Efficacy of oral ondansetron, a selective antagonist of 5-HT3 receptors, in the treatment of nausea and vomiting associated with cyclophosphamide- based chemotherapies

L. X. Cubeddu, K. Pendergrass, T. Ryan, M. York, G. Burton, M. Meshad, D. Galvin, A. A. Ciociola, N. Fuenmayor, I. Hoffmann, L. B. Anthony, R. F. Berris, L. Bricker, W. Cieplinski, T. Crowley, N. DiBella, Lawrence Einhorn, P. Eisenberg, R. Figlin

Research output: Contribution to journalArticle

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Abstract

We evaluated the efficacy and safety of oral ondansetron, a selective antagonist of 5-HT3 receptors, for the treatment of nausea and vomiting associated with cyclophosphamide-based chemotherapy (>500 mg/m2). In this trial 324 chemotherapy-naive cancer patients, mostly females with breast cancer, were randomized to receive either placebo or ondansetron 1 mg, 4 mg, or 8 mg three times per day for 3 days. There were no differences in the doses of cyclophosphamide, doxorubicin, and methotrexate between the study groups. All ondansetron dose groups were superior to the placebo control group (p <.001) for all measured efficacy parameters (complete response, number of emetic episodes, therapeutic failures, need of rescue antiemetics). No emetic episodes were reported by 9 (12%), 29 (37%), 48 (64%), and 47 (66%) of the placebo patients and the 1-mg, 4-mg, and 8-mg dose of ondansetron patients, respectively. Nausea was reduced and food intake was improved for all the ondansetron groups. A more severe emetic response was observed in patients receiving cyclophosphamide and doxorubicin combination chemotherapy. In this subgroup of patients, 66%, 38%, 25%, and 16% of the placebo group and 1-mg, 4-mg, and 8-mg ondansetron patients, respectively, required rescue antiemetics. No significant toxic effects were observed in this study. A higher incidence of headaches and gastrointestinal complaints (constipation, abdominal pain) were observed in the three ondansetron groups. In conclusion, oral ondansetron is an effective and well-tolerated antiemetic treatment in the management of cancer patients receiving ambulatory cyclophosphamide- based chemotherapy. These results support the view that serotonin and 5-HT3 receptors play an important role in cyclophosphamide-induced nausea and vomiting.

Original languageEnglish (US)
Pages (from-to)137-146
Number of pages10
JournalAmerican Journal of Clinical Oncology: Cancer Clinical Trials
Volume17
Issue number2
StatePublished - 1994
Externally publishedYes

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Receptors, Serotonin, 5-HT3
Ondansetron
Cyclophosphamide
Nausea
Vomiting
Drug Therapy
Emetics
Antiemetics
Placebos
Therapeutics
Doxorubicin
Poisons
Constipation
Combination Drug Therapy
Methotrexate
Abdominal Pain
Headache
Neoplasms
Eating
Breast Neoplasms

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Efficacy of oral ondansetron, a selective antagonist of 5-HT3 receptors, in the treatment of nausea and vomiting associated with cyclophosphamide- based chemotherapies. / Cubeddu, L. X.; Pendergrass, K.; Ryan, T.; York, M.; Burton, G.; Meshad, M.; Galvin, D.; Ciociola, A. A.; Fuenmayor, N.; Hoffmann, I.; Anthony, L. B.; Berris, R. F.; Bricker, L.; Cieplinski, W.; Crowley, T.; DiBella, N.; Einhorn, Lawrence; Eisenberg, P.; Figlin, R.

In: American Journal of Clinical Oncology: Cancer Clinical Trials, Vol. 17, No. 2, 1994, p. 137-146.

