Premium
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
Author(s) -
Robak,
Błoński,
Kasznicki,
Konopka,
B. Ceglarek,
Dmoszyńska,
Maria Soroka-Wojtaszko,
Skotnicki,
Bernadeta Nowak,
Dwilewicz-Trojaczek,
Tomaszewska,
Hellmann,
Lewandowski,
Kazimierz Kuliczkowski,
Potoczek,
Zdziarska,
Hansz,
Jason Kroll,
Komarnicki,
Hołowiecki,
Paweł Grieb
Publication year - 2000
Publication title -
british journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.907
H-Index - 186
eISSN - 1365-2141
pISSN - 0007-1048
DOI - 10.1046/j.1365-2141.2000.01850.x
Subject(s) - medicine , cladribine , prednisone , gastroenterology , refractory (planetary science) , chemotherapy , chronic lymphocytic leukemia , surgery , leukemia , astrobiology , physics
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 response (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 was a first‐line treatment (45.4% and 82.5% respectively) than in the pretreated 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 beginning of 2‐CdA treatment was shorter in the pretreated group (16.3 months) than in the untreated group (19.4 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 resulted 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 effective, relatively well‐tolerated drug, especially in previously untreated CLL.