524PD - Cefepime versus cefoperazone/sulbactum plus amikacin as empirical antibiotic therapy in cancer patients with febrile neutropenia

Date 18 December 2016
Event ESMO Asia 2016 Congress
Session Supportive and palliative care
Topics Cytotoxic agents
Complications/Toxicities of treatment
Supportive measures
Presenter Ponraj Madasamy
Citation Annals of Oncology (2016) 27 (suppl_9): ix170-ix176. 10.1093/annonc/mdw599
Authors P. Madasamy
  • Department Of Medical Oncology, JIPMER, 605006 - Pondicherry/IN

Abstract

Background

Cefepime is recommended first line therapy for patients with febrile neutropenia (FN). In view of rising incidence of resistance to 3rd generation cephalosporins at our center we aimed to compare the efficacy and safety of cefepime monotherapy with cefoperazone/sulbactum plus amikacin as empirical antibiotic in cancer patients with FN

Methods

In this prospective, open label, single-center study, high risk FN episodes in both adults and pediatric patients with hematological or solid malignancies were randomized to receive either cefoperozone/sulbactum (2 g every 8 h for adults and 150 mg/kg/day for pediatrics) plus Amikacin 20mg/kg every 24 hrs or cefepime (2 g every 8 h for adults and 150 mg/kg/day) intravenously. The primary outcome was positive response to study antibiotics (defervescence within 72 hrs, afebrile period continued for more than 48 hrs, no requirement for 2nd line antibiotcs). The secondary outcome was to study the effectiveness of discontinuation of empirical antibiotic at 72 hours in fever of unknown origin (FUO) and hemodynamically stable patients, irrespective of grade and duration of neutropenia

Results

For efficacy, 278 FN episodes were assessable (139 cefepime,139 cefoperozone/sulbactum plus Amikacin). The microbiologically documented infection (MDI) rate was 27% (n = 75) in the entire cohort; Pseudomonas (12%), Klebsiella (6%), Acinetobacter (5%), E.Coli (2%). The positive response to antibiotics was similar in both groups (cefepime-55%, cefeperozone/sulbactum plus Amikacin-51%; p = 0.7) including in sub-group of MDI (37% and 38% respectively). The number of patients who had successful antibiotic discontinuation after 72 hrs was same in both groups [41% (n = 29) & 38.5% (n = 27) respectively] Mortality rate was 10% (14 in cefepime group and 13 patients in cefeperozone/sulbactum plus Amikacin group). Drug related adverse events were reported in 3% versus 7% respectively

Conclusions

The efficacy of cefepime monotherapy is equivalent to cefoperazone/sulbactum plus amikacin in cancer patients with febrile neutropenia. Antibiotic discontinuation in FUO patients who become afebrile after 72 hrs is a safe and feasible approach

Clinical trial indentification

Legal entity responsible for the study

JIPMER

Funding

JIPMER, Pondicherry

Disclosure

All authors have declared no conflicts of interest.