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

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

Research output: Contribution to journalArticle

42 Citations (Scopus)

Abstract

BACKGROUND. This double blind parallel group study assessed the acute antiemetic efficacy of four oral doses of dolasetron mesylate in cancer patients receiving their first course of intravenous chemotherapy with doxorubicin and/or cyclophosphamide. METHODS. Patients were randomized to receive 25, 50, 100, or 200 mg of dolasetron mesylate 30 minutes prior to chemotherapy and were monitored for nausea and emetic episodes for the next 24 hours. RESULTS. Three hundred and nineteen cancer patients at 32 sites completed the study. Most patients were female (81%); of this group, 69% had breast carcinoma. A highly statistically significant linear trend demonstrating improved response with higher doses was detected for complete response (no emetic episodes and no rescue medication) (P < 0.001), for complete plus major response (0-2 emetic episodes and no rescue medication) (P < 0.001), and for patient visual analog scale assessments of nausea (P = 0.001) and general satisfaction with antiemetic therapy (P = 0.001). No serious adverse events were noted. The most frequent adverse event was mild, self-limiting headache, which has been reported with other drugs in this class. CONCLUSIONS. Single oral doses of dolasetron mesylate were found to be effective in preventing acute emesis in cancer patients receiving moderately emetogenic chemotherapy.

Original languageEnglish (US)
Pages (from-to)1216-1224
Number of pages9
JournalCancer
Volume79
Issue number6
DOIs
StatePublished - Mar 15 1997
Externally publishedYes

Fingerprint

Vomiting
Emetics
Drug Therapy
Antiemetics
Nausea
Neoplasms
Visual Analog Scale
Doxorubicin
Cyclophosphamide
Headache
dolasetron
Breast Neoplasms
Pharmaceutical Preparations

Keywords

  • 5-hydroxytryptamine (5-HT) receptor antagonist
  • antiemetic
  • cyclophosphamide
  • dolasetron
  • dose- response trial
  • doxorubicin
  • emesis
  • nausea

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Randomized, double blind, dose-response trial across four oral doses of dolasetron for the prevention of acute emesis after moderately emetogenic chemotherapy. / Rubenstein, Edward B.; Gralla, Richard J.; Hainsworth, John D.; Hesketh, Paul J.; Grote, Thomas H.; Modiano, Manuel R.; Khojasteh, Ali; Kalman, Leonard A.; Benedict, Claude R.; Hahne, William F.

In: Cancer, Vol. 79, No. 6, 15.03.1997, p. 1216-1224.

Research output: Contribution to journalArticle

Rubenstein, EB, Gralla, RJ, Hainsworth, JD, Hesketh, PJ, Grote, TH, Modiano, MR, Khojasteh, A, Kalman, LA, Benedict, CR & Hahne, WF 1997, 'Randomized, double blind, dose-response trial across four oral doses of dolasetron for the prevention of acute emesis after moderately emetogenic chemotherapy', Cancer, vol. 79, no. 6, pp. 1216-1224. https://doi.org/10.1002/(SICI)1097-0142(19970315)79:6<1216::AID-CNCR22>3.0.CO;2-1
Rubenstein, Edward B. ; Gralla, Richard J. ; Hainsworth, John D. ; Hesketh, Paul J. ; Grote, Thomas H. ; Modiano, Manuel R. ; Khojasteh, Ali ; Kalman, Leonard A. ; Benedict, Claude R. ; Hahne, William F. / Randomized, double blind, dose-response trial across four oral doses of dolasetron for the prevention of acute emesis after moderately emetogenic chemotherapy. In: Cancer. 1997 ; Vol. 79, No. 6. pp. 1216-1224.
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abstract = "BACKGROUND. This double blind parallel group study assessed the acute antiemetic efficacy of four oral doses of dolasetron mesylate in cancer patients receiving their first course of intravenous chemotherapy with doxorubicin and/or cyclophosphamide. METHODS. Patients were randomized to receive 25, 50, 100, or 200 mg of dolasetron mesylate 30 minutes prior to chemotherapy and were monitored for nausea and emetic episodes for the next 24 hours. RESULTS. Three hundred and nineteen cancer patients at 32 sites completed the study. Most patients were female (81{\%}); of this group, 69{\%} had breast carcinoma. A highly statistically significant linear trend demonstrating improved response with higher doses was detected for complete response (no emetic episodes and no rescue medication) (P < 0.001), for complete plus major response (0-2 emetic episodes and no rescue medication) (P < 0.001), and for patient visual analog scale assessments of nausea (P = 0.001) and general satisfaction with antiemetic therapy (P = 0.001). No serious adverse events were noted. The most frequent adverse event was mild, self-limiting headache, which has been reported with other drugs in this class. CONCLUSIONS. Single oral doses of dolasetron mesylate were found to be effective in preventing acute emesis in cancer patients receiving moderately emetogenic chemotherapy.",
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AU - Rubenstein, Edward B.

AU - Gralla, Richard J.

AU - Hainsworth, John D.

AU - Hesketh, Paul J.

AU - Grote, Thomas H.

AU - Modiano, Manuel R.

AU - Khojasteh, Ali

AU - Kalman, Leonard A.

AU - Benedict, Claude R.

AU - Hahne, William F.

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N2 - BACKGROUND. This double blind parallel group study assessed the acute antiemetic efficacy of four oral doses of dolasetron mesylate in cancer patients receiving their first course of intravenous chemotherapy with doxorubicin and/or cyclophosphamide. METHODS. Patients were randomized to receive 25, 50, 100, or 200 mg of dolasetron mesylate 30 minutes prior to chemotherapy and were monitored for nausea and emetic episodes for the next 24 hours. RESULTS. Three hundred and nineteen cancer patients at 32 sites completed the study. Most patients were female (81%); of this group, 69% had breast carcinoma. A highly statistically significant linear trend demonstrating improved response with higher doses was detected for complete response (no emetic episodes and no rescue medication) (P < 0.001), for complete plus major response (0-2 emetic episodes and no rescue medication) (P < 0.001), and for patient visual analog scale assessments of nausea (P = 0.001) and general satisfaction with antiemetic therapy (P = 0.001). No serious adverse events were noted. The most frequent adverse event was mild, self-limiting headache, which has been reported with other drugs in this class. CONCLUSIONS. Single oral doses of dolasetron mesylate were found to be effective in preventing acute emesis in cancer patients receiving moderately emetogenic chemotherapy.

AB - BACKGROUND. This double blind parallel group study assessed the acute antiemetic efficacy of four oral doses of dolasetron mesylate in cancer patients receiving their first course of intravenous chemotherapy with doxorubicin and/or cyclophosphamide. METHODS. Patients were randomized to receive 25, 50, 100, or 200 mg of dolasetron mesylate 30 minutes prior to chemotherapy and were monitored for nausea and emetic episodes for the next 24 hours. RESULTS. Three hundred and nineteen cancer patients at 32 sites completed the study. Most patients were female (81%); of this group, 69% had breast carcinoma. A highly statistically significant linear trend demonstrating improved response with higher doses was detected for complete response (no emetic episodes and no rescue medication) (P < 0.001), for complete plus major response (0-2 emetic episodes and no rescue medication) (P < 0.001), and for patient visual analog scale assessments of nausea (P = 0.001) and general satisfaction with antiemetic therapy (P = 0.001). No serious adverse events were noted. The most frequent adverse event was mild, self-limiting headache, which has been reported with other drugs in this class. CONCLUSIONS. Single oral doses of dolasetron mesylate were found to be effective in preventing acute emesis in cancer patients receiving moderately emetogenic chemotherapy.

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