OBJECTIVES: Low-risk febrile neutropenic patients can be treated without hospitalization with oral antibiotic regimens. Combination regimens are recommended. Our objective was to evaluate the feasibility of quinolone monotherapy (moxifloxacin) in this setting. METHODS: In this open-label pilot study, eligible low-risk febrile neutropenic patients identified using pre-defined criteria (MASCC Risk Index) received oral moxifloxacin (400 mg) in our emergency center and were discharged after a 4-8 h observation period to ensure clinical stability. They subsequently received moxifloxacin 400 mg daily as outpatients. Success of monotherapy, outpatient management, the development of adverse events, and major medical complications were recorded. RESULTS: The trial was closed without reaching the target sample size of 40 patients due to slow accrual. Twenty-one evaluable patients were enrolled, with sarcoma and breast cancer being the predominant underlying neoplasms. Most patients (76%) were severely neutropenic (</=100 cells/mm(3)) on enrollment. There were 13 episodes (62%) of unexplained fever and eight documented infections including five episodes (24%) of bacteremia. The overall success rate of monotherapy was 95%. One patient with unexplained fever and persistent neutropenia required hospitalization and responded to alternative therapy. No significant toxicity or severe medical complications occurred. CONCLUSIONS: Oral outpatient quinolone monotherapy for low-risk febrile neutropenic patients appears feasible and needs to be formally evaluated in large randomized clinical trials.
OBJECTIVES: Low-risk febrile neutropenicpatients can be treated without hospitalization with oral antibiotic regimens. Combination regimens are recommended. Our objective was to evaluate the feasibility of quinolone monotherapy (moxifloxacin) in this setting. METHODS: In this open-label pilot study, eligible low-risk febrile neutropenicpatients identified using pre-defined criteria (MASCC Risk Index) received oral moxifloxacin (400 mg) in our emergency center and were discharged after a 4-8 h observation period to ensure clinical stability. They subsequently received moxifloxacin 400 mg daily as outpatients. Success of monotherapy, outpatient management, the development of adverse events, and major medical complications were recorded. RESULTS: The trial was closed without reaching the target sample size of 40 patients due to slow accrual. Twenty-one evaluable patients were enrolled, with sarcoma and breast cancer being the predominant underlying neoplasms. Most patients (76%) were severely neutropenic (</=100 cells/mm(3)) on enrollment. There were 13 episodes (62%) of unexplained fever and eight documented infections including five episodes (24%) of bacteremia. The overall success rate of monotherapy was 95%. One patient with unexplained fever and persistent neutropenia required hospitalization and responded to alternative therapy. No significant toxicity or severe medical complications occurred. CONCLUSIONS: Oral outpatientquinolone monotherapy for low-risk febrile neutropenicpatients appears feasible and needs to be formally evaluated in large randomized clinical trials.
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