TY - JOUR
T1 - A multicenter, double-blind, randomized comparison of oral ondansetron 8 mg b.i.d., 24 mg q.d., and 32 mg q.d. in the prevention of nausea and vomiting associated with highly emetogenic chemotherapy
AU - Needles, Burton
AU - Miranda, Eduardo
AU - Garcia Rodriguez, Francisco M.
AU - Diaz, Luis Baez
AU - Spector, Jesse
AU - Craig, Johnny
AU - Cohen, Gary
AU - Krasnow, Steven
AU - Brogden, Janice
AU - Ames, Michael
N1 - Funding Information:
Acknowledgements This study was supported by a grant from Glaxo Wellcome Inc. The S3AA3012 Study Group includes the authors and the following investigators, who enrolled subjects in this clinical trial: Ravi Patel, M.D., Comprehensive Blood and Cancer Center, Bakersfield, Calif.; Enrique Velez-Garcia, M.D., FACP, University of Puerto Rico School of Medicine, San Juan, Puerto Rico; Eric P. Lester, M.D., Lakeland Medical Center, St. Joseph, Mich.; Dirk G. Kieback, M.D., Baylor University, Houston, Tex.; Ellioth Fishkin, M.D., Elizabeth General Medical Center–Oncology Program, Elizabeth, N.J.; Harvey Sher, M.D., Jacksonville, Fla.; Naveed M. Chowhan, M.D., Cancer Care Center, New Albany, Ind.; M.H. Zarrabi, M.D., VA Medical Center, Northport, N.Y.; Bipin R. Amin, M.D., St. Alexius Medical Center, Bismarck, N.D.; Luis A. Meza, M.D., Southwest Oncology Associates, Lafayette, LA; Israel Wiznitzer, M.D., North Shore Cancer Research Group, Inc., Highland Park, Ill.; Michael Kos-mo, M.D., Southwest Cancer Care, Poway, Calif.; Gordon D. McLaren, M.D., VA Medical Center, Fargo, N.D.; Peter A. Beat-ty, M.D., Physicians Plus Oncology-Hematology Clinic at Meriter Hospital, Madison, Wis.; Patrick J. Byrne, M.D., Northern Virginia Oncology Group, P.C., Falls Church, Va.; Margaret A. Deutsch, M.D., Raleigh Internal Medicine Associates, Raleigh, NC; Mitchell Alden, D.O., Grandview Medical Research, Sellers-ville, Pa.; John Rainey, M.D., Louisiana Oncology Associates, La- fayette, La.; David Mintzer, M.D., Philadelphia Hematology-Oncology Associates, Inc., Philadelphia, Pa.; James A. Reeves, Jr., M.D., Lee Coast Research Center, Inc., Ft. Myers, Fla.; Richard Grapski, M.D., Worcester, Mass.; Bruce Bank, M.D., Northwest Oncology and Hematology, Elk Grove Village, Ill.; Mark R. Fes-en, M.D., Hutchinson Clinic, P.A., Hutchinson, Kan.; Grant W. Harrer, M.D., Big Sky Health Care – Great Fall Clinic, Great Falls, Mont.; Glen Shamdas, M.D., VA Medical Center, Fargo, N.D.; Linda S. Sylvester, M.D., First Coast Medical Group, Jacksonville, Fla.; Peter D. Eisenberg, M.D., Marin Oncology Associates, Greenbrae, Calif.; Joseph Dibenedetto, Jr., M.D., Oncology Hematology Associates, Providence, R.I.; Tracy Dobbs, M.D., East Tennessee Oncology/Hematology, Knoxville, Tenn.; Joel W. Abramowitz, M.D., Hematology-Oncology Associates of Houston, P.A., Houston, Tex.; Gerald Miletello, M.D., Baton Rouge General Regional Cancer Center, Baton Rouge, La.; Phillip J. Stella, M.D., St. Joseph Mercy Hospital, Ann Arbor, Mich.; David Perry, M.D., Washington Cancer Institute, Washington, D.C.; David A. Decker, M.D., Cancer Care Associates, Royal Oak, Mich.; Ronald Goldberg, M.D., Rainier Oncology Professional Services, Puyallup, Wash.; Gary Burton, M.D., LSUMC Department of Hematology Oncology, Shreveport, La.; and Luis R. Bar-reras, M.D., Broward Oncology Associates, Ft. Lauderdale, Fla.
