title: Efficacy and safety of intravenous itraconazole as empirical antifungal therapy for persistent fever in neutropenic patients with hematological malignancies in Japan.
abstract: Recently, empirical antifungal therapy with intravenous itraconazole (ITCZ) for neutropenic patients with antibiotics-resistant fever has been approved by Japanese Ministry of Health, Labour and Welfare on the bases of previous multicenter trials of foreign countries. In this study, we conducted a single-arm, multicenter, prospective study in order to evaluate the efficacy of empirical ITCZ injection on Japanese patients. Sixty-eight patients with hematological diseases who underwent anticancer chemotherapy or stem cell transplantation were enrolled. In this study, we found that the overall clinical response rate to ITCZ injection was 67.6% and success rate of achieving composite endpoints including survival, defervescence during neutropenia, no breakthrough fungal infections, and no premature discontinuation of drug was 50.0%. Mild adverse reactions were observed in 6 patients (8.8%). Further analysis revealed that possible/probable deep fungal infection according to the 2002 and 2008 criteria defined by EORTC/MSG were found in 19.1 and 7.5% of the patients, respectively. Interestingly, response rate to ITCZ injection of possible/probable cases according to the 2002 and 2008 criteria was 61.5% (8/13) and 100% (5/5), respectively. These results not only proved the good efficacy and safety of empirical ITCZ injection for Japanese patients, but also indicated a utility of the drug on future "presumptive" approach.
authors.affiliation: Department of Hematology, Saiseikai Nakatsu Hospital Osaka, Osaka, Japan. kenohta@med.osaka-cu.ac.jp
authors.forename: Kensuke
authors.initials: K
authors.lastname: Ohta
authors.forename: Saori
authors.initials: S
authors.lastname: Nishiki Kosaka
authors.forename: Yoshitaka
authors.initials: Y
authors.lastname: Nakao
authors.forename: Takeo
authors.initials: T
authors.lastname: Kumura
authors.forename: Kiyomichi
authors.initials: K
authors.lastname: Hagihara
authors.forename: Erina
authors.initials: E
authors.lastname: Sakamoto
authors.forename: Shuichiro
authors.initials: S
authors.lastname: Okamoto
authors.forename: Asao
authors.initials: A
authors.lastname: Hirose
authors.forename: Yasutaka
authors.initials: Y
authors.lastname: Aoyama
authors.forename: Ryousuke
authors.initials: R
authors.lastname: Yamamura
authors.forename: Yoshiki
authors.initials: Y
authors.lastname: Hayashi
authors.forename: Yukari
authors.initials: Y
authors.lastname: Umemoto
authors.forename: Yoshiki
authors.initials: Y
authors.lastname: Terada
authors.forename: Yasunobu
authors.initials: Y
authors.lastname: Takeoka
authors.forename: Takahiko
authors.initials: T
authors.lastname: Nakane
authors.forename: Hideo
authors.initials: H
authors.lastname: Koh
authors.forename: Masayuki
authors.initials: M
authors.lastname: Hino
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000935:Antifungal Agents; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D005334:Fever / Q000188:drug therapy* / Q000209:etiology; D019337:Hematologic Neoplasms / Q000150:complications*; D006801:Humans; D017964:Itraconazole / Q000008:administration & dosage* / Q000633:toxicity; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000188:drug therapy* / Q000209:etiology; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000935:Antifungal Agents; D017964:Itraconazole