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Pegylated Liposomal Doxorubicin Combined with Cytarabine and Granulocyte Colony-Stimulating Factor for Treating Newly Diagnosed Older and Unfit Acute Myeloid Leukemia Patients: A Prospective, Single-Center, Single-arm, Phase II Study

Background

There are few effective treatments for older patients with acute myeloid leukemia (AML). A study was done to test a new treatment combining pegylated liposomal doxorubicin (PLD), low-dose cytarabine (LDAC), and granulocyte colony-stimulating factor (G-CSF) for elderly patients newly diagnosed with AML.

Study Details

Twenty-two patients were included in the study. The average age was 71.5 years, and most patients (72.7%) were over 70. The treatment involved one cycle to start and four cycles to consolidate, followed by maintenance therapy.

Results

The study showed promising results:

  • Overall response rate: 77.3% (17 patients responded)
  • Complete remission rate: 63.6% (14 patients achieved complete remission)
  • Median overall survival: 15 months
  • Median progression-free survival: 7.5 months
  • Median duration of response: 11.9 months

However, some patients faced challenges, including:

  • 57.1% relapsed after a median of 12.3 months
  • Common serious side effects included febrile neutropenia (77.8%) and infections (63.6%), particularly pneumonia (45.5%).
  • One patient died within 30 days of treatment (4.5%).

Conclusion

The combination of PLD, LDAC, and G-CSF is a well-tolerated option that offers high rates of remission and low early mortality for newly diagnosed older and unfit AML patients.

Next Steps

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