title: Durable response but prolonged cytopenia after cladribine treatment in relapsed patients with indolent non-Hodgkin's lymphomas: results of a Japanese phase II study.
abstract: We conducted a phase II study to evaluate the efficacy and safety of cladribine (2-chlorodeoxyadenosine [2-CdA]) for patients with refractory or relapsed indolent B-cell lymphoma or mycosis fungoides. Forty-five patients were enrolled, and 43 patients, including 34 with follicular lymphoma, were eligible. 2-CdA was given by continuous intravenous infusion at a dose of 0.09 mg/kg daily for 7 consecutive days, and this schedule was repeated every 4 weeks up to a maximum of 6 cycles. The overall and complete response rates were 58.1% (25/43; 90% confidence interval, 44.5%-70.9%) and 14.0% (6/43), respectively. The disease progression-free proportions of all 43 eligible and all 25 responding patients at 2 years were 30.3% and 48.1%, respectively. Neutropenia and thrombocytopenia of grade 3 or 4 were observed in 53.3% and 37.8% of patients, respectively, with prolonged cytopenia observed in patients with increased numbers of treatment cycles. Nonhematologic toxicities of grade 3 or greater included diarrhea, arrhythmia, malaise, and gastrointestinal bleeding in 1 patient each, an increase in glutamic-pyruvic transaminase level in 2 patients, and infection in 5 patients. Two treatment-related deaths were observed. Four patients developed myelodysplastic syndrome (MDS) at 13 months to 2 years after completion of the 2-CdA treatments. 2-CdA is an active agent with acceptable toxicity for refractory or relapsed indolent lymphoma; however, prolonged myelosuppression and the potential development of MDS should be carefully monitored.
authors.affiliation: Department of Hematology and Cell Therapy, Aichi Cancer Center Hospital, Aichi, Japan. mi-ogura@naa.att.ne.jp
authors.forename: Michinori
authors.initials: M
authors.lastname: Ogura
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Morishima
authors.forename: Yukio
authors.initials: Y
authors.lastname: Kobayashi
authors.forename: Naokuni
authors.initials: N
authors.lastname: Uike
authors.forename: Susumu
authors.initials: S
authors.lastname: Sugai
authors.forename: Takaaki
authors.initials: T
authors.lastname: Chou
authors.forename: Masaharu
authors.initials: M
authors.lastname: Kasai
authors.forename: Ikuo
authors.initials: I
authors.lastname: Miura
authors.forename: Tohru
authors.initials: T
authors.lastname: Murayama
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Matsuno
authors.forename: Shigeo
authors.initials: S
authors.lastname: Nakamura
authors.forename: Shigeo
authors.initials: S
authors.lastname: Mori
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Ohashi
authors.forename: Kensei
authors.initials: K
authors.lastname: Tobinai
mesh_terms: D000328:Adult; D000368:Aged; D017338:Cladribine / Q000008:administration & dosage* / Q000633:toxicity*; D005260:Female; D006801:Humans; D007564:Japan; D016393:Lymphoma, B-Cell / Q000150:complications / Q000188:drug therapy; D008228:Lymphoma, Non-Hodgkin / Q000150:complications / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D009182:Mycosis Fungoides / Q000150:complications / Q000188:drug therapy; D009190:Myelodysplastic Syndromes / Q000139:chemically induced; D016609:Neoplasms, Second Primary / Q000139:chemically induced; D010198:Pancytopenia / Q000139:chemically induced*; D012008:Recurrence; D012074:Remission Induction / Q000379:methods; D016879:Salvage Therapy / Q000379:methods; D016019:Survival Analysis
chemical_list: D017338:Cladribine