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: Michinori Ogura, Yasuo Morishima, Yukio Kobayashi, Naokuni Uike, Susumu Sugai, Takaaki Chou, Masaharu Kasai, Ikuo Miura, Tohru Murayama, Yoshihiro Matsuno, Shigeo Nakamura, Shigeo Mori, Yasuo Ohashi, Kensei Tobinai, Cladribine Study Group
• Journal: International journal of hematology (Int J Hematol) Vol. 80 Issue 3 Pg. 267-77 (Oct 2004) ISSN: 0925-5710 [Print] Japan
• PMID: 15540903 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Cladribine

Topics

• Adult
• Aged
• Cladribine (administration & dosage, toxicity)
• Female
• Humans
• Japan
• Lymphoma, B-Cell (complications, drug therapy)
• Lymphoma, Non-Hodgkin (complications, drug therapy, mortality)
• Male
• Middle Aged
• Mycosis Fungoides (complications, drug therapy)
• Myelodysplastic Syndromes (chemically induced)
• Neoplasms, Second Primary (chemically induced)
• Pancytopenia (chemically induced)
• Recurrence
• Remission Induction (methods)
• Salvage Therapy (methods)
• Survival Analysis