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Bendamustine monotherapy in advanced and refractory chronic lymphocytic leukemia
R Kath1, K Blumenstengel, H J Fricke
1Klinik und Poliklinik für Innere Medizin II der Friedrich Schiller Universität Jena, Germany. Roland.Kath@polkim.med.uni-jena.de
Journal of Cancer Research and Clinical Oncology
|February 24, 2001
Summary
Bendamustine shows high effectiveness in treating advanced or relapsed chronic lymphocytic leukemia (CLL), achieving a 75% objective remission rate. However, caution is advised for immunocompromised patients due to potential infectious complications.
Area of Science:
- Hematology
- Oncology
- Pharmacology
Background:
- Chronic lymphocytic leukemia (CLL) is a lymphoproliferative malignancy.
- Bendamustine is an alkylating agent with activity against various lymphoid malignancies.
- Limited treatment options exist for advanced, refractory, or relapsed CLL.
Purpose of the Study:
- To evaluate the efficacy and safety of bendamustine in patients with advanced, refractory, or relapsed CLL.
- To assess treatment outcomes including remission rates and overall survival.
- To monitor toxicity and immunological changes associated with bendamustine therapy.
Main Methods:
- An open-label, phase II study involving 23 patients with advanced, refractory, or relapsed CLL.
- Bendamustine administered at 60 mg/m2 (≤70 years) or 50 mg/m2 (>70 years) for 5 days, repeated every 29 days.
- Remission assessment based on Cheson et al. (1996) criteria; toxicity evaluated using WHO criteria.
Main Results:
- An objective remission rate of 75% (15/20 patients) was observed, including 6 complete remissions (CR).
- Median overall survival was 13.6 months, and 16.6 months for responders.
- Significant WHO grade III/IV leukocytopenia occurred in 51% of cycles, leading to 13% treatment-related mortality, primarily in immunocompromised patients. CD4/CD8 ratio declined during treatment.
Conclusions:
- Bendamustine is a highly effective treatment for advanced or refractory CLL.
- Potential for severe immunosuppression and infectious complications exists in pretreated or immunocompromised patients.
- Prophylactic antibiotics and careful monitoring are recommended for high-risk patients undergoing bendamustine therapy.