title: Efficacy and tolerability of imipenem-cilastatin versus ceftazidime plus tobramycin as empiric therapy of presumed bacterial infection in neutropenic cancer patients.
abstract: The efficacy and tolerability of monotherapy with imipenem-cilastatin (I-C) were compared with that of ceftazidime plus full-course therapy with an aminoglycoside (tobramycin) (C&T) in the treatment of presumed bacterial infection in neutropenic cancer patients. A total of 106 adult patients diagnosed with presumed bacterial infection and an underlying malignancy with an absolute neutrophil count (ANC) < 500/mm3 were enrolled in this open-label study. A total of 131 febrile episodes occurred. Forty-five patients in the I-C group and 41 in the C&T group, who were well matched on demographic and baseline characteristics, were evaluable for efficacy and safety. Seventy-two hours after the start of therapy, no significant between-group differences in treatment outcomes, including withdrawals or deaths, were seen. Thirty-five (78%) of 45 patients in the I-C group and 29 (71%) of the 41 in the C&T group had successful outcomes at the final evaluation. Superinfection occurred in 8 (18%) I-C patients and 3 (7%) C&T patients. Within the subgroup of patients with an initial ANC < 100/mm3, the final evaluation showed no significant differences in treatment outcome between groups. Of the 131 in the safety population 30 (46%) I-C patients and 28 (42%) C&T patients had one or more adverse experiences; drug-related adverse events occurred in 25 (38%) patients in the I-C group and 11 (17%) patients in the C&T group. The data suggest that imipenem-cilastatin should be considered for initial empiric therapy of presumed bacterial infection in neutropenic cancer patients.
authors.affiliation: Fairfax Hematology/Oncology Associates, Annandale, Virginia.
authors.forename: J A
authors.initials: JA
authors.lastname: Miller
authors.forename: T
authors.initials: T
authors.lastname: Butler
authors.forename: R A
authors.initials: RA
authors.lastname: Beveridge
authors.forename: A N
authors.initials: AN
authors.lastname: Kales
authors.forename: R A
authors.initials: RA
authors.lastname: Binder
authors.forename: L J
authors.initials: LJ
authors.lastname: Smith
authors.forename: W M
authors.initials: WM
authors.lastname: Ueno
authors.forename: G
authors.initials: G
authors.lastname: Milkovich
authors.forename: S
authors.initials: S
authors.lastname: Goldwater
authors.forename: A
authors.initials: A
authors.lastname: Marion
mesh_terms: D000328:Adult; D001424:Bacterial Infections / Q000150:complications / Q000188:drug therapy*; D002442:Ceftazidime / Q000008:administration & dosage / Q000627:therapeutic use*; D015377:Cilastatin / Q000008:administration & dosage / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D004361:Drug Tolerance; D005260:Female; D005334:Fever / Q000188:drug therapy; D006801:Humans; D015378:Imipenem / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications*; D009503:Neutropenia / Q000150:complications*; D012720:Severity of Illness Index; D014031:Tobramycin / Q000008:administration & dosage / Q000627:therapeutic use*
chemical_list: D015377:Cilastatin; D015378:Imipenem; D002442:Ceftazidime; D014031:Tobramycin