Cladribine with or without prednisone in the treatment of previously treated and untreated B-cell chronic lymphocytic leukaemia - updated results of the multicentre study of 378 patients
T. Robak et al., Cladribine with or without prednisone in the treatment of previously treated and untreated B-cell chronic lymphocytic leukaemia - updated results of the multicentre study of 378 patients, BR J HAEM, 108(2), 2000, pp. 357-368
Between January 1992 and January 1999, we treated 378 B-chronic lymphocytic
leukaemia (CLL) patients with cladribine (2-CdA), and 255 of the patients
were also treated with prednisone. A total of 194 patients were previously
untreated, and 184 had relapsed or refractory disease after previous other
therapy. Complete response (CR) was obtained in 111 (29.4%) and partial res
ponse (PR) In 138 (36.5%) patients, giving an overall response (OR) rate of
65.9%. CR and OR were achieved more frequently in patients in whom 2-CdA w
as a first-line treatment (45.4% and 82.5% respectively) than in the pretre
ated group (12.5% and 48.4% respectively) (P < 0.0001). The median duration
of OR for previously untreated patients was 14.7 months and for pretreated
patients 13.5 months (P = 0.09). The median survival evaluated from the be
ginning of 2-CdA treatment was shorter in the pretreated group (16.3 months
) than in the untreated group (194 months) (P < 0.0001). A total of 117 (63
.9%) patients died in the pretreated group and 63 (32.6%) in the untreated
group. In pretreated patients, 2-CdA + prednisone (P) and 2-CdA alone resul
ted in similar OR (51.0% and 45.0% respectively; P = 0.4). In contrast, in
untreated patients, 2-CdA + P produced a higher OR (85.4%) than 2-CdA alone
(72.1%) (P = 0.04). Infections and fever of unknown origin, observed in 91
(49.4%) pretreated and 74 (38.1%) untreated patients (P = 0.03), were the
most frequent toxic effects. Our results indicate that 2-CdA is an effectiv
e, relatively well-tolerated drug, especially in previously untreated CLL.