title: Phase II clinical study of cladribine in the treatment of hairy cell leukemia.
abstract: We conducted a phase II clinical study to evaluate the therapeutic efficacy of cladribine (2-chlorodeoxyadenosine [2-CdA]) in the treatment of Japanese patients with hairy cell leukemia (HCL). Seven patients with classic HCL and 3 with a prolymphocytic HCL variant were administered 2-CdA (0.09 mg/kg per day) by continuous intravenous infusion for 7 days. Seven patients responded to this therapy, with 5 patients achieving a complete response (CR). After a median follow-up of 792 days (range, 599-1253 days), there were no cases of clinical relapse, and the median duration of the response in the responders was 670+ days (range, 470+ to 1121+ days). The median duration of the CR in the CR patients was 953+ days (range, 480+ to 1121+ days). At treatment initiation, most patients had hematologic impairment as a manifestation of HCL. During the early stage after administration, further hematologic impairment occurred, but subsequent peripheral blood counts gradually recovered as 2-CdA treatment showed antitumor activity. Infections occurred at a high incidence at this time, but all cases could be controlled with appropriate treatment. 2-CdA was surmised to represent a useful therapeutic approach for Japanese patients with HCL.
authors.affiliation: Department of Hematology and Oncology, Osaka University Graduate School of Medicine, Osaka, Japan. ta-mach@pop.cypress.ne.jp
authors.forename: Takashi
authors.initials: T
authors.lastname: Machii
authors.forename: Takaaki
authors.initials: T
authors.lastname: Chou
authors.forename: Muneou
authors.initials: M
authors.lastname: Suzuki
authors.forename: Yokiko
authors.initials: Y
authors.lastname: Ohe
authors.forename: Shuichi
authors.initials: S
authors.lastname: Katagiri
authors.forename: E Kiyoshi
authors.initials: EK
authors.lastname: Kitano
authors.forename: Kiyoshi
authors.initials: K
authors.lastname: Kitano
authors.forename: Yoshihide
authors.initials: Y
authors.lastname: Fujiyama
authors.forename: Tooru
authors.initials: T
authors.lastname: Izumi
authors.forename: Chihiro
authors.initials: C
authors.lastname: Shimazaki
authors.forename: Koji
authors.initials: K
authors.lastname: Nanba
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Ohashi
authors.forename: Teruo
authors.initials: T
authors.lastname: Kitani
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D017338:Cladribine / Q000008:administration & dosage*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007943:Leukemia, Hairy Cell / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D012074:Remission Induction; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D017338:Cladribine