Oral antibiotics for fever in low-risk neutropenic patients with cancer: A double-blind, randomized, multicenter trial comparing single daily moxifloxacin with twice daily ciprofloxacin plus amoxicillin/clavulanic acid combination therapy - EORTC infectious diseases group trial XV

Winfried V. Kern, Oscar Marchetti, Lubos Drgona, Hamdi Akan, Mickel Aoun, Murat Akova, Robrecht De Bock, Marianne Paesmans, Claudio Viscoli, Thierry Calandra

Research output: Contribution to journalArticlepeer-review

Abstract

Purpose: This double-blind, multicenter trial compared the efficacy and safety of a single daily oral dose of moxifloxacin with oral combination therapy in low-risk febrile neutropenic patients with cancer. Patients and Methods: Inclusion criteria were cancer, febrile neutropenia, low risk of complications as predicted by a Multinational Association for Supportive Care in Cancer (MASCC) score > 20, ability to swallow, and ≤ one single intravenous dose of empiric antibiotic therapy before study drug treatment initiation. Early discharge was encouraged when a set of predefined criteria was met. Patients received either moxifloxacin (400 mg once daily) monotherapy or oral ciprofloxacin (750 mg twice daily) plus amoxicillin/clavulanic acid (1,000 mg twice daily). The trial was designed to show equivalence of the two drug regimens in terms of therapy success, defined as defervescence and mprovement in clinical status during study drug treatment (<10% difference) Results: Among the 333 patients evaluated in an intention-to-treat analysis, therapy success was observed in 80% of the patients administered moxifloxacin and in 82% of the patients administered combination therapy (95% CI for the difference, -10% to 8%, consistent with equivalence). Minor differences in tolerability, safety, and reasons for failure were observed. More than 50% of the patients in the two arms were discharged on protocol therapy, with 5% readmissions among those in either arm. Survival was similar (99%) in both arms. Conclusion: Monotherapy with once daily oral moxifloxacin is efficacious and safe in low-risk febrile neutropenic patients identified with the help of the MASCC scoring system, discharged early, and observed as outpatients.

Original languageEnglish
Pages (from-to)1149-1156
Number of pages8
JournalJournal of Clinical Oncology
Volume31
Issue number9
DOIs
Publication statusPublished - Mar 20 2013

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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