A Phase II study of ondansetron as antiemetic prophylaxis in patients receiving carboplatin for advanced ovarian cancer

Smith, D. B.; Rustin, G. J. S.; Howells, N.; Lambert, H. E.; McQuade, B.

doi:10.1093/oxfordjournals.annonc.a058029

Cited by 7 publications

(5 citation statements)

References 3 publications

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“…However, the results of this study show better efficacy than previously reported by Smith et al [6] and Harvey et al [7] where less than optimal doses of ondansetron com binations were administered. Similar results have, how ever, been observed in other studies where patients re ceived other non-cisplatin-based chemotherapy regimens.…”

Section: Discussioncontrasting

confidence: 62%

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A Randomised, Double-Blind, Parallel-Group Study to Compare the Efficacy and Safety of Ondansetron (GR38032F) plus Dexamethasone with Metoclopramide plus Dexamethasone in the Prophylaxis of Nausea and Emesis Induced by Carboplatin Chemotherapy

et al. 1997

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A double-blind, parallel-group study in 189 ovarian cancer patients compared the efficacy of ondansetron 8 mg i.v. (OND) and metoclopramide 60 mg i.v. (MET) both in combination with dexamethasone 20 mg i.v. in the prevention of carboplatin-induced emesis. On day 1, complete or major control of emesis (0–2 emetic episodes) was observed in 97% patients from the OND group compared with 74% patients from the MET group (p < 0.001). Similarly, a worst-day analysis over days 1–3 showed complete or major control of emesis in 87% patients (OND) compared wth 66% patients (MET) (p < 0.001). Similar findings in favour of the OND group were observed for nausea grade on day 1 and the worst-day grade during days 1-3. OND was better tolerated than MET. Fewer patients from the OND group (13%) reported adverse events compared with the MET group (21 %). Extrapyramidal type symptoms were observed in 6 (6%) patients from the MET group (paraesthesia, involuntary movement of the jaw and tongue, and restlessness), compared with none from the OND group. Ondansetron plus dexamethasone is a highly effective and well-tolerated treatment and is significantly superior to metoclopramide plus dexamethasone in the prevention of carboplatin-induced emesis.

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Section: Discussioncontrasting

confidence: 62%

“…Two small studies have also been reported, one conducted in the United Kingdom and one in New Zea land [6,7], which suggest that although good response rates were observed during the acute phase of treatment, some 40-50% of patients experienced prolonged symp toms of emesis over the 4 days following carboplatin che motherapy.…”

Section: Introductionmentioning

confidence: 99%

A Randomised, Double-Blind, Parallel-Group Study to Compare the Efficacy and Safety of Ondansetron (GR38032F) plus Dexamethasone with Metoclopramide plus Dexamethasone in the Prophylaxis of Nausea and Emesis Induced by Carboplatin Chemotherapy

et al. 1997

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“…Furthermore, the urinary excretion of 5-HIAA fol lows a similar time course to the pattern of emesis [ 15]. As occurs with cyclophosphamide, ondansetron can prevent both the 'acute' and 'delayed' phase of carboplatininduced emesis [16].…”

Section: Carboplatin-lnduced Em Esismentioning

confidence: 99%

The Severity and Pattern of Emesis following Different Cytotoxic Agents

Martín¹

1996

Oncology

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Different cytotoxic drugs induce different patterns of emesis. This is relevant to clinical practice since we often see in the medical literature oversimplifications in the recommendation for management of chemotherapy-induced emesis, so that the same guidelines are given for cisplatin and non-cisplatin-containing chemotherapy. In particular, cisplatin induces a biphasic pattern of emesis which is characterized by an acute immediate phase and a delayed phase. These two phases are clearly different, especially when cisplatin is given in short i.v. administration (e.g. over 20 min to 1 h) and in high doses (100–120 mg/m²). On the other hand, cyclophosphamide and carboplatin induce a quite different pattern of emesis, characterized by a monophasic curve which, although more intense in the first 24 h, may continue for a number of days. The antiemetic response to 5-HT₃ receptor antagonists on days 2–5 is good in the case of carboplatin and cyclophosphamide and poor in the case of cisplatin (delayed emesis after cisplatin). This firmly suggests that the pathogenesis of cisplatin-induced emesis may differ from that induced by other cytotoxic drugs, especially in the delayed phase of emesis. We think that we should reserve the term ‘delayed emesis’ for the late emesis induced by cisplatin, while ‘prolonged emesis’ could be a better denomination for the late emesis induced by cyclophosphamide and carboplatin. The main clinical implication of these observations is that 5-HT₃ receptor antagonists should be administered over 3–5 days in the case of carboplatin and cyclophosphamide, while a short treatment during the first day could be sufficient to control the acute phase of cisplatin-induced emesis.

