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Sequential azacitidine plus lenalidomide combination for elderly patients with untreated acute myeloid leukemia
Daniel A Pollyea1, James Zehnder, Steve Coutre
1Department of Medicine, Stanford University School of Medicine, Stanford, CA, USA.
Haematologica
|December 18, 2012
Summary
This study shows that combining azacitidine and lenalidomide is an active front-line therapy for older patients with acute myeloid leukemia (AML), offering a new treatment option.
Area of Science:
- Hematology
- Oncology
- Clinical Trials
Background:
- Older adults with acute myeloid leukemia (AML) have limited therapeutic options and poor prognoses.
- Novel treatment strategies are urgently needed for this patient population.
Purpose of the Study:
- To evaluate the efficacy and safety of azacitidine in combination with lenalidomide as a first-line therapy for elderly patients with AML.
Main Methods:
- A sequential combination therapy was administered to patients aged 60 years or older with untreated AML.
- Azacitidine (75 mg/m2 for 7 days) was followed by escalating doses of lenalidomide (daily for 21 days) every 6 weeks.
- Treatment continued until disease progression, toxicity, or 12 cycles.
Main Results:
- The overall response rate was 40%, with a 28% complete remission rate.
- Median time to complete remission was 12 weeks, with a median duration of 28 weeks.
- Therapy-related AML and high Hematopoietic Cell Transplantation Comorbidity Index scores predicted poor response. Early death occurred in 17% of patients.
Conclusions:
- The sequential combination of azacitidine and lenalidomide demonstrates clinical activity in older patients with AML.
- Adverse events were generally manageable, primarily gastrointestinal, fatigue, and myelosuppression.
- Further clinical studies are warranted to explore this combination therapy.
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