Introduction: High-dose cytarabine (HiDAC) is a widely used post-remission consolidation therapy for patients with acute myeloid leukemia (AML). However, the optimal regimen for HiDAC administration remains unclear, with studies on the use of granulocyte colony-stimulating factor (G-CSF) yielding mixed results. This study aims to evaluate the safety and efficacy of the HiDAC-123 regimen without routine G-CSF support in patients who achieved first complete remission (CR) after a single cycle of induction chemotherapy.

Methods: This retrospective analysis included adult patients (≥18 years) diagnosed with AML between June 1, 2013, and June 1, 2023. All patients achieved CR or CR with incomplete hematological recovery (CRi) after one cycle of intensive induction chemotherapy. The standard HiDAC dosing was 3 g/m², with dose adjustments based on age and renal function. A total of 24 patients received 48 cycles of HiDAC-123 with G-CSF, while 51 patients received 110 cycles of HiDAC-123 without G-CSF. Primary endpoints were relapse and overall survival rates. Secondary endpoints included time to marrow recovery, incidence of documented infections, and need for platelet transfusions within the 28-day consolidation cycle.

Results: The mean age was 57.9 years in the HiDAC-123 with G-CSF group and 51.7 years in the HiDAC-123 without G-CSF group (p=0.0285). The relapse incidence was higher in the G-CSF group 54.2% versus 41.2% (p=0.292), with the average time to disease recurrence of 240 versus 343 days (p=0.0730). Overall survival rates were 41.7% versus 54.9%, respectively (p=0.285). Time to marrow recovery (WBC > 1.0 and ANC > 500) was faster in patients receiving G-CSF (4.00 days versus 6.85 days, p=0.000667). The incidence of infections was lower in the G-CSF group (22.9% versus 26.4%, p=0.372). The average number of platelet transfusions required was similar between the two cohorts (1.56 versus 1.6, p=0.855).

Conclusions: The HiDAC-123 regimen with G-CSF support resulted in faster marrow recovery and fewer infections but did not significantly impact relapse or overall survival rates. The study's limitations include its small sample size and retrospective design. Further prospective trials are necessary to evaluate the effects of G-CSF on the safety and efficacy of the HiDAC-123 regimen.

Disclosures

No relevant conflicts of interest to declare.

This content is only available as a PDF.
2024
Sign in via your Institution