Supportive Care in Cancer

, Volume 4, Issue 2, pp 141–146 | Cite as

Dose-ranging evaluation of the antiemetic efficacy of intravenous dolasetron in patients receiving chemotherapy with doxorubicin or cyclophosphamide

  • Paul J. Hesketh
  • David R. Gandara
  • Ann M. Hesketh
  • Anna Facada
  • Edith A. Perez
  • Lauri M. Webber
  • Lorene A. Martin
  • Michael B. Cramer
  • William F. Hahne
Original Article

Abstract

Selective 5-HT3 antagonists have proven to be safe and effective for the prevention of chemotherapy-induced nausea and vomiting. Dolasetron is a new highly selective addition to this class of antiemetics that has been shown to have significant antiemetic activity in patients receiving cisplatin-containing regimens. This pilot study was designed to evaluate the antiemetic efficacy of dolasetron in cancer patients receiving doxorubicin and/or cyclophosphamide. This study used an openlabel, non-randomized design to evaluate the efficacy and safety of intravenous dolasetron in the prevention of emesis in patients receiving doxorubicin (25–75 mg/m2) and/or cyclophosphamide (400–1200 mg/m2). Sixty-nine patients received a single, intravenous dose of dolasetron over 15–20 min beginning 30 min prior to the start of chemotherapy. Dose levels of dolasetron studied were: 0.3, 0.6, 1.2, 1.8 and 2.4 mg/kg. Patients were monitored for emesis, nausea and adverse events for 24 h after the start of chemotherapy. Overall, 61% of patients experienced complete control of emesis. No significant trend towards increased antiemetic efficacy (P = 0.076) or nausea control with increasing dolasetron dose was noted, although the power to detect significant differences was limited by the small number of patients on the 0.3-mg/kg and 2.4-mg/kg dose levels. Age, gender, and type of chemotherapy were significant predictors of complete antiemetic control. Adverse events were generally mild and included headache, chills, light-headedness, fever, diarrhea, dizziness, and asymptomatic prolongation of ECG intervals. Intravenous dolasetron is safe and effective in the prevention of emesis induced by doxorubicin and/or cyclophosphamide.

Key words

Dolasetron Dose-ranging trial Emesis Nausea Antiemetic 

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Copyright information

© Springer-Verlag 1996

Authors and Affiliations

  • Paul J. Hesketh
    • 1
  • David R. Gandara
    • 2
  • Ann M. Hesketh
    • 1
  • Anna Facada
    • 3
  • Edith A. Perez
    • 2
  • Lauri M. Webber
    • 1
  • Lorene A. Martin
    • 4
  • Michael B. Cramer
    • 4
  • William F. Hahne
    • 4
  1. 1.Section of Medical OncologySt. Elizabeth's Medical CenterBostonUSA
  2. 2.UCD Cancer CenterUniversity of CaliforniaSacramentoUSA
  3. 3.Section of Medical OncologyBoston University Medical CenterBostonUSA
  4. 4.Marion Merrell Dow Inc.Kansas CityUSA

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