FLUDARABINE IN UNTREATED AND PREVIOUSLY TREATED B-CLL PATIENTS - A REPORT ON EFFICIENCY AND TOXICITY

Background. It has been shown that fludarabine (FLU) is superior to co nventional treatment in B-CLL for rate and quality of response, leadin g to CR even at the molecular level. In this paper we report out preli minary results with this drug in B-CLL patients. Methods and Patients. Twenty-seven B-CLL patients (16 refractory to previous therapy, 7 res ponsive and treated for subsequent disease reexpansion, 4 untreated wi th 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 1 4 of them (56%) were responsive. All four untreated patients responded : 1 CR (PCR analysis showed the persistence of clonal VDJ rearrangemen t) 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 p atients we recorded 6 responses (39%): 1 CR (6%) and 5 PR (33%). Besid es 2 cases of lethal myelotoxicity, we observed 2 cases of encephalopa thy and 2 cases of heart failure. Four deaths may have been related to FLU therapy (15%). Conclusions. We confirm the effectiveness of FLU a nd the improved outcome, in terms of toxicity and response rate, it pr ovides in untreated B-CLL patients. Further studies are needed to expl ore the possible negative effects of FLU on neuronal and heart functio n, and the impact of this drug on survival in selected groups of patie nts.