Panipenem versus cefepime as empirical monotherapy in adult cancer patients with febrile neutropenia: a prospective randomized trial.
OBJECTIVE
To compare the efficacy and safety of panipenem/betamipron with cefepime as empirical monotherapy for adult cancer patients with febrile neutropenia, a randomized, open-label, comparative trial was performed.


METHODS
All enrolled patients were randomly assigned to receive either panipenem or cefepime. All febrile episodes were classified as microbiologically defined infection (MDI), clinically defined infection (CDI) or unexplained fever (UF). Clinical responses to antibiotic therapy were defined as success, initial response but regimen modified or failure.


RESULTS
A total of 116 patients were enrolled: 55 patients in the panipenem group and 61 patients in the cefepime group. Demographic and clinical characteristics were similar in the two groups (P > 0.05). In the final evaluation, the success rate for the panipenem group (89.1%) was similar to that of the cefepime group (91.8%) (non-inferiority, P = 0.002, 95% confidence interval: -13.48%, 10.35%). Of the 18 bacterial isolates, nine (50%) were gram-positive and nine (50%) were gram-negative. The prevalence of adverse events in the panipenem group (23.6%) were similar to those in the cefepime group (23.0%) (P = 0.93). All of the adverse events were well tolerated and transient.


CONCLUSIONS
Although larger studies are necessary, panipenem appeared to be as effective and safe as cefepime for empirical monotherapy in the treatment of adult cancer patients with febrile neutropenia.
Kwon
Ki Tae
KT
Division of Infectious Diseases, Samsung Medical Center, Sungkyunkwan University School of Medicine, 50 Irwon-dong, Gangnam-ku, Seoul 135-710, South Korea.
Cheong
Hae Suk
HS
Rhee
Ji-Young
JY
Wi
Yu Mi
YM
Ryu
Seong Yeol
SY
Heo
Sang Taek
ST
Moon
Chi Sook
CS
Ki
Hyun Kyun
HK
Kim
Ki Hyun
KH
Jung
Chul Won
CW
Peck
Kyong Ran
KR
Song
Jae-Hoon
JH
D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D001424:Bacterial Infections / Q000188:drug therapy / Q000209:etiology; D000077723:Cefepime; D002511:Cephalosporins / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D005334:Fever / Q000188:drug therapy / Q000209:etiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications* / Q000188:drug therapy; D009503:Neutropenia / Q000188:drug therapy* / Q000209:etiology; D011446:Prospective Studies; D015996:Survival Rate; D013845:Thienamycins / Q000627:therapeutic use*; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D002511:Cephalosporins; D013845:Thienamycins; D000077723:Cefepime; C039536:panipenem