Copyright:
Copyright 2007 Elsevier B.V., All rights reserved.
PY - 1999/9
Y1 - 1999/9
N2 - The objectives of this study were to compare the efficacy and safety of orally administered ondansetron 8 mg b.i.d., 24 mg q.d., and 32 mg q.d. in the prevention of nausea and vomiting associated with high-dose cisplatin- based chemotherapy (cisplatin ≥50 mg/m2). This was a randomized, parallel- group, double-blind study conducted in North America. It was planned that all patients would receive one of the following orally administered ondansetron treatments 30 min before starting cisplatin dosing (administered over ≤ 3 h): 8 mg b.i.d. with 8 h between doses (124 patients), 24 mg q.d. (116 patients), and 32 mg q.d. (117 patients). Use of prophylactic corticosteroids was not permitted. During the 24-h study period, the highest complete response rate (no emesis, rescue antiemetic therapy, or withdrawal) occurred in patients who received ondansetron 24 mg q.d.: 76/115 or 66%, as against 68/124 (55%) after ondansetron 8 mg b.i.d. and 64/117 (55%) after ondansetron 32 mg q.d. Complete control of nausea (no nausea, no rescue, no withdrawal) occurred in more patients in the ondansetron 24 mg q.d. group (64/114, 56%) than in the ondansetron 8 mg b.i.d. group (43/121, 36%) or in the ondansetron 32 mg group (55/117, 50%). These results demonstrate that following highly emetogenic cisplatin-based chemotherapy (≥ 50 mg/m2), oral ondansetron 24 mg q.d. is more effective than 8 mg b.i.d. for overall control of nausea, and at least as effective if not more effective in the control of acute vomiting than 8 mg b.i.d. or 32 mg q.d. Ondansetron 24 mg q.d. was well tolerated, and no new or unexpected adverse events were identified.
AB - The objectives of this study were to compare the efficacy and safety of orally administered ondansetron 8 mg b.i.d., 24 mg q.d., and 32 mg q.d. in the prevention of nausea and vomiting associated with high-dose cisplatin- based chemotherapy (cisplatin ≥50 mg/m2). This was a randomized, parallel- group, double-blind study conducted in North America. It was planned that all patients would receive one of the following orally administered ondansetron treatments 30 min before starting cisplatin dosing (administered over ≤ 3 h): 8 mg b.i.d. with 8 h between doses (124 patients), 24 mg q.d. (116 patients), and 32 mg q.d. (117 patients). Use of prophylactic corticosteroids was not permitted. During the 24-h study period, the highest complete response rate (no emesis, rescue antiemetic therapy, or withdrawal) occurred in patients who received ondansetron 24 mg q.d.: 76/115 or 66%, as against 68/124 (55%) after ondansetron 8 mg b.i.d. and 64/117 (55%) after ondansetron 32 mg q.d. Complete control of nausea (no nausea, no rescue, no withdrawal) occurred in more patients in the ondansetron 24 mg q.d. group (64/114, 56%) than in the ondansetron 8 mg b.i.d. group (43/121, 36%) or in the ondansetron 32 mg group (55/117, 50%). These results demonstrate that following highly emetogenic cisplatin-based chemotherapy (≥ 50 mg/m2), oral ondansetron 24 mg q.d. is more effective than 8 mg b.i.d. for overall control of nausea, and at least as effective if not more effective in the control of acute vomiting than 8 mg b.i.d. or 32 mg q.d. Ondansetron 24 mg q.d. was well tolerated, and no new or unexpected adverse events were identified.
KW - 5-HT
KW - Nausea
KW - Ondansetron
KW - Oral antiemetic
KW - Vomiting
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U2 - 10.1007/s005200050274
DO - 10.1007/s005200050274
M3 - Article
C2 - 10483821
AN - SCOPUS:0032812906
SN - 0941-4355
VL - 7
SP - 347
EP - 353
JO - Supportive Care in Cancer
JF - Supportive Care in Cancer
IS - 5
ER -