Abstract
Background: Alkylating agents have shown activity in leukemia. Bendamustine, an active alkylating agent in lymphoma and chronic lymphocytic leukemia, was given in a fractionated twice daily schedule for 4 days to patients with acute leukemia and myelodysplastic syndrome (MDS) to define the dose-limiting toxicities (DLT) and maximum tolerated dose (MTD). Patients and Methods: Adults with refractory acute leukemia or high-risk MDS were treated with bendamustine at a starting dose of 50 mg/m2 IV over 1-2 hours twice daily for 4 days. Dose escalations were by 25 mg/m2 in the 1st 3 levels. The study used the 3 + 3 design. Results: A total of 25 patients were treated. Their median age was 57 years; the median salvage number was 3. Grade 2 creatinine elevations were observed in 1 of 6 patients at the 50 mg/m 2 dose, in 2 of 13 patients at the 75 mg/m2 dose, and in 3 of 6 patients at the 100 mg/m2 dose. This was considered significant, even though DLT was not reached. One patient achieved marrow complete remission. Significant reductions of marrow blasts (50% or more) were observed in 6 of 25 patients (24%). Conclusion: Bendamustine fractionated dose level of 100 mg/m2 IV twice daily for 4 days (800 mg/m2 per course) was associated with Grade 2 renal toxicity. The proposed phase II schedule is 75 mg/m2 IV twice daily for 4 days. Future studies should evaluate this schedule in less heavily treated patients.
Original language | English (US) |
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Pages (from-to) | 197-200 |
Number of pages | 4 |
Journal | Clinical Lymphoma, Myeloma and Leukemia |
Volume | 12 |
Issue number | 3 |
DOIs | |
State | Published - Jun 2012 |
Externally published | Yes |
Keywords
- Fractionated dose schedule
ASJC Scopus subject areas
- Hematology
- Oncology
- Cancer Research