Multicenter phase II study of oral idarubicin in treated and untreated patients with B-chronic lymphocytic leukemia

Idarubicin is the first anthracycline that can be administered orally facil itating antineoplastic chemotherapy at an improved quality of life. In diff erent studies idarubicin has proved clinical effectiveness in patients with advanced low grade non Hodgkin's lymphoma. We performed a phase II study i n 19 patients with untreated and pretreated B-CLL of Binet stage A-C, Idaru bucin was administered orally at a dose of 15mg/m(2) over 3 days every 4 we eks. Of 19 evaluable patients (m:f, 16:3, median age 64 years, range 41-80 years) 7 were previously untreated while 12 patients had received prior the rapy with fludarabine, chlorambucil or sim ilar non-anthracycline containin g regimens. 12 pts had Binet stage C, 5 Binet stage B and 2 Binet stage A. Five patients achieved a partial remission (26%), 5 patients had stable dis ease (26%) and 9 patients showed progressive disease (47%), resulting in an overall response of 26% (5/19). There was no correlation of response rate with Binet stages or previous treatment regimens. Treatment associated side effects consisted predominantly of mild nausea and vomiting (26%) as well as minor infections (21%) and diarrhoea (16%). These data demonstrate that oral idarubicin as a single agent is well toler ated but of limited effectiveness in B-CLL. Further studies are needed to a ssess different doses and schedules of oral idarubucin and to test it in co mbination with other chemotherapeutic agents.