Section: Optimizing Efficacymentioning

confidence: 99%

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: 99%

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

Schnell¹

2003

The Oncologist

187

167

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“…Significantly less delayed vomiting was noted in both ACTH arms. c. 5-HT 3 antagonists: Four randomized trials comparing a 5-HT 3 antagonist to placebo for the prevention of delayed emesis after cisplatin have been reported [17, 56,60,74]. Prophylaxis for the prevention of acute emesis was uniform in each trial across the study arms.…”

Section: Single Agentsmentioning

confidence: 99%

“…Complete response rates during the primary study period of day 2/3 were not significantly different. The fourth trial randomized patients to receive one of two schedules of ondansetron alone, ondansetron combined with dexamethasone, or placebo during days 2-6 after cisplatin-based chemotherapy [60]. No significant differences were noted between the ondansetron alone and placebo arms.…”

Section: Single Agentsmentioning

confidence: 99%

Consensus proposals for the prevention of acute and delayed vomiting and nausea following high-emetic-risk chemotherapy

Kris

Hesketh

Herrstedt

et al. 2004

Support Care Cancer

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This paper uses an evidence-based approach whenever possible to formulate recommendations, emphasizing the results of controlled trials concerning the best use of antiemetic agents. We address issues of dose, schedule, and route of administration of five selective 5-HT(3) antagonists. We conclude that for each of these five drugs, there is a plateau in therapeutic efficacy above which further dose escalation does not improve outcome. Furthermore, for all classes of antiemetic agents, a single dose is as effective as multiple doses or a continuous infusion. The oral route is as efficacious as the intravenous route of administration, even with chemotherapy of high emetic risk. Selective antagonists of the type 3 serotonin receptor (5-HT(3)) in combination with dexamethasone and aprepitant are the standard of care for the prevention of emesis following chemotherapy of high emetic risk.

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“…Previously, antiemetic therapy for CINV consisted solely of corticosteroids, with a rate of successful acute CINV control of ~30% (10). The CINV control rate increased to ~70% with the advent of first-generation 5-HT3RA medications (11). The first-generation 5-HT3RAs proved to be effective in the control of acute nausea and vomiting; however, a proportion of patients suffer delayed nausea and vomiting, which constitutes a major problem in cancer chemotherapy.…”

Section: Discussionmentioning

confidence: 99%

A phase II clinical trial of palonosetron for the management of delayed vomiting in gynecological cancer patients receiving paclitaxel/carboplatin therapy

Takatori

Shoji

Miura

et al. 2015

Molecular and Clinical Oncology

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Abstract. There are currently no studies demonstrating the effects of palonosetron on delayed chemotherapy-induced nausea and vomiting (CINV) in gynecological cancer patients receiving chemotherapy with moderately emetogenic chemotherapeutic agents. We conducted a phase II clinical trial to assess the efficacy and safety of palonosetron in patients receiving paclitaxel̸carboplatin (TC) therapy. The study population consisted of 42 patients who had been diagnosed with gynecological malignancies and treated with TC. On day 1, 0.75 mg̸body palonosetron and 19.8 mg̸body dexamethasone were administered intravenously immediately prior to TC therapy. Dexamethasone in daily doses of 6.6 mg̸body was also administered intravenously on days 2 and 3. The efficacy and safety of palonosetron + dexamethasone were evaluated by the self-completion method using the Multinational Association of Supportive Care in Cancer Antiemesis Tool during an observation period lasting from day 1 through day 8 of the initial cycle of TC therapy. The severity of the nausea was assessed using a visual analog scale. During the acute (0-24 h), delayed (24-96 h) and overall (0-96 h) periods, the complete response rates were 95.2, 90.5 and 85.7%, respectively, whereas the complete control rates were 90.5, 85.7 and 78.6%, respectively. Grade ≥2 constipation and diarrhea developed in 1 patient (2.4%) each. The palonosetron + dexamethasone regimen proved to be effective for delayed CINV in gynecological cancer patients receiving TC therapy. This combined antiemetic regimen was associated with only mild adverse reactions and may serve as supportive therapy, allowing cancer chemotherapy to be continued while maintaining an adequate quality of life.

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A multicentre, double-blind study comparing placebo, ondansetron and ondansetron plus dexamethasone for the control of cisplatin-induced delayed emesis

Abstract: In contrast to some previous investigations, in this study, ondansetron alone appears to have a minor role in the control of cisplatin-induced delayed emesis and nausea. In conclusion, the combination of oral ondansetron plus dexamethasone is superior to ondansetron and to placebo.

Cited by 68 publications

References 17 publications

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

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

Consensus proposals for the prevention of acute and delayed vomiting and nausea following high-emetic-risk chemotherapy

A phase II clinical trial of palonosetron for the management of delayed vomiting in gynecological cancer patients receiving paclitaxel/carboplatin therapy

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