title: Cefepime versus ticarcillin and clavulanate potassium and aztreonam for febrile neutropenia therapy in high-dose chemotherapy patients.
abstract: An open labeled randomized trial comparing the efficacy and cost of empirically applied cefepime (C) as monotherapy versus combination therapy consisting of ticarcillin and clavulanate potassium and aztreonam (T/A) was performed in febrile neutropenic patients following high-dose chemotherapy (HDC) +/- radiation, with or without peripheral blood stem cell support. Over a 28-month period, 126 patients were screened and included in the study. Using afebrile status following 3 days of therapy as a primary endpoint, both regimens produced comparable clinical response rates (C = 55% vs. T/A = 61%). Also, the use of vancomycin for resistant gram-positive infections and alteration of gram-negative infection coverage was similar in both groups (C = 40% vs. T/A = 47% and C = 29% vs. T/A = 24%). Both treatment groups had similar needs for empirical antifungal therapy (C = 25% vs. T/A = 22%). There was a postrandomization difference between the two groups in that the "C" group had a significantly higher number of allogeneic transplants and non-stem-cell-supported patients, whereas the "T/A" group had a significantly greater number of autologous peripheral blood stem cell patients (p < 0.0001). Despite this difference, the C group had a significantly lower cost ratio than the T/A group (p = 0.016). In conclusion, we have shown that C treatment of febrile neutropenic patients following HDC results in similar efficacy and lower cost when compared to T/A, despite the inclusion of higher risk patients in the C group.
authors.affiliation: University of Louisville Hospital, James Graham Brown Cancer Center, Blood and Marrow Transplant Program, Louisville, Kentucky, USA. donaldrfleming@charter.net
authors.forename: Donald R
authors.initials: DR
authors.lastname: Fleming
authors.forename: Craig
authors.initials: C
authors.lastname: Ziegler
authors.forename: Timothy
authors.initials: T
authors.lastname: Baize
authors.forename: Leslie
authors.initials: L
authors.lastname: Mudd
authors.forename: George H
authors.initials: GH
authors.lastname: Goldsmith
authors.forename: Roger H
authors.initials: RH
authors.lastname: Herzig
mesh_terms: D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000191:economics / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000627:therapeutic use; D001398:Aztreonam / Q000191:economics / Q000627:therapeutic use*; D000077723:Cefepime; D002511:Cephalosporins / Q000191:economics / Q000627:therapeutic use*; D019818:Clavulanic Acid / Q000191:economics / Q000627:therapeutic use*; D003365:Costs and Cost Analysis; D004359:Drug Therapy, Combination / Q000191:economics / Q000627:therapeutic use; D005260:Female; D005334:Fever; D006801:Humans; D016867:Immunocompromised Host; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy* / Q000276:immunology* / Q000532:radiotherapy; D009503:Neutropenia; D009894:Opportunistic Infections / Q000276:immunology / Q000517:prevention & control*; D036102:Peripheral Blood Stem Cell Transplantation; D013982:Ticarcillin / Q000191:economics / Q000627:therapeutic use*
chemical_list: D000900:Anti-Bacterial Agents; D000970:Antineoplastic Agents; D002511:Cephalosporins; D019818:Clavulanic Acid; D000077723:Cefepime; D013982:Ticarcillin; D001398:Aztreonam