ASCO 2024: What’s the Right Dose of Azacitidine for Low- and Intermediate-Risk MDS Patients?

Dr. Guillermo Garcia Manero and his colleagues published an abstract updating the active study results for oral azacitidine for low- and intermediate-risk MDS patients at the ASCO 2024 conference in June. 

The ASTREON study's purpose is to evaluate the safety and efficacy of oral azacitidine in patients with low—to intermediate-risk MDS, as per the International Prognostic Scoring System Revised (IPSS-R). It is currently in phases 2 and 3, but it is not recruiting new patients at this time. 

The study randomized patients to receive oral azacitidine at either 200 mg or 300 mg daily for 14 days per 28-day cycle, along with the best supportive care, including transfusions, treatment for anemia, and infection prevention in MDS patients. 

Which Patients Could Join the Study? 

• Patients selected were adults (≥ 18 years) with low- or intermediate-risk MDS 
• Patients had to have blood cell counts of any type.
• Patients needed to have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.

What Results Has the Study Shown So Far? 

In December 2023, the study showed similar adverse effects in 47 patients taking 200 mg and 300 mg of oral azacitidine; the most common were blood cell-related side effects and gastrointestinal concerns. 47 patients received at least one dose of oral azacitidine (200 mg: 24 patients, 300 mg: 23 patients)

• Blood cell counts improved in 36.4% of patients taking 200 mg) and 33.3% taking 300 mg. 
• Anemia was improved in 31.6% of patients taking 200 mg and 27.8% of patients taking 300 mg.
• One death in the 300 mg ground was considered treatment-related.
• The safety of azacitidine in the doses of 200 mg and 300 mg is consistent with the drug’s safety profile.

The study's results support the continued evaluation of oral azacitidine in patients with low- to intermediate-risk MDS. 

Additional research is needed to discover new treatment combinations and drug doses for patients with MDS. You can contribute to accelerating research by joining the HealthTree Community! 

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Source: 

• Clinical Trial: A Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Participants With International Prognostic Scoring System Revised (IPSS-R) Low- or Intermediate-risk Myelodysplastic Syndrome (MDS)
• Preliminary safety and efficacy of oral azacitidine (Oral-AZA) in patients (pts) with low-/Intermediate (Int)-risk myelodysplastic syndromes (MDS): Phase 2 results from the ASTREON trial