title: Cladribine treatment in two-hour intravenous infusion for previously-treated low grade B-cell lymphoma: a pilot study.
abstract: Cladribine is approved to be used in 24-hour continuous infusion for the treatment of low-grade lymphoma by the Ministry of Health, Labor and Welfare in Japan. Pharmacokinetic studies showed that the antitumor activity of cladribine by 2-hour infusion should be comparable to that given by continuous infusion. The safety and anti-tumor activity of short infusion of cladribine was shown in hairy cell leukemia, chronic lymphocytic leukemia and low-grade non-Hodgkin's lymphoma in Europe. We therefore underwent a pilot study to confirm the safety and efficacy of cladribine given by 2-hour infusion for Japanese patients with relapsed or refractory indolent B-cell lymphoma. Cladribine at a dose of 0.09 mg/kg was administered in 2-hour intravenous infusion for 5 consecutive days. The treatment was repeated at a 28-day interval for at least 2 cycles, and its efficacy and toxicity were investigated. Fourteen patients were entered into this study. Eight patients (57%) responded to cladribine, including 2 (14%) complete response (CR) and 6 (43%) partial response (PR). The median duration of response was 20+ and 21+ months for CR, and 12 months ranging from 3 to 34 months for PR, respectively. Grade 3 or 4 neutropenia and lymphocytopenia occurred in 43% and 71% of patients, respectively, but there was no febrile neutropenia or opportunistic infection associated with cladribine treatment. No other adverse events greater than grade 3 were encountered. The tumor response and degree of toxicity were comparable with those observed in cladribine treatment given by continuous infusion at a same dose. Cladribine can be administered in 2-hour infusion in an outpatient clinic and is therefore quite convenient for patients.
authors.affiliation: Division of Medical Oncology, Hematology and Infectious Disease, Department of Medicine, Fukuoka University Hospital, Jonan-ku, Fukuoka, Japan. yasushi@fukuoka-u.ac.jp
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Takamatsu
authors.forename: Junji
authors.initials: J
authors.lastname: Suzumiya
authors.forename: Kentaro
authors.initials: K
authors.lastname: Ogata
authors.forename: Keiko
authors.initials: K
authors.lastname: Katayose
authors.forename: Hidenori
authors.initials: H
authors.lastname: Sasaki
authors.forename: Kenji
authors.initials: K
authors.lastname: Ishitsuka
authors.forename: Nobuhiro
authors.initials: N
authors.lastname: Kimura
authors.forename: Kazuo
authors.initials: K
authors.lastname: Tamura
mesh_terms: D000328:Adult; D000368:Aged; D000553:Ambulatory Care / Q000379:methods; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D044466:Asian People; D017338:Cladribine / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D007564:Japan; D016393:Lymphoma, B-Cell / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D012008:Recurrence; D012189:Retrospective Studies
chemical_list: D000970:Antineoplastic Agents; D017338:Cladribine