Open randomized study of cefepime versus piperacillin-gentamicin for treatment of febrile neutropenic cancer patients.
An open-label randomized trial comparing the efficacy and safety of cefepime versus piperacillin plus gentamicin (P+G) given intravenously for the treatment of febrile episodes in neutropenic patients with underlying malignancy was conducted at two oncology centers. Over a 30-month period 111 patients were enrolled and 99 patients were found to be suitable for evaluation. At the 72-h time of evaluation, cefepime monotherapy and P+G combination therapy produced comparable clinical response rates (78% for both). P+G and cefepime produced comparable response rates in microbiologically documented (78 versus 71%), clinically documented (100 versus 100%), and possible (75 versus 79%) infections. The P+G and cefepime treatments achieved comparable microbiological eradication of gram-negative (100 versus 71%) (P = 0.09) and gram-positive (44 versus 70%) (P = 0.37) organisms. There were no statistically significant differences in the rates of superinfection between the groups; however, more superinfections of fungal origin were noted in the P+G group. Cefepime was demonstrated to be an effective and safe treatment for febrile episodes in neutropenic patients with malignancies, and its lack of nephrotoxicity compared to P+G was noteworthy. Cefepime appears to be a candidate for monotherapy in febrile neutropenic cancer patients.
Yamamura
D
D
Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
Gucalp
R
R
Carlisle
P
P
Cimino
M
M
Roberts
J
J
Rotstein
C
C
D000328:Adult; D001424:Bacterial Infections / Q000188:drug therapy; D000077723:Cefepime; D002511:Cephalosporins / Q000627:therapeutic use*; D004359:Drug Therapy, Combination / Q000627:therapeutic use*; D005260:Female; D005334:Fever / Q000188:drug therapy*; D005839:Gentamicins / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000139:chemically induced / Q000150:complications*; D009503:Neutropenia / Q000188:drug therapy*; D010878:Piperacillin / Q000627:therapeutic use*
D002511:Cephalosporins; D005839:Gentamicins; D000077723:Cefepime; D010878:Piperacillin