Real-world experience of non-intensive regimens in elderly patients with acute myeloid leukemia

Elderly patients with acute myeloid leukemia (AML) have adverse biology status and a higher prevalence of co-morbidities, which prevents these patients from receiving intensive chemotherapy.¹ The current mainstay treatment for patients with AML who are ineligible for intensive chemotherapy consists of hypomethylating agents and low-dose cytarabine.²

Dr. Govind Kanakasetty, from Kidwai Memorial Institute of Oncology, Bangalore, India, and colleagues, conducted this single-center, retrospective analysis aimed to assess overall survival (OS) in elderly patients (median age = 68 years; range, 61–84) with newly diagnosed, immunophenotypically confirmed de novo or secondary AML. Secondary outcomes included response rates, survival across groups and safety assessments.

Patients received one of the following treatment regimens: a hypomethylating agent (HMA; n = 58), either azacitidine (100 mg/m²/day, for 7 days every 28 days) or decitabine (20 mg/m², for 5 days every 28 days); low-dose cytarabine (LDAC; n = 81; 20 mg/day, bi-daily, every 28 days); or best supportive care (BSC; n = 49) with or without hydroxyurea, with transfusion of blood products, and treatment of infections.

Key findings:

All data are shown as HMA group versus LDAC group versus BSC group, where applicable

Efficacy

• Median survival: 6.4 months (95% CI, 4.2–8.5) vs 3.9 months (95% CI, 2.5–5.2) vs 1.2 months (95% CI, 1.1–1.2)
• Median cycles of treatment: 4 (range, 1–20) vs 2 (range, 1–18)
• Overall response rate did not differ between HMA and LDAC groups, P = 0.12
• Complete response rates for treatment groups: 20.6% vs 7.4%, P = 0.02
• Stable disease rates for treatment groups: 32.7% vs 13.5%, P = 0.02
• One-year survival rate in treatment groups: 17.2% vs 6%, P = 0.03
• Transfusion independence achieved in treatment groups: 11.6 months vs 6.4 months, HR = 0.62 (95% CI, 0.3–1.2), P = 0.2

Safety

• Rate of grade 3–4 adverse events in the treatment groups including:
  • Neutropenia: 68.9% vs 65.4%, P = 0.54
  • Thrombocytopenia: 65.5% vs 76.5%, P = 0.13
• Rate of hospital admission per patient-year of follow-up: 1.52 vs 1.47, HR = 0.93 (95% CI, 0.7–1.4), P = 0.9

In conclusion, this real-world experience shows that HMAs are more effective than LDAC in the treatment of elderly patients with AML. Furthermore, the authors concluded that achieving a response to therapy or attaining transfusion independence improves survival. However, due to the single-center retrospective nature of this analysis, these findings need to be further validated in prospective multicenter trials. The authors of this study also commented on the additional challenges present in developing countries, including access to healthcare and funding, highlighting the need for cost-effective newer therapies for elderly patients with AML.