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“…Most of the patients suffered from severe emesis with a mean number of 13.5 vomiting episodes per patient. Data from 79 patients included in 3 anti-emetic trials using ondanse tron for the prevention of carboplatin-induced emesis were identified in a Medline literature search [11][12][13]. Although the numbers are small, there is clear evidence that ondansetron is efficacious in reducing carboplatin-induced emesis.…”

Section: Severity and Pattern Of Carboplatin-induced Em Esismentioning

confidence: 99%

“…The publications of these stud ies of 'noncisplatin-induced emesis' do not provide enough detailed data for a subgroup analysis of carboplatin-treated patients. A Medline search revealed only 3 studies of anti-emetic treatment for patients receiving car boplatin [11][12][13] . 3).…”

Section: Introductionmentioning

confidence: 99%

Pathophysiology, Severity, Pattern, and Risk Factors for Carboplatin-induced Emesis

et al. 1996

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Carboplatin has proven efficacy in the treatment of ovarian cancer and has been proven to be less toxic compared to the parent compound cisplatin. Nevertheless, emesis is still a major problem associated with carboplatin-containing chemotherapy. Several investigators have focussed on the understanding of the pathophysiology and pattern of cisplatin-induced emesis. Data describing both the pathomechanisms and pattern of carboplatin-induced emesis are still lacking. This paper combines data from the literature with our own experience with the pattern and control of carboplatin-induced emesis, and presents data contributing to the understanding of the underlying pathomechanisms. Carboplatin induces a significant increase in urinary 5-HIAA excretion, the main metabolite of serotonin. 5-HIAA excretion levels remain elevated over 3 days following chemotherapy. Carboplatin-induced emesis is observed in about 40% of patients despite anti-emetic prophylaxis with 5-HT₃ antagonists. Vomiting after carboplatin extends over days 1–3 with an equal distribution regarding the severity on each day. Analysis of the pattern of emesis revealed that delayed emesis ( > 24 h after chemotherapy) is a major problem associated with carboplatin therapy. Description of the pattern of emesis as ‘prolonged emesis’ seems to be appropriate. 5-HT₃ receptor antagonists such as ondansetron seem to be efficacious both in the control of acute and prolonged emesis following carboplatin chemotherapy, but randomly controlled data comparing ondansetron with other anti-emetic regimens have not yet been published. Univariate analysis reveals gender and combination therapy containing carboplatin and cyclophosphamide and/or anthracyclines as risk factors for emesis.

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A Phase II study of ondansetron as antiemetic prophylaxis in patients receiving carboplatin for advanced ovarian cancer

Cited by 7 publications

References 3 publications

A Randomised, Double-Blind, Parallel-Group Study to Compare the Efficacy and Safety of Ondansetron (GR38032F) plus Dexamethasone with Metoclopramide plus Dexamethasone in the Prophylaxis of Nausea and Emesis Induced by Carboplatin Chemotherapy

A Randomised, Double-Blind, Parallel-Group Study to Compare the Efficacy and Safety of Ondansetron (GR38032F) plus Dexamethasone with Metoclopramide plus Dexamethasone in the Prophylaxis of Nausea and Emesis Induced by Carboplatin Chemotherapy

The Severity and Pattern of Emesis following Different Cytotoxic Agents

Pathophysiology, Severity, Pattern, and Risk Factors for Carboplatin-induced Emesis

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