European researchers have published the final results of the randomized clinical trial showing a higher response rate and improved progression-free survival for Treanda® (bendamustine) compared with chlorambucil for the initial treatment of patients with Binet Stage B and C chronic lymphocytic leukemia (CLL). These results were published in the September 10, 2009 issue of the Journal of Clinical Oncology.[1] Preliminary results of this study were presented at the 2007 and 2008 meetings of the American Society of Hematology.
Treanda is a bifunctional agent with both alkylator and purine-like activity that is currently in Phase II-III testing in a variety of diseases in the United States. One advantage of Treanda is that it is not cross-resistant with other alkylating agents. Treanda has been marketed and used clinically in Europe for many years in patients with non-Hodgkin’s lymphoma, CLL, multiple myeloma, breast cancer, and other solid tumors such as lung cancer.
This study included 319 patients with previously untreated Stage B and C CLL who were randomly allocated to initial therapy with Treanda or chlorambucil. The following table summarizes the main findings of this trial:
Table 1: Treanda® versus chlorambucil for initial treatment of CLL
| Treanda | Chlorambucil |
Number of Patients | 162 | 157 |
Overall Response Rate | 68% | 31% |
Complete Response Rate | 31% | 2% |
Median Progression-free Survival | 21.6 months | 8.3 months |
Median Remission Duration | 21.8 months | 8.0 months |
These authors reported that grade 3-4 toxicities occurred in 40% of patients treated with Treanda compared with 19% of patients treated with chlorambucil. These authors suggest that Treanda should replace chlorambucil as the standard alkylating agent for the treatment for CLL.
Comments: These authors suggested that Treanda has better efficacy than chlorambucil for the initial treatment of CLL with a “manageable toxicity profile.” In all probability, patients with newly diagnosed CLL treated with Treanda will also receive Rituxan® (rituximab).
Reference:
[1]Knauf WU, Lissichkov T, Aldaoud A, et al. Phase III randomized study of bendamustine compared with chlorambucil in reviously untreated patients with chronic lymphocytic leukemia. Journal of Clinical Oncology. 2009;27:4378-4384.
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