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Japanese Journal of Clinical Oncology Advance Access published online on January 17, 2008
Japanese Journal of Clinical Oncology, doi:10.1093/jjco/hym151
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© The Author (2008). Published by Oxford University Press. All rights reserved

Panipenem Versus Cefepime as Empirical Monotherapy in Adult Cancer Patients with Febrile Neutropenia: A Prospective Randomized Trial

Ki Tae Kwon1, Hae Suk Cheong2, Ji-Young Rhee3, Yu Mi Wi2, Seong Yeol Ryu4, Sang Taek Heo5, Chi Sook Moon6, Hyun Kyun Ki7, Ki Hyun Kim8, Chul Won Jung8, Kyong Ran Peck2, and Jae-Hoon Song2,9

1 Division of Infectious Diseases, Daegu Fatima Hospital, Daegu
2 Division of Infectious Diseases, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul
3 Division of Infectious Diseases, Department of Internal Medicine, Dankook University Hospital, Cheonan
4 Division of Infectious Diseases, Department of Medicine, Dongsan Medical Center, Keimyung University, Daegu
5 Division of Infectious Diseases, Department of Internal Medicine, Gyeongsang National University Hospital, Gyeongsangnam-Do
6 Division of Infectious Diseases, Department of Medicine, Busan-Paik Hospital, Inje University, Busan
7 Division of Infectious Diseases, Department of Internal Medicine, Konkuk University Hospital, Seoul
8 Division of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul
9 Asian-Pacific Research Foundation for Infectious Diseases (ARFID), Seoul, South Korea

For reprints and all correspondence: Kyong Ran Peck, Division of Infectious Diseases, Samsung Medical Center, Sungkyunkwan University School of Medicine, 50 Irwon-dong, Gangnam-ku, Seoul 135-710, South Korea. E-mail: krpeck{at}skku.edu

Received May 23, 2007; accepted October 12, 2007

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.

Key Words: febrile neutropenia • monotherapy • panipenem


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