Research output: Contribution to journalArticle

Cubeddu, LX, Pendergrass, K, Ryan, T, York, M, Burton, G, Meshad, M, Galvin, D, Ciociola, AA, Fuenmayor, N, Hoffmann, I, Anthony, LB, Berris, RF, Bricker, L, Cieplinski, W, Crowley, T, DiBella, N, Einhorn, L, Eisenberg, P & Figlin, R 1994, 'Efficacy of oral ondansetron, a selective antagonist of 5-HT3 receptors, in the treatment of nausea and vomiting associated with cyclophosphamide- based chemotherapies', American Journal of Clinical Oncology: Cancer Clinical Trials, vol. 17, no. 2, pp. 137-146.
Cubeddu, L. X. ; Pendergrass, K. ; Ryan, T. ; York, M. ; Burton, G. ; Meshad, M. ; Galvin, D. ; Ciociola, A. A. ; Fuenmayor, N. ; Hoffmann, I. ; Anthony, L. B. ; Berris, R. F. ; Bricker, L. ; Cieplinski, W. ; Crowley, T. ; DiBella, N. ; Einhorn, Lawrence ; Eisenberg, P. ; Figlin, R. / Efficacy of oral ondansetron, a selective antagonist of 5-HT3 receptors, in the treatment of nausea and vomiting associated with cyclophosphamide- based chemotherapies. In: American Journal of Clinical Oncology: Cancer Clinical Trials. 1994 ; Vol. 17, No. 2. pp. 137-146.
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abstract = "We evaluated the efficacy and safety of oral ondansetron, a selective antagonist of 5-HT3 receptors, for the treatment of nausea and vomiting associated with cyclophosphamide-based chemotherapy (>500 mg/m2). In this trial 324 chemotherapy-naive cancer patients, mostly females with breast cancer, were randomized to receive either placebo or ondansetron 1 mg, 4 mg, or 8 mg three times per day for 3 days. There were no differences in the doses of cyclophosphamide, doxorubicin, and methotrexate between the study groups. All ondansetron dose groups were superior to the placebo control group (p <.001) for all measured efficacy parameters (complete response, number of emetic episodes, therapeutic failures, need of rescue antiemetics). No emetic episodes were reported by 9 (12{\%}), 29 (37{\%}), 48 (64{\%}), and 47 (66{\%}) of the placebo patients and the 1-mg, 4-mg, and 8-mg dose of ondansetron patients, respectively. Nausea was reduced and food intake was improved for all the ondansetron groups. A more severe emetic response was observed in patients receiving cyclophosphamide and doxorubicin combination chemotherapy. In this subgroup of patients, 66{\%}, 38{\%}, 25{\%}, and 16{\%} of the placebo group and 1-mg, 4-mg, and 8-mg ondansetron patients, respectively, required rescue antiemetics. No significant toxic effects were observed in this study. A higher incidence of headaches and gastrointestinal complaints (constipation, abdominal pain) were observed in the three ondansetron groups. In conclusion, oral ondansetron is an effective and well-tolerated antiemetic treatment in the management of cancer patients receiving ambulatory cyclophosphamide- based chemotherapy. These results support the view that serotonin and 5-HT3 receptors play an important role in cyclophosphamide-induced nausea and vomiting.",
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T1 - Efficacy of oral ondansetron, a selective antagonist of 5-HT3 receptors, in the treatment of nausea and vomiting associated with cyclophosphamide- based chemotherapies

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AU - Pendergrass, K.

AU - Ryan, T.

AU - York, M.

AU - Burton, G.

AU - Meshad, M.

AU - Galvin, D.

AU - Ciociola, A. A.

AU - Fuenmayor, N.

AU - Hoffmann, I.

AU - Anthony, L. B.

AU - Berris, R. F.

AU - Bricker, L.

AU - Cieplinski, W.

AU - Crowley, T.

AU - DiBella, N.

AU - Einhorn, Lawrence

AU - Eisenberg, P.

AU - Figlin, R.

PY - 1994

Y1 - 1994

N2 - We evaluated the efficacy and safety of oral ondansetron, a selective antagonist of 5-HT3 receptors, for the treatment of nausea and vomiting associated with cyclophosphamide-based chemotherapy (>500 mg/m2). In this trial 324 chemotherapy-naive cancer patients, mostly females with breast cancer, were randomized to receive either placebo or ondansetron 1 mg, 4 mg, or 8 mg three times per day for 3 days. There were no differences in the doses of cyclophosphamide, doxorubicin, and methotrexate between the study groups. All ondansetron dose groups were superior to the placebo control group (p <.001) for all measured efficacy parameters (complete response, number of emetic episodes, therapeutic failures, need of rescue antiemetics). No emetic episodes were reported by 9 (12%), 29 (37%), 48 (64%), and 47 (66%) of the placebo patients and the 1-mg, 4-mg, and 8-mg dose of ondansetron patients, respectively. Nausea was reduced and food intake was improved for all the ondansetron groups. A more severe emetic response was observed in patients receiving cyclophosphamide and doxorubicin combination chemotherapy. In this subgroup of patients, 66%, 38%, 25%, and 16% of the placebo group and 1-mg, 4-mg, and 8-mg ondansetron patients, respectively, required rescue antiemetics. No significant toxic effects were observed in this study. A higher incidence of headaches and gastrointestinal complaints (constipation, abdominal pain) were observed in the three ondansetron groups. In conclusion, oral ondansetron is an effective and well-tolerated antiemetic treatment in the management of cancer patients receiving ambulatory cyclophosphamide- based chemotherapy. These results support the view that serotonin and 5-HT3 receptors play an important role in cyclophosphamide-induced nausea and vomiting.

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