title: [Itraconazole for secondary prophylaxis of invasive fungal infection in patients undergoing chemotherapy and stem cell transplantation].
abstract: OBJECTIVE
  To evaluate the efficacy and safety of itraconazole for secondary prophylaxis of previous proven or probable invasive fungal infection (IFI) in patients undergoing chemotherapy or allogeneic hematopoietic stem cell transplantation (HSCT) in agranulocytosis state.
  
  
  METHODS
  A phase IV prospective, open-label, multicenter trial was conducted to evaluate itraconazole (200 mg q12h intravenously d1-2, 200 mg/d) as secondary antifungal prophylaxis in patients (18-65 years old) undergoing chemotherapy or HSCT with previous proven or probable IFI. Itraconazole was started when patients' neutrophils＜1.5 × 10⁹/L, and stopped when chemotherapy patients' neutrophils ＞0.5 × 10⁹/L and stem cell transplant recipients' neutrophils＞1.0 × 10⁹/L. The primary end-point of the study was the incidence of proven, probable or possible IFI.
  
  
  RESULTS
  Seventy one patients from November 2008 to September 2010 were enrolled in the trial. The median duration of itraconazole prophylaxis was 14 (4-35) days. No patients died of drug-related toxicity within trial. Five cases occurred IFI during the trial. The cumulative incidence of invasive fungal disease was 7.0%. One patient was withdrawn from the study due to treatment-related adverse events (liver malfunction and severe phlebitis).
  
  
  CONCLUSIONS
  Itraconazole appears to be safe and effective for secondary prophylaxis of systemic fungal infection after chemotherapy and allogeneic HSCT. The observed incidence of 7.0% is considerably lower than the relapse rate reported in historical controls, suggesting that itraconazole is a promising prophylactic agent in this population.
authors.affiliation: The Center of Hematology and Bone Marrow Transplantation, the First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou 310003, China.
authors.forename: Ji-min
authors.initials: JM
authors.lastname: Shi
authors.forename: Chun
authors.initials: C
authors.lastname: Wang
authors.forename: Yu-hong
authors.initials: YH
authors.lastname: Zhou
authors.forename: Kang
authors.initials: K
authors.lastname: Yu
authors.forename: Xin
authors.initials: X
authors.lastname: Du
authors.forename: Yi
authors.initials: Y
authors.lastname: Luo
authors.forename: Zhen
authors.initials: Z
authors.lastname: Cai
authors.forename: Jing-song
authors.initials: JS
authors.lastname: He
authors.forename: Xiu-jin
authors.initials: XJ
authors.lastname: Ye
authors.forename: Jie
authors.initials: J
authors.lastname: Zhang
authors.forename: Wan-zhuo
authors.initials: WZ
authors.lastname: Xie
authors.forename: He
authors.initials: H
authors.lastname: Huang
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000935:Antifungal Agents / Q000627:therapeutic use*; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D017964:Itraconazole / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009181:Mycoses / Q000517:prevention & control*; D011446:Prospective Studies; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000935:Antifungal Agents; D017964:Itraconazole