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.

BackgroundEffective treatment options are limited for elderly patients with acute myeloid leukemia (AML). A prospective phase II study was conducted to investigate the safety and efficacy of pegylated liposomal doxorubicin (PLD) combined with low-dose cytarabine (LDAC) and granulocyte colony-stimulating factor (G-CSF) in newly diagnosed older and unfit AML patients.MethodsTwenty-two patients were enrolled and deemed evaluable. The study included one cycle of induction and four cycles of consolidation, followed by maintenance therapy.ResultsThe median age of enrolled patients was 71.5 years (range, 63 to 82 years), and 16 patients (72.7%) were over 70 years of age. The overall response rate (ORR) was 77.3% (n = 17) and the complete remission (CR)/complete remission with incomplete recovery (CRi) rate was 63.6% (n = 14) after the first induction cycle. With a median follow-up of 12.4 months, eight patients (57.1%) relapsed, with a median time to relapse of 12.3 months. The median duration of response (DOR) was 11.9 months (95% CI, 6.4 to NA months), the median overall survival (OS) was 15 months (95% CI, 8.4 to 21.6 months), and the median progression-free survival (PFS) was 7.5 months (95% CI, 4.6 to 15.1 months). Common grade 3 or greater adverse events included febrile neutropenia (77.8%) and infection (63.6%), with pneumonia being the most common (10, 45.5%). There was one death (4.5%) within 30 days.ConclusionThe combination of PLD, LDAC, and G-CSF is well-tolerated and exhibits high rates of CR/CRi and low early mortality, providing an attractive treatment option for newly diagnosed elderly and unfit AML patients.