Fludarabine in untreated and previously treated B-CLL patients: a report on efficacy and toxicity

I Division of Hematology, S. Martino Hospital, Genoa.

BACKGROUND. It has been shown that fludarabine (FLU) is superior to conventional treatment in B-CLL for rate and quality of response, leading to CR even at the molecular level. In this paper we report our preliminary results with this drug in B-CLL patients. METHODS AND PATIENTS. Twenty-seven B-CLL patients (16 refractory to previous therapy, 7 responsive and treated for subsequent disease reexpansion, 4 untreated with active disease) were administered FLU at a dose of 25 mg/sqm for 5 days every 4 weeks. RESULTS. Twenty-five patients were evaluable and 14 of them (56%) were responsive. All four untreated patients responded: 1 CR (PCR analysis showed the persistence of clonal VDJ rearrangement) and 3 PR, while 67% of the previously responsive group again showed a reaction: 2 PR (33%) and 2 nodular PR (33%). Among the refractory patients we recorded 6 responses (39%): 1 CR (6%) and 5 PR (33%). Besides 2 cases of lethal myelotoxicity, we observed 2 cases of encephalopathy and 2 cases of heart failure. Four deaths may have been related to FLU therapy (15%). CONCLUSIONS. We confirm the effectiveness of FLU and the improved outcome, in terms of toxicity and response rate, it provides in untreated B-CLL patients. Further studies are needed to explore the possible negative effects of FLU on neuronal and heart function, and the impact of this drug on survival in selected groups of patients.

This article has been cited by other articles:

				M. A. Boogaerts, A. Van Hoof, D. Catovsky, M. Kovacs, M. Montillo, P. L. Zinzani, J. L. Binet, W. Feremans, R. Marcus, F. Bosch, et al. Activity of Oral Fludarabine Phosphate in Previously Treated Chronic Lymphocytic Leukemia J. Clin. Oncol., November 15, 2001; 19(22): 4252 - 4258. [Abstract] [Full Text]

				N. Kalil and B. D. Cheson Chronic Lymphocytic Leukemia Oncologist, October 1, 1999; 4(5): 352 - 369. [Abstract] [Full Text]

				P. Fidias, B. A. Chabner, and M. L. Grossbard Purine Analogs for the Treatment of Low-Grade Lymphoproliferative Disorders Oncologist, June 1, 1996; 1(3): 125 - 139. [Abstract] [Full Text] [PDF]