An open-label dose comparison study of ondansetron for the prevention of emesis associated with chemotherapy prior to bone marrow transplantation |
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Authors: | Cynthia L Osowski Suzanne P Dix Mike Lynn Terri Davidson Lisa Cohen Tammi Miyahara Mary C Sexauer Robert Joyce Andrew Yeager John R Wingard |
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Institution: | (1) Department of Pharmaceutical Services, Emory University Hospital, Atlanta, Ga., USA, US;(2) Oncology & Hematology Associates of Kansas City, Kansas City, Mo., USA, US;(3) Department of Biostatistics, Emory University, Atlanta, Ga., USA, US;(4) Winship Cancer Center, Emory University, Atlanta, Ga., USA, US;(5) Stem Cell Transplant Program, Baptist Medical Center, Jacksonville, Fla., USA, US;(6) Bone Marrow Transplant and Leukemia Program, Department of Medicine, Emory University Hospital, Atlanta, Ga., USA, US;(7) Bone Marrow Transplant Program, Division of Hematology/Oncology, University of Florida, Gainesville, Fla., USA, US |
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Abstract: | Nausea and vomiting are significant side effects in bone marrow transplant (BMT) patients who receive high-dose preparative
regimens. Higher than conventional ondansetron doses and continuous infusion might improve emetic control, because of the
high doses and combinations of chemotherapy (CT) used in this setting. Our objective was to conduct a prospective, randomized
study comparing two different administration methods of high-dose ondansetron during a BMT preparative regimen in breast cancer
patients. Patients were eligible if they were nonpregnant women over 18 but under 65 years of age, undergoing highly emetogenic
CT in preparation for autologous BMT. All patients received ondansetron as an intermittent (INT=24 mg i.v. q 12 h/day) or
continuous intravenous infusion (CIV=8 mg i.v. loading dose followed by a continuous infusion of 2 mg/h per day). A total
of 66 patients were enrolled in the study (n=34, INT; n=32, CIV). There was no statistical difference between treatment groups in the worst grade of emesis for the entire study
period (P=0.49). Greater than 90% of all patients were graded as failures (≥5 emetic episodes or need for rescue antiemetics). Complete
control (no vomiting episodes) and complete plus major control (1–2 emetic episodes) per day ranged from 8% to 85% and 11%
to 91%, respectively. There was no significant difference between the treatment arms in: grade of emesis, episodes of vomiting
and retching, nausea scores, and mean number of rescue medications administered. There were no differences in efficacy when
high-dose ondansetron was given as CIV or INT for the control of nausea and vomiting in breast cancer patients undergoing
high-dose CT for autologous BMT. Ondansetron alone was not adequate to provide sustained control of CT-induced nausea and
vomiting over the entire 5-day study period. A combination of antiemetics targeting various mechanisms of CT-induced nausea
and vomiting may be necessary to improve response rates. |
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Keywords: | Ondansetron Bone marrow transplantation Nausea Vomiting |
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