Randomized, double-blind cross-over study of acute cisplatin-induced nausea and vomiting, comparing a new schedule of the combination of metoclopramide and methylprednisolone versus metoclopramide alone

Dı́az-Rubio, Eduardo; Gonzalez-Larriba, J. L.; Rosell, R.; A, Abad Gurumeta; Martín, Miguel; Valerdi, Juan José; Barriga, J. J.

doi:10.1093/oxfordjournals.annonc.a057780

Annals of Oncology

1990

DOI: 10.1093/oxfordjournals.annonc.a057780

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Randomized, double-blind cross-over study of acute cisplatin-induced nausea and vomiting, comparing a new schedule of the combination of metoclopramide and methylprednisolone versus metoclopramide alone

Eduardo Dı́az-Rubio

J. L. Gonzalez-Larriba

R. Rosell

et al.

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1992

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Cited by 5 publications

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“…Furthermore, these compounds can induce acute dystonie reactions, particularly in young patients [7], Cor ticosteroids such as dexamethasone and méthylpredniso lone are not effective anti-emetics when given alone to patients receiving cisplatin chemotherapy [2, 8], How ever, the combination of a corticosteroid with a benzamide produces greater anti-emetic efficacy than that pro duced by the benzamide alone [9][10][11]. The new anti emetic ondansetron is the first potent and highly selective 5-HT3 receptor antagonist to be developed and marketed.…”

mentioning

confidence: 99%

A Comparison of Ondansetron with Alizapride plus Methylprednisolone in the Control of Cisplatin-lnduced Emesis

Depierre

Lebeau²,

D'allens³

1992

Oncology

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This randomised, single-blind, parallel-group study was carried out in 48 French pneumology centres to compare the anti-emetic efficacy of ondansetron and an alizapride plus methylprednisolone (ALI/MPS) combination in patients receiving high-dose cisplatin. A total of 220 patients were recruited of whom 209 were evaluable (100 on ondansetron and 109 on ALI/MPS). Thirty minutes before cisplatin, patients received either ondansetron (8 mg i.v.) or alizapride (4 mg/kg i.v.) combined with methylprednisolone (500 mg i.v.). The ondansetron and alizapride injections were repeated 4 and 8 h later. Thereafter, patients received oral ondansetron (8 mg) or alizapride (50 mg) 3 times daily for 5 days. Ondansetron was significantly superior to ALI/MPS in the control of acute emesis (p < 0.001); 88/100 (88%) of ondansetron, and 69/109 (63%) of ALI/MPS patients experienced less than 3 emetic episodes. Similarly, ondansetron was superior to ALI/MPS for the control of acute nausea (visual analogue scale at 24 h; 13 vs. 22 mm respectively, p = 0.0012). The superiority of ondansetron over days 2-6 was not as great as that over the first 24 h, although there was a trend in favour of ondansetron. More patients treated with ondansetron wished to take the same anti-emetic treatment again (83% for ondansetron vs. 56% for ALI/MPS, p < 0.001). Both treatments were well tolerated. This study shows that ondansetron is superior to a ben-zamide-corticosteroid combination in the control of acute cisplatin-induced emesis.

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mentioning

confidence: 99%

A Comparison of Ondansetron with Alizapride plus Methylprednisolone in the Control of Cisplatin-lnduced Emesis

Depierre

Lebeau²,

D'allens³

1992

Oncology

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Ondasetron versus granisetron in the prevention of chemotherapy-induced nausea and vomiting. Results of a prospective randomized trial

Gebbia

Cannata

Testa

et al. 1994

Cancer

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Background. A single‐institution, prospective, randomized open trial was performed to compare ondansetron and granisetron in the prevention of chemotherapyrelated nausea and vomiting. The effect of antemetic drugs was analyzed indipendently for patients treated with highly emetogenic chemotherapy (Study 1), and those treated with moderately emetogenic regimens (Study 2). Methods. In Study 1. 182 patients treated with chemotherapeutic regimens containing high dose cisplatin (more than 70 mg/m2) were randomized to receive 24 mg of ondasentron intravenously (i. v.) or 3 mg of granisetron i. v. for the control of acute emesis. Patients treated with fractionated chemotherapy and those followed‐up for delayed emesis also received 8 mg of ondansetron orally twice a day or 3 mg of granisetron i. v. on the days after Day 1. In Study 2, 164 patients were randomized to receive either 16 mg of ondansetron i. v. or 3 mg of granisetron i. v. to prevent emesis in the first 24 hours. Results. In the ondansetron group in Study 1, a complete response (CR) (i. e., no vomiting, nausea possible) from acute emesis was achieved in 52% of cases, a major response (MR) in 29%, and a minor response (MiR) in 14%. In the granisetron group in Study 1, a CR was seen in 49% of patients, an MR in 24%, and an MiR in 12% Failure was recorded in 5% and 15% of cases in the ondansetron and granisetron groups, respectively. No statistically significant difference in any response category was seen between the two groups. In the ondansetron group, a complete protection from delayed emesis was recorded in 39% of cases, an MR in 32%, an MiR in 21%. and failure in 16%. In the granisetron arm, 36% of the patients had a CR, 22% had an MR, 14% had an MiR, and 14% experienced treatment failure. Again, these differences did not reach statistical significance. In Study 2, no statistical significant difference was observed between the ondansetron arm and the granisetron arm, both for acute and delayed emesis. Both ondansetron and granisetron were tolerated very well by most patients, with no severe side effects. In the group of patients treated with ondansetron, however, the incidence of headache (9%) was higher than in the group treated with granisetron (4%). Conclusions. These data suggest that although both ondansetron and granisetron are very effective drugs for the control of acute emesis, their efficacy against delayed emesis is still not entirely satisfactory.

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Management der Chemotherapie-induzierten Emesis: Was ist Standard nach 20 Jahren klinischer Forschung?

Bois

1998

Med Klin

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Randomized, double-blind cross-over study of acute cisplatin-induced nausea and vomiting, comparing a new schedule of the combination of metoclopramide and methylprednisolone versus metoclopramide alone

Cited by 5 publications

References 5 publications

A Comparison of Ondansetron with Alizapride plus Methylprednisolone in the Control of Cisplatin-lnduced Emesis

A Comparison of Ondansetron with Alizapride plus Methylprednisolone in the Control of Cisplatin-lnduced Emesis

Ondasetron versus granisetron in the prevention of chemotherapy-induced nausea and vomiting. Results of a prospective randomized trial

Management der Chemotherapie-induzierten Emesis: Was ist Standard nach 20 Jahren klinischer Forschung?

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