PHASE-II TRIAL OF FLUDARABINE MONOPHOSPHATE IN PATIENTS WITH MANTLE-CELL LYMPHOMAS

Purpose: The aim of this phase II trial was to assess the efficacy of fludarabine monophosphate in untreated and pretreated mantle-cell lymp homas (MCL). Patients and Methods: Fifteen patients with MCL were incl uded in the study. In two cases, fludarabine was the first-line therap y the second in four cases, the third in five cases, and the fourth in four cases. The diagnosis of MCL was based on the criteria of the Eur opean Lymphoma Task Force (ELTF), with morphologic, immunologic, and c ytogenetic data; patients were treated with intravenous fludarabine 25 mg/m(2)/d for 5 days every 4 weeks. Results: Toxicity of fludarabine was mild: World Health Organisation (WHO) grade 3 and 4 granulocytopen ia occurred in 15 of 56 assessable cycles (cy) (27%), there was no gra de 3 or 4 thrombocytopenia, one grade 3 bacterial lung infection, and no treatment-related death. There were five partial responses (33%) bu t no complete response. The duration of these responses was short and ranged from 4 to 8 months. Conclusion: These results suggest that flud arabine can be moderately effective in the treatment of MCL. Fludarabi ne appears to be far less effective than in chronic lymphocytic leukem ia (CLL) and follicular non-Hodgkin's lymphoma (NHL). Therefore, fluda rabine should be evaluated in association with other chemotherapeutic agents in MCL. (C) 1998 by American Society of Clinical Oncology.