Pharmacy Medical News about chronic lymphocytic leukemia;Bendamustine;Chlorambucil

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Phase III randomized study of bendamustine compared with chlorambucil in previously untreated patients with chronic lymphocytic leukemia
Journal of Clinical Oncology, 08/31/09

Knauf WU et al. – Bendamustine offers significantly greater efficacy than chlorambucil, and a manageable toxicity profile, when used as first-line therapy in patients with advanced CLL.

Methods

Randomized, open-label, parallel-group, multicenter study
162 patients received bendamustine (100 mg/m2 iv on d 1-2)
157 patients received chlorambucil (0.8 mg/kg po on d 1 & 15)
Patients were ≤ 75 y of age
Tx cycles were repeated q4w for a maximum of 6 cycles

Results

CR or PR was achieved in 110 (68%) bendamustine-treated patients and 48 (31%) of 157 chlorambucil-treated patients
More patients showed a CR with bendamustine than chlorambucil (31% vs. 2%)
Median PFS was 21.6 mos with bendamustine and 8.3 mos with chlorambucil
Bendamustine was associated with an improvement in duration of remission compared with chlorambucil (median, 21.8 vs. 8.0 mos)
Hematologic grade 3-4 adverse events were more common with bendamustine than with chlorambucil (40% vs. 19%)
Severe infections (grade 3-4) occurred in 8% of bendamustine-treated patients and 3% of chlorambucil-treated patients

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