A pilot study of bendamustine in elderly patients with high-risk MDS and AML
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C Strupp1, S Knipp, J Hartmann
1Department of Hematology, Oncology and Clinical Immunology, Heinrich-Heine-University, Düsseldorf, Germany.
Abstract:
We examined the efficacy of bendamustine in 15 pretreated patients (12 men, 3 women, median age 69 years) with acute myeloid leukaemia (AML) or myelodysplastic syndromes (MDS) 3 AML, 5 sAML, 5 CMML II, 1 RAEB II. Patients belonged to the following cytogenetic groups: 3 complex abnormal karyotypes, 7 normal karyotypes, 1 case with 20q- as sole anomaly and 4 single aberrations. The patients received in median two cycles of bendamustine (range 1-5) with a dose of 100 mg/m(2) at Day 1 + 2 (repeated after 28 days). Nine of 15 patients had no side effects of the treatment, six patients suffered from vomiting and epigastric pain as adverse effects of bendamustine. According to the IWG criteria, no complete remission or reduction of transfusions frequency have been observed. Three patients showed no response, one patient with AML died due to progressive disease. In 11 of 12 patients with initial leukocytosis (median 68,975 microl(-1), range 24,000-149,000 microl(-1)), a significant reduction of leukocytosis was achieved with bendamustine with a median duration of 4 weeks. In summary, treatment with bendamustine in patients with high-risk MDS or sAML with leukocytosis can result in a significant reduction of leukocytes, but fails to achieve hematological responses or improvement of transfusions dependency.
Insights
Bendamustine effectively reduced leukocytosis in patients with high-risk myelodysplastic syndromes (MDS) or secondary acute myeloid leukemia (sAML). However, it did not achieve complete remission or improve transfusion dependence.
Area of Science:
- Hematology
- Oncology
- Pharmacology
Background:
- Acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) are serious hematologic malignancies.
- High-risk subtypes often present with leukocytosis, necessitating effective treatment strategies.
- Bendamustine is an alkylating agent with activity in various hematologic cancers.
Purpose of the Study:
- To evaluate the efficacy and safety of bendamustine in pretreated patients with AML or MDS.
- To assess bendamustine's impact on leukocytosis, hematological response, and transfusion requirements.
Main Methods:
- A cohort of 15 pretreated patients with AML or MDS received bendamustine (100 mg/m(2) on Days 1+2) for a median of two cycles.
- Patients were assessed for adverse effects, complete remission, transfusion frequency, and leukocytosis reduction.
- International Working Group (IWG) criteria were used for response evaluation.
Main Results:
- Bendamustine was generally well-tolerated, with vomiting and epigastric pain reported in six patients.
- No complete remission or reduction in transfusion frequency was observed.
- Significant reduction in leukocytosis was achieved in 11 of 12 patients with initial leukocytosis, lasting a median of 4 weeks.
- One patient with AML died due to progressive disease.
Conclusions:
- Bendamustine can effectively reduce leukocytosis in patients with high-risk MDS or sAML.
- The drug failed to induce hematological responses or improve transfusion dependency in this patient group.
- Further investigation may be warranted for specific indications, but bendamustine is not a primary treatment for achieving remission in these conditions.
