title: Piperacillin-tazobactam monotherapy in high-risk febrile and neutropenic cancer patients.
abstract: Combination therapy with a beta-lactam plus an aminoglycoside has been the standard approach for treating febrile neutropenia for many years. More recently, beta-lactam monotherapy has also been shown to be a reliable and safe approach. In the present study, 763 eligible patients with fever and neutropenia received piperacillin-tazobactam monotherapy. On day 3, according to the study protocol, 165 patients with persistent fever who fulfilled the study entry criteria were randomised to receive vancomycin or a placebo. The success rate was 51% in the intention-to-treat analysis and 62% in the per-protocol analysis. The overall mortality rate was 8% (58/763), with only 18 (2.4%) deaths attributed to the initial or subsequent infection. Randomisation had no influence on the study endpoints. The adverse event rate was evaluated only in the patient population not included in the randomised part of the study. Among these patients, adverse events probably or definitely related to piperacillin-tazobactam therapy were uncommon, confirming the favourable safety profile of piperacillin-tazobactam. It was concluded that piperacillin-tazobactam could be considered as monotherapy for patients with high-risk febrile neutropenia.
authors.affiliation: University of Genova and the National Institute for Cancer Research, Genoa, Italy. viscolic@unige.it
authors.forename: C
authors.initials: C
authors.lastname: Viscoli
authors.forename: A
authors.initials: A
authors.lastname: Cometta
authors.forename: W V
authors.initials: WV
authors.lastname: Kern
authors.forename: R
authors.initials: R
authors.lastname: Bock
authors.forename: M
authors.initials: M
authors.lastname: Paesmans
authors.forename: F
authors.initials: F
authors.lastname: Crokaert
authors.forename: M P
authors.initials: MP
authors.lastname: Glauser
authors.forename: T
authors.initials: T
authors.lastname: Calandra
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D004791:Enzyme Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D005060:Europe; D005334:Fever / Q000188:drug therapy* / Q000209:etiology; D019337:Hematologic Neoplasms / Q000150:complications*; D006801:Humans; D007223:Infant; D007275:Injections, Intravenous; D008875:Middle Aged; D008877:Middle East; D009503:Neutropenia / Q000188:drug therapy* / Q000209:etiology; D009656:North America; D010397:Penicillanic Acid / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D010878:Piperacillin / Q000008:administration & dosage / Q000627:therapeutic use*; D000078142:Tazobactam; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D004791:Enzyme Inhibitors; D010397:Penicillanic Acid; D000078142:Tazobactam; D010878:Piperacillin