title: Once-daily, oral levofloxacin monotherapy for low-risk neutropenic fever in cancer patients: a pilot study in China.
abstract: This pilot study assesses the safety and efficacy of once-daily, oral levofloxacin monotherapy in Chinese patients with low-risk febrile neutropenia. In this prospective, single-arm, open-label, multicenter clinical trial, 46 adult Chinese patients with solid tumors and low-risk febrile neutropenia were included. Patients received oral levofloxacin monotherapy (500 mg orally/day) until day 12, followed by 7 days of follow-up (day 19). Body temperature was measured three times per day. On days 2, 3, 5-7, 9, 12, and 19, disease symptoms and vital signs were recorded, adverse drug reactions were assessed, and blood samples were collected to determine the whole-blood cell count and the absolute neutrophil count. Blood cultures and chest radiographs were performed simultaneously until negative results were found. Oral levofloxacin was effective and well tolerated in 97.6% of patients irrespective of the cancer type and cause of fever. Body temperature began to decline in 24.4, 68.3, and 90.2% of patients, respectively, at 12, 24, and 48 h after initiating levofloxacin therapy. On days 5 and 7, 95.1 and 97.6% of the patients had complete defervescence, respectively. The median time for absolute neutrophil count recovery to at least 1500/mm after initiation of treatment was 3 days. Only one patient reported mild diarrhea. This pilot study showed that oral levofloxacin quickly and effectively reduced fever, initiated neutrophil recovery, and was well tolerated in Chinese low-risk febrile neutropenic patients with solid tumors. Further study is needed to compare patient data of levofloxacin with the standard amoxicillin/ciprofloxacin protocol in this population for both safety and efficacy.
authors.affiliation: aZhongshan Hospital, Fudan University bShanghai Pulmonary Hospital, Tongji University, Shanghai cTongji Medical College Huazhong University of Science & Technology, The Central Hospital of Wuhan, Wuhan dFuzhou Pulmonary Hospital of Fujian, Fuzhou eBeijing Hospital of T.C.M Affiliated to Capital University of Medicine Sciences, Beijing, China.
authors.forename: Lixian
authors.initials: L
authors.lastname: He
authors.forename: Caicun
authors.initials: C
authors.lastname: Zhou
authors.forename: Su
authors.initials: S
authors.lastname: Zhao
authors.forename: Heng
authors.initials: H
authors.lastname: Weng
authors.forename: Guowang
authors.initials: G
authors.lastname: Yang
mesh_terms: D000284:Administration, Oral; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000627:therapeutic use; D044466:Asian People; D001772:Blood Cell Count; D064147:Febrile Neutropenia / Q000188:drug therapy* / Q000209:etiology; D006801:Humans; D064704:Levofloxacin / Q000008:administration & dosage* / Q000627:therapeutic use; D009369:Neoplasms / Q000150:complications / Q000188:drug therapy*; D010865:Pilot Projects; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D064704:Levofloxacin