Prolonged azacitidine schedule delayed transformation to leukemia in patients with MDS

A 7-day azacitidine regimen significantly delayed time to leukemia in patients with higher-risk myelodysplastic syndromes (MDS) compared to a 5-day regimen. These results were published in the International Journal of Hematology.

A phase 3 head-to-head study of 7-day azacitidine (AZA-7) and a 5-day azacitidine (AZA-5) regimen revealed a trend for AZA-7 to improve survival. In this analysis, data from the JALSG MDS212 study were reviewed for evidence of an effect on delaying transformation to leukemia.

The median ages of cohorts AZA-7 (92 patients) and AZA-5 (95 patients) were 73 (range, 57 to 91) and 74 (range, 48 to 86) and male:female ratios were 64:28 and 66:29, respectively and bone marrow blasts were 11% (range 2% to 27%) and 8% (range 1% to 29%), respectively.

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Patients received a median of 5 cycles of AZA-7 and 6 cycles of AZA-5; mean dose intensities were 72.0% and 74.3%, respectively.

At the last follow-up, 59 patients in the AZA-7 cohort and 68 patients in the AZA-5 cohort had died. The median survival time was 538 days for AZA-7 and 477 days for AZA-5 (P =.293). AZA-7 was associated with a 10.6% higher 2-year overall survival.

A complete response was achieved by 14.1% of AZA-7 and 6.6% of AZA-5 recipients (P =.156). No significant differences in erythroid, platelet or neutrophil responses were observed.

More AZA-5 recipients developed leukemia than AZA-7 recipients (54 versus 40). AZA-7 was associated with a reduced risk of transformation to leukemia (hazard ratio [HR]1.75; P =.023).

This study was limited because it was not a pre-determined analysis.

Although this study did not provide conclusive evidence of superiority, these results indicated that the AZA-7 regimen was associated with improved survival and a significantly reduced risk of transformation to leukemia.

Disclosure: Some authors declared their affiliation with biotech, pharmaceutical, and/or device companies. For a full list of disclosures, see the original reference.


Miyazaki Y, Kiguchi T, Sato S, et al.; Japan Adult Leukemia Study Group. Prospective comparison of 5- and 7-day administration of azacitidine in myelodysplastic syndromes: a JALSG MDS212 study. Int J Hematol. Published online May 4, 2022. doi:10.1007/s12185-022-03347-3

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