FLUDARABINE MONOPHOSPHATE IN REFRACTORY B-CHRONIC LYMPHOCYTIC-LEUKEMIA - MAINTENANCE MAY BE SIGNIFICANT TO SUSTAIN RESPONSE

In the present study we report our results on the efficacy of Fludarab ine monophosphate in 20 B-chronic lymphocytic leukemia (CLL) patients, refractory to conventional chemotherapy. Of the 20 patients 14 were m ales and 6 females with a median age of 58 years (44-70). Eight had Bi net stage B and 12 stage C. They were previously treated with chloramb ucil, prednisone, mini-CHOP or irradiation. Their disease duration pri or to fludarabine administration was 49 months (7-180). Fludarabine wa s given at a dose of 25mg/m(2) daily, for five consecutive days, month ly for six months and if responding for six additional months. Treatme nt was administered on an outpatient basis. Complete response (CR) was observed in 7 patients (33%) and partial remission (PR) in 5 (25%). O f the complete responders 5 were males and 2 females with a median age of 60 years (range 55-68); three of them had stage B and 4 stage C di sease; the median number of fludarabine courses for achieving CR was 3 (range 2-5). In all CR patients a residual monoclonal CD5/CD19 positi ve lymphocyte population was found in the peripheral blood. All CRs re lapsed shortly after discontinuation of therapy within 12 months. The main toxicity observed was upper respiratory tract and/or pulmonary in fections in 8 patients, requiring hospitalization. Among the CRs one p atient died during the administration of the third course of therapy, due to a severe hypersensitivity reaction with Stevens-Johnson syndrom e. The importance of maintenance therapy is also stressed as PR was su stained in some patients using 3 day cycles every 2-4 months. One pati ent was maintained in this fashion for 60 + months. This study showed that fludarabine is effective in CLL patients refractory to convention al chemotherapy thus it may be given as the treatment of choice if suc h patients still require treatment.