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

• Published in: Japanese journal of clinical oncology 2008-01, Vol.38 (1), p.49-55
• Main Authors: Kwon, Ki Tae, Cheong, Hae Suk, Rhee, Ji-Young, Wi, Yu Mi, Ryu, Seong Yeol, Heo, Sang Taek, Moon, Chi Sook, Ki, Hyun Kyun, Kim, Ki Hyun, Jung, Chul Won, Peck, Kyong Ran, Song, Jae-Hoon
• Format: Article
• Language: English
• Subjects: Anti-Bacterial Agents - therapeutic use; Bacterial Infections - drug therapy; Bacterial Infections - etiology; Cephalosporins - therapeutic use; Drug Therapy, Combination; febrile neutropenia; Female; Fever - drug therapy; Fever - etiology; Humans; Male; Middle Aged; monotherapy; Neoplasms - complications; Neoplasms - drug therapy; Neutropenia - drug therapy; Neutropenia - etiology; panipenem; Prospective Studies; Survival Rate; Thienamycins - therapeutic use; Treatment Outcome
• ISSN: 0368-2811; 1465-3621
• DOI: 10.1093/jjco/hym151

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.