Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

Guadecitabine offers limited advantage over other standards for high-risk AML

Key clinical point: For treatment-naive patients with acute myeloid leukemia (AML) who are ineligible for chemotherapy, guadecitabine offers similar efficacy to other standard treatments until at least four cycles are administered, after which guadecitabine offers a slight survival advantage.

Major finding: Among patients who received at least four cycles of therapy, those in the guadecitabine group had a median overall survival of 15.6 months, compared with 13 months for those who received azacitidine, decitabine, or low-dose cytarabine.

Study details: ASTRAL-1 was a prospective, randomized, phase III trial involving 815 patients with treatment-naive AML who were ineligible for chemotherapy.

Disclosures: The study was funded by Astex and Otsuka. The investigators reported additional relationships with Celgene, Janssen, and other companies.


Fenaux P et al. EHA Congress, Abstract